Daily Archives: June 17, 2020

New data from a head-to-head study comparing risankizumab-rzaa to secukinumab in patients with moderate to severe plaque psoriasis were recently presented online at the American Academy of Dermatology virtual annual meeting.

In this 52-week, phase 3b, open-label, active-comparator study, patients were randomized to receive risankizumab 150mg subcutaneously (n=164) at baseline, week 4, then every 12 weeks thereafter, or secukinumab 300mg subcutaneously at baseline, weeks 1, 2, 3, and 4, then every 4 weeks thereafter. The co-primary end points were the proportion of patients with a 90% reduction in the Psoriasis Area and Severity Index score (PASI 90 response) at week 16 (noninferiority) and at week 52 (superiority) from baseline.

Results showed that the study met both primary end points of noninferiority and superiority. A greater proportion of patients treated with risankizumab achieved a PASI 90 response at week 16 (74% vs 66%) and at week 52 (87% vs 57%; P <.001) compared with secukinumab.

Risankizumab also met key secondary end points including a superior rate of complete skin clearance (PASI 100 response) at week 52 compared with secukinumab (66% vs 40%; P <.001). Moreover, 88% of patients treated with risankizumab achieved a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 52 compared with 58% of patients treated with secukinumab (P <.001).

Risankizumab and secukinumab demonstrated comparable rates of adverse reactions. The most common were nasopharyngitis, upper respiratory tract infection, headache, arthralgia and diarrhea.

Risankizumab, an interleukin-23 antagonist, is marketed under the trade name Skyrizi and is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Secukinumab, an interleukin-17A antagonist, is marketed under the trade name Cosentyx and is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is also approved for the treatment of active psoriatic arthritis or ankylosing spondylitis in adults.

For more information visit abbvie.com.

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Superior Skin Clearance Observed With Risankizumab in Head-to-Head Psoriasis Study - Monthly Prescribing Reference

On this page:BasicsTopical MedicationsOral TreatmentsBiologics

Theres no cure for psoriasis, but there are a lot of medications that can treat the chronic skin condition. Whether youre newly diagnosed or still searching for the right treatment (yup, sometimes theres a little trial and error), the number of choices can seem daunting. There are topicals, oral medications, and biologic drugs. While they all have the same overall goalclear your skinthey do it in different ways. Some medications soothe and calm an outbreak, while others prevent future flares. The treatment plan you end up on is often determined by your type of psoriasis, its severity and location, and your overall healthy history. Here, well walk you through all your options.

Psoriasis is a chronic condition that causes red, stinging patches or bumps on your arms, legs, and even your scalp. When you have this disease, your skin cells turn over faster than they should, leading to a buildup of cells on your body's surface that turn into those inflamed, scaly spots.

At first glance, it looks like a skin issue. And while thats true, experts say it starts on a deeper levelin your immune system. An overactive immune system, along with a genetic predisposition for psoriasis, and at least one other factor such as infection, obesity, or smoking are thought to be the driving forces behind the condition.

As we mentioned, there are several different types of psoriasis: plaque psoriasis (the most common type), scalp psoriasis, guttate, pustular, inverse, erythrodermic, and even psoriatic arthritis, which is a combo of psoriasis and arthritis. The medication youre prescribed is often determined by your type, and may include topical treatments, drugs taken orally, and injections. Let's start by taking a look at topical medications for psoriasis.

These creams, ointments, foams, shampoos, and lotions are applied directly to the affected areas, and are often prescribed for mild to moderate casespsoriasis that covers 1% to 10% of your body. Topical treatments can be used alone, or in combination with another treatment prescribed by your doctor. For example, you may use a cream along with an oral medication and/or light therapy. Topicals are used for these types of psoriasis:

The most common types of topical treatments prescribed for psoriasis include:

Corticosteroids work by reducing inflammation and redness. Theyre often prescribed to clear a current flare but wont necessarily stop your psoriasis from coming back in the future. There are various forms, including liquids, foams, and creams that come in various strengths. Examples include:

Side effects include:

These creams, liquids, and foams are believed to stop the overgrowth of skin cells, which may help prevent future psoriasis flares. They also help clear current patches by sloughing off scaly skin and flattening plaques so they are less noticeable.

Dovonex (calcipotriene) is a synthetic form of vitamin D that comes in a cream or a liquid for scalp psoriasis. You apply it twice a day for up to eight weeks.

Vectical (calcitriol) is a natural form of vitamin D that comes in an ointment formulation to use twice daily. While most topicals are okay to use during pregnancy, Vectical is not.

Enstilar (calcipotriene and betamethasone dipropionate) is a foam thats a combination of a synthetic form of vitamin D and a steroid. Its approved for adults only and used once a day for up to a month.

Taclonex (calcipotriene and betamethasone dipropionate) is a liquid vitamin D-steroid combo thats approved for use in children ages 12 and up. Use it once a day for up to a month.

Research has shown that using a vitamin D analogue with a corticosteroid may not only be more effective than using either one alone, but the combo can even reduce the side effects that can come with strong steroid use. But side effects can include:

Yes, the vitamin A derivatives that smooth wrinkles and clear acne can also help with psoriasis. Topical retinoids help alleviate redness, scaling, and inflammation, and regulate the high-speed skin-cell growth associated with the condition. Because of their risk of birth defects, retinoids should be avoided if youre pregnant or planning to become pregnant.

Tazorac (tazarotene), available as a gel or cream, is approved for adults and comes in two strengths. It is used once a day and can be applied daily for up to a year.

Duobril (halobetasol propionate and tazarotene) is one of the newest topical medications. This combo product contains a vitamin A derivative (called tazarotene) with an anti-inflammatory cream. You use it daily as needed.

Side effects include:

Anthralin is a man-made version of goa powder, a natural substance that comes from the araroba tree. Like many of the other topicals, this helps halt the excessive growth of skin cells and is approved for adults. It comes in a variety of formulations including a cream, ointment, and paste which can be used once a day on the skin. It also comes in a shampoo which can be used on the scalp. Anthralin-containing products include:

Side effects include:

Taken by mouth, oral medications target your overactive immune system (or parts of it) to reduce inflammation and/or slow down skin cell production. With so many choices, your doctor can help you find the best oral option for you to take alone or in combination with other forms of treatment like topicals, phototherapy, or biologics. Oral medications are most often prescribed for the following psoriasis types:

The most commonly prescribed oral options include:

Trexall and Rheumatrex (methotrexate) work by targeting and slowing the growth of skin cells. They come with a risk of toxicity, so theyre only taken once or twice a week, and not prescribed for long-term use. Methotrexate isnt safe to take if youre pregnant or nursing or have any blood issues like low white blood cell count or anemia.

Side effects include:

Gengraf (cyclosporine) was initially used as a medication to ward off organ rejection. It works on severe psoriasis by slowing an overactive immune system. The drug is taken daily either in pill form or a liquid that you dilute in juice.

Side effects: Cyclosporine can cause decreased kidney function, flu-like symptoms, high blood pressure, and cholesterol. This is another medication thats not safe while pregnant or nursing, and shouldnt be taken for longer than a year. Avoid cyclosporine if you take anti-cancer, anti-fungal, anti-convulsants, or anti-inflammatory medications, as well as antibiotics, aspirin, or ibuprofen.

Xeljanz (tofacitinib), one of the newer oral medications, inhibits a family of intracellular nonreceptors called Janus kinase, a.k.a. a JAK inhibitor. In doing so, it decreases cytokines, proteins that cause inflammation. By lowering inflammation in those with psoriasis, you get less symptoms.

Side effects include:

Soriatane (acitretin) is a form of vitamin A (a.k.a. a retinoid) that helps regulate those out-of-control skin cells. Its taken orally daily. If youre pregnant or planning to start a family within the next three years or have experienced sensitivity to retinoids in the past, this medication isnt an option for you.

Side effects include:

Otezla (apremilast) is one of the newest oral treatments. It works by reducing inflammation. Less inflammation may mean less outbreaks, or at least less severe ones. This cant be taken with some other medications such as phenobarbital and rifampin.

Side effects include:

Prednisone and Medrol (methylprednisone). Sometimes prescribed as pills or injections, these meds work by reducing inflammation and slowing cell growth. They help calm a flare-up but arent recommended for long-term use.

Side effects include:

These drugs are commonly prescribed (alone or along with other meds) for moderate-to-severe psoriasis because theyre so effectiveespecially the newer kids on the block like Skyrizi, Cimzia, and Ilumya.

Biologics are known as systemic treatments because they spread throughout the body and do their work from the inside out, but unlike other drugs that affect your entire immune system, these zero in on very specific partsvarious proteins or white blood cells that contribute to psoriasis such as tumor necrosis factor (TNF), interleukin 17, interleukin 23, and T-cells. By blocking these proteins and cells, the drugs can stop a psoriasis flare.

Interestingly, psoriasis biologics may help with other inflammatory issues such as heart disease. A recent study in JAMA Cardiology found that those who took biologics for psoriasis had a significant reduction in coronary inflammation, too.

Biologics are made from living cells of animals, humans, or bacteria and are given through an intravenous drip (IV) or injected in your thigh, upper arm, stomach, or butt either by a health care provider, caregiver, or yourself. (Dont worry, your M.D. will make sure you know exactly how to do this before sending you off to self-inject.)

Theyre used to treat these types of psoriasis:

There are several types of biologics:

Stelara (ustekinumab) is injected into your body to block a protein called IL-23. This helps ease the inflammation that can cause symptoms of both moderate to severe psoriasis and psoriatic arthritis. The drug requires two starter injections four weeks apart followed by four doses done 12 weeks apart.

Ilumya (tidrakizumab-asmn) and Skyrizi (risankizumab-rzaa) require two initial doses, four weeks apart, to block the IL-23 protein. This is followed by four doses per year, every 12 weeks.

Tremfya (guselkumab) also targets IL-23 with two starter doses four weeks apart and then every eight weeks.

Side effects include:

One cause of plaque psoriasis (which accounts for 80% of all psoriasis cases) is the excess production of a protein called tumor necrosis factor (TNF) which tells your skin cells to grow at an accelerated rate. These medications, which block TNF so that your skin cells grow more slowly, need to be taken over a long period of time to clear your skin.

Unlike some psoriasis medications, TNF inhibitors can be taken while pregnant or nursing (but of course, not without talking to your OB/GYN). However, youll want to avoid this category of biologics if you have multiple sclerosis (MS) or have an immediate relative with MS. Anti-TNF therapy has been associated with the demyelinating disease.

Cimzia (certolizumab pegol) can either be injected by yourself or you can have it injected at your doctors offices with two doses the first time, then two doses two weeks later, followed by two doses two weeks after that. Following these initial shots, you have one every other week.

Enbrel (etanercept) is unique because it is also approved for use in children. Although dosage can vary, you typically inject yourself with Enbrel twice a week for the first three months and then once a week for three months after that.

Humira (adalimumab) starts with two doses on day one and continues with one dose every other week. Cyltezo and Amjevita are approved biosimilars to Humira.

Remicade (infliximab) is given as an IV infusion that takes about two hours at your health care providers office. You begin with three starter doses administered during a six-week period, and then get one infusion every eight weeks. Inflectra and Renflexis are biosimilar.

Side effects include:

These biologics contain a human antibody that blocks a protein called interleukin 17 (IL 17), which causes inflammation and an immune response. Before prescribing these biologics, your M.D. will make sure you dont have latent tuberculosis, meaning you carry the tuberculosis bacteria but dont have an active disease. IL 17 inhibitors can trigger a case.

Cosentyx (secukinumab) is self-injected; two doses a week for four weeks and then once a month.

Siliq (brodalumab) targets four of the IL-17 proteins (others target just one). You take one dose weekly for three weeks and then one dose every two weeks. (Siliq carries a warning about suicidal behavior and thoughts.

Taltz (ixekizumab) is self-injected; two doses on the first day and then one injection every two weeks for three months. After that, you do it just once per month.

Side effects include:

These medications target T-cells, a type of white blood cell that causes inflammation.

Orencia (abatacept) is prescribed as a once-a-week shot for psoriatic arthritis, but it doesnt help with skin psoriasis.

Side effects include:

In some cases, your physician may prescribe a biologic along with another medication such as a topical treatment or oral medication. Some people develop anti-drug antibodies (ADAs) to biologics, making them less effective after a while. A review in the British Journal of Dermatology found that combining a biologic with the systemic oral medication methotrexate may help prevent ADAs.

Some medications are safe to take while pregnant or breastfeeding, while others, such as methotrexate, should be avoided. Discuss your options with your doctor so you can create a customized treatment plan.

You may be desperate to try anything to soothe your skin, but skip the fad diets, tanning beds, and Vicks VapoRubtheres little to no research verifying their efficacy, and they can irritate or dry out your skin.

Yes. Many of the medications are approved for both conditions, including the Cimzia, Enbrel, Humira, Stelara, Remicade, Cosentyx, methotrexate, Otezla, and systemic steroids.

Some people notice their biologic doesnt work as well over time. Experts say your body may have outsmarted the drug by creating antibodies against it. If your psoriasis is no longer responding to a certain drug, your doctor will likely switch you to something else.

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What Are the Medication Options for Psoriasis? - HealthCentral.com

Patients with psoriasis often have other physical diseases, and these somatic comorbidities can have a bigger effect on the patients mental health than the skin symptoms from their psoriasis, according to a study published in JAMA Dermatology.

Researchers in Sweden used a population-based registry data from Swedish patients in routine clinical care. Patients with psoriasis were matched with control participants without psoriasis by age, sex, and municipality. All participants in the study were free of existing psychiatric illness (PI).

Little is known about the independent risks imparted by skin psoriasis compared with somatic comorbidity on the development of PI or whether they have additive or synergistic associations, the authors explained.

A total of 93,239 patients with skin psoriasis and 1,387,495 control participants were enrolled between January 2005 and December 2010. Patients with psoriasis had their first diagnosis during the study period. For the study, PI was a composite measure of depression, anxiety, and suicidality, which was composed of suicidal ideation, suicide attempt, and completed suicide. The Elixhauser Comorbidity Index (ECI) and the Charlson Comorbidity Index (CCI) were used to calculate comorbidity profiles for each patient in the year before baseline.

The authors found that the interaction between skin psoriasis and ECI and between skin psoriasis and CCI were not statistically significant, which indicated skin psoriasis and somatic comorbidities do not act synergistically. The authors noted that both skin psoriasis and somatic comorbidity are independent risk factors for PI onset.

Patients who were sicker (with both skin psoriasis and somatic comorbidity) had the highest rate of incident PI. However, patients with skin psoriasis but no somatic comorbidity actually had a lower rate of PI onset compared with the control participants who had somatic comorbidity.

The authors speculated that the somatic comorbidities in the ECI and CCI may be considered severe compared with skin psoriasis, which explains why they may contribute more to PI onset. They also noted that since somatic comorbidity is broadly defined, patients may have multiple diseases compared with the patients with skin psoriasis and no somatic comorbidity who only had 1 recorded disease.

They recommended that future research understand the interaction of clinical severity with somatic comorbidity and PI in patients with psoriasis. They also noted that the findings support use of holistic patient management.

"I would be delighted if our study could support the trend towards a more holistic view on psoriasis care," coauthor Marcus Schmitt-Egenolf, MD, PhD, dermatologist and professor at Ume University, said in a statement. At the doctor's office, lifestyle factors should be discussed in the awareness that individual responsibility may be limited by available personal and community resources. Such an approach may improve the complete triad of psoriasisskin symptoms, somatic and mental health alike.

Reference

Geale K, Henriksson M, Jokinen J, Schmitt-Egenolf M. Association of skin psoriasis and somatic comorbidity with the development of psychiatric illness in a nationwide Swedish study.JAMA Dermatol.Published online June 3, 2020.doi:10.1001/jamadermatol.2020.1398

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What Is the Impact of Psoriasis on Patients' Mental Health? - AJMC.com Managed Markets Network

Unforeseen adverse events associated with biotechnological medications for the treatment of psoriasis are not uncommon. Investigators from the University of Bologna in Italy have published evidence-based recommendations on the management of unforeseen events in patients with psoriasis who are treated with these therapies in Dermatologic Therapy.

According to the authors of the paper, the use of biotechnological medications for psoriasis should be avoided during pregnancy and lactation as there is currently a lack of robust data on the safety of these therapies during these times. Based on current evidence, some monoclonal antibodies may cross the placenta after the first trimester. New anti-IL23 and IL1-17 therapies should be avoided because of these concerns.

The authors suggest clinicians should speak with women with psoriasis who have become pregnant about the safety risks associated with biotechnological therapies and should evaluate whether or not to discontinue therapy. Etanercept and certolizumab are cited as agents that may not cross the placental barrier to the embryo and are suggested as safer therapeutic options for moderate-to-severe psoriasis. Few safety data on the use of biotechnologic agents during lactation exist, suggesting clinicians may wish to practice caution when considering these therapies in women who are considering breastfeeding.

The authors recommend clinicians screen patients with psoriasis for latent tuberculosis prior to and during anti-TNF- treatment. Biologic therapies anti-TNF- or anti-IL12/23 may be initiated 1 month following prophylactic therapy for latent tuberculosis, according to guidelines in the US. For patients with psoriasis who have HIV, the authors cited recent expert opinion statements that supported the consideration of anti-TNF-, ustekinumab, and apremilast for patients who have close monitoring and control of HIV load and CD4 count.

In terms of surgical procedures, the authors stated that no interruption of biologic therapy is needed for patients with psoriasis who are set to undergo low-risk interventions. For moderate- and high-risk surgeries, the authors suggest the administration of biologic agents should be stopped 3 to 4 times the half-lives of the therapy prior to intervention. Biologic therapy could be restarted 1 to 2 weeks after surgery if the patient is free from complications.

The authors wrote that any clinician who treats psoriasis with biotechnologic therapy may experience 1 unexpected events, stating that it should be good practice to know how to manage them. Further study is needed to form a consensus-based guideline on how to manage these events in this patient population.

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Reference

Sacchelli L, Magnano M, Loi C, Patrizi A, Bardazzi F. The unforeseen during biotechnological therapy for moderatetosevere psoriasis: How to manage pregnancy and breastfeeding, infections from Mycobacterium tuberculosis, hepatitis B virus, hepatitis C virus, and HIV, surgery, vaccinations, diagnosis of malignancy, and dose tapering [published online April 14, 2020]. Dermatol Ther. doi:10.1111/dth.13411

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Management Strategies for Unforeseen Events of Psoriasis Biotech Therapies - Dermatology Advisor

Findings of this global survey Beyond the visible: rosacea and psoriasis of the face show that regardless of the disease (rosacea (ROS) or psoriasis of the face (PsO)), almost all (90%) of the patients surveyed felt their disease was partially or totally uncontrolled, and experienced a similar impact on working life, with 40% of sufferers across both diseases admitting that their condition impairs their work activities.1

Over half of patients surveyed felt their disease significantly affected their daily lives (58% ROS vs 55% PsO), with 1 in 2 people self-reporting moderate-to-severe depression (49% ROS vs 54% PsO) and at least a third self-reporting moderate-to-severe anxiety (34% ROS vs 43% PsO).1

However, when it comes to assessing new patients, quality of life (QoL) and psychosocial impact is not top of mind for HCPs, with only a limited number of doctors surveyed mentioning that they investigate QoL issues in practice (9% ROS vs 22% PsO).1

Based on these findings involving over 600 patients with facial skin disease (rosacea or psoriasis)* and 361 doctors across 6 countries, the report explores the challenge of controlling the two diseases, quality of life issues, similarities and disparities in disease management, mental health impacts, as well as HCP attitudes and approaches, with the aim of improving disease outcomes.

Commenting on the findings, Prof. Dr Jerry Tan, Adjunct Professor, Western University, Ontario, Canada, and one of the expert authors of the report says:

"This ground-breaking study is helping to evolve treatment practice in rosacea and psoriasis. There is much to be learned from current practice and the striking similarities between rosacea and psoriasis of the face, in terms of impact on patients' productivity and daily lives, which further demonstrates the importance of improving outcomes."

Invisible symptoms such as stinging, burning and itching are driving disease burden for many sufferers, yet only a quarter of doctors surveyed are routinely assessing these symptoms with their rosacea patients (27% ROS vs 40% PsO).1

Though more than half of all patients in the survey, regardless of disease, were ashamed of their condition, it was rosacea patients that were more likely to blame themselves for flare-ups (28% ROS vs 20% PsO), said they experience low self-esteem (34% ROS vs 20% PsO) and low confidence (30% ROS vs 18% PsO).1

Almost half (46%) of rosacea patients and almost a third (30%) of patients with psoriasis on the face still believed their disease was triggered by lifestyle choices, demonstrating a need for increased patient education.1

The benefits of achieving 'clear' (IGA 0) are well-established in both diseases, and positively, 44% of rosacea patients surveyed recognized that 'clear' skin is possible (vs 35% PsO).1

Encouragingly, the majority of sufferers surveyed expressed a desire to understand more about their disease (73% ROS vs 65% PsO), leading the report's authors to highlight the need for HCPs to empower their patients through knowledge, discuss the invisible as well as visible impacts, and help them to understand the benefits of aiming for 'clear' (IGA 0) to improve outcomes.1

* All patients surveyed claimed to be experiencing a moderate to severe disease impact on their lives

Self-reported, measured using Patient Health Questionnaire-9 (PHQ-9)

Self-reported, measured using General Anxiety Disorder-7 scale (GAD-7)

References:

About rosacea

Rosacea is a common inflammatory skin disease that presents variable clinical characteristics, of which the most common are flushing, persistent erythema, and inflammatory lesions. It mainly affects the central areas of the face, such as the cheeks and nose. The disease can affect both adult men and women, usually after the age of 30. Additionally, symptoms such as stinging, burning and increased sensitivity of the skin are common. The eyes are often affected, and might present as red, dry or itchy.

Although the cause of the disease is still under debate, various trigger factors are known, including spicy foods, alcohol, emotional stress, sun/UV-exposure, hot baths and beverages. Demodex, generally harmless mites, can also be found in the skin in an elevated quantity in people with rosacea.

Rosacea may worsen over time if left untreated. People that suspect they suffer from rosacea should visit their dermatologist or healthcare provider for diagnosis and discuss what treatment is right for them. Because rosacea is a highly visible disease, it is known to cause embarrassment and anxiety in some patients, which in turn may cause frustration and have a negative impact on their social life.

About psoriasis

Psoriasis is a chronic, inflammatory skin disease estimated to affect approximately 125 million people worldwide.3 It ranges in severity from a few scattered red, scaly plaques (lesions), to involvement of almost the entire body surface. It may worsen with age, or wax and wane in its severity.4

Having psoriasis can be a heavy physical, social, emotional and economic burden. It may also increase the risk of developing other conditions like heart disease or diabetes. While there is currently no cure for psoriasis, there is a range of treatment options to alleviate symptoms.3

About Rosacea: Beyond the Visible

Rosacea: Beyond the Visible is a global disease awareness campaign, launched in June 2018 by Galderma. The campaign was initially launched to raise awareness of an expert-authored report highlighting the results of a global market research study involving >700 people with rosacea and >550 physicians, which investigated the true burden of rosacea. The campaign has a dedicated Twitter @Beyond_visible and @Rosacea_beyondthevisible Instagram channel, through which information is shared and those living with rosacea and HCPs are encouraged to participate in conversations about the reality of life with this skin disease.

About Beyond the visible: rosacea and psoriasis of the face

A global market research study involving 300 rosacea patients, 318 patients with psoriasis on the face and 361 doctors in 6 different countries (Canada, France, Germany, Italy, Poland and the USA) investigating their experience of living with, or treating patients living with, rosacea or psoriasis of the face. An expert-authored report of the findings was released in May 2020 and seeks to address three key questions What is the true extent of the burden patients face? How does it differ across the two facial skin diseases? By looking at the impact of facial skin disease from different angles, what insights can we gain to help patients and doctors achieve the best outcomes?

About Galderma

Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit http://www.galderma.com

Click here to view the survey results infographic: https://mma.prnewswire.com/media/1167325/Galderma_Rosacea_Psoriasis_PDF.pdf

Galderma media relations contact: Sbastien CrosHead of Corporate Communications[emailprotected] +41-21-642-76-94

https://www.galderma.com

SOURCE Galderma

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Galderma Global Research Reveals Struggles of People With Rosacea and Psoriasis of the Face Experiencing a Lack of Control and Impact on Mental...

Phase 2 Results of Tildrakizumab Show Significant Joint, Skin Improvements in Adults With Active Psoriatic Arthritis

Tildrakizumab is an IL-23 inhibitor indicated for adults with moderate-to-severe plaque psoriasis and is under investigation for PsA.1

PsA is a chronic, inflammatory disease affecting the joints and places where tendons and ligaments connect to bone.2 The disease leads to inflammation, which causes swelling, pain, and stiffness in the joints, as well as fatigue. PsA affects up to 42% of people with plaque psoriasis in the United States, and typically begins between ages 30 and 50, although it can start at any age.2

Of 500 patients screened for the study, 391 were randomized and received 1 or more doses of the drug. From baseline to week 24, 1 case of pyelonephritis and urinary tract infection and 1 case of chronic tonsillitis was reported. No deaths or major adverse cardiac events occurred.1

In adults with active PsA, the new phase 2 results met primary and secondary efficacy and safety endpoints with statistical significance at week 24. In patients who received tildrakizumab, signs and symptoms including tender and swollen joints, levels of skin clearance, and minimal disease activity response all improved through week 24 and were maintained through week 52. For patients who received 100 mg of the drug, results were seen as early as 8 weeks.1

REFERENCES

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Phase 2 Results of Tildrakizumab Show Significant Joint, Skin Improvements in Adults With Active Psoriatic Arthritis - Pharmacy Times

Eight months after UCB announced that a little-watched drug candidate outperformed J&Js blockbuster Stelara, the Belgian pharma is out with full data that one investigator calls remarkable.

In the Phase III trial, 58.6% of patients who took UCBs IL-17 blocker bimekizumab were completely cleared of skin lesions after 16 weeks, compared to 20.9% of patients on Stelara. The UCB drug also outperformed Stelara at how many patients were clear after one year and at lesser benchmarks for plaque clearance, with more than 8 out of 10 patients showing 90% improvement, compared to roughly half on Stelara.

In a second study, first announced positive in November, bimekizumab was compared to placebo. In that one, 68% of patients on the treatment arm saw their skin completely clear and over 90% saw a 90% improvement. For placebo that number was 1.2%.

It really showed some quite impressive, remarkable I dont know how you want to say it, but extremely high level of responses, Kenneth Gordon, lead investigator on the placebo-controlled study, told Endpoints News.

Gordon singled out a couple distinct characteristics about the responses that stood out. Those included how sweepingly the drug alleviated symptoms, how quick it did so, and how long it lasted.

If you compare it to other clinical trials programs, both the speed and magnitude of the responses were around the highest weve seen, Gordon said.

Researchers often caution against comparing different clinical trials, such comparisons will be crucial for a drug like bimekizumab. The plaque psoriasis is a highly competitive market, suffuse with approved biologics from some of the worlds biggest drugmakers. Stelara is just one of several options patients can currently choose from.

The new data were released in abstracts for the annual American Academy of Dermatology meeting. On Friday afternoon, AbbVie also released abstracts from its open-label Phase III trial testing Skyrizi, an IL-23 inhibitor approved last year for psoriasis, against Novartis Cosentyx.

While trouncing Cosentyx, Skyrizi showed a virtually identical ability as UCBs drug to clear plaque psoriasis after one year: 66%. In addition, Eli Lillys IL-17 inhibitor beat J&J Tremfya last year in a head to head trial on psoriasis. UCB also beat AbbVies Humira last year, although results have yet to be announced.

From a medical perspective, though, Gordon suggested that asking which one is best might not be the best approach. Instead, prescribing decisions may come down to matching individual patients to the best drug.

Bimekizumab blocks multiple cytokines involved in plaque psoriasis, IL-17a and IL-17f. Because IL-17f exists in greater quantities in plaques, but IL-17a is more active, it had been an open question whether it was best to blockade both or if you could just target one and have the same effect.

Though cautioning no trial has been completed, Gordon said the latest data seem to resolve that debate. He argued the new insight, along with some of the other new molecules, represented a capstone on the progress the field has made since the chemotherapy drug methotrexate was first given to modest effect in the 1950s.

This might be culminating biologic molecule for psoriasis we have in the near future, he said. Now the question is how can we best apply each of our medications.

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UCB flashes the data behind its positive psoriasis readouts. Can it compete in a crowded field? - Endpoints News

Immune-mediated inflammatory conditions such as inflammatory bowel disease (Crohn disease [CD], ulcerative colitis [UC]), psoriasis, and rheumatoid arthritis (RA) are frequently treated with antitumor necrosis factor-alpha (TNF-) agents. TNF- inhibitors (TNFIs) have shown significant clinical safety and efficacy profiles in these inflammatory conditions; however, the potential risks of long-term use are a consistent concern of both physicians and patients.

As the TNF- pathway plays a critical role in tumor surveillance, there is concern that inhibition of this pathway could predispose patients to certain malignancies.1 One such cancer that is of great concern with respect to the TNF- pathway is melanoma.1 As the use of TNFIs and other biologics have grown increasingly popular, there has been noteworthy research interest in the actual risk of melanoma in these patients.

When evaluating a study estimating the risk of melanoma in patients receiving TNFIs, it is critical to determine if the comparison group is either the general population or patients with inflammatory conditions treated with other systemic therapy. There is a meager number of studies specifically evaluating the latter, especially studies with IBD and psoriasis. Interestingly, Esse and colleagues recently published a systematic review and meta-analysis in JAMA Dermatology specifically evaluating the risk of melanoma in patients with IBD, RA, and psoriasis who were treated with biologic therapy compared to those who had received only other conventional systemic therapy.2

The authors identified 7 studies, all of which were published between 2007 and 2019, and were cohort studies that were conducted in several countries (United States, Denmark, Sweden, and Australia). These studies included a total of 34,029 patients who received biologic therapy compared with 135,370 biologic-naive patients who had received conventional systemic therapy. Mean patient-follow duration ranged from 1 year to 5.48 years. Most studies included TNFIs, however, there were some patients receiving abatacept and rituximab were also included in the meta-analysis.

There were no significant differences found in the pooled relative risk (pRR) estimates for patients treated with biologic therapy compared with those who were treated with conventional therapy in IBD (pRR, 1.20; 95% CI, 0.60-2.40) and RA (pRR, 1.20; 95% CI, 0.83-1.74).

All of the included studies were considered high-quality studies, according to the review authors, and there was no evidence of publication bias or significant heterogeneity in the studies across the patient groups. When specifically looking at each biologic agent individually (TNFIs, abatacept, rituximab), there remained no statistically significant difference in melanoma risk when compared with patients receiving conventional therapy. If individual RA studies were excluded, sensitivity analyses showed that the pRR continued to not be statistically significant from patients receiving conventional therapy.

A key distinguishing factor of this study was inclusion of patients with inflammatory conditions whom were biologic naive and their comparison with those receiving standard therapies. This study is interesting to juxtapose with several prior studies evaluating similar melanoma outcomes. Singh and colleagues published a similar systemic review and meta-analysis in Clinical Gastroenterology and Hepatology in 2014 that specifically evaluated the risk of melanoma in patients with IBD.3 This review evaluated 12 studies that included 172,837 patients with IBD and found a pooled crude incidence rate (IR) of melanoma in patients with IBD of 27.5 cases per 100,000 person-years (95% CI, 19.9-37). Overall, IBD was associated with a 37% increased risk of melanoma. This relative risk was higher in those patients with CD (RR, 1.80; 95% CI, 1.17-2.75) compared with those with UC (RR, 1.23; 95% CI, 1.01-1.50). This increased risk of melanoma was found to be independent of biologic therapy.

Another systematic review published by Peleva and colleagues in the British Journal of Dermatology in 2018 evaluated 8 prospective cohort studies evaluating the risk of all cancers in patients with psoriasis who were treated with biologic therapies.4 The authors found an increase in nonmelanoma skin cancer (NMSC) particularly squamous cell carcinoma but there was no evidence of increased risk of melanoma. This review was limited by the inclusion of only 1 study evaluating melanoma risk in patients treated with ustekinumab.

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Melanoma Risk and Biologic Therapy: Is There a Link? - Cancer Therapy Advisor

MUMBAI, India and PRINCETON, N.J., June 12, 2020 /PRNewswire/ -- Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" including its subsidiaries and/or associate companies) today announced that one of its wholly owned subsidiaries presented further evidence of the long-term use and cost-effectiveness of ILUMYATM (tildrakizumab-asmn) in moderate-to-severe plaque psoriasis at the American Academy of Dermatology (AAD) Virtual Meeting Experience 2020.

Click to Tweet#NEWS: @SunPharma_Live announces long-term evidence offering insights into the clinical use of a treatment option in a cross section of people with moderate-to-severe plaque psoriasis. Read more: bit.ly/36VsmDI#AADVMX2020

Long-term analyses of the reSURFACE 1 and 2 extension studies found that ILUMYA offers sustained and improved results in patients with moderate-to-severe plaque psoriasis who received treatment for up to four years with no new safety concerns recorded.1,2 Furthermore, the safety profile of ILUMYA was reconfirmed in a five-year analysis that demonstrated low and similar exposure-adjusted incidence rates of malignancies from year four to year five. A majority of malignancies were singular events with similar incidence rates as seen in the general US population.3

Another post-hoc analysis of 335 patients who were predominately bio nave showed that those who achieved PASI 50 or higher after 6 months of treatment with ILUMYA saw continued improvement and sustained response rates when they maintained treatment for up to three years. Those patients who achieved PASI 90 at week 28 had rapid improvements as early as week 4.4

Mean Percent Change from Baseline PASI Score Over Time

Week 28 (n)

Week 52 (n)

Week 148 (n)

PASI 50-74 at Week 28

64.4% (34)

79.4% (34)

81.4% (22)

PASI 75-89 at Week 28

83.5% (79)

83.8% (78)

94.8% (63)

PASI 90-99 at Week 28

95% (131)

85.3% (131)

92.4% (117)

PASI 100 at Week 28

100% (91)

98% (90)

95.4% (81)

*95% confidence interval | Data are as observed and sample size at each study week is based on subjects with non-missing data.

ILUMYA 100 mg was well-tolerated, with a low rate of adverse events (AEs) that were comparable or numerically lower than placebo or etanercept based upon exposure-adjusted rates for many AE categories. The most common (1%) adverse reactions associated with ILUMYA are upper respiratory infections, infection site reactions, and diarrhea.

"Notably, 85 percent of the patients included in our analysis had never used a biologic before even though they have been living with psoriasis for over a decade," said lead investigator Kim Papp, M.D., Ph.D., founder and president of Probity Medical Research in Waterloo, Ontario, Canada. "This tells dermatologists that ILUMYA will treat different types of patients who have moderate-to-severe plaque psoriasis. ILUMYA is a good treatment option to consider for treatment navepatients; for patients having inadequate response to topicals or who are intolerant to or not responding well to oral treatments; and for any patient in need of a new treatment to address the chronic nature of this disease."

Six additional long-term analyses showed ILUMYA offers similar efficacy and safety results in patients with metabolic syndrome or patients who are over 65 years of age, factors that may make treatment more complex.5 6,7,8,9,10 Metabolic syndrome has a higher prevalence in patients with moderate-to-severe psoriasis compared to the overall population and an impact on response rates to many anti-TNF and IL-17 treatments.8 The analyses found that metabolic syndrome had minimal effect on the positive results seen in people treated with ILUMYA for up to three years and there was no increase in cardiac events or worsening of diabetes, compared to those without metabolic syndrome.

Furthermore, a 10-year cost analysis study revealed that ILUMYA is among the most cost-effective first-line therapies for treating moderate-to-severe plaque psoriasis and is more cost-effective than many other biologics, including risankizumab, secukinumab, guselkumab, ixekizumab, adalimumab, ustekinumab, etanercept, or certolizumab pegol.11

"It is exciting to share this wealth of clinical insights that continue to confirm the potential of ILUMYA to manage moderate-to-severe plaque psoriasis effectively and safely across different types of patients and as a cost-effective, first-line biologic treatment option," said Alan Mendelsohn, M.D., Associate Vice President, Dermatology Medical Affairs, Sun Pharma. "We are dedicated to continue bringing insights and support on the use of ILUMYA in daily clinical practice as well as exploring its potential for people living with other chronic autoimmune diseases."

ILUMYA is approved for adults with moderate-to-severe plaque psoriasis and is being evaluated for other possible uses. See ongoing studies below for more information.12,13 Visit http://www.ILUMYA.com to learn more about the ILUMYA SUPPORT Lighting the Way program that helps patients get started with treatment, understand cost and saving options, and connect with experts and others living with plaque psoriasis.

Please click here for Full Prescribing Information and Medication Guide.

Notable ILUMYA Analyses Presented at the AAD Virtual Meeting Experience 2020

The 2020 AAD Virtual Meeting Experience is accessible via registration here. *Abstract sponsored by Almirall who markets tildrakizumab-asmn in EU

About the reSURFACE Extension Studies

The Phase-3 studies (reSURFACE 1andreSURFACE 2) were randomized, placebo-controlled, multicenter, three-part studies designed to evaluate efficacy and safety of ILUMYA100 mg and 200 mg in moderate-to-severe plaque psoriasis compared to placebo and comparative drug and to assess safety and tolerability. Participants with at least 50 percent improvement in PASI 50 at base study completion who received ILUMYA within 12 weeks of base study end (week 52 or 64) were eligible to enroll in the extension study and continued on the same ILUMYA dose once every 12 weeks. Researchers evaluated PASI and PGA response (score of 0 or 1 with 2 grade reduction from baseline) and incidence rates for prespecified adverse events, including severe infections, cardiovascular events and drug-related hypersensitivities.

About ILUMYA(tildrakizumab-asmn)

ILUMYA (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, in the United States. ILUMYAhas also been approved for moderate-to-severe plaque psoriasis in Australia and under the brand name ILUMETRITM in Europe.

IMPORTANT SAFETY INFORMATION

ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any other excipients.

Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trial. If a serious hypersensitivity reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.

ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and discontinue ILUMYA until the infection resolves.

Evaluate patients for TB infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after ILUMYA treatment.

Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines.

Most common (1%) adverse reactions associated with ILUMYA include upper respiratory infections, injection site reactions, and diarrhea. Adverse reactions that occurred at rates less than 1% but greater than 0.1% in the ILUMYA group and at a higher rate than in the placebo group included dizziness and pain in extremity.

About Sun Dermatology

Sun Dermatology (the branded dermatology division of a wholly owned subsidiary of Sun Pharmaceutical Industries Inc.) is committed to expanding its dermatology portfolio to bring healthcare providers and patients around the world more treatment options and ongoing support for conditions like moderate-to-severe plaque psoriasis. Sun Pharmaceutical Industries Ltd., along with its subsidiaries, is ranked second in dermatology prescription volume within the U.S. per IQVIA and is the fourth largest specialty generic pharmaceutical company globally. In addition to ILUMYA, Sun Dermatology is comprised of several branded products with a focus on various dermatologic conditions.

About Sun Pharmaceutical Industries Ltd. (CIN - L24230GJ1993PLC019050)

Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 7% of annual revenues in R&D. For further information, please visit http://www.sunpharma.com& follow us on Twitter @SunPharma_Live.

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Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.

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Local steroid injections are associated with clinically meaningful improvements in active dactylitis in patients with psoriatic arthritis (PsA), according to the results of a multicenter study published in Clinical Rheumatology.

Nonsteroidal anti-inflammatory drugs (NSAIDs) and local corticosteroid injections are currently recommended for the treatment of dactylitis in patients with PsA; however, there is very little information on the efficacy of local corticosteroid injections. In an observational prospective study, investigators aimed to compare the efficacy of local steroid injections and NSAIDs on the digital flexor tendon sheath for the treatment of active dactylitis in patients with PsA.

The Leeds Dactylitis Index basic (LDI-b) score was calculated at baseline, with patients rating their local pain intensity and functional impairment on 10 cm scales for each involved digit. Assessments were repeated at 1 and 3 months, postprocedure. Researchers recorded the presence of local or systemic events at each examination.

The primary objective of interest was a clinically meaningful treatment response, defined as the reduction of visual analog pain (VAS-pain) and functional impairment (VAS-FI) scores by 5 points or VAS-pain and VAS-FI scores <2. The secondary objective of interest was complete dactylitis remission (VAS-pain=0 and VAS-FI=0).

A total of 24 patients with 38 dactylic fingers were treated with steroid injections and 22 patients with 35 dactylic fingers were treated with NSAIDs. At baseline, there was no significant difference in VAS-pain score, finger circumference, or LDI-b between groups, though VAS-FI score was significantly higher in the steroid-treated group (7.871.53) than the NSAID-treated group (6.891.82; P =.018).

Significant improvements in clinical parameters were observed at 1 and 3 months in both groups; however, there were no improvements in VAS-pain scores at either time point in the NSAID-treated group. The reduction in VAS-pain (P <.001), VAS-FI (P <.001), and LDI-b values (P =.008) was greater in the steroid-treated group compared with the NSAID-treated group at 1 month. This trend continued at 3 months, post-treatment (P <.001 for all). A clinically meaningful treatment response was observed in 87% of dactylic fingers in the steroid-treated group compared with 17% in the NSAID-treated group (P <.001) at 1 month. This difference remained significant at 3 months as well. Complete remission was observed exclusively in the steroid-treated group in 1 and 7 cases at 1 and 3 months, respectively.

According to multiple regression analysis, the steroid injections were associated with a clinical response at both 1 (odds ratio [OR], 20.104; 95% CI, 2.481-162.9; P =.002) and 3 months (OR, 27.950; 95% CI, 3.227-142.1; P =.002), postprocedure.

Researchers noted that patients were given the choice to receive local steroid injections or NSAID treatment, and that the lack of randomization represented a limitation of the study. In addition, it was unclear what long-term maintenance may be needed to maintain the efficacy of steroid injections given the short duration of the study.

[T]hese data support the use of steroid injections into the digital flexor tendon sheath for psoriatic dactylitis, the researchers concluded. [L]ocal steroid injection can be recommended as a safe and effective first-line therapy for psoriatic dactylitis.

Reference

Girolimetto N, Macchioni P, Citriniti G, et al. Effectiveness of steroid injection for hand psoriatic dactylitis: results from a multicentre prospective observational study [published online May 16, 2020]. Clin Rheumatol. doi:10.1007/s10067-020-05142-z

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Steroid Injections Improve Pain and Functionality Measures in Hand Psoriatic Dactylitis - Rheumatology Advisor