Category Archives: Psoriasis

MoonLake Immunotherapeutics to initiate global Phase 2 studyofthe Nanobody sonelokimabin patients with active psoriatic arthritis

ZUG, Switzerland, September 26, 2022 MoonLake Immunotherapeutics AG (MoonLake), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced U.S. Food and Drug Administration (FDA) clearance for a Phase 2 clinical study of the nanobody sonelokimab in patients with active psoriatic arthritis (PsA). This is a global clinical study that also includes several European countries.

This new study is subsequent to the completion of a global Phase 2b study in moderate-to-severe psoriasis (NCT03384745) and the initiation of the Phase 2 MIRA study in moderate-to-severe hidradenitis suppurativa (NCT05322473).

The global, randomized, double-blind, placebo-controlled study (M1095-PSA-201, ARGO) is designed to evaluate the efficacy and safety of different doses of sonelokimab compared to placebo, with adalimumab as an active reference arm, in approximately 200 patients with active PsA. The primary endpoint of the study is the American College of Rheumatology (ACR) 50 response defined as the percentage of participants achieving 50% improvement in signs and symptoms of disease from baseline, compared to placebo. This study is the first in PsA to use the Nanobody.

The study will also include a range of secondary endpoints reflecting the heterogeneous and multi-faceted nature of the disease, including the assessment of skin clearance (including Psoriasis Area and Severity Index (PASI) 100), disability, enthesitis, pain, as well as other levels of ACR response (including ACR70). Patient enrollment is expected to begin in 2022, with the first sites being initiated in Europe and in the United States.

Sonelokimab (M1095) is an investigational Nanobodydesigned to treat inflammatory disease by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. In addition, sonelokimab is designed to directly target sites of inflammation and penetrate difficult-to-reach inflamed tissues.

Kristian Reich,Co-founder andChief Scientific Officer at MoonLake, said: The initiation of the ARGO study represents an important milestone in the development of the IL-17A and IL-17F inhibiting Nanobody sonelokimab for the treatment of inflammatory skin and joint conditions. I am particularly excited to see how the small size and albumin-binding properties of sonelokimab will further elevate the anti-inflammatory potential of IL-17A and IL-17F inhibition to improve treatment outcomes across various disease domains of PsA including arthritis, enthesitis and psoriasis.

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About the ARGO studyThe ARGO study (M1095-PSA-201) is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of the Nanobodysonelokimab, administered subcutaneously, in the treatment of adult patients with active psoriatic arthritis. The study will comprise approximately 200 patients, and will evaluate different doses of sonelokimab, with placebo control and adalimumab as an active reference arm. The primary endpoint of the study is the percentage of participants achieving 50% improvement in signs and symptoms of disease from baseline, compared to placebo, as measured by the American College of Rheumatology (ACR) 50 response. The study will also evaluate a number of secondary endpoints, including improvement compared to placebo in ACR70, complete skin clearance as measured by at least a 100 percent improvement in the Psoriasis Area and Severity Index (PASI100), physical function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI), enthesitis as measured by the Leeds Enthesitis Index and pain as measured by the Patients Assessment of Arthritis Pain (PtAAP).

About MoonLake ImmunotherapeuticsMoonLake Immunotherapeutics AG is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The companys focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at http://www.moonlaketx.com.

About NanobodiesNanobodies represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and the ability to design multivalent therapeutic molecules with bespoke target combinations.

The terms Nanobody and Nanobodies are trademarks of Ablynx, a Sanofi company.

About SonelokimabSonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody consisting of three VHH domains covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema.

Sonelokimab has been assessed in a randomized, placebo-controlled Phase 2b study in 313 patients with moderate-to-severe plaque-type psoriasis. Sonelokimab demonstrated a rapid and durable clinical response (Investigators Global Assessment Score 0 or 1, Psoriasis Area and Severity Index 90/100) in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575).

In an earlier Phase 1 study in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196203). Recently, a phase 2 trial in hidradenitis suppurativa (NCT05322473, M1095-PSA-201,MIRA) including multiple arms and over 200 patients has been initiated (announced on May 5, 2022).

Sonelokimab is not yet approved for use in any indication.

About Psoriatic ArthritisPsoriatic arthritis (PsA) is a chronic and progressive inflammatory arthritis associated with psoriasis primarily affecting the peripheral joints. The clinical features of PsA are diverse, involving pain, swelling, and stiffness of the joints, which can result in restricted mobility and fatigue.PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. The symptom burden of PsA can have a substantial negative impact on patient quality of life. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology.

Cautionary Statement Regarding Forward Looking StatementsThis press release contains certain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLakes expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: plans for preclinical studies, clinical trials and research and development programs; and the anticipated timing of the results from those studies and trials. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words anticipate, believe, continue, could, estimate, expect, intend, may, might, plan, possible, potential, predict, project, should, would and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking.

Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLakes business in general and limited operating history, difficulty enrolling patients in clinical trials, and reliance on third parties to conduct and support its preclinical studies and clinical trials.

Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based.

MoonLake Immunotherapeutics InvestorsMatthias Bodenstedt, CFOinfo@moonlaketx.com

MoonLake Immunotherapeutics MediaPatricia Sousap.marquesdesousa@moonlaketx.com

Matthew Cole, Mary-Jane ElliottConsilium Strategic CommunicationsTel: +44 (0) 20 3709 5700media@moonlaketx.comMoonLake@consilium-comms.com

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MoonLake Immunotherapeutics to initiate global Phase 2 study of the Nanobody sonelokimab in patients with active psoriatic arthritis - BioSpace

Healthcare is an area where diversity and inclusion (D&I) can directly affect a persons quality of life and treatment outcomes. Recently in the field of dermatology, a focus on D&I is helping to redress historical bias and open avenues of research, bringing benefits to patients and healthcare systems alike.

Historically, medical textbooks have described skin symptoms in Caucasian-dominated language, based on lighter skin tones causing diagnosis and treatment disparities, with patients with darker skin tones being under-diagnosed and under-treated.1 Today, medical education programmes are rewriting textbooks, materials, and trainings to bridge this knowledge gap and reduce the chances of skin colour impacting accurate diagnosis and treatment. The British Association of Dermatologists highlighted the issue, noting that descriptors for rashes and lesions have been based on people of European ancestry.2 It observed that it is vital that the language used for describing rashes/lesions in dermatology is updated, to be inclusive and reflective of the UKs ethnic diversity. Demand is clear: a new clinical handbook of signs and symptoms in black and brown skin called Mind the Gap, has been viewed online more than 100,000 times.3

Janssen, as part of the pharmaceutical companies of Johnson & Johnson, has a 130-year heritage in healthcare. As we rise to the call to help address historical inequities, we are proud to take a multi-faceted approach which includes the active embedding of D&I principles throughout our organisation. In immunology, were reframing clinical trials, drug development, and support networks for patients suffering with chronic skin conditions and other diseases. D&I must be integral to beliefs and behaviours to be truly transformative in healthcare.

Dr Mehbub Shafi, Medical Advisor at Janssen-Cilag Ltd, notes changes seen since his medical training: Dermatological conditions affect patients of all skin tones, but symptoms can manifest differently, he says. While lack of awareness of these differences may have been an issue in the past, I can see that things are improving.

A clear example can be seen in psoriasis, an incurable chronic condition affecting 1.8 million people in the UK, 14 million Europe-wide and 125 million globally.4,5,6 The effects can be both physically and psychologically scarring. Research has shown that 37% of psoriasis patients experienced suicidal thoughts, while the impact on family members is evidenced by 37% of close relatives and partners reporting their relationships suffered because of the condition.7,8 Every aspect of life is impacted for example, people with psoriasis miss an average of 306 hours of work per year, more than eight weeks based on a 7.5-hour work day.9

Dr Shafi notes: There is the medical aspect, which is huge, but the psychological and psycho-social aspects are important too because patients living with a dermatological disease often have a higher incidence of mental health issues. Addressing diversity and inclusivity to achieve optimal treatment is pivotal in improving outcomes for patients with darker skin tones.

Diversity is relevant not just in psoriasis diagnosis, but also in treatment where, for example, higher doses of phototherapy may be needed for darker skin.10 Janssens UK medical education programme, aimed at and targeted to dermatologists across the UK, has focussed specifically on diversity and skin of colour. Janssen is also actively working with the UK dermatological community to develop resources supporting diagnosis and treatment in diverse communities,through partnerships with patient advocacy groups and patient advisors to ensure materials are tailored to diverse patient needs.

When it comes to decision-making in dermatological R&D, Janssen works with patients to enshrine the patient voice. This helps us deliver on the Johnson & Johnson credo: our first responsibility is to patients, doctors and nurses, followed by our responsibility to the communities in which we live and work, and then the global community, says Dr Shafi.

In addition to supporting better access to care, we are also raising awareness in the healthcare community about important issues in the diagnosis and treatment of diverse or under-represented groups. It is important to gain feedback from patients living with psoriasis and healthcare professionals, understanding their concerns and then implementing and driving activities that will have an impact.

At Janssen, the patient voice is central to pursuing novel research and improving therapies, to support work to stop and even cure dermatological diseases. Janssen will continue working with patients and experts to promote health equity for all as we work towards our mission to redefine treatments for dermatological diseases by delivering transformational and accessible therapies.

For more information, please visit http://www.janssen.com/uk

References

1 Takeshita J, Gelfand JM, Li P, et al. Psoriasis in the US Medicare Population: Prevalence, Treatment, and Factors Associated with Biologic Use. J Invest Dermatol 2015; 135(12): p2955-2963

2 British Association of Dermatologists. Improving Descriptors in Dermatology. Available at: https://www.bad.org.uk/healthcare-professionals/inclusivity-and-representation/descriptors-in-dermatology. Last accessed: September 2022

3 Dhillon R, Booth AJ & Mukwende M. Mind the Gap. British Dental Journal 2021; 230(273)

4 Psoriasis Association. About Psoriasis. Available at: https://www.psoriasis-association.org.uk/about-psoriasis. Last accessed: September 2022.

5 Augustin M, Alvaro-Gracia JM, et al. A framework for improving the quality of care for people with psoriasis. Psoriasis White Paper. JEADV 2012; 26(4): p1-16

6 National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Last accessed: September 2022

7 Pompili M, Innamorati M, et al. Suicide risk and psychiatric comorbidity in patients with psoriasis. Journal of International Medical Research 2016; 44(1): p6166.

8 Eghlileb A, Davies E and Finlay A. Psoriasis has a major secondary impact on the lives of family members and partners. British Journal of Dermatology 2007; 156(6): p124550.

9 Mustonen A, et al. How much of the productivity losses among psoriasis patients are due to psoriasis. BMC Health Services Research 2015; 15(87)

10 National Psoriasis Foundation. Psoriasis and skin of color. 2021. Available at: https://www.psoriasis.org/advance/diagnosing-psoriasis-in-skin-of-color/. Last accessed: September 2022

Dr Mehbub Ali Shafi is Medical Adviser, Dermatology, The Janssen Pharmaceutical Companies of Janssen-Cilag Ltd.

* EM-80125 | September 2022

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How diversity and inclusion continues to be incorporated in dermatology - PMLiVE

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Arcutis Announces Topline Results From ARRECTOR Pivotal Phase 3 Trial Of Roflumilast Foam 0.3% In Scalp A - Benzinga

Ottawa, Aug. 15, 2022 (GLOBE NEWSWIRE) -- The global psoriasis treatment market size was accounted at USD 27.36 billion in 2022. Psoriasis is a skin disease which is produced as a result of autoimmune disorder which occurs in the individual it is an inflammatory process that the body undergoes in which the skin cells are produced in excess. and the symptoms include extreme itching all over the body or in the particular part affected, pain may be associated with the condition sometimes and extreme dryness of the skin with flakiness.

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This disease does not spread through touch or contact but may be inherited from the ancestors but cannot be labeled as a genetic disorder. The red lesions which appear on the skin are accompanied by flaky skin eruptions. This disease has been divided under two headings of psoriatic arthritis and plaque psoriasis. In certain individuals so this is also associated with joint complaints which is termed as psoriatic arthritis.

Key Takeaways:

Report highlights

Regional Snapshots

The region of North America has the largest market for psoriasis treatment as a result of the huge population suffering with this autoimmune disorder. The geriatric population has also proved to be a driving factor for the growth of the psoriasis treatment market. The prevalence of psoriasis in the region of North America is such that special campaigns have been organized by the government in order to spread awareness regarding the treatment facilities and symptoms of the disease. The modern lifestyle which is followed in this region has hampered the food habits of the people which also increases the risk associated with the disease.

The European market has proved to be the next largest after the region of North America which has shown great prevalence for this disease.

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Scope of the Report

Market dynamics

Drivers

The rapidly increasing number of patients of psoriasis has helped to increase the demand for its treatment. This has led to a rapid demand and supply of medicines which are used to treat psoriasis in the market. The key market players have conducted rapid research and development programs in order to introduce effective medicines and treatment options to the patients. this autoimmune skin disorder has not remained restricted to a particular age group and has shown its prevalence in people belonging to almost every age. It has no specific causative factor but is seen to be developed as a result of autoimmune disorder in the body. The symptoms of this disease present itself in the form of dry skin eruptions and can reach a severe stage if not managed in time.

Restraints

The high cost associated with the use of modern medicines have imposed and additional pressure on the common man suffering with this autoimmune skin disorder. The lack of disposable income in the hands of the people as a result of inflation has affected the growth of the market to a great extent. The occurrence of the pandemic had a considerable effect on the psoriasis treatment market as a result of the restricted movements imposed by the government and the strict guidelines of the hospital regarding follow-ups and regular visits. As a result of this the treatment of many patients got hampered and hence the symptoms aggravated over the period of time. Though the online pharmacies played an important role in maintaining the speed of the market it did not play a significant role.

Opportunities

The rapid demand for faster and better treatment of psoriasis within a shorter period of time has proved to be a great opportunity for the market. With the increasing life expectancy, the number of elderly people suffering with this skin disorder has increased. Parenteral applications which are available in the market over the counter has proved to be the biggest opportunity for the growth of the market. Lucrative offers and schemes which are offered by the insurance companies in order to encourage the people for psoriasis treatment has proved to be a great opportunity for the market.

The long-term treatment which is associated with this autoimmune skin disorder is also a wonderful opportunity as the demand and supply keeps continuing over the period of time of treatment. With the rapid advancements seen in the method of treatment and the use of modern medicine the number of side effects associated with the use of these chemically formulated drugs have also reduced.

Challenges

The treatment of this autoimmune skin disorder takes a very long period of time which proves to be a challenge for the growth of the market. The patient usually loses confidence and patience which results in a breach of the treatment and shows a direct impact on the growth of the market. With the use of advanced medicine for the treatment of the disease the cost of the treatment also increases tremendously. This makes it impossible for the common man to opt for the treatment with the help of advanced medicines.

Recent Developments

Market Segmentation

By Drug Class

By Treatment Type

By Type

By Route of Administration

By Distribution Channel

By Geography

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Psoriasis Treatment Market Size to Hit USD 51.24 Bn by 2030 - GlobeNewswire

Ventyx Biosciences VTYX announced positive data from the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial of VTX958, a novel and selective allosteric TYK2 inhibitor.

The Phase 1 clinical trial was a dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTX958 in single and multiple ascending doses with 96 adult healthy volunteers.

VTX958 was well tolerated across all 7 cohorts in the SAD portion and all 5 cohorts in the MAD portion of the Phase 1 trial with no discontinuations due to adverse events.

William Sandborn, President and Chief Medical Officer, commented: "Data from the Phase 1 trial of VTX958 demonstrate an excellent safety profile and class-leading TYK2 inhibition as measured by IC50and IC90coverage. We believe these data will allow us to explore high levels of target inhibition in future clinical studies, which may support clinical differentiation in relevant disease populations, such as psoriasis, psoriatic arthritis and lupus.

The company is planning to move forward VTX958 into multiple Phase 2 trials, for diseases like psoriasis, Crohn's disease and psoriatic arthritis, in thefourth quarterof 2022.

Price Action : Ventyx shares closed Mondays trading 2 percent higher at $18.60

Original post:
Ventyx Sees Initiation Of Mid-Stage Psoriasis Study In Q4 2022 Following Positive Data From Initial-Stage - Benzinga

Bullies are messing with the wrong one.

29 year old Jude Duncan of Glasgow, Scotland battles psoriasis that leaves red, flaky blotches on her skin that form scales so painful sometimes she struggles to walk. But she says those who stare and giggle at her condition are just bullies living through an Instagram filter.

For a long time I was depressed and anxious because of it.I just hid away from theworldbecause of it, she told the Glasgow Times. It was also sore and irritating. I could wake up with blood on my pillow if I scratched it in my sleep. The more depressed I got about it the worse the condition got. It felt like a vicious cycle.

The 29 year old says shes struggled with psoriasis for nine years. She first noticed a small patch appear on her forehead before it took over around 40% of her face.

I couldnt put on a foundation to cover it up so it was pretty visible and people would stare, she said. If I went on dates I would need full blown conversations about it before it, and if I didnt I would get some nasty comments.

Duncan believes her condition may have been triggered by the stress of her fourth year at university and writing her dissertation. Shes now on medication which has helped to clear up her skin and reduce her symptoms.

It took me a long time to be comfortable and happy in my skin. It is something I am going to have to keep working on, she said.

Part of her work includes speaking out during Psoriasis Action Month, with the goal of educating others to treat people with visible differences with kindness and understanding.

Now I am working to raise awareness. Just because someone looks different from you doesnt mean they are infectious or have something wrong with them, she said.

Duncan has become more confident about her condition, which in the past has left her feeling embarrassed and isolated.

The first couple years I was really insecure and ashamed of it. It became all-consuming because I worried about what people thought about my patches, she said. On the flip side though I found this amazing online community who related to me and I made great friends. It helped me build up my resilience.

Managing stress and relaxing your body is important, but certain types of food and drink, along with tobacco, can be huge culprits for triggering autoimmune conditions. For some, the sun will exacerbate symptoms. Salt water from the ocean, however, can be good for clearing up skin conditions.

Also, eating an anti-inflammatory diet can reportedly help immensely for controlling flare-ups. Some people with psoriasis try to combat its distressing effects by following a paleo diet. A paleo diet, by definition, mainly consists of meat, fish, vegetables, and fruit, and excludes dairy or grain products and processed food.

According to the Paleo Dietwebsite, Foods that cause inflammation include refined carbohydrates, wheat and other cereal grains, soda and other sugar-sweetened beverages, margarine, shortening and lard, and processed meats.

These types of foods can cause insulin (a hormone that controls our blood sugar) to spike in our bodies, which can contribute to inflammation and also alter our gut health, meaning change the ration of good bacteria vs. bad bacteria, which can wreak havoc on the body.

Overall, getting an adequate amount of rest and 7-8 hours of sleep every night is a tried and true method of putting less stress on your body, therefore lessening the severity of certain conditions like psoriasis.

Some skin infections such as staphylococcus (staph) can look like psoriasis and they can be contagious. However, psoriasis itself is not an infection and it is never contagious.

So if you have this condition or if a loved one does, there is no reason to be concerned about it being spread from person to person. If youre swimming, hugging, or playing a contact sport with someone who has psoriasis, you dont need to be fearful about getting this condition too.

If lifestyle changes are not doing the trick, or if you are unable to incorporate them during a highly stressful time, some psoriasis patients can reduce the severity of their flare-ups by using a topical solution. Still, many times treatments applied to the skins surface just arent enough to clear stubborn psoriasis. Thats where systemic treatment treatment that travels through your entire body rather than being aimed at one area can be beneficial for patients. Systemic treatments are available via oral medication and injections. Some have been around since the early 70s, while others are relatively new to the landscape.

I have patients who come in after having been to many other medical practices and not really getting much hope or really good treatments for their psoriasis,Dr. George Han, a dermatologist at Northwell Health/Lenox Hill Hospital, explains to SurvivorNet. And well give the patient a systemic medicine that these days are very effective. We have treatments where over half of the patients who have moderate to severe psoriasis are getting 100% clear.

I have patients who come in after having been to many other medical practices and not really getting much hope or really good treatments for their psoriasis,Dr. George Han, a dermatologist at Northwell Health/Lenox Hill Hospital, explains to SurvivorNet. And well give the patient a systemic medicine that these days are very effective. We have treatments where over half of the patients who have moderate to severe psoriasis are getting 100% clear.

Psoriasis can start at any age, but most often develops in adults between 20 and 30-years-old and between 50 and 60-years-old.

It affects men and women equally, and theres no cure. But a range of treatments can improve symptoms and the appearance of skin patches.

For some its just a minor irritation, but for others it can have a big impact on their quality of life.

My advice to anyone dealing with psoriasis would be to just be gentle with yourself. Youre already going through a lot but the condition doesnt define you.

She also says words matter.

Try and say positive things like if you did good self-care or find something you like about yourself.

Going forward, Jude is focusing on accepting her psoriasis in an effort to be happy and comfortable in her own skin.

Learn more about SurvivorNet's rigorous medical review process.

Link:
Woman, 29, Slams Bullies Who 'Giggle And Whisper' At Her Unsightly Psoriasis Sores And Scabs, Leaving Her Depressed And 'Struggling To Walk' -...

In patients with psoriatic arthritis (PsA), serum calprotectin levels are associated with the presence of carotid plaques, according to a study published in Frontiers in Immunology.1

In PsA patients, serum calprotectin level was independently associated with the presence of carotid plaques, probably involving platelet and endothelial cells activation, Isaac Cheng, PhD, of The Chinese University of Hong Kong in Shatin, China, and colleagues, wrote. Moreover, subclinical carotid atherosclerosis was associated with the inflammatory burden (as reflected by the disease duration) in these patients.

While the association between PsA and increased cardiovascular (CV) disease risk is well established, only limited data is available on the underlying mechanisms.

This cross-sectional study included 78patients (52.6% male, mean age 52 years) with PsA but without CV disease. Calprotectin levels in serum were quantified and high-resolution ultrasound was used to determine carotid intima-media thickness and the presence of plaque.

Of the patients, 37.2% had carotid plaques. Serum calprotectin level was significantly higher in the group with carotid plaques compared with those without carotid plaques (721.3 ng/ml vs 564.6 ng/ml, P = 0.005). Serum calprotectin level correlated with PsA disease duration and mean carotid intima-media thickness.

Least absolute shrinkage and selection operator regression was performed to screen out 19 predictive variables including age, gender, traditional CV risk factors, medication use, clinical features and disease activity. Ln-calprotectin (OR: 3.38, 95% CI [1.37, 9.47]; P = 0.026) and PsA disease duration (1.09, 95% CI [1.01, 1.18]; P = 0.013) were statistically significant in predicting carotid plaque.

Investigators developed a nomogram for discriminating the presence of carotid plaque, which they said was an easy reference for clinical practice, with good accuracy, sensitivity and specificity (AUC 0.744, sensitivity 65%, specificity 79%). They concluded that serum calprotectin level may be a useful biomarker associated with a high inflammatory burden and the presence of subclinical carotid atherosclerosis in patients with PsA.

A limitation of the study was that most of the patients had low disease activity, thus the results may not be applicable to patients with moderate or high disease activity.

Reference:

Cheng IT, Meng H, Li M, et al. Serum Calprotectin Level Is Independently Associated With Carotid Plaque Presence in Patients With Psoriatic Arthritis.Front Med (Lausanne). 2022;9:932696. Published 2022 Jul 8. doi:10.3389/fmed.2022.932696

More here:
Serum Calprotectin Levels Linked to Subclinical Carotid Atherosclerosis in Patients With Psoriatic Arthritis - Rheumatology Network

Wilde founded the successful skincare brand tbh, which often reposts images of customers on social media with their bare skin and blemishes. She attributes this to their very vocal base of Gen Z customers who she says are demanding greater representation from brands than generations before. I think that it has really been a bottom-up movement where customers have demanded a more balanced and more realistic portrayal of beauty.

The acceptance of different skin types, and the language around how we talk about skin, trails behind other movements, like body positivity. Beauty writer Jessica DeFino agrees, saying that skincare still has a lot of catching up to do. Whats missing, she says, is a challenge to the idea of healthy skin or normal skin. The body positivity movement has benefited immensely from challenging the idea that fat equals unhealthy. The skincare space needs to have that same reckoning in order to move forward with a meaningful movement of acceptance.

Model Onella Muralidharan wants there to be greater awareness of conditions like vitiligo. Credit:Bella Management

Onella Muralidharan won Bella Managements Unsigned Model Competition in 2021. The 23-year-old curve model has vitiligo, a condition in which parts of the skin lack pigmentation, and says she never thought she would be a model. Im curvy, and I have a skin condition that is quite apparent. I didnt really feel like I hit those beauty standards.

While she says she never really struggled with accepting her vitiligo, she certainly faced judgment from the outside world. When I worked in retail, customers would come up to me and ask, What happened to you?, Whats on your face? She adds that the most ignorant comments have come from adults, rather than children. Fully grown adults often feel like theyre entitled to an answer from people who look different.

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The fashion industry is slowly changing, she says. She has featured in campaigns for beauty brand Mecca, appeared on morning show Studio 10, and walked in Australian Fashion Week. Makeup artists will consult her about whats she comfortable with, and adapt their use of makeup to her needs. I dont want my different skin tones covered up, says Muralidharan. Mum put some foundation on me when I was about 7, and after that, I have never wanted to cover it up.

For Muralidharan, the key to spreading acceptance for conditions like vitiligo is education about what it is and how to act considerately around others.

Visibility for a range of skin conditions is certainly growing. Celebrities like Kim Kardashian, Cara Delevigne and Cyndi Lauper have been open about living with psoriasis. Kendall Jenner has walked the red carpet with acne and Alicia Keys has forgone makeup altogether. This kind of visibility is important, says Smith, to enhance public understanding, break barriers, minimise social stigmatisation, discrimination, and humiliation.

Its impossible, however, to consider the importance of these celebrity stories without accounting for the immense privilege they hold. They all fit a certain beauty ideal and have a level of wealth that gives them access to top-of-the-line beauty products, treatments and medicines.

Cara Delevigne chose not to cover her psoriasis at the 2022 Met Gala. Credit:Getty Images

Its much easier (and therefore less effective or revolutionary) for celebrities and influencers who conform to traditional beauty standards in other ways white, thin, pouty lips, wide eyes, youthful-looking to reveal a perceived flaw and still be considered beautiful, Defino says.

Rather than only slightly widening the goal posts to include a privileged few, we need to create a world without any such goal posts at all.

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Why skin is the forgotten frontier of the beauty acceptance movement - Sydney Morning Herald

Since the medicine's first approval in 2016, nearly 130,000 people in the U.S. have been treated with Taltz

INDIANAPOLIS, Aug. 8, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today the availability of a new, citrate-free formulation of Taltz (ixekizumab) injection 80 mg/mL. The new formulation, which was recently approved by The U.S. Food and Drug Administration in May 2022, includes the same active ingredient as the original formulation. The new Taltz formulation significantly reduced injection site pain experienced by some people immediately following injection as shown by an 86% decrease in a visual analog scale (VAS) of pain versus the original formulation. Taltz is approved to treat adults and children six years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, adults with active psoriatic arthritis, active ankylosing spondylitis (AS) and active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

"Taltz has long delivered effective treatment with a well-established safety profile that addresses symptoms for people living with plaque psoriasis, psoriatic arthritis, AS and nr-axSpA," said Ashley Diaz-Granados, vice president, U.S. Immunology at Lilly. "We're proud of our investment in research that keeps the patient experience at the center. This new formulation provides yet another reason to choose Taltz, and we look forward to introducing it to patients who have not yet tried Taltz and providing a seamless transition for those already enjoying the medicine's benefits."

Taltz citrate-free demonstrated a safety profile consistent with the original formulation. The safety information for Taltz can be found below.

Existing Taltz patients will not need a new prescription, nor should they experience a gap in their therapy. The new formulation is currently being shipped across the U.S. with anticipated broad availability for both new and existing Taltz patients by the end of the month. In the interim, the original formulation of Taltz continues to be available until it is replaced by the citrate-free formulation. The citrate-free formulation of Taltz was approved by the European Medicines Agency in December 2021 with several markets launching now and many more anticipated in the coming months.

"Today is an exciting milestone for the nearly 30 million people around the world who live with the challenging symptoms of these autoimmune diseases that affect the skin and joints," said April Armstrong, M.D., MPH, professor of dermatology and associate dean of clinical research, Keck School of Medicine at the University of Southern California. "In my six years of prescribing Taltz, I've seen firsthand the significant impact Taltz has had for patients across multiple indications. The availability of Taltz as a citrate-free formulation represents an important advance in patient care that will allow more patients to experience less injection-site pain."

Lilly is committed to improving experiences for people treated with Taltz, providing the same active ingredient in a new citrate-free formulation. Lilly's investment into patient-centric research is evident as Taltz has been studied in more than 10,000 people in clinical trials globally and has been available in most markets for more than five years.1 In the U.S., more people living with psoriasis are treated with Taltz compared to any other IL-17A antagonist, adding to the nearly 130,000 people in the U.S. who have been treated with the medicine.2

To learn more about real success stories with Taltz, please visit Taltz.com.

IMPORTANT SAFETY INFORMATION FOR TALTZ

CONTRAINDICATIONSTaltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONSInfectionsTaltz may increase the risk of infection. In clinical trials of adult patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

Pre-Treatment Evaluation for TuberculosisEvaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active TB during and after treatment.

HypersensitivitySerious hypersensitivity reactions, including angioedema and urticaria (each 0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel DiseasePatients treated with Taltz may be at an increased risk of inflammatory bowel disease. In clinical trials, Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group than the placebo group.During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

ImmunizationsPrior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.

ADVERSE REACTIONSMost common adverse reactions (1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profiles observed in adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis were consistent with the safety profile in adult patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis and conjunctivitis, influenza, and urticaria in pediatric psoriasis.

Please see fullPrescribing InformationandMedication Guidefor Taltz. SeeInstructions for Useincluded with the device.

IX HCP ISI 07MAY2020

About TaltzTaltz(ixekizumab) is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.

About the Citrate-Free Injection Pain StudyThe citrate-free injection pain study (N=70) was a subject-blind, randomized, crossover study in healthy participants ages 18-75 years to determine injection site pain differences between Taltz citrate-free formulation compared to the original formulation of Taltz. The primary endpoint, pain intensity on injection, was measured by the Visual Analog Scale (VAS) of pain 0-100mm.3

About LillyLilly unites caring with discovery to create medicines that make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 47million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer's disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visitLilly.comandLilly.com/newsroomor follow us onFacebook, Instagram, Twitterand LinkedIn.

P-LLY

Cautionary Statement Regarding Forward-Looking StatementsThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Taltz as a treatment for people with moderate to severe plaque psoriasis, active psoriatic arthritis, active ankylosing spondylitis and active non-radiographic axial spondyloarthritis and other conditions and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with study results to date. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

PP-IX-US-5653 08/2022 Lilly USA, LLC 2022. All rights reserved.

Taltz is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

SOURCE Eli Lilly and Company

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Lilly's Taltz (ixekizumab) Now Available in New, Citrate-Free Formulation to Reduce Injection Site Pain for Improved Patient Experience - PR Newswire

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Cleveland Clinic Dermatologist, Dr. Melissa Piliang says getting a little sun is a good idea if you have skin conditions like psoriasis or atopic dermatitis, but warns of the risks of too much sun.

If you have skin conditions such as eczema or psoriasis, you've probably been told that some time in the sun could be good for your skin. A Cleveland Clinic dermatologist says this is true, but it's important to make sure you're not overdoing it.

Cleveland Clinic Dermatologist, Dr. Melissa Piliang says getting a little sun is a good idea if you have skin conditions like psoriasis or atopic dermatitis, but warns of the risks of too much sun.

"It's important to keep in mind though, the sun increases your risk of skin cancer, especially the most deadly type of skin cancer, melanoma, so you still want to be careful and practice smart sun behaviors," Dr. Piliang said.

So what is the ideal amount of time to spend out in the sun? Dr. Piliang says if you're out in the sun to help with your skin condition, try to stay out there for no longer than five to 10 minutes at a time to avoid getting sunburned.

Dr. Piliang recommends wearing broad spectrum, water-resistant sunscreen with an SPF over 30 on all areas of your body you don't want exposed directly to the sun, as well as a hat and sun-protective clothing.

While the sun can be beneficial for these skin conditions, Dr. Piliang reminds patients not to rely on it as the sole method of therapy and treatment such as light therapy and prescription medications.

"There are so many treatment options out there beyond just the sunlight or moisturizers you can buy over the counter. The dermatologist can help you get your skin clear and on a treatment that is safe and effective and you can tolerate well Dr. Piliang said.

There is currently no known cure for skin conditions like eczema or psoriasis, but Dr. Piliang says light therapy and medication can really make a difference.

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Cleveland Clinic: Can the sun be beneficial for some skin conditions? - WFMJ