Category Archives: Psoriasis

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.

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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.

Lifeline 13 11 14. Beyond Blue 1300 22 4636.

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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

Almirall and Happify Health go live with digital therapeutics support for psoriasis patients 08 August 2022

BARCELONA, Spain, and NEW YORK, USA -- May 24, 2022 - Today, Happify Health, the Intelligent Healing Company, and Almirall, S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, announced that Claro, a digital program developed via the innovative partnership of both companies, is live and now available to people with psoriasis in Spain, Italy and United Kingdom.

Claro was built to improve the mental wellbeing of people with psoriasis by providing cognitive behavioral therapy, positive psychology and mindfulness. Since its launch, engagement rates on Claro are high, with active users on the platform completing an average of 2.6 activities per week.

Psoriasis is one of the world's most prevalent skin diseases, affecting about 60 million people worldwide1. It is estimated that 20 to 30% of people, globally, with moderate to severe psoriasis also suffer from mental health issues like anxiety and depression2. Approximately 80% of those affected with psoriasis have mild to moderate symptoms, with direct healthcare costs for treatment of psoriasis exceeding $65 billion annually.

"At Almirall, we are proud to offer psoriasis patients a wide range of medicines that cover the whole spectrum of the disease, from mild to severe. Claro helps us to fulfill our commitment to people living with psoriasis, providing them with an enhanced solution addressed to their wellbeing so they can get their lives back." said Dr. Volker Koscielny, MD, Chief Medical Officer of Almirall.

"Psoriasis is a significant burden in the daily life of 71% of people who suffer from it according to the National Psoriasis Foundation in the UK3," said Theo Ahadome, Senior Vice President of Commercialization at Happify Health."A 2019 study in Maedica, the Journal of Clinical Medicine establishes a clear link between skin-psychology and quality of life for people with psoriasis.3This partnership gives us the opportunity to study how effective digital programs are at keeping psoriasis patients engaged during treatment for psoriasis and improving their quality of life."

About Almirall

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

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

For more information, please visit almirall.com

[1]H.L. Richards, D.G. Fortune, C.E. Griffiths, C.J. Main The contribution of perceptions of stigmatization to disability in patients with psoriasis J Psychosom Res., 50 (2001), pp. 11-15.

[2]The prevalence of comorbid depression in patients with psoriasis is estimated at between 20% and 30%, and rates as high as 62% have been reported. E.A. Dowlatshahi, M. Wakkee, L.R. Arends, T. Nijsten The prevalence and odds of depressive symptoms and clinical depression in psoriasis patients: A systematic review and meta-analysis J Invest Dermatol., 134 (2014), pp. 1542-1551. M. Esposito, R. Saraceno, A. Giunta, M. Maccarone, S. ChimentiAn Italian study on psoriasis and depression Dermatology., 212 (2006), pp. 123-127.

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

Disclaimer

Almirall SA published this content on 08 August 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 August 2022 10:24:09 UTC.

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HELLERUP, Denmark, Aug. 4, 2022 /PRNewswire/ -- UNION therapeutics A/S (UNION), a privately-held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious diseases, announces that the first patient has been enrolled in ADESOS, a Phase 2b dose-finding study evaluating the safety and efficacy of orismilast MR tablet in adult patients with moderate to severe AD. The purpose of the study is to identify the appropriate dose regimen for Phase 3 studies.

In November 2021, the US Food and Drug Administration (FDA) granted Fast Track designation to orismilast MR tablet for the treatment of moderate to severe AD. The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. This underscores the need for new treatment options with potential to fulfil the unmet medical needs for people affected by AD.

UNION has recently investigated the inhibitory effect of orismilast on the secretion of various inflammatory cytokines in human peripheral blood mononuclear cells in vitro. Orismilast underlined its potential in AD, psoriasis, and HS by demonstrating broad anti-inflammatory properties with potent inhibition of the main cytokines involved in these indications1). Data from the study will be presented at the 31st EADV (European Academy of Dermatology and Venereology) Congress at 7-11 September 2022.

Kim Kjller, Chief Executive Officer of UNION therapeutics said:"Orismilast modified release tablet holds the potential to become a first-in-class treatment and become an efficacious treatment option for patients who need systemic therapy for atopic dermatitis. The initiation of the ADESOS study marks an important advancement of UNION's pipeline."

Jonathan Silverberg, MD, PhD, MPH, Associate Professor of Dermatology at The George Washington University School of Medicine and Health Sciences and Signatory Investigator for ADESOS adds: "AD is one of the most common chronic skin diseases worldwide. Despite recent advancements in the treatment of AD, there are still many unmet needs for safe and effective oral treatments. Orismilast modified release tablet has the potential to be an effective and patient-friendly treatment option in AD."

About the ADESOS Phase 2b studyThe Phase 2b study is a randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy and safety of orismilast MR tablet in patients with moderate to severe AD. The study will target 210 patients who will be randomized to three active doses (20mg, 30mg, and 40 mg) of orismilast relative to placebo administered twice daily. The study will be conducted in centers in Europe and the US.

About orismilastUNION is developing orismilast, which is a potent next-generation phosphodiesterase type-4 (PDE4) inhibitor operating early in the inflammation cascade to induce a broad spectrum of downstream anti-inflammatory effects. Orismilast has the potential to inhibit many inflammatory pathways involved in dermatological and immunological diseases and holds potential to become a safe and efficacious treatment option in various dermatological and immunological diseases.

UNION has two product candidates with orismilast in its clinical stage pipeline: Orismilast MR tablet currently investigated for the treatment of psoriasis, AD and HS; and topical orismilast with clinical proof of concept established in AD. UNION is progressing orismilast as a modified release tablet to minimize the occurrence of gastrointestinal side effects typically associated with PDE4-inhibition.

In November 2020, the FDA cleared UNION's Investigational New Drug (IND) application for orismilast MR tablet, and in November 2021, the FDA granted Fast Track designation to orismilast MR tablet for the treatment of moderate to severe AD.

In September 2021, UNION entered into a strategic partnership and licensing agreement with Innovent Biologic for orismilast in Mainland China, Hong Kong, Macau and Taiwan2).

About atopic dermatitisAD is a chronic inflammatory skin disease affecting approximately 3% of the adult population worldwide and is the most common skin disease among children, with the disease commonly occurring by five years of age3). There was approximately 26 million diagnosed cases of AD in 2021 in the Seven Major Markets (US, France, Germany, Italy, Spain, UK, and Japan)4). Disease symptoms are characterized by recurrent eczematous skin lesions and intense itch. AD has a substantial psychosocial impact on patients and relatives5). During disease flares, approximately 80% of patients may experience disturbed sleep, which may also disrupt the sleep of family members6). The disease also appears to impact the mood and patients have an increased risk of anxiety and depression7).

Sources

1. In vitro study to assess the effect of orismilast on cytokine production in human PBMCs. Study number: DSK0001

2. https://uniontherapeutics.com/union-therapeutics-and-innovent-biologics-enter-into-strategic-collaboration-and-license-agreement-for-orismilast-a-next-generation-pde4-inhibitor-for-inflammatory-dermatology-conditions-1/

3. https://pubmed.ncbi.nlm.nih.gov/25925336/

4. Decision Resources Group (2020): Atopic Dermatitis Disease Landscape & Forecast. Published November 12, 2020

5. https://pubmed.ncbi.nlm.nih.gov/33006135/

6. https://pubmed.ncbi.nlm.nih.gov/24290431/

7. https://pubmed.ncbi.nlm.nih.gov/27616422/

ContactsMorten Boesen, Chief Financial Officer, UNION therapeutics A/S+45 2381 5487morten.boesen@uniontherapeutics.com

Sarah Toft-Jrgensen, Director of Communications and IR, UNION therapeutics A/S+45 5385 3044stj@uniontherapeutics.com

About UNION therapeuticsUNION therapeutics is a privately held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with multiple candidates in clinical development. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and seasoned pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at http://www.uniontherapeutics.com

This information was brought to you by Cision http://news.cision.com

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UNION therapeutics announces enrollment of the first patient in ADESOS Phase 2b study of orismilast MR tablet in patients with atopic dermatitis -...

The U.S. Food and Drug Administration (FDA) approved Zoryve (roflumilast) cream 0.3 percent for the treatment of plaque psoriasis, including intertriginous areas (where skin rubs against other skin) in people 12 years of age and older, according to a press release issued by Arcutis, the manufacturer of the drug. Once-daily Zoryve is the first and only approved topical phosphodiesterase-4 (PDE4) inhibitor, the first and only FDA-approved steroid-free cream in its class.

PDE4 inhibitors suppress the immune system by reducing the action of an overactive enzyme (phosphodiesterase 4), thereby reducing inflammation.

It is always great to have another topical option to treat psoriasis, so this approval is exciting, says Marisa Garshick, MD, a board-certified dermatologist at MDCS Dermatology in New York City. Zoryve will be a good choice for those patients who prefer to avoid a topical steroid, she adds.

This approval offers yet another steroid-free option for people with plaque psoriasis; in May, the FDA approved Vtama (tapinarof) cream 1 percent for topical treatment of mild, moderate, or severe plaque psoriasis in adults.

FDA approval is based on data from two phase 3 randomized, double-blind, vehicle-controlled (Zoryve was compared to a placebo or dummy cream) trials that included a total of 881 people, called the DERMIS1 and DERMIS2 studies, presented at the 2021 Clinical Dermatology Conference in Las Vegas, Nevada.

The primary endpoint wasInvestigator Global Assessment (IGA)success, defined as clear or almost clear skin with at least a 2-grade improvement from baseline, and at least a 2-grade IGA score improvement from baseline at eight weeks. In the 2 trials, 42.4 percent and 37.5 percent of the patients treated with Zoryve achieved an IGA success rate, compared with 6.1 percent and 6.9 percent in the control groups, respectively.

Nearly 3 in 4 people (73.5 percent) completed 52 to 64 weeks of treatment, and fewer than 1 percent of participants discontinued because the medication didn't work.

In addition to clearing the skin, Zoryve improved the severity and impact of itch. Of participants with a Worst Itch-Numerical Rating Score (WI-NRS) of 4 or higher at baseline, 2 out of 3 people using Zoryve achieved at least a 4-point reduction at week 8. The WI-NRS is a questionnaire that asks patients to rate their itch from 0 (no itch) to 10 (worst imaginable itch) in the past 24 hours, according to an article published October 23, 2021, in BMC Health and Quality of Life Outcomes.

While topical steroids are a very effective option for psoriasis, their use over time should be limited, says Dr. Garshick. There are certain locations on the body, including the face and skin folds, where their use should be limited to prevent thinning of the skin, she adds.

Zoryve is the only topical that has data specifically focusing on the treatment of intertriginous plaques (those found in skin folds), said Frank Watanabe, the president and CEO of Arcutis, in the statement. For people who have psoriasis in those areas, which can include areas such as the underarms, under the breasts, or the groin area, Zoryve can be a safe and effective option, says Garshick.

Unlike steroids, there is no restriction on how long Zoryve can be used to treat plaque psoriasis, according to the approval statement. When used chronically (over a long period of time), topical steroids can cause stretch marks in areas like the thighs or the armpits, according to the American Academy of Dermatology (AAD).

In general, Zoryve is safe and easy to tolerate for those with psoriasis, says Garshick. The most commonly reported side effects in people using Zoryve were diarrhea (3.1 percent), headache (2.4 percent), insomnia (1.4 percent), nausea (1.2 percent), application site pain (1 percent), upper respiratory tract infection (1 percent), and urinary tract infection (1 percent).

The current wholesale acquisition cost (WAC) pricing is $825 for a 60 gram (g) tube of Zoryve, according toArcutis. The actual cost to the patient will depend on insurance coverage.

The company offers a savings program; people with commercial insurance that provides Zoryve coverage will pay $25 a tube, and those with commercial insurance that does not cover Zoryve will pay $75 a tube. Financially eligible patients who dont have insurance or who are underinsured may access the cream through the Arcutis Cares Patient Assistance Program.

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FDA Approves New Treatment for People With Plaque Psoriasis - Everyday Health

Bri Morrell from Leicester was diagnosed with psoriasis, an irritating skin condition which causes red, scaly patches to appear on her skin

Image: mediadrumimages/@thatgirlpatches)

A woman who says 70 percent of her body is covered in red marks has opened up about having psoriasis.

Bri Morrell from Leicester was diagnosed with the irritating condition, which causes red, scaly patches to appear on her skin, earlier this year.

The customer service advisor believes the condition was triggered after suffering a period of depression.

Psoriasis causes the skin cells to grow at a rapid rate, with new skin cells growing every three days, instead of at a one-month rate.

As a result, there is an excess of skin cells that pile up on the surface, causing inflammation, swelling and redness.

These patches cover nearly 70 per cent of Bri's body, causing itching, soreness and in some cases bleeding when her skin splits open.

Psoriasis affects every inch of Bri's body. It doesn't just affect her bare skin, but also her scalp and even her fingernails and toenails.

To ease the psoriasis and irritation, Bri wears baggy and loose-fitting clothes, lessening her contact to tight-fitting materials.

Bri's psoriasis started in her early 20s, slowly appearing before taking over her body.

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She believes it was triggered by a low period of her life when Bri suffered a period of depression.

Psoriasis can be brought on by stress, depression, or changes in hormones, as well as many other things.

Despite visiting the doctors, Bri says she didn't receive any treatment for her skin.

She was offered an immune-suppressing drug, however, she turned down the treatment due to the multitude of harsh side effects that accompany the drugs.

Instead, to manage the irritation, Bri uses a cream which reduces the soreness and dryness of the skin.

Bri wants to inspire others, using her Instagram as a platform to spread body positivity to others and reduce the stigma around the skin disease.

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"I never got psoriasis until I was in my early twenties," said Bri.

"There isn't one part of my body it doesn't affect.

"I have it on my scalp, face, back, chest, stomach, legs, toes, hands, nails.

"Around seventy percent of my body is covered.

"It was triggered by a low period in my life.

"My condition can cause me low periods, but that's generally when other things are bothering me, and the psoriasis is like a straw that broke the camel's back.

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"I find the itchiness and flakiness the most annoying part.

"It can be embarrassing when it's in my scalp or ears as I worry people may think it's down to me not washing my hair.

"When I'm not using my cream, I struggle to get about as my skin is so sore and literally splits open, but I used the regularly which helps control my psoriasis."

Bri says she has had to change her attitudes and has spoken about the amazing support she has had in place through her journey.

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"I've had to overcome caring what people think and learn to love myself despite not fitting into European beauty standards," she said.

"I've always been very fortunate to date understanding people who not only accept my psoriasis, but actually find it attractive as they say it's different and unique.

"If I dated a guy who was embarrassed or irritated by my skin then he wouldn't last long.

"My family is extremely supportive of my skin and have helped me to embrace it, as well as my ex-partner.

"I've never received hate online, but I have had funny stares from people before.

"I think there is a lack of education on skin conditions, so a lot of the time people don't know what they're dealing with."

Bri hopes to educate people about psoriasis and help people accept their individual beauty, regardless of their skin.

"I was confident enough to embrace it," said Bri.

"I'm proud of the fact that I embrace my skin and have helped others to feel less embarrassed about having a skin condition.

"I'm proud of building my Instagram with content that I've been told by others has inspired them not to hide their own skin.

"I think it's important to learn to love yourself so much that something like a skin condition won't get you down.

"Stop comparing yourself to other people on social media. I am really bad for that, and it's never done me any good. Ever since I stopped, I've felt so much better within myself."

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Woman says 70% of her body is covered in red marks due to rare condition - The Mirror

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