Category Archives: Psoriasis

By David Bautz, PhD

NASDAQ:SNGX

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SGX302 for Psoriasis

Soligenix, Inc. SNGX will be developing synthetic hypericin (the active ingredient in HyBryte) as part of a photodynamic therapy in mild-to-moderate psoriasis patients under the research name SGX302. Psoriasis is a common, chronic, noncontagious, multisystem inflammatory condition that most commonly presents on the skin of the elbows, knees, scalp, back, and thighs. There are multiple types of psoriasis, with plaque psoriasis, being the most common and affecting 80-90% of all individuals with psoriasis. Plaque psoriasis involves the hyperproliferation of epidermal keratinocytes that results in red or white, scaly, and typically itchy skin lesions. In addition, approximately 20% of psoriasis patients suffer from psoriatic arthritis, an inflammatory joint disease associated with psoriasis (Zacharlae, 2003). There is no known cure for the disease, thus depending upon the severity of the condition and how responsive it is to treatment, some patients are on therapy for life.

While psoriasis itself is not life-threatening, there are several conditions that are associated with the disease, including cardiovascular disease (Shlyankevich et al., 2014) and hypertension (Armstrong et al., 2013). In addition, patients with psoriasis have an increased risk for a number of non-skin cancers, including cancer of the lung, upper gastrointestinal tract, urinary tract, liver, and pancreas (Richard et al., 2013).

The severity of psoriasis is dependent on how much of a person's body surface area (BSA) is affected by the condition. Mild psoriasis typically covers

Soligenix previously tested synthetic hypericin in a small Phase 1/2 trial involving 13 patients with psoriasis (Rook et al., 2010). Results showed that of the 11 evaluable patients, six responded to treatment with hypericin. There were no deaths or serious adverse events and the only reported adverse events were mild to moderate and included itching, burning, erythema, and pruritis at that application site.

The company is currently evaluating different topical formulations of synthetic hypericin while at the same time working with psoriasis experts to finalize a clinical trial protocol. We anticipate a Phase 2a study initiating in the second half of 2022. We estimate that the company has sufficient capital to conduct the trial without the need to raise additional capital.

HyBryte NDA Anticipated in Second Half of 2022

Soligenix previously completed a Phase 3 clinical trial of HyBryte (SGX301, synthetic hypericin) in patients with cutaneous T cell lymphoma (CTCL). The FLASH (Fluorescent Light Activated Synthetic Hypericin) trial was a randomized, double blind, placebo controlled study that enrolled 169 patients with either Stage IA, IB, or IIA mycosis fungoides (the most common type of CTCL) (NCT02448381).

The trial consisted of three treatment cycles, with each cycle lasting eight weeks. Each study subject had three target lesions treated during the trial. In Cycle 1, patients were randomized 2:1 (n=116 for SGX301; n=50 for placebo) to receive twice weekly treatment of either 0.25% SGX301 or placebo (an ointment with the same light exposure as for SGX301) for six weeks, with treatment response determined at the end of the eighth week. In Cycle 2, all subjects received 0.25% SGX301 on their target lesions, and for those that decided to continue in the trial there was a third treatment cycle where 0.25% SGX301 was applied to all of the patient's lesions.

The results for Cycle 1 showed a statistically significant treatment response in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessed at 8 weeks with 16% of patients receiving SGX301 responding compared to only 4% receiving placebo responding (P=0.04).

In Cycle 2, a total of 155 patients received 0.25% SGX301 on their target lesions (110 receiving 12 weeks of SGX301 and 45 receiving six weeks of placebo treatment followed by six weeks of SGX301 treatment). The results of Cycle 2 showed that continued treatment out to 12 weeks resulted in increased efficacy as shown by a 40% responder rate (P0.0001 compared to both placebo and six-week treatment data). Response rates further improved in Cycle 3 with 49% of patients electing to receive SGX301 for 18 weeks demonstrating a 50% or greater reduction in the combined CAILS. (P0.0001 compared to the end of Cycle 1).

Importantly, after 12 weeks of treatment with HyBryte, there is a similar response on both patch (37% response; P=0.0009) and plaque (42% response; P0.001) lesions when compared to Cycle 1 placebo lesion responses.

HyBryte is a safe and well tolerated CTCL treatment that shows positive effects in a relatively short period of time and has increasing efficacy with continued use. Since CTCL is a long-lasting condition, safety and tolerability are at the forefront of prescribing physicians concerns when treating patients, and many other CTCL therapies have a number of potential serious side effects, particularly with extended use. We believe the data that Soligenix has compiled for SGX301 in treating CTCL positions it as a promising front-line therapy for a large percentage of patients.

Soligenix is now in a position to submit an NDA to the U.S. FDA for HyBryte in the second half of 2022. HyBryte has received both Orphan Drug and Fast Track designations from the U.S. FDA as well as Orphan Drug designation from the European Medicines Agency (EMA).

The company is planning to commercialize HyBryte in the U.S. in lieu of seeking a commercialization partnership. Since the CTCL market is a specialized market, Soligenix can cost effectively market the drug with a launch cost of less than $10 million. This way, the company is able to keep 100% of the drug's value. For overseas markets, we anticipate a commercial partnership and the company is currently in discussions with potential partners. Approval will be sought first in the U.S. followed by other key markets worldwide.

Arbitration with Emergent BioSolutions Offers Potential Upside

Soligenix is currently involved in an arbitration dispute with Emergent BioSolutions, Inc. EBS in which Soligenix alleges that EBS fraudulently induced the company into entering into contracts with its subsidiaries and that the subsidiaries breached agreements with Soligenix. The disputed agreements pertain to the manufacture of RiVax bulk drug substance (BDS) that Emergent released despite the BDS being out-of-specification. This resulted in Soligenix having to suspend the Phase 1c trial evaluating RiVax in healthy adults. Soligenix presented its case at an arbitration hearing in January 2022 and we anticipate a decision on the case this summer. Manufacturing issues have been a problem for EBS in other circumstances, as shown in the report from the House Select Subcommittee on the Coronavirus Crisis titled "The Coronavirus Vaccine Manufacturing Failures of Emergent BioSolutions" from May 2022. While difficult to predict how the arbitration may be decided, the fact that EBS has a history of poor manufacturing practices likely bodes well for Soligenix, which is seeking in excess of $19 million from EBS.

Financial Update

On May 13, 2022, Soligenix announced financial results for the first quarter of 2022. The company reported revenues of $0.2 million for the first quarter of 2022, compared to $0.1 million for the first quarter of 2021. The revenues are derived from government contracts and grants to support the development of RiVax along with grants to support the development of SGX943, ThermoVax, and CiVax. R&D expenses for the first quarter of 2022 were $1.7 million, compared to $1.3 million for the first quarter of 2021. The increase was primarily due to increased expenses associated with the preparation of the upcoming HyBryte NDA filing. G&A expenses for the first quarter of 2022 were $2.6 million, compared to $1.0 million for the first quarter of 2021. The increase was primarily due to an increase in legal and consulting services associated with the arbitration against Emergent BioSolutions, Inc.

Soligenix exited the first quarter of 2022 with approximately $22.9 million in cash and cash equivalents. As of May 6, 2022, Soligenix had approximately 43.1 million shares outstanding, and when factoring in stock options, warrants, and the potential convertible debt the fully diluted share count is approximately 47.6 million.

Conclusion

Soligenix has a number of important milestones/events upcoming in 2022, including the NDA filing for HyBryte and the initiation of a psoriasis clinical trial for SGX302, both of which we anticipate in the second half of 2022. The current cash position, along with additional financial instruments available to the company, should provide funding into 2023, and the arbitration outcome with EBS provides potential upside to the company's cash position. We have removed CiVax from our model as the current COVID-19 vaccines are seeing oversupply issues and we believe there is not likely to be a follow up vaccine market. With this change our valuation decreased to $4.00 per share.

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SNGX: Phase 2a Trial of SGX302 in Psoriasis to Initiate in Second Half of 2022 - Benzinga - Benzinga

BARCELONA, Spain, May 23, 2022 Almirall S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, announced today the commercial launch in Denmark of Wynzora cream (50 g/g calcipotriol and 0.5 mg/g betamethasone as dipropionate), developed for the topical treatment of mild to moderate plaque psoriasis in adults including scalp.Denmark joins Spain, Germany and the United Kingdom, which were the first European countries to make the cream available on prescription. Following the launch of this innovative topical, Almirall became the only biopharmaceutical company in Europe to offer psoriasis patients multiple options covering the entire spectrum of the disease, from topicals to oral systemics and biologics.

Powered byPAD Technology, a new method of mixing oil and water, Wynzora Cream is the only calcipotriol and betamethasone dipropionate topical that allows the combination of active ingredients in an aqueous cream2,3. Wynzora offers high efficacy and fast onset of action within 1 week.3,4 The results from a pooled analysis of two randomized Phase III trials demonstrated that this CAL/BDP PAD-cream offered superior efficacy and patient quality of life in the topical treatment of psoriasis in comparison to the calcipotriol and betamethasone dipropionate gel formulation for all efficacy endpoints including PGA treatment success, mPASI, and PASI75 after 8 weeks of once-daily use4.

After eight weeks of treatment, the clinical investigation also showed that a significantly greater proportion of subjects treated with CAL/BDP PAD-cream reported that psoriasis had no effect at all on their life (DLQI 0 or 1) compared to CAL/BDP gel4. Superior patient treatment convenience (PTCS) at Week 8 was also achieved with CAL/BDP PAD-cream compared to the CAL/BDP gel.4

The results of pooled data from Phase III clinical trials were published in the Journal of the European Academy of Dermatology and Venereology (JEADV)4.Psoriasis is one of the world's most prevalent skin diseases, affecting approximately at least 100 million individuals worldwide5 and about 2.2% of adults in Denmark (102,000 estimated people)6. The disease negatively affects quality of life and represents a significant burden in the daily life of 71% of patients[vii], affecting the overall emotional wellbeing of 88% of people who suffer from the condition[viii].

I find it highly commendable that new innovation and improvement in topical treatment of psoriasis is brought to light. Based on the phase III trials, the PAD formulation may provide additional benefit to patients with mild to moderate plaque psoriasis in terms of efficacy, quality of life and favourable safety profile of the CAL/BDP PAD-cream stated Lars Iversen, Professor, Aarhus University Hospital.

The Danish Psoriasis Association is pleased to learn that this novel innovative treatment is made available to Danish psoriasis patients. The possibility to improve the quality of life and adherence to treatment are obviously very important features in topical treatment of psoriasis, said Lars Werner, Managing Director, Danish Psoriasis Association.

The deployment of Wynzora Cream in the rest of Europe is on track for 2022. Almirall started marketing the cream in the UK, Spain and Germany in February and expects to roll out in other European countries in the coming months once national marketing authorisations are granted. The product has received regulatory approval in 14 countries in Europe with the name Wynzora, and in Austria with the name Winxory.

"The launch of Wynzora Cream in Europe is on schedule and we are very pleased that Danish patients can now have this novel treatment option available to them. Initial feedback on the product in the UK, Germany and Spain is very positive and we are convinced that this innovative formulation will represent a substantial improvement for patients thanks to its galenic characteristics," said Gianfranco Nazzi, CEO of Almirall.

The Wynzora journey started more than a decade ago fuelled by our desire to meet the demand of patients through our innovative PAD Technology. It is a special feeling to see this new drug being made available also to patients in our home country, Denmark, while we continue the global roll-out., stated Jesper J. Lange, CEO of MC2 Therapeutics, developer of the PAD Technology and Wynzora Cream.

In February 2021, Almirall and MC2 Therapeutics entered into a strategic agreement under which MC2 Therapeutics granted Almirall exclusive European rights to commercialise Wynzora Cream for treatment of plaque psoriasis. Both companies announced the successful completion of a decentralised procedure in July 2021. The cream is also commercialized in the US by MC2 Therapeutics in collaboration with another company.

About pooled analysis of two randomized Phase III trials

WYNZORA (CAL/BDP PAD-cream) demonstrated superiority for all efficacy end points after 8 weeks of treatment. PGA treatment success for CAL/BDP PAD-cream (43.2%) was greater than CAL/BDP gel (31.9%; P<0.0001), the mean percent reduction in mPASI for CAL/BDP PAD-cream was 64.6% compared to 56.4% for CAL/BDP gel (P<0.0001), DLQI 0/1 was obtained by 43.8% in CAL/BDP PAD-cream versus 34.2% CAL/BDP gel (P=0.0005) and superior patient treatment convenience (PTCS) at Week 8 (40.4) was achieved with CAL/BDP PAD-cream compared to CAL/BDP gel (37.0; P<0.0001). There was no adverse drug reaction reported with a frequency of >1%, associated with CAL/BDP PAD-cream.4

About Almirall

Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patients needs through science to improve their lives. Our Noble Purpose is at the core of our work: Transform the patients' world by helping them realize their hopes and dreams for a healthy life. We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.

The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange and is a member of the IBEX35 (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenues in 2021 were 836.5 million euros.

For more information, please visit almirall.com

[ii] Prstegaard M, et al. Phase 3 trial demonstrates superior patient treatment convenience of MC2-01 calcipotriene plus betamethasone dipropionate cream compared to current topical suspension. J of Skin. 2020;4(5):s62

[iii] Stein Gold L, et al. A phase 3, randomized trial demonstrating the improved efficacy and patient acceptability of fixed dose calcipotriene and betamethasone dipropionate cream. J Drugs Dermatol. 2021;20(4): 420-425 doi:10.36849/JDD.5653.

[iv] Pinter A, et al. A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed dose calcipotriene and betamethasone dipropionate cream for the topical treatment of plaque psoriasis. JEADV 2022; 36, 228236.

[v] World Health Organization. (2016). Global report on psoriasis. World Health Organization. https://apps.who.int/iris/handle/10665/204417

[vi] ParisiR,IskandarI Y K,KontopantelisE,AugustinM,GriffithsC E M,AshcroftD Met al.National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling studyBMJ2020;369:m1590doi:10.1136/bmj.m1590

[vii] National Psoriasis Foundation 2008 Survey Snapshot. Available from: PTT-24087-quality-of-life-issues-and-measurement-in-patients-with-psor (researchgate.net)

[viii] Armstrong AW, Schupp C, Wu J, et al. PLoS One. 2012;7(12):e52935;

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Almirall launches the innovative Wynzora cream in Denmark for the treatment of mild to moderate plaque psoriasis including scalp in adults[i] -...

A skin rash is an irritated or swollen area of skin and is often a symptom of other medical issues, such as allergies or substance intolerances. Affected areas may redden, itch, cause pain, blister or become raw. Skin rashes can appear quickly or over time, and while most will disappear quickly, some rashes may need long-term treatment if symptoms persist.

Though there are many types of skin rashes, below are some of the most common.

Eczema is a very common skin rash that causes swelling and may involve dryness, itching, scaly patches, infections and blisters. Eczema occurs in newborns, children and adults, and it affects more than 31 million people in the U.S., according to the National Eczema Association. This skin condition can present in many forms, including:

A number of factors contribute to eczema, among them being a persons environment and genetics. In most cases of eczema, an environmental factor triggers an immune response reaction, causing inflammation and eczema symptoms in the skin. This instance is often referred to as a flare up.

Atopic dermatitis is a common form of skin rash and the most common type of eczema. It can affect people of all age groups, from newborns to seniors. This type of skin rash is caused by an overreaction of the immune system to small irritants.

Atopic dermatitis is most common in children, with some reports saying close to 25% of children in the U.S. may have the disease, says Joshua Grosshandler, an Ohio-based dermatologist and fellow of the American Academy of Dermatology. All races can be affected but, in the U.S., there seems to be a higher number of African Americans and Asians than Caucasians.

Dr. Grosshandler explains that atopic dermatitis typically affects those with an atopic diathesis, or a predisposition to seasonal allergies, asthma and food allergies. Atopic dermatitis is a complex disease and is not fully understood.

Research suggests that family history of atopic dermatitis, food allergies, seasonal allergies, asthma, the immune system and environment all likely have a role in causing atopic dermatitis, says Dr. Grosshandler. Atopic dermatitis is a chronic potential lifelong condition and cannot be cured, so the goal of treatment is to control the condition, which includes reducing flares, decreasing symptoms like itch and improving the appearance of the skin.

A variety of medications and skin care routines can be used to help control symptoms, according to Dr. Grosshandler, including:

If youve ever gone hiking only to come home itching and scratching around your ankles, elbows or arms, you may have experienced contact dermatitisirritation or inflammation caused by coming into contact with an allergen or substance like poison ivy, poison oak or another external factor.

Contact dermatitis refers to a group of skin conditions for which the rash is due to direct contact with a causative agent either resulting in the irritation of the skin or an allergic reaction, says Dr. Grosshandler. The two main types are allergic contact dermatitis and irritant contact dermatitis.

Allergic contact dermatitis refers to a skin rash that appears as a delayed allergic reaction. This type of rash may appear one to two days after the skin is exposed to an allergen, such as poison ivy.

Irritant contact dermatitis refers to when skin cells are damaged due to exposure to an irritating substance. These reactions make up nearly 80% of all contact dermatitis cases, according to the National Eczema Association.

Both types of contact dermatitis can develop in anyone, although there are some groups that have a higher risk, such as those with atopic dermatitis, adds Dr. Grosshandler. Some allergens known to cause the condition include nickel, urushiol (the oil in poison ivy, poison oak and poison sumac), fragrance and latex.

Symptoms of contact dermatitis are often itchy, bumpy or flaky skin around the affected area. More severe cases can result in oozing blisters and heavy swelling. Symptoms may also cause disruptions in sleep and day-to-day activities due to discomfort.

To treat contact dermatitis:

Dermatologists may also prescribe steroids to help address itching and accompanying symptoms. In both allergic and irritant cases of contact dermatitis, its important to know and avoid the substance that causes the reaction. For severe allergic reactions, contact your health care provider.

Rosacea is very common in the U.S., with reports of 14 million people affected, according to the American Academy of Dermatology Association. It typically occurs in individuals between 30 and 50 years of age, with women being more likely to be affected than men.

There are four types of rosacea:

Fair-skinned individuals with light hair, light eyes and a Northern European ancestry have the classic background for rosacea, but it can affect those of all skin colors and genetic backgrounds, says Dr. Grosshandler.

The exact cause of rosacea is unknown, but there are multiple theories that involve genetics, environmental factors, vascular changes, inflammation and the immune system, explains Dr. Grosshandler. Sun exposure, for example, can cause the symptoms to intensify. Untreated rosacea tends to worsen over time.

While there isnt a cure for rosacea, there are different approaches to help manage the symptoms. Common rosacea triggers to consider avoiding include:

Medication can also be used to help treat rosacea. Prescription medications [to treat rosacea] include topical metronidazole, topical sodium sulfacetamide sulfur, topical ivermectin, topical azelaic acid, topical tetracycline, topical oxymetazoline, oral tetracycline antibiotics and vascular lasers such as the PDL, says Dr. Grosshandler. He also suggests implementing a consistent skin care routine with sunscreen, gentle cleansers and moisturizers to help manage outbreaks.

Psoriasisa type of rash identified by the itchy, red, scaly texture it creates on skinis thought to be caused by an autoimmune disorder, and it can follow a viral infection such as strep throat. However, the underlying cause of psoriasis is still unknown. If left untreated, psoriasis can worsen and become very painful.

Psoriasis is a common skin condition with approximately 2% of the population affected, says Dr. Grosshandler. Psoriasis can start at any age, but ages 15 to 25 and 50 to 60 are two peaks to see it present.

There are several types of psoriasis, according to the National Institute of Arthritis and Musculoskeletal Diseases.

Much like eczema, experts think psoriasis may be caused by a mixture of geneticspeople with the condition tend to have relatives who also suffer from psoriasisand environmental triggers. Mental health problems, being overweight, infection and some medications are also known triggers of psoriasis.

Medicinal treatment options for psoriasis include topical steroids, topical vitamin D creams, methotrexate (an immune suppressor used to slow the growth and division of cells), retinoids, biologic response monitors (injectable medications used to block, decrease or stop inflammation) Phosphodiesterase 4 (PDE4) inhibitors (used to suppress rapid cell turnover and inflammation) and immunosuppressants, among others.

Phototherapythe use of ultraviolet (UV) light on the affected area of skinis a treatment method typically used when large areas of the body are affected. This treatment can be offered in a doctors office or, if prescribed a proper UV light, at home.

While some rashes are not harmful and can be treated with gentle washing, others can be more severe and spread at rapid rates. If you experience skin rash symptoms, speak with your health care provider to discuss proper diagnosis and treatment.

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Your Guide To Types Of Skin Rashes - Forbes

As with other medical conditions, the understanding of psoriasis has changed over time. Psoriasis likely affected the earliest humans, but it was not until the 1800s that doctors recognized psoriasis as its own condition.

Through the ages, psoriasis has gone from being a feared condition to one that people can treat to control most, if not all, of their symptoms effectively.

Several philosophers both well-known and less prominent from ancient civilizations described psoriasis-like lesions on the skin.

In Ancient Greece, Hippocrates (460377 B.C.E.) described inflammatory skin conditions, including psoriasis, using two words: psora, meaning itch, and lopoi, describing dry, scaly skin.

Centuries later, in the Roman Empire, a nobleman named Cornelius Celsus (25 B.C.E.50 C.E.) described a skin condition that affects the skin and nails.

Starting in ancient times and persisting through the Middle Ages, people did not write much about skin conditions. When they did, they tended to lump them together.

The grouping of skin conditions did not end for several centuries. During the Middle Ages, people living with psoriasis shared the same treatment essentially being cast out from society as people living with leprosy.

During the Renaissance, an Italian named Girolamo Mercuriale (15301606) wrote a book called De Morbis Cutaneis (Diseases of the Skin). This book, which became one of the more important works on skin diseases, described psoriasis as a skin condition called lepra grecorum.

In 1809, an English doctor named Robert Willan (17571812) produced a simple diagnostic description of several skin conditions, including psoriasis. He also defined some psoriasis types, including guttate, scalp, and palmar psoriasis. However, in his description, he used the term lepra vulgaris.

Many consider Willan to be the founder of dermatology as a medical practice.

Doctors continued to group leprosy and psoriasis until the 1800s, when an Austrian physician named Ferdinand Ritter von Hebra (18161880) wrote the book Atlas der Hautkrankeiten (Atlas of Skin Diseases). Unlike many before him, von Hebra separated leprosy from psoriasis in his works.

Many look to von Hebra as the father of modern dermatology and still see his book as one of the most influential books on skin diseases of all time. In 1841, he named psoriasis.

Then, in 1860, Ernest Bazin connected psoriasis to a form of arthritis, calling it arthritic psoriasis.

Also in the 1800s, Dr. Heinrich Kbner noted that psoriasis plaques appear in uncommon areas due to skin abrasion, burns, bruises, and other injuries. This is now known as the Kbner phenomenon, but scientists still do not understand why it occurs.

Throughout the rest of the 1800s into the 1900s, doctors continued to describe and refine what they knew about psoriasis.

As the 20th century progressed, doctors and researchers learned more about the disease and developed detailed descriptions of various subtypes.

In 1973, John M. Moll and Verna Wright made a milestone discovery. They published a paper describing how psoriasis and psoriatic arthritis form part of the same unique disease, explaining that it is different than rheumatoid arthritis.

Researchers today understand that psoriasis is more than just a skin disease. It is a chronic autoimmune disorder that causes systemic inflammation. This newer understanding has helped shape modern medical treatments, including the use of biologics.

Advances in knowledge about psoriasis through the years have led to changes in the treatment landscape. In more recent years, the quality of available treatment has improved dramatically.

Early treatments focused mostly on internal medication. The rationale for this stemmed from the belief that applying a topical treatment to a skin lesion would drive the infection inward, leading to infection of the organs.

Beginning in the 1700s and persisting into the 19th century, early psoriasis treatments often included options such as mercury and arsenic. Little is known about what effect they had on psoriasis or the person, but these treatments can be toxic. As recently as 1956, medical literature mentioned the use of mercury in topical ointments for psoriasis.

As the years progressed, so did psoriasis treatment options:

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Psoriasis: A brief history plus what we know now - Medical News Today

Clinicians should be aware of differences between male and female patients with psoriasis, how the disease manifests and how treatment should be approached.

With psoriasis, differences in disease manifestation and treatment outlook and goals exist between male and female patients using systemic agents, including conventional system agents (CSA) and tumor necrosis factor inhibitors or ustekinumab (TNFi/UST). However, few studies have addressed sex differences as they pertain to systemic agent use, such as CSA discontinuation and switch from CSA to TNFi/UST.

Past research has shown that female patients have higher expectations for achieving treatment goals than male patients. Female patients anticipate faster skin improvement and a return to normal life, even though male patients may present with more severe psoriasis. These differences in psoriasis severity and treatment goals between male and female patients may determine how clinicians manage their treatment. Female patients, for example, may discontinue treatment prematurely or request a treatment change if their skin clearance is slower than expected.

For a paper published in Frontiers in Pharmacology, my colleagues and I utilized a health administrative database to examine sex differences in patterns of CSA use and determine factors linked with switching to (or adding) a TNFi/UST. Our retrospective cohort study included 1,644 patients with psoriasis (mean age, 61; 55.7% female) who started a CSA between 2002 and 2015. The study team used Cox regression models with the Least Absolute Shrinkage and Selecting Operator (LASSO) to identify socioeconomic and clinical characteristics that predicted switch/add-on TNFi/UST.

We observed similar rates for switch and add-on of TNFi/UST between male and female patients with psoriasis. However, most predictors of switch/add-on were sex-specific. For example, among males, we found an increased risk for longer psoriasis disease duration and obesity by at least 2.3-fold. Among female patients, prior use of NSAIDs and the presence of certain mental health disorders increased the risk for switch/add-on by 2.7-fold. Interestingly, female patients with rheumatoid arthritis (RA) as a comorbidity had a 60% reduced risk for switch/add-on (Table).

Our findings may help clinicians improve the management of male and female patients with moderate-to-severe psoriasis in need of systemic agent treatment. Since most countries with a universal healthcare system reimburse biologic agents only for patients who do not respond well to CSA or among whom CSA are contraindicated, a need exists to improve access to biologic agents. For male patients with obesity and for those who have lived with psoriasis for an extended time, and for female patients who experience pain or mental health symptoms, treatment with biologic agents may save them the burden of going through a failed treatment experience and help improve their psoriasis outcomes faster, especially since biologic agents are known for being more effective than CSA.

My colleagues and I also included variables related to psoriasis treatments such as the type of initial CSA received, the specialty of the prescriber, and prior use of topical agents and phototherapy. However, none of these variables were selected by our model, thus possibly indicating that the decision of the healthcare professional to prescribe a biologic agent among male and female patients with psoriasis was mostly based on patients clinical profiles and not on these factors.

We were surprised to find that psoriatic arthritis (PsA) was not associated with a risk for switch in both male and female patients, while RA was linked with a decreased risk for switch among female patients. Since PsA and RA are immune-mediated conditions for which biologic agents can also be prescribed, additional research is warranted to better understand the reduced risk for switch/add-on of TNFi/UST among female patients with both psoriasis and RA.

Additionally, larger studies, specifically those focused on psoriasis severity, are needed to confirm our findings and their impact on clinical practice and provincial drug policy. Larger studies will also allow comparisons between individual CSAs and the assessment of predictors of switch to TNFi/UST and those for receiving these agents as add-on, separately.

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Examining Sex Differences in the Management of Psoriasis - Physician's Weekly

Pediatric patients with psoriasis exhibited significant improvements in self-reported outcomes and objective measures of complete skin clearance when treated with ixekizumab vs placebo, with no new safety findings identified.

Ixekizumab showed results including long-term improvement in patient-reported outcomes and objective measures of complete skin clearance among pediatric patients with psoriasis, according to study findings published in JAMA Dermatology.

Affecting approximately 1% of children and adolescents, psoriasis has a significant impact on the quality of life of pediatric patients and their parents.

Moreover, disease manifestations in certain locations, such as the face, scalp, palms and soles, nails, and genital region, could have a disproportionately greater effect on a patients quality of life, because of its high visibility or challenge in treating given the involvement of more sensitive areas that may be more recalcitrant to topical agents, noted researchers.

Among the several biologic agents approved for first-line treatment of moderate to severe psoriasis in children aged 6 to 18 years, ixekizumab has been shown to be superior to placebo after 12 weeks of treatment in the phase 3 multicenter randomized IXORA-PEDS clinical trial (NCT03073200), with responses sustained through week 48.

The extension period of the IXORA-PEDS trial lasting through week 108 was evaluated by researchers to determine long-term efficacy and safety of ixekizumab for pediatric patients with moderate to severe psoriasis, defined as Psoriasis Area and Severity Index (PASI) of 12 or higher, static Physicians Global Assessment (sPGA) score of 3 or higher, and psoriasis-affected body surface area of 10% or greater at screening and baseline.

A total of 171 patients (mean [SD] age, 13.5 [3.04] years; 99 female children [57.9%]) were randomized to either ixekizumab (n = 115) or placebo (n = 56). Of 166 patients who entered the maintenance period, 139 (83.7%) completed week 108 of the trial, the study authors wrote. Data analysis, which followed the intention-to-treat principle, was conducted from May to October 2021.

Several primary/secondary efficacy and safety outcomes at week 108 were evaluated:

Findings showed that primary and gated secondary end points that were achieved by week 12 were sustained through week 108, with patients achieving PASI 75 (91.7%), PASI 90 (79.0%), PASI 100 (55.1%), sPGA 0 or 1 (78.3%), and sPGA 0 (52.4%). Moreover, 55 patients (78.5%) reported an Itch NRS improvement of 4 points or higher.

Regarding treatment efficacy on more sensitive affected areas, clearance of nail psoriasis was reported in 68.1%, clearance of palmoplantar psoriasis was reported in 90.0%, clearance of scalp psoriasis was reported in 76.2%, and clearance of genital psoriasis was reported in 87.5% of patients who received ixekizumab through 108 weeks.

No new safety findings during weeks 48 to 108 of the trial were identified, including no new cases of inflammatory bowel disease or candida infection.

Additional studies are warranted to address lingering questions, such as the effect of ixekizumab on additional patient-reported outcomes and the effectiveness and safety of ixekizumab for children with psoriasis in the real world, concluded researchers.

Reference

Paller AS, Seyger MMB, Magarios GA, et al. Long-term efficacy and safety of up to 108 weeks of ixekizumab in pediatric patients with moderate to severe plaque psoriasis: the IXORA-PEDS randomized clinical trial. JAMA Dermatol. Published online April 13, 2022. doi:10.1001/jamadermatol.2022.0655

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Ixekizumab Effective Long-term for Treatment of Psoriasis in Pediatric Patients - AJMC.com Managed Markets Network

Introduction

Psoriasis is an inflammatory skin disease triggered by the immune system. Only a few studies have been conducted on the incidence and prevalence of psoriasis worldwide. According to a systematic review, the prevalence in adults ranged from 0.91% (the United States) to 8.5% (Norway). In adults, it varied from 78.9/100,000 person-years (the United States) to 230/100,000 person-years (Italy).1 The disease burden of psoriasis should not be underestimated. The global report on psoriasis by WHO (World Health Organization) showed that global average DALY (disability-adjusted life year) for psoriasis was estimated at 1,050,660 in 2010, which is twice as much as for acute hepatitis C.2 The continued development of effective therapies for patients with psoriasis is urgently needed. It has long been recognized that patient preferences support the principle of patient-centeredness in clinical decisions.3 During past decades, a growing number of patient preferences are now being measured using elicitation methods that quantify them in the clinical setting, such as standard gamble, time trade-off, person trade-off and discrete choice experiment (DCE).4 Several methods have more recently also been used for psoriasis treatment.57 In recent years, the study of quantifying psoriasis patients treatment preferences is expanding to include regulatory marketing authorization decisions of new biologic treatments.810 To adjust decision-making for patient opinion on the meaning and significance of treatment attributes, such as the balance between estimated effects and adverse reactions, quantitative assessments of patient preferences may be helpful in regulatory marketing approvals.11,12 Adherence to a treatment program could be improved by better tailoring it to patient preferences.12

Patients with psoriasis are often treated with multiple disease-modifying anti-psoriasis drugs. Each of these drugs has its own characteristic and method of action, as well as a different frequency of administration and chance for adverse events and monitoring requirements. Patients with mild disease (PASI 10) and mild or moderate quality-of-life impairment (DLQI 10) may only need topical therapy.13 Patients with severe or moderate psoriasis (PASI >10) or significant quality-of-life restrictions (DLQI >10) has several options for treatment. These include phototherapies, conventional systemic immunosuppressive medications, or modern small molecules or biologic agents. Individual risk factors, associated diseases, national guidelines, and approval criteria (which might consider economic aspects) can impact the choice of treatment.13 Clinicians should therefore inform patients of the extent of and probability of experiencing side effects associated with these treatments. Although treatment costs can be an important determinant of preference, they are less relevant in countries with universal health-care systems, as is the case for most of developing regions. Despite the fact that treatment costs can be a determinant of preference, in regions with universal health-care systems, as is the case for the majority of developing regions, treatment costs are less relevant in determining preference.

As professionals, clinicians should get to know our patients perspectives and preferences when discussing potential treatments. This will allow patients to participate in decisions about their treatment, aligning with their preferences.12 Quantitative assessments of patient preferences have the potential to support both clinicians and regulators when they consider patient perspectives. In considering patient perspectives, both clinicians and regulators can benefit from quantitative assessments. Presently, numerous studies have investigated preference associated with psoriasis. A systematic review summarized 23 studies identified 4 areas of preferences related to psoriasis, which covered preferences for treatment options (eg, state preferences with regard to two different ointments or a cream vs an ointment), preferences for attributes of treatment (eg, frequency of drug administration, treatment benefits or avoidance of potential adverse effects), preferences for different health states (eg, health state utility), preferences for different health state domains (eg, interquartile range).4 For treatment attributes, efficacy (eg, duration of benefit, coverage, lesion severity, etc.) and safety (eg, risk of infection, unspecified adverse events, etc.) were selected in most studies.14 Additionally, the global report on psoriasis pointed out that onset speed (get better skin quickly) and complete removal of skin lesions (recover from all skin lesions) are the top two importance of patient needs related to treatment of psoriasis, which accounted for more than 90%.2 However, few studies have evaluated the onset speed, complete removal of skin lesions, and cost-related indicators. Lack of evidence concerning the extent to which patients feel that biologic treatments would be cost-effective and acceptable in a middle-income country, especially in the context of China. The present study examines the preferences of psoriasis patients in China with moderate-to-severe psoriasis regarding biologic therapies and the heterogeneity within these perceptions. It is based on these preferences that one can estimate the relative importance of different treatment characteristics, as well as calculate patients willingness to pay (WTP) for biologic treatments in China with primarily out-of-pocket payment markets.

A study invitation was sent to the members of the Chinese online psoriasis community via email, social media and mobile application. During the study, each participant was informed about the research procedure and provided their informed consent before completing the survey. The survey was distributed online by a consulting and marketing research company (Adelphi FocusRx). For inclusion, there were the following criteria: established moderate-to-severe diagnosis psoriasis (BSA 3%, PASI 3, DLQI 6, based on the guideline for psoriasis in China), over 18years of age, the experience of receiving biologic treatments, and the ability to properly understand and answer the raised questions. The sample size for the DCE was calculated using the Johnson and Orme methodology that the sample size required for the main effects depends on the number of choice tasks (t), the number of alternatives (a), and the number of analysis cells (c) according to the following equation: N > 500c/(t a).15 Data were collected from October 2020 to January 2021.

A DCE method was used to determine treatment preferences for patients with moderate-to-severe psoriasis, which is a cross-sectional survey method used for quantitative assessment of patient preferences for health-care policies, services, and interventions.16,17 Based on the random utility theory (RUT), DCE quantifies the relative importance of one treatment characteristic versus another. In RUT-based approach, the utility (U) of alternative j for individual i in the choice set k was specified as: Uijk=Xijk+ijk, where Uijk is the utility function of individual i from choosing alternative j in choice set k. Xijk represents a linear specification of the DCE attributes. It is assumed that the utility of a product can be determined by the value of the characteristics of that product (ie, attributes) and their levels. In a DCE, respondents are given a choice of hypothetical scenarios with different attributes and levels. Respondents are asked to choose their preferred option for each question and select the option that yields the maximum utility. By modeling the choices respondents make between alternative treatments described by different choice questions, the utility of each treatment can be estimated. Also, DCEs can be used to measure and explain the heterogeneity among the preferences of patients. When out-of-pocket costs are taken into account in a DCE, the results can be used to calculate the value of or WTP for improvements in medication attributes.18,19

To determine attributes and levels to include in the DCE, we followed a stepwise process. The first step was to review previous literature on patient preferences for treatment in psoriasis and to identify 13 potential treatment characteristics.8,10,20 The second step was to consult 5 dermatologists to make sure the attributes and levels described reflected current clinical practice in China.21 Thirdly, a nominal group technique was used for two focus groups with patients with moderate-to-severe psoriasis (n = 11) and these patients were asked to identify new attributes and rank all potential attributes from the most to the least important. The focus groups were audio recorded and conducted using an interview guide, which lasted approximately 60 minutes. Furthermore, five dermatologists, the research team, and eleven patient research partners reviewed and discussed the results from the focus groups during several validation meetings. These meetings revealed four attributes: the average time for achieving 50% reduction after initiation of treatment, proportion of achieving 100% reduction after 3-months treatment, proportion of maintaining 100% reduction after 5-years treatment and monthly average cost on medication. Each attribute was revealed to have four levels based on current clinical knowledge of existing therapies. All attributes and levels included in the DCE are displayed in Table 1.

Table 1 Attributes and Levels in Discrete Choice Experiment

Based on the recommendations of experimental designs for discrete-choice experiments released by the ISPOR task force,22 the current study adopted a fractional factorial design to lighten respondent burden by reducing the number of choice sets. We used R Package choiceDes for a D-efficient experimental design. Designing using the D-efficient method results in orthogonality, level balance, minimum balance, and overlap, all favorable features. Then, 13 choice-set questions were generated from the design. Each choice set included two hypothetical treatment options: alternative of medication A and alternative of medication B. Figure 1 presents an example of a choice question (the questionnaire can be found in the following website: http://qs.focusrxonline.com/limesurvey/index.php/441618?lang=zh-Hans). The participants accessed an online survey website and answered the questionnaire. Prior to entering the DCE, the survey began with information about psoriasis, demographics, and disease-related questions. Thus, the study was designed to make it possible to complete the survey in approximately 30 minutes.

Figure 1 Example of presented discrete choice experiment question.

Before statistical analysis, we checked the quality of the collected questionnaires. If respondents chose either Medicine A or Medicine B for all choices, it indicated that they were inattentive to the choice questions. Therefore, the questionnaire results of the respondents will not be included. The rest of the questionnaire results are retained for statistical analysis. Then, statistical analysis was conducted based on the recommendations of statistical methods for the analysis of discrete choice experiments released by the ISPOR task force.23 Demographic data were analyzed using descriptive statistics. Using conditional logit models, we estimated preference weights for respondents choices among pairs of treatment alternatives, where the different treatment and cost aspects were entered as separate categorical variables (effects-coded). When coding effects, zero indicates the mean of all attribute levels rather than the omitted level as in dummy coding. With this procedure, each attribute level has a parameter estimate, where the parameter on the omitted level of each attribute is the negative sum of the parameters on the other levels of that attribute. The resulting log-odds estimates can be interpreted as preference weights. The relative importance (%) was calculated by dividing the distance between the highest and lowest preference weights for each attribute divided by the sum of all preference weight differences. Patient preference was assessed based on preference weights and relative importance.

The preference weights were used to estimate WTP for improvements in treatment efficacy. WTP is the mean maximum monetary equivalent that an individual is willing to pay for a given improvement in treatment efficacy. WTP represents the variation in out-of-pocket costs that yield a decrease in estimated utility that exactly balances the increase in utility yielded by an improved treatment efficacy. For example, WTP for an improvement in the average time for achieving 50% reduction after initiation of treatment from 5-weeks (WEEK5) to 4-weeks (WEEK4) is calculated as the level of cost (X) that satisfies following equation: COST(X) = WEEK4 WEEK5. represents the coefficients for each attribute level. X may fall between two cost levels since the cost levels are categorical. Interpolating linearly was used between the preferences for the surrounding cost levels to determine the value of X.24

This study was conducted in accordance with the Declaration of Helsinki. The survey was approved by the medical ethics committee of the Renji Hospital, Shanghai, China (no. KY2020-110).

Totally, 613 individuals responded to the invitation, of which 456 consented and completed the survey. There were 437 patients who completed the questionnaire, among whom 201 had no variation in their responses and were excluded from the analysis.

The characteristics of the remaining 236 patients are summarized in Table 2. Most of the patients were male (approximately 62.3%), were 2635 years old (approximately 46.2%), and had at least some college education (47%). Median monthly household income was between RMB 4000 and RMB 5999. The main psoriasis characteristics of these respondents were light red and partly scaly (approximately 40.3%). Most of these respondents whose psoriasis surface area was equal to the size of 35 hands (approximately 22.5%) and mainly distributed in the legs or hips (approximately 59.3%) and scalp (approximately 56.4%).

Among the participants, preference weights derived from the attribute levels indicated that the participants preferred lower costs of biologic treatments and a higher likelihood of retaining PASI 100 after three-month treatment. Preference weights derived from the attribute levels showed that the participants favored the lower cost of biologic treatments and higher probability of keeping PASI 100 at 3 months (Figure 2 and Supplementary Table 1). The distance score of the reduction of monthly costs from RMB 7000 to 1000 is 0.711, whereas improvements from 20% to 50% in the probability of keeping PASI 100 at 5-years is 0.164, improvements from 10% to 40% in the probability of achieving PASI100 at 3 months is 0.221, and improvements from 8 weeks to 2 weeks in the time to achieve PASI50 after initiation the biologic treatment is 0.101, respectively.

Figure 2 Preference weights for attribute levels and Relative importance of attributes (overall results, n = 236). Preference weights are showed on the vertical scale, describing how much each level was selected within one attribute. Non-overlapping error bars indicate statistically significant differences across levels within attributes; Relative importance is relatively described values calculated by the distance between the highest and the lowest attribute levels.

Across all participants, the attribute regarded as the most important was monthly cost (relative importance [RI]: 59.4%), probability of achieving PASI100 at 3 months (RI: 18.5%), probability of keeping PASI100 at 5-years (RI: 13.6%) and time to achieve PASI50 after initiation the biologic treatment (RI: 8.5%).

According to the monthly income, entire cohort is divided into low-income subgroup and high-income subgroup based on the monthly income of less than 8000 and more than 8000.

Preference weights derived from the attribute levels showed that the high-income subgroup preferred the lower cost of biologic treatments and the time to achieve PASI50 after initiation of the biologic treatment (Figure 3). The distance score of the reduction of monthly costs from RMB 7000 to 1000 is 0.370, whereas improvements from 20% to 50% in the probability of keeping PASI 100 at 5-years is 0.110, improvements from 10% to 40% in the probability of achieving PASI100 at 3 months is 0.327, and improvements from 8 weeks to 2 weeks in the time to achieve PASI50 after initiation the biologic treatment is 0.223, respectively. Across all participants, the attribute regarded as most important was monthly cost (RI: 35.9%), probability of achieving PASI100 at 3-month (RI: 31.7%), probability of keeping PASI100 at 5-years (RI: 21.7%) and time to achieve PASI50 after initiation the biologic treatment (RI: 10.7%).

Figure 3 Preference weights for attribute levels and Relative importance of attributes. Orange represents thehigh-income subgroup (monthly income more than RMB 8000, n = 52); Blue representsthe low-income subgroup (monthly income less than RMB 8000, n = 184). Preference weights are showed on the vertical scale, describing how much each level was selected within one attribute. Non-overlapping error bars indicate statistically significant differences across levels within attributes; Relative importance is relatively described values calculated by the distance between the highest and the lowest attribute levels.

Preference weights derived from the attribute levels showed that the low-income subgroup favored the lower cost of biologic treatments, probability of keeping PASI100 at 5-years and the probability of achieving PASI100 at 3 months (Figure 3). The distance score of the reduction of monthly costs from RMB 7000 to 1000 is 0.83, whereas improvements from 20% to 50% in the probability of keeping PASI 100 at 5-years is 0.19, improvements from 10% to 40% in the probability of achieving PASI100 at 3 months is 0.22, and improvements from 8 weeks to 2 weeks in the time to achieve PASI50 after initiation the biologic treatment is 0.20, respectively. Among this subgroup participants, the attribute regarded as most important was monthly cost (relative importance [RI]: 57.6%), probability of achieving PASI100 at 3 months (RI: 15.4%), time to achieve PASI50 after initiation the biologic treatment (RI: 14%) and probability of keeping PASI100 at 5-years (RI: 13.0%).

According to the matching degree between the psoriasis and the picture features, the patients were divided into five subgroups: Mild, Moderate, Severe, Very Severe, Clear disease.

Preference weights derived from the attribute levels showed that the Mild disease subgroup preferred the lower cost of biologic treatments (RI: 34.9%), the probability of keeping PASI100 at 5-years (RI: 34.5%), the probability of achieving PASI100 at 3 months (RI: 24.6%) and the time to achieve PASI50 after initiation the biologic treatment (RI: 6.0%); Across the Moderate disease subgroup, the attribute regarded as the most important was the monthly cost (RI: 36.0%), and the time to achieve PASI50 after initiation the biologic treatment (RI: 25.8%), probability of achieving PASI100 at 3 months (RI: 20.2%), probability of keeping PASI100 at 5-years (RI: 17.9%), respectively; Preference weights showed that the Severe disease subgroup favored the lower cost of biologic treatments (RI: 39.6%), the probability of achieving PASI100 at 3 months (RI: 32.3%), the probability of keeping PASI100 at 5-years (RI: 19.2%) and the time to achieve PASI50 after initiation the biologic treatment (RI: 8.8%); And in very severe disease subgroup, the attribute regarded as the most important was the monthly cost (RI: 49.6%), probability of keeping PASI100 at 5-years (RI: 22.3%), probability of achieving PASI100 at 3 months (RI: 18.0%), and the time to achieve PASI50 after initiation the biologic treatment (RI: 10.1%); Across the Clear disease subgroup, the attribute regarded as the most important was the monthly cost (RI: 62.7%), and the time to achieve PASI50 after initiation the biologic treatment (RI: 25.9%), probability of achieving PASI100 at 3 months (RI: 10.4%), probability of keeping PASI100 at 5-years (RI: 1.0%), respectively. The distance scores of each attribute are summarized in Figure 4.

Figure 4 Preference weights for attribute levels (results in disease condition subgroup n =191). (A) Mild disease subgroup (n = 40); (B) moderate disease subgroup (n = 95); (C) severe disease subgroup (n = 53); (D) very severe disease subgroup (n = 31); (E) clear disease subgroup (n = 17). Preference weights are showed on the vertical scale, describing how much each level was selected within one attribute. Non-overlapping error bars indicate statistically significant differences across levels within attributes.

According to the disease location distributed in body, the entire cohort was divided into the following subgroups: Legs or hips, Toes and feet, Buttocks, Groin or genital area, Stomach, chest, or back, Arms, Fingers or hands, Nails, Neck, Face or ears, Scalp. Across the foot and toe subgroup, the attribute regarded as the most important was probability of keeping PASI100 at 5-years (RI: 37.3%), the monthly cost (RI: 34.1%), probability of achieving PASI100 at 3 months (RI: 22.8%), and the time to achieve PASI50 after initiation the biologic treatment (RI: 5.8%), respectively. And in leg and hip subgroup, the attribute regarded as the most important was the monthly cost (RI: 66.8%), probability of keeping PASI100 at 5-years (RI: 15.2%), probability of achieving PASI100 at 3 months (RI: 12.7%), and the time to achieve PASI50 after initiation of the biologic treatment (RI: 5.3%), respectively. Additionally, preference weights and relative importance of attributes in other disease location subgroups are displayed in Supplementary Figure 1-22.

As expected, all patients were willing to pay more for improvement in probability of keeping PASI100 at 5-years (from RMB 666 to 1379), probability of achieving PASI100 at 3-month (from RMB -15 to 1867) and time to achieve PASI50 after initiation of the biologic treatment (from RMB 376 to 858). The WTP estimates for improving treatment efficacy in other subgroups (monthly income subgroup, disease condition subgroup, disease location subgroup) are summarized in Table 3.

Table 3 Willingness to Pay for Improvements in Treatment Efficacy in Overall Cohort and Subgroup

Our study was designed to quantify and explore psoriasis patients preference among different biological agents from a Chinese perspective and estimated the WTP for different attributes. Among patients with psoriasis, non-adherence rates are high partly due to a disagreement between recommended treatments and individual preferences.25 Compliance can be greatly improved by following patients preference. To our knowledge, there are no relevant studies conducted in China, which to a large extent provide references for future research on psoriasis from the perspective of geographical location. All four attributes (the average time for achieving 50% reduction after initiation of treatment, proportion of achieving 100% reduction after 3-months treatment, proportion of maintaining 100% reduction after 5-years treatment and monthly average cost on medication) were consistent with a prior expectation in terms of the direction and magnitude of the estimated coefficients. Among them, the average time for achieving 50% reduction after initiation of treatment and proportion of achieving 100% reduction after 3-months treatment represented quick response, proportion of maintaining 100% reduction after 5-years treatment was related to the long-term, sustained efficacy.

Overall cohort and most subgroups, regardless of their individual characteristics, attached the highest importance to monthly cost. The probability of achieving PASI100 after 3-months treatment was the second preferred attribute by patients in the entire cohort. Additionally, in the monthly income subgroup, most of patients prioritized quick response (achieving PASI100 at 3-month) compared with long-term, sustained efficacy (achieving PASI100 at 5-year). Moreover, results showed high-income subgroup favored more about onset speed of efficacy than low-income subgroup. In contrast, low-income subgroup only attached the greatest interest to the monthly cost. A systematic review about psoriasis showed that many preference studies conducted previously focused on the efficacy and safety, especially from the perspective of physicians.26 However, from the patients point of view, several studies included the attribute of cost. For instance, a German study included the treatment expenditure per month in the process attributes and calculated the relative importance score (RIS) of participants stratified based on disease duration, number of previous therapies, etc.27 Another study conducted in German showed compared with other attributes, the attribute of cost is not given as much attention.28 Italian studies on biologics for psoriasis included the cost attribute and illustrated that treatment costs and expected therapeutic response concurrently can provide valuable insights which complement and improve the traditional risk-benefit profile and drive treatment decisions.29,30 Probably this depends on different health systems and medicine reimbursement policies in Europe. However, in the process of choosing treatment strategies, medical expenditure has gradually become an important factor for patients in the context of China. It may be due to the income gap between patients in developing and developed countries. With the progress of health insurance negotiations in China during recent two years, the price of biological agents has dropped significantly, to a certain extent, which met the needs of some patients who tend to use biological agents. But the price of biologic agents was still high compared with other types of therapy and became a factor affecting the patients choice when considering the cost. This finding indicated the expenditure should be raised extensive attention, especially in China. And one strategy, called reduced doses, can be used well for clinical setting to control the expenditure, which seek for the minimal doses necessary to reach a good response while achieving a potential reduction of adverse effects. Many studies on optimal dosing strategy using biologic agents for psoriasis involved advantages in terms of drug-exposure risk and cost saving.3133 Regarding efficacy attribute, several DCE researches adopted PASI90 response for testing patients preferences on efficacy. For instance, Schaarschmidts finding indicated both patients and physicians considered PASI90 response is more important (RIS 21.4 and 20.8, respectively) than other attributes.34 But we chose PASI50 and PASI100 in our study, which were common endpoint of clinical trials. First, 50% and 100% reduction are easier to understand for participants than PASI 75 or PASI 90 response. Second, 50% reduction can roughly test participants the response to the concern about quick efficacy. Third, to determine whether or not the PASI50 response is still important for patients. Likewise, we found that quick response may be concerned as the secondary factor. It could indicate that psoriasis as facial skin disease has influences on patients appearance and impression, which are related to physiological and psychosocial function of patients.35 A higher incidence of anxiety and depression, along with lower quality of life, may be attributed to psoriasis. So, quick response may help patients with psoriasis get rid of the troubles caused by the disease.36 As for onset speed of efficacy, several studies on psoriasis-related treatment found that patients preferred differently. For instance, a research about patients with psoriasis preferred durability over onset speed of efficacy in psoriasis treatment in Japan.37 It is noteworthy that the most preferred element was sustained efficacy after drug withdrawal even though those drugs are not currently available in the clinical setting. In addition, for WTP, we can find from the results that patients are willing to spend higher costs for better efficacy. Especially in the high-income subgroup, the values of WTP for efficacy improving are higher than that in the low-income subgroup, which is consistent with our prior expectation. Clearly, the efficacy of biologic agents is still an unmet need for patients.

Several limitations exist in this study. Discrete choice experiment is a theoretical method, which that can be cognitively challenging. It means that actual patients might choose actual medications differently and participants are required to choose one of the two scenarios regardless of whether they like either. A direct conclusion based on individual preferences cannot be made from average preferences. Obviously, the treatment decisions made for each patient are based on their individual preferences. In order to better advise patients about their treatment options, physicians should be aware of what the majority of patients are concerned about and what their preferences are influenced by sociodemographic and disease-related characteristics. To optimize treatment satisfaction, adherence, and outcomes, physicians should incorporate their knowledge of each patients preferences, needs, and concerns into their therapeutic decisions. Some results of subgroup analyses are not consistent with our expectations due to the limited number of participants in the study. Subgroups with different demographic characteristics may differ significantly in their preferences, but a large sample size study is still required to verify this in the future. It is possible that some deviations will occur since the study was only conducted online. Several elderly patients may not be familiar with using digital devices, which limits the distribution of socio-demographic characteristics of participants in this survey. Additionally, the research questionnaire did not include a safety attribute. The safety profile is an important attribute among biologic agents, non-biologic systemic agents and topical compounds in the management of psoriasis.38,39 For example, the risk of infections caused by biologics is also a key safety profile.40 And during the COVID-19 pandemic, clinical management of patients with psoriasis is challenging due to their impaired immune status, especially for those using biologics inhibiting key pathogenic cytokines such as TNF-a and IL-17.41 In our study, the preferences were evaluated in patients with psoriasis using the biologic agents, and the risk of adverse events was similar among biologic agents. Some studies indicated that, despite individual risk tolerances, responders were willing to accept risks above likely clinical exposures to improve psoriasis symptoms or compatible with their personal and professional lifestyle.28,42 Considering that some biologic agents have just been listed in China, the efficacy and cost of biologic agents were primarily considered in order to estimate the economic burden, so this attribute was not included in our research questionnaire.

In conclusion, people are concerned about treatment cost when making decisions regarding the biological treatment regardless of incomes. In the efficacy attribute, the probability of achieving PASI100 at 3-month was the most sensitive factor. Clinicians might change their perceptions of what aspects of treatment plans need to be discussed with patients and their families during consultations based on our findings. It is necessary to conduct future studies using larger and more representative samples to enforce our current findings and to facilitate the measurement of potential preference heterogeneity among individuals.

Ethical approval was obtained from the Renji Hospital (no. KY2020-110).

All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; All authors took part in drafting the article or revising it critically for important intellectual content and agreed to submit to the current journal; All authors gave final approval of the version to be published and agree to be accountable for all aspects of the work.

This study was funded by Lilly Suzhou Pharmaceutical Co. Ltd.

Erjia Ye and Guanshen Dou are employees of Eli Lilly and Company. The other authors have no conflicts of interest.

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21. Goh SSL, Lai PSM, Liew SM, Tan KM, Chung WW, Chua SS. Development of a PATIENT-Medication Adherence Instrument (P-MAI) and a HEALTHCARE PROFESSIONAL-Medication Adherence Instrument (H-MAI) using the nominal group technique. PLoS One. 2020;15(11):e0242051. doi:10.1371/journal.pone.0242051

22. Reed Johnson F, Lancsar E, Marshall D, et al. Constructing experimental designs for discrete-choice experiments: report of the ISPOR Conjoint Analysis Experimental Design Good Research Practices Task Force. Value Health. 2013;16(1):313. doi:10.1016/j.jval.2012.08.2223

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Patient preference for biologic treatments of psoriasis | PPA - Dove Medical Press

Psoriatic arthritis (PsA) is an inflammatory arthritis of the joints that occurs in some people who have psoriasis. Both PsA and psoriasis are autoimmune diseases, meaning they are caused by a persons own immune system going astray. Its long been known that people who have one autoimmune condition are more prone to developing others.

Its not surprising, then, that some people with PsA also develop an autoimmune thyroid disorder.

The thyroid is a butterfly-shaped gland at the base of the throat. For such a small part of the body, it can wreak a lot of havoc. This is because the thyroid has many crucial functions, including regulating heartbeats and controlling how speedy or sluggish your metabolism is.

Even among the general population, thyroid disease is not rare. According to theAmerican Thyroid Association (ATA), an estimated 20 million Americans have a thyroid condition. But because symptoms can be nonspecific and hard to attribute directly to the thyroid, up to 60 percent of people are unaware they have it, the ATA says.

Like other glands, the thyroid excretes hormones into the body. When it pumps out too little (hypothyroidism) or too much (hyperthyroidism), a person can feel tired or amped up and may gain or lose weight. Other common symptoms of thyroid problems include depression, constipation, and difficulty concentrating from too little of the hormones, and nervousness, palpitations, and insomnia from too much.

Autoimmune conditions that affect the thyroid include Hashimoto's disease, which causeshypothyroidism, and Graves disease, which causes hyperthyroidism.

With some autoimmune diseases, such as rheumatoid arthritis, people develop autoantibodies, which mistakenly target the persons own tissue, as part of the disease. But those with psoriatic arthritis do not develop these autoantibodies, says Andrew Wang, MD, PhD, a rheumatologist at Yale Medicine and an assistant professor of immunology at the Yale School of Medicine in New Haven, Connecticut.

RELATED:Psoriatic Arthritis vs Rheumatoid Arthritis: What's the Difference?

It's more common for people with autoantibody diseases to also develop autoimmune thyroiditis than it is for those with conditions that dont make autoantibodies, Dr. Wang explains. This means that the co-occurrence rate between autoimmune thyroid disease and PsA is not as high as for other autoimmune diseases, like RA, he says.

Nonetheless, even among people with psoriasis, whether or not they also have PsA, rates of thyroid disease are higher than in the general population. A meta-analysis by Chinese researchers published in BMJ Open in January 2022 found that people with psoriasis have a higher prevalence of autoimmune thyroid disease, most commonly hypothyroidism.

Very few studies have examined the rate of thyroid disease specifically in people with PsA. In a review of the two diseases published in Cureus in January 2021, California researchers found just 45 high-quality articles on the topic.

Most of the studies they examined do show a positive association, meaning if someone has one condition they were more likely than the general public to have the other. But six of the studies showed no increased connection.

The researchers found that the coupling was more common in people who are obese. In some studies, young women were also more prone, but in other research this wasnt the case. People who developed psoriasis in midlife or later, known as late-onset disease, were also more likely to have a thyroid condition than those with early onset.

Because of the small number of studies, though, the researchers could not provide a concrete explanation for the concurrence of the two conditions. More prospective and retrospective studies are needed to assess the association between them before any conclusion can be made, they wrote.

The good news is that regardless of what medications a person is taking to control their psoriatic arthritis, they can continue on them while undergoing treatment for any thyroid condition, Dr. Wang says. Among all the drugs, none of them would affect psoriatic arthritis treatment, he says.

Intriguingly, the Cureus review found hints that some thyroid treatments may actually improve PsA symptoms. For example, the drug propylthiouracil, which is used to treat hyperthyroidism, was found in several studies to clear psoriatic lesions. And two studies noted that after a thyroidectomy (a surgical procedure for hyperthyroidism that removes part of the thyroid), there was marked improvement in psoriatic skin lesions.

Because symptoms of thyroid disease may be vague, doctors dont always think to check the thyroid when PsA patients complain of things like fatigue, insomnia, or weight gain, Wang says.

Its important for people with psoriatic arthritis to make sure your doctor is listening to you, he says. If youre experiencing new or unusual symptoms, I would advocate that your doctor consider the thyroid, he says. A simple blood test checking for thyroid hormone levels can reveal whether thats the source of the problem.

The rest is here:
Psoriatic Arthritis and Thyroid Disease Can Appear Together - Everyday Health

A Scots make-up artist (MUA) with a 'zombie-like' skin condition has bravely opened up on feeling 'judged' by people who think she has a 'contagious rash'.

Danielle Robertson, 32, was diagnosed with psoriasis aged 16 and has endured crippling flare-ups ever since.

Psoriasis is believed to be related to the immune system where sufferers produce more skin cells, causing flaky patches of skin which form scales.

'Scunnered' with 'hiding away' and determined to help others feel good in their own skin, Danielle recently exposed her uncomfortable 'patchy and spotty' flare-up to over 80,000 followers on social media.

While the brave beautician joked she looked like 'an apocalyptic zombie', she demonstrated the 'transformative' power of make-up that 'camouflages' her insecurities.

Danielle, from Bishopton, Renfrewshire told the Record: "It's human nature for people to stare at something different but it has really knocked my confidence in the past.

"Psoriasis can be mistaken for lots of things that are contagious, like impetigo, or seen as dirty. Clients worry I have something like that and ask 'what's on your skin?' which makes me self-conscious.

"After Christmas I got a bad flare up and felt so down. I was stuck in the house, hiding away which isn't great for a public-facing job like mine.

"I was scunnered and wanted to embrace my skin condition to show others that it's okay to have it."

So talented Danielle decided to lay bare her condition on YouTube and TikTok.

Lengthy videos explain her psoriasis before showing how products can conceal flare ups.

"I'm no doctor and I don't claim to be," she added.

"I also think people should be free to go barefaced, no matter what their skin issue is.

"But to me, make-up is like camouflage. If showing other people how it has helped me can make a difference to them, then it's worth it."

Going au naturale is a far cry from Danielle's glamorous career in beauty.

The high-flyer has painted faces in Los Angeles and Dubai as a global make-up artist for Urban Decay.

Alongside a constant stream of bridal clients, Danielle's nine-to-five is with beauty giant, L'Oral who own luxury names such as Armani and Yves Saint Laurent.

"I've had a number of pinch me moments," she said.

"But amongst all the highs, I've had times where I felt like I couldn't go into work as my psoriasis was so bad. I would feel so conscious.

"That's why I wanted to break down the stigma with posting about it."

She added: The reaction has been amazing and I feel it's now almost part of my online profile.

"To anyone else suffering from any skin condition; don't be fazed by something that's just a phase. It does get better and there are products out there to help."

You can follow Danielle by heading to her Facebook page Danielle Roberts Make-Up Artist, or at at daniellerobertsmua on Instagram and TikTok as well as her YouTube channel.

Psoriasis affects around two in 100 people in the UK, find more information on the NHS website.

Don't miss the latest news from around Scotland and beyond - Sign up to our daily newsletter here .

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Scots make-up artist with 'zombie' psoriasis helping others to transform problem skin - Daily Record

Rashes can be thought of as a dysfunctional community of skin cells. Your skin harbors dozens of distinct cell types, including those that form blood vessels, nerves and the local immune system of the skin. For decades, clinicians have largely been diagnosing rashes by eye. While examining the physical appearance of a skin sample under a microscope may work for more obvious skin conditions, many rashes can be difficult to distinguish from one another.

At the molecular level, however, the differences between rashes become more clear.

Scientists have long known that molecular abnormalities in skin cells cause the redness and scaliness seen in conditions like psoriasis and eczema. While almost all the various cell types in your skin can release chemicals that worsen inflammation, which ones leads to rash formation remains a mystery and may vary from patient to patient.

But molecular testing of skin rashes isnt a common practice because of technological limitations. Using a new approach, my colleagues and I were able to analyze the genetic profiles of skin rashes and quantitatively diagnose their root causes.

Traditional genetic analyses work by averaging out the activity of thousands of genes across millions of cells.

Genetically testing tissue samples is standard practice for conditions like cancer. Clinicians collect and analyze tumor biopsies from patients to determine a particular cancers unique molecular characteristics. This genetic fingerprint helps oncologists predict whether a cancer will spread or which treatments might work best. Cancer cells lend themselves to this form of testing because they often grow into recognizable masses that make them easy to isolate and analyze.

But skin is a complex mixture of cells. Collapsing these unique cell communities into a single group may obscure genetic signatures essential to diagnosis.

Recent technological advances called single-cell RNA sequencing, however, have enabled scientists to preserve the identity of each type of cell that lives in the skin. Instead of averaging the genetic signatures across all cell types in bulk, single-cell RNA sequencing analyses allow each cell to preserve its unique characteristics.

Using this approach, my colleagues and I isolated over 158,000 immune cells from the skin samples of 31 patients. We measured the activity of about 1,000 genes from each of those cells to create detailed molecular fingerprints for each patient. By analyzing these fingerprints, we were able to pinpoint the genetic abnormalities unique to the immune cells residing in each rash type. This allowed us to quantitatively diagnose otherwise visually ambiguous rashes.

We also observed that some patients had treatment responses consistent with what we expected with our predicted diagnoses. This suggests that our concept could viably be expanded for further testing.

To make our approach available to clinicians and scientists, we developed an open source web database called RashX that contains the genetic fingerprints of different rashes. This database will allow clinicians to compare the genetic profile of their patients rashes to similar profiles in our database. A closely matching genetic fingerprint might yield clues as to what caused their patients rash and lead to potential treatment avenues.

The rapid development of drugs that target the immune system in recent years has inundated doctors with difficult treatment decisions for individual patients. For example, while certain drugs that act on the immune system are known to work well for conditions like psoriasis or eczema, many patients have atypical rashes that cant be precisely diagnosed.

An open source database like ours could help enable clinicians to profile and diagnose these rashes, providing a stepping stone to choose a suitable treatment.

Furthermore, chronic inflammatory diseases that affect organs other than the skin share similar genetic abnormalities. Lab tests that can illuminate the root causes of skin diseases can likely be expanded to many other conditions.

Our RashX project initially focused on just two very common types of rashes, psoriasis and eczema. It is unknown whether other types of rashes will have similar genetic profiles to psoriasis and eczema or instead have their own unique fingerprints. It is also unclear which parts of the fingerprint would best predict drug response.

But RashX is a living web resource that will grow more useful as more scientists collaborate and contribute new data. Our lab is also working to simplify the process of developing genetic profiles of rashes to make participating in this area of research more accessible for clinics around the world. With more data, we believe that projects like RashX will make precision testing for rashes an essential next step in diagnosis and treatment.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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What is that rash? - ASBMB Today