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Category Archives: Psoriasis
The Weekly Roundup: May 22-26 – Dermatology Times
Posted: May 30, 2023 at 12:10 am
Expanding Ethnic Hair Care
In this months Cosmetic Conundrums column, Zoe Diana Draelos, MD, discusses solutions for ethnic and Afro-textured hair care.
A recent study supports a degree of correlation between trough serum concentration of infliximab and clinical response to infliximab in patients with the condition.
Researchers analyzed dermatoses associated with obesity and insulin resistance in pediatric patients.
Renata Block, MMS, PA-C, spearheaded a skin cancer screening event for veterans in her hometown.
As many as 1 in 5 patients with psoriasis experience depression as a comorbidity.
Topline results for the topical sodium channel blocker are expected in 2024.
The adalimumab biosimilar will be commercially available in the US starting July 1, 2023.
The first-of-a-kind product uses a topically applied small peptide fluorescent dye and handheld imager to non-invasively detect a biomarker of early tissue changes.
In part 3 of this Frontline Forum series, John M. Strasswimmer, MD, PhD; Andrew H. Weinstein, MD; Neal Bhatia, MD; Laura Ferris, MD; and Aaron S. Farberg, MD, discuss solutions for managing and treating patients with basal cell carcinoma.
New research into the diseases pathogenesis may inform future treatment options.
Cream containing epigallocatechin gallate (EGCG) or EGCG combined with L-carnitine yielded a greater anti-sebum effect.
If you werent able to attend SCALE 2023 or want to review the latest data, our full recap has you covered.
In this weeks Pointers with Portela, the 208SkinDoc gives his best product recommendations for Mother's Day gifts.
The autosomal recessive disorder is primarily caused by mutations in the TGM5 gene and less frequently in the CSTA gene.
While receiving checkpoint inhibitor therapy, patients with advanced melanoma benefitted from a telehealth exercise program.
Click here to answer this week's poll.
The JAK inhibitor demonstrated promising efficacy and safety.
Yuflyma will be available to US patients in July 2023.
The clinical and histologic subtypes encompassed by granulomatous dermatitis include palisaded neutrophilic granulomatous dermatitis and interstitial granulomatous dermatitis. This review compares the features of each cutaneous eruption.
This week's edition of the Mainstream Patient features stories about facial balancing, eyelid surgery 101, dermatologist-recommended sunscreen sticks, and more.
In this months Finance & Practice Management column, we illustrate the importance of developing and maintaining a budget for physicians at all stages of their careers.
Coastal regions require environmentally-protective sun protection measures and best practices.
In patients with high levels of VEGF-A and more severe psoriasis, downregulation of blood vessel area is more abrupt.
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Pediatric Psoriasis Market: A Study of the Industry’s Key Applications … – The Navajo Post
Posted: at 12:10 am
[Vancouver, Canada, 16-05-2023] Emergen Research, a leading provider of market research solutions, is thrilled to announce the release of its highly anticipated collection of comprehensive market research content. This innovative offering aims to empower businesses across industries with valuable insights and data-driven strategies to drive growth and success.
In todays competitive marketplace, staying ahead of the curve is essential for businesses of all sizes. Understanding consumer behavior, market trends, and emerging opportunities is crucial for making informed decisions and developing effective strategies. Emergen Research recognizes this need and has invested significant resources in developing a cutting-edge market research content library.
The newly launched Pediatric Psoriasis market research content is meticulously crafted by industry experts, leveraging extensive data analysis, and a deep understanding of various markets. This rich collection includes in-depth reports, whitepapers, case studies, trend analyses, and industry insights covering a wide range of sectors, including but not limited to technology, healthcare, finance, consumer goods, and manufacturing.
Request Free Sample Copy (To Understand the Complete Structure of this Report [Summary + TOC]) @ https://www.emergenresearch.com/request-sample/52
The global pediatric psoriasis market was valued at USD 9.76 billion in 2019 and is expected to reach USD 21.38 billion by the year 2027, at a CAGR of 10.3%. The global Pediatric psoriasis market is growing at a significant pace owing to the growing demand for therapy for diseases such as pediatric psoriasis, favorable government initiatives followed by intensive product development. Considering the factors such as considering the physical development and rate of cutaneous absorption, treating a child with psoriasis has been a huge challenge. With the advent of technology, research has contributed significantly to the various development of treatment for the disease across the globe. Psoriasis is a life-long devitalizing disease that has a significant impact both emotionally and physically including other aspects of life of children. The prolonged sun exposure makes it more demanding while considering phototherapy in children for the rest of their life. Therefore, long-term treatment of psoriasis, with phototherapy or drugs, needs critical evaluation.
Competitive Landscape:
The latest study provides an insightful analysis of the broad competitive landscape of the global 777 market, emphasizing the key market rivals and their company profiles. A wide array of strategic initiatives, such as new business deals, mergers & acquisitions, collaborations, joint ventures, technological upgradation, and recent product launches, undertaken by these companies has been discussed in the report.
AbbVie Inc.; Amgen Inc.; Johnson & Johnson; Novartis AG; Eli Lilly & Company; AstraZeneca; Celgene Corporation; UCB; and Merck, Boehringer Ingelheim and LEO Pharma
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Market Segmentation:
The report bifurcates the Pediatric Psoriasis market on the basis of different product types, applications, end-user industries, and key regions of the world where the market has already established its presence. The report accurately offers insights into the supply-demand ratio and production and consumption volume of each segment.
Our goal at Emergen Research is to empower businesses with the knowledge and insights necessary to make informed decisions and thrive in todays dynamic business landscape. Our market research content is designed to equip professionals and organizations with comprehensive analyses, actionable recommendations, and a competitive edge to achieve their growth objectives.
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Target Audience of the Global Pediatric Psoriasis Market Report:
Key features and benefits of Emergen Researchs market research content include:
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Emergen Research is a market research and consulting company that provides syndicated research reports, customized research reports, and consulting services. Our solutions purely focus on your purpose to locate, target, and analyze consumer behavior shifts across demographics, across industries, and help clients make smarter business decisions. We offer market intelligence studies ensuring relevant and fact-based research across multiple industries, including Healthcare, Touch Points, Chemicals, Types, and Energy.
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Phototherapy Lamps Market are set to witness a CAGR of 5.8 … – Digital Journal
Posted: at 12:09 am
PRESS RELEASE
Published May 29, 2023
By the end of 2022, the market forPhototherapy Lamps Marketis projected to be worth US$ 3.2 Billion, up from US$ 3.0 Billion in 2021. The overall demand for phototherapy lamps is also anticipated to increase at a CAGR of 5.8% between 2022 and 2032, reaching an estimated value of US$ 5.6 Bn by 2032, due to the growing use of phototherapy lamps for treating a variety of medical disorders, including psoriasis and neonatal jaundice.
Based on product, the LED segment dominated the phototherapy lamps market in 2021, accounting for approximately 37.1% of the market, and it is expected to grow at a higher CAGR during the forecast period.
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According to the reports regional insights, North America will continue to dominate the global phototherapy lamps market in terms of revenue throughout the forecast period.
The adoption of phototherapy as a safer treatment option for skin disorders has increased significantly in the US and Canadas healthcare markets.
Consumer lifestyles in North America will continue to increase the prevalence of common skin diseases, which will primarily be treated with phototherapy lamps.
Furthermore, North Americas dominance in the global market has been supported by a robust infrastructure for the adoption of phototherapy lamps.
According to the report, phototherapy lamps sold in the United States and Canada will generate nearly $700 million in revenue in 2017.
Skin care clinics to emerge as the largest end-user of phototherapy lamps
According to the report, hospitals will initially experience high traction in terms of end-users, but skin care clinics are expected to have the highest revenue share in the global market.
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LED-based phototherapy lamps to register highest sales
According to the study, LED-based phototherapy lamps are the best-selling products on the global market.
The low risk of burns, low cost of production, and ease of installation will continue to drive demand for LED-based phototherapy lamps in the near future.
The LED segment will account for nearly US$ 1.6 billion in revenue in the global phototherapy lamps market by the end of 2026.
According to the study, demand for UV-based phototherapy lamps will be strong, while halogen lamps will lose traction near the end of the forecast period.
Growing effectiveness of phototherapy in psoriasis treatment to drive the sales of phototherapy lamps:
Phototherapy lamps will be primarily used in the treatment of psoriasis due to their applications. Phototherapy lamps sold for the treatment of psoriasis are expected to bring in more than $500 million in 2017.
The use of phototherapy lamps in the treatment of neonatal jaundice is expected to grow at the fastest CAGR of 8.1% during the forecast period.
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Leading manufacturers of phototherapy lamps have been profiled in the report. Koninklijke Philips N.V., General Electric Company, Drgerwerk AG & Co. KGaA, Bistos Co. Ltd., TSE SPOL. S. R. O., The Daavlin Company, Fanem Ltda., Herbert Waldmann GmbH & Co. KG, Natus Medical Incorporated, and Schulze & Bohm GmbH are expected to actively partake in the expansion of the global phototherapy lamps market through 2026.
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Phototherapy Lamps Market are set to witness a CAGR of 5.8 ... - Digital Journal
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Celltrion seeks approval for Stelara biosimilar in EU – The Investor
Posted: at 12:09 am
Celltrion's corporate logo (Celltrion)
Celltrion said Friday that the company has submitted a marketing authorization application for CT-P43, the company's ustekinumab biosimilar referencing Stelara, to the European Medicines Agency.
Stelara is one of Janssen's top-selling drugs. In 2022, Stelara generated $9.7 billion in revenue, according to a report released by Statista.
The global market for ustekinumab last year was estimated at $17.7 billion, Celltrion added.
Celltrion said its CT-P43, like the reference drug Stelara, can be used to treat patients with psoriasis, psoriatic arthritis, Crohns disease and ulcerative colitis.
Celltrion added it is seeking EMA approval for the same indications that have been labeled for Stelara.
Previously, Celltrion conducted a global phase 3 clinical trial to compare the efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque psoriasis.
If it wins approval, Celltrion will look to boost its sales.
"If CT-P43 wins the EMA approval, the company will be able to increase competitiveness in the autoimmune disease therapeutics market, where the company has previously launched treatments such as Remsima, Remsima SC and Yuflyma," Celltrion said.
By Shim Woo-hyun (ws@heraldcorp.com)
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Celltrion seeks approval for Stelara biosimilar in EU - The Investor
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Peter Marinkovich, MD: FDA Approval of B-VEC Gene Therapy for … – MD Magazine
Posted: at 12:09 am
In this HCPLive interview, Peter Marinkovich, MD, associate professor of dermatology at Stanford University School of Medicine, spoke about the US Food and Drug Administration (FDA) approval of beremagene geperpavec (B-VEC) (VYJUVEK) for patients with dystrophic epidermolysis bullosa (DEB).1
Marinkovich had been a primary investigator in the multi-center, randomized, double-blind, placebo-controlled GEM-3 trial sponsored by Krystal Biotech.
The phase 3 trial had met both its primary and secondary endpoints, with B-BEC-treated patients having a substantially greater rate of achieving complete wound healing from DEB than placebo at 3 and 6 months (P <.005).2
Before the PDUFA dates announcement, trial data on 31 DEB patients indicated that around 70% of wounds had closed within 6 months of treatment, including the patient that had the dominant form of DEB.
It's just the the culmination of a number of multi-year effort to develop this topical gene therapy drug, and it's so exciting to actually be able to be in this position to be able to offer something back to the very deserving patient population who does not currently have any approved therapies and who are very much in need, Marinkovich explained.
The treatments PDUFA data had been extended to May 2023 resulting from a regulatory update that the FDA deemed important. Krystal Biotech then submitted its manufacturing information update related to a replaced hardware unit in B-VECs manufacturing process.
This is a vector that's based on the HSV-1 backbone, he said. HSV-1 over its many thousands of years of cohabitation with humans has evolved a way to be able to evade the immune systemAs a gene therapy vector, to have a vector that can evade the immune system, it really makes it much easier to use.
Marinkovich explained the function of the treatment and how it addresses wound healing for DEB patients. He then went into related research in which he had been involved.
Some of the things that we're currently studying are the effects of feedback on mucosal surfaces in addition to the skin, he said. And that was a very promising report of a single patient who's had their eyes treated, and was able to show some improvement in the vision as well as very good safety over multiple applications.
Marinkovich noted that these are all areas that EB patients suffer from and that they could benefit from B-VEC therapy. He concluded with his thoughts on the future for DEB patient options.
I'm super happy about the FDA decision, they also seem to recognize the important need of the EB patients to get a corrective therapy like this one, Marinkovich said. And I feel so happy for the EB patients to be able to have corrective therapy and be able to finally, after all these years, be able to actually start to get some benefit.
The quotes contained here were edited for clarity. For further information about Marinkovichs take on the FDAs approval of B-VEC therapy, view the video above.
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Peter Marinkovich, MD: FDA Approval of B-VEC Gene Therapy for ... - MD Magazine
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Nick Stucky, MD, Phd: Implications for Media Influence on Minoxidil … – MD Magazine
Posted: at 12:09 am
Nick Stucky, MD, PhD, continued his discussion of his teams findings on rates of prescription of oral minoxidil following the publication of an article by The New York Times, noting the biggest implications of the findings.1
Stucky is vice president of research at Truveta, working also as a physician-scientist and bioengineer. Additionally, he is known for being a start-up founder, faculty teaching, and having been research director.
After having described the findings, Stucky in this interview segment first described the studys limitations in general.
One thing is that we get data from our member healthcare systems, so they provide care to a certain population, he explained. We have 17% of the US healthcare daily delivered care within our dataset, so it's quite large. But there are always potential biases if you're not actually surveying the whole US population.
Stucky also added that there may be a skew toward insured patients, for example. He added that there were certain questions by reviewers regarding whether the article led to increased prescribing for all hair loss medications.
And so we added kind of a control armwhich was another hair loss medication that wasn't mentioned in that article, Stucky explained, adding that this group had no changes in prescribing.
He then highlighted some of the biggest implications from his teams findings, noting that they did not know for sure whether the article had a direct impact on the providers or the patients who read the single media publication.
But yes, I mean, I think it definitely says that we're all human, and we all are sort of influenced by our environment, Stucky said. And certainly, this indicates that either practitioners or patients can be profoundly impacted in terms of how they interact with the healthcare system, by a single article.
Additionally, Stucky mentioned that he believes there are other important implications for his teams findings.
I think many providers probably had concerns about whether it was safe, whether there'd be any adverse effects, but those had mostly been put to rest by these handful of studies that have come out, he said. But nobody was aware of them and so by, in this case, a New York Times article, but really any other media that we're consuming, we can learn really valuable (insights).
The interview segments quotes were edited for clarity. For more information on the research described here, view the full video above.
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Nick Stucky, MD, Phd: Implications for Media Influence on Minoxidil ... - MD Magazine
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Tildrakizumab Linked With HRQOL Improvement in Psoriasis in a Real-World Setting – AJMC.com Managed Markets Network
Posted: May 18, 2023 at 1:28 am
Treatment with tildrakizumab improved health-related quality of life (HRQoL) and patient-reported symptoms in those with psoriasis in a real-world setting, according to a new study published in The Journal of Dermatological Treatment.
The antiinterleukin-23 p19 monoclonal antibody is approved for treatment of adults with moderate to severe plaque psoriasis.
Psoriasis and its symptoms, which can include itch, pain and scaling, have substantial negative effects on patients QOL. Previous research shows patients report negative effects on sleep and rest, limitations on daily activities, and disruption to social interactions. Many also experience depression, anxiety or addiction.
The chronic multisystem disease manifests most noticeably as skin inflammation, the study authors said. Plaque psoriasis, the most common form of the condition, often appears on the skin of the knees, elbows, scalp, buttocks and trunk.
Of all the symptoms of psoriasis, itch has been reported to contribute the most to reductions in patients emotional well-being, sleep, and daily activity.
However, in general, the relationship between clinical treatment of psoriasis and patients HRQoL is poorly understood and may be underestimated by clinicians, the researchers wrote. There is therefore an unmet need for greater understanding of this relationship to inform the choice of therapeutic intervention.
To address the knowledge gap, the investigators carried out a phase 4 study under real-world conditions. The current research outlines results after 28 weeks of treatment with tildrakizumab.
All participants received tildrakizumab 100mg at weeks 0 and 4, and every 12 weeks thereafter. The researchers measured progress via the Psychological General Well-Being Index (PGWBI), Dermatology Life Quality Index (DLQI), and Itch-, Pain-, and Scaling-Numerical Rating Scale scores. Of the 55 enrolled patients, 53 were evaluated at week 28.
Data showed:
Just over half of patients included were male and the majority were White. The mean patient age was 48.6 years.
Despites PGWBI score improvements seen for general health and positive well-being, no statistically significant improvements were seen from baseline to week 28 for anxiety, vitality, depressed mood, and self-control.
However, the treatment did result in improvements in reported itching, pain, and scaling beginning at week 4 and these were maintained throughout the study window.
Clinical trials have often focused on the effects of skin clearance on the HRQOL of patients with psoriasis. Complete skin clearance has been associated with higher scores on measures of HRQOL compared with almost complete clearance, the authors explained.
Previous research on theimpact of the efficacy of tildrakizumab treatment has shown absolute Psoriasis Area Severity Index scores correlated with DLQI total scores.
In controlled clinical trials, strict inclusion and exclusion criteria may preclude findings from fully representing or characterizing the patient population in real-world clinical practice, the researchers said.
To date, there has been little published real-world evidence regarding HRQOL in patients with moderate to severe plaque psoriasis treated with tildrakizumab, they added.
The relatively small sample size marks a limitation to the current study, and it remains unclear whether tildrakizumab treatment may affect patients HRQOL over a longer period of time.
Additional research is recommended to further guide clinicians in choosing optimal treatment strategies to improve HRQOL in patients with moderate to severe psoriasis, the authors concluded.
Reference
Bhatia N, Heim J, Schenkel B, Vasquez JG. Quality of life and patient-reported symptoms in a phase 4, real-world study of tildrakizumab in patients with moderate-to-severe psoriasis: week 28 interim analysis. J Dermatolog Treat. Published online May 11, 2023. doi:10.1080/09546634.2023.2200872
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Clinical Utility of Deucravacitinib for the Management of Moderate to … – Dove Medical Press
Posted: at 1:28 am
1School of Medicine, University of California at San Francisco, San Francisco, CA, USA; 2Department of Dermatology, University of California at San Francisco, San Francisco, CA, USA
Correspondence: Joy Q Jin, Box 1212, Floor 01, Room 101, 2340 Sutter Street, San Francisco, CA, 94115, USA, Tel +1 415-353-7800, Fax +1 415-502-4126, Email [emailprotected]
Introduction: Psoriasis is a chronic, immune-mediated skin condition with significant detriments to physical/mental health. While systemic therapies are available for the treatment of moderate-to-severe psoriasis, patients can experience therapeutic failure, loss of efficacy, or medical contraindications that require other therapeutic options.Objective: With the recent approval of deucravacitinib, a first-in-class TYK2 small molecule inhibitor administered orally for psoriasis patients, we reviewed data from randomized controlled trials (RCTs) to synthesize its clinical utility. To our knowledge, this is the first systematic review and meta-analysis of deucravacitinib comparing its clinical efficacy to placebo in psoriasis.Methods: A literature search was conducted in PubMed (MEDLINE), Embase, and the Cochrane Central Register of Controlled Trials to identify RCTs studying deucravacitinib in human patients with moderate-to-severe psoriasis.Results: One placebo-controlled Phase II RCT and two placebo-controlled/active-comparator Phase III RCTs were included for review. Patients (N=1953) treated with deucravacitinib 6 mg daily showed marked improvement in disease severity (Psoriasis Area and Severity Index (PASI), static Physician Global Assessment (sPGA) and quality-of-life outcomes compared to patients administered comparator (apremilast) and placebo. Clinical improvement given deucravacitinib was noted for scalp psoriasis but not fingernail psoriasis. Meta-analysis (deucravacitinib, n=888; placebo, n=466) comparing rates of clearance (sPGA 0/1) demonstrated superior efficacy of deucravacitinib compared to placebo (odds ratio, 12.87; 95% confidence interval, 8.97 18.48; 2=4.08, I2=51%). Deucravacitinib was well-tolerated, with similar rate of occurrence and type of adverse events reported among patients treated with placebo or apremilast at Week 12 16. No cardiovascular events, serious infections, or lab abnormalities were noted.Conclusion: Deucravacitinib possesses good efficacy, with no report of safety concerns associated with prior JAK inhibitors used for psoriasis. Meta-analysis demonstrated deucravacitinibs superiority compared to placebo, indicating its promising clinical utility. Further studies are needed to observe long-term safety and efficacy, and to compare deucravacitinib to existing treatments.
Keywords: apremilast, deucravacitinib, meta-analysis, placebo, plaque psoriasis, systematic review
Psoriasis is a chronic inflammatory disorder of the skin and joints that affects 8 million Americans and 23% of the population globally.1 Psoriasis has a profound impact on both the physical and psychosocial health of those affected. Patients are subject to increased risk of developing comorbid systemic disease, including cardiovascular disease, diabetes, anxiety, depression, and all-cause mortality.2
A variety of therapies are available for the treatment of psoriasis, including topical medications, phototherapy, oral and biologic agents. Oral immunosuppressants such as methotrexate and cyclosporine may be highly effective for some patients, but such treatments have significant potential for adverse effects.3 For individuals with a more severe psoriatic disease course, treatment with a systemic therapy such as a biologic agent is often required. Recent advancements surrounding new targeted agents have yielded promising results; here, we review the clinical potential of deucravacitinib (ie, BMS-986165, SotyktuTM), a new oral small molecule approved by the US Food and Drug Administration (FDA) in September 2022 for the treatment of moderate-to-severe psoriasis.
The pathogenesis of psoriasis is characterized by aberrant keratinocyte differentiation and excessive growth of the epidermis, leading to the formation of erythematous patches and plaques with thick overlying scale.4 Psoriasis pathogenesis involves a complex interplay of genetic (eg, susceptibility alleles) and environmental factors, which can combine to trigger systemic inflammatory cascades leading to disease presentation.4 While psoriatic immune dysregulation is complex and not fully elucidated, T helper 17 (Th17) cells are known to be a central component that, when aberrantly activated, produce important effector cytokines acting in a positive feedback loop to recruit additional immune cells and accelerate psoriasis development.5,6
Involvement of the interleukin (IL)-23/IL17 pathway mediates psoriasis via the activation and promotion of keratinocyte proliferation.5 Cytokines like TNF-, IL-17, and IL-23 are the targets of biologic agents used in psoriasis.7,8 Many of these same cytokines, including IL-23, bind to type I and II cytokine receptors, which possess no inherent catalytic activity and must rely on Janus kinase (JAK) proteins to mediate their effects.7 Tyrosine kinase 2 (TYK2) is one of four members of the JAK family of proteins.7
JAK/STAT signaling refers to a system comprised of a dimeric transmembrane cytokine receptor, a pair of intracellular JAKs, and a family of Signal Transducers and Activators of Transcription (STATs).7 Upon binding of a cytokine to its receptor, a conformational change in the receptor proteins occur, leading to autophosphorylation of intracellular JAKs.7 This enables another conformational change leading to the phosphorylation of STATs, which then dissociate from the receptor complex before translocating to the nucleus and acting as transcription factors.7
TYK2 pairs with other JAK family members to mediate the signaling of IL-12 and IL-23 receptors, as well as type I IFN receptors; TYK2 inhibition leads to reduced Th17 cell polarization, increased suppressive functions of regulatory T cells, and additional downstream effects protective against psoriasis development.912 Given TYK2s role downstream of current biologic targets such as IL-12 and IL-23, TYK2 inhibition may serve as a promising strategy that can address existing challenges in the treatment of moderate-to-severe psoriasis.12
In September 2022, deucravacitiniban oral, first-in-class, small molecule, selective allosteric inhibitor of TYK2was approved by the FDA for the treatment of psoriasis in the U.S.13 Deucravacitinib binds to the catalytically inactive pseudokinase regulatory domain of TYK2 and stabilizes an inhibitory interaction between the regulatory and catalytic domains.13 Through this method, TYK2 is inactivated and cannot interact with other receptors to lead to downstream signal transduction.11,14 In preclinical studies, deucravacitinib was revealed to inhibit TYK2 with high selectivity and minimal off-target effects on other JAK family members,11,14 suggesting that deucravacitinib may possess an improved safety profile compared to less specific JAK inhibitors, which have been associated with hyperlipidemia, increased risk of infections, and other systemic changes.1416
Given recent FDA-approval and promising clinical data, we aimed to investigate deucravacitinibs clinical utility for the treatment of moderate-to-severe psoriasis. To our knowledge, no systematic review has been conductedhere, we performed a systematic review with meta-analysis to synthesize the findings from randomized controlled trials (RCTs) studying deucravacitinib for psoriasis.
As a review, all data used were non-identifiable and publicly available; institutional review board approval was not required at the University of California, San Francisco. The study protocol and design are reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2020 guidelines.17 A literature search was conducted in PubMed (MEDLINE), Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) in March 2023 using a combination of the terms (deucravacitinib OR sotyktu) AND (psoriasis).
The efficacy of new psoriasis treatments is measured in clinical trials via standardized, objective disease severity metrics, including the Psoriasis Area and Severity Index (PASI) and Physician Global Assessment (PGA).18,19 These tools utilize grading scales to stratify disease severity based on clinical characteristics including body surface area involvement and degree of erythema, induration, and scaling. Given the impact psoriatic disease has on patients psychosocial health and quality of life, concomitant assessment of these domains with tools such as the Dermatology Life Quality Index (DLQI) is appropriate and often co-reported in clinical trials or post hoc studies.19
Studies included in this review were RCTs investigating human subjects with moderate-to-severe psoriasis (thus, only Phase II trials and above, as Phase I trials were conducted in healthy participants),20 defined in clinical trials as static PGA (sPGA) 3, PASI 12, and body surface area (BSA) 10%, treated with deucravacitinib. RCTs that studied psoriatic arthritis but not psoriasis were excluded.21 Study characteristics including clinical trial name/number, number of patients, intervention dose and frequency, treatment duration, clinical efficacy, and safety outcomes were obtained using a standardized table tailored to this review.
Initial screening of studies was performed manually by two independent reviewers (J.Q.J., R.K.S.). Any queries in eligibility criteria were resolved via adjudication by an additional reviewer (W.L.). Data abstraction was performed by two independent reviewers (J.Q.J., R.K.S.). All randomized studies included for analysis were assessed for risk of bias by two independent authors (J.Q.J., R.K.S.) using the Critical Appraisal Skills Programme (CASP) checklist for RCTs.22
Primary outcomes sought for the purpose of this review included an sPGA of 0 or 1 (indicating clear or almost clear disease). Secondary outcomes included an sPGA of 0, a 75%, 90%, or 100% improvement in the PASI score (ie, PASI 75, PASI 90, or PASI 100), a DLQI score of 0 or 1, scalp-specific PGA (ss-PGA) of 0 or 1, and a PGA of Fingernail Psoriasis (PGA-F) of 0 or 1. The final endpoint was determined to be Week 1216, as all included studies reported efficacy measures within this timepoint.
Meta-analysis was performed using the Cochrane Review Manager 5.4 application comparing the sPGA 0/1 rates of deucravacitinib versus placebo. Only data from patients receiving the FDA-approved dose of deucravacitinib (6 mg per day) or placebo were included for meta-analysis. An odds ratio (OR) was calculated using the Mantel-Haenszel fixed-effects method, which was chosen over the Peto method as the latter is better suited for rare event occurrences.23 Significance of heterogeneity was assessed using the 2 test (P<0.1 set as statistically significant) and presented as the I2 test (I2>50% indicates significant heterogeneity, I2<25% indicates non-significant heterogeneity).
Following the application of inclusion and exclusion criteria (PRISMA diagram shown in Figure 1), three RCTs were included for review, including one Phase II placebo-controlled trial (NCT02931838)24 and two Phase III placebo-controlled and active-comparator (apremilast) RCTs (POETYK PSO-1, POETYK PSO-2).25,26 The three RCTs were composed of a total of 1953 patients with moderate-to-severe psoriasisincluding 1065 treated with deucravacitinib, 422 treated with apremilast, and 466 who received placebo. Overall, deucravacitinib patients showed marked improvement in disease severity and quality-of-life outcomes compared to apremilast and placebo groups; deucravacitinib patients with scalp psoriasis demonstrated marked improvement compared to apremilast and placebo groups, but improvements in fingernail psoriasis measures were not significant (Table 1). The risk of bias assessment of all studies is presented in Table 2.
Table 1 Clinical Outcomes Reported in Deucravacitinib Randomized Controlled Trials for Moderate-to-Severe Psoriasis
Table 2 Risk-Bias Assessment of Included Studies
Figure 1 PRISMA diagram showing study selection.
NCT02931838 was a 12-week, randomized, placebo-controlled, dose-ranging Phase II clinical trial that included 267 adults with moderate-to-severe plaque psoriasis (sPGA 3, PASI 12, and BSA 10%; mean baseline PASI was 18).24 The primary clinical outcome assessed was PASI 75 at Week 12 compared to baseline. Patients were randomly assigned to one of six groups to receive placebo medication or deucravacitinib orally at the following frequencies: 3 mg every other day (QOD), 3 mg daily (QD), 3 mg twice daily (BID), 6 mg BID, or 12 mg QD. Detailed clinical outcomes can be found in Table 1; improvements in PASI scores were associated with higher doses of deucravacitinib and were improved compared to placebo groups. Nearly 70% of the cohort that received deucravacitinib 3 mg BID (closest to the FDA-approved dosage of 6 mg once daily) achieved PASI 75 at Week 12, compared to 6.7% of the placebo cohort. Improvements in clinical outcomes were correlated with biomarker changes and patient-reported quality-of-life (percent of patients who achieved DLQI 0/1).27
POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) were randomized, double-blind, double-dummy Phase III trials that compared the efficacy and safety of deucravacitinib versus an active-comparator (apremilast) and placebo.25,26 A total of 666 patients (PSO-1) and 1020 patients (PSO-2) were randomized 2:1:1 to deucravacitinib 6 mg QD, apremilast 30 mg BID, or placebo. All participants receiving placebo were crossed over to receive deucravacitinib at Week 16; patients receiving apremilast who did not achieve PASI 50 (PSO-1) or PASI 75 (PSO-2) by Week 16 were also switched to the deucravacitinib group. In PSO-2, deucravacitinib patients achieving PASI 75 at Week 24 were re-randomized 1:1 to deucravacitinib at the same dosing schedule or placebo for the remainder of the study. If the newly switched placebo patients exhibited disease relapse, they were re-started on deucravacitinib.
Detailed clinical outcomes for both studies are reported in Table 1; briefly, deucravacitinib was shown to be more effective than both comparator and placebo at Week 16 for both primary endpoints assessed (PASI 75 and sPGA 0/1). The percent of patients who achieved PASI 75 in PSO-1 and PSO-2 (vs apremilast, placebo) were 58.7% (vs 35.1%, 12.7%) and 53.6% (vs 40.2%, 9.4%), respectively. The percent of patients who achieved sPGA 0/1 in PSO-1 and PSO-2 (vs apremilast, placebo) were 53.6% (vs 32.1%, 7.2%) and 50.3% (34.3%, 8.6%), respectively.
In all included studies, deucravacitinib was well-tolerated, with similar percentages and types of adverse events (AEs) reported among patients treated with placebo or comparator drugs at Week 12 or 16.2426 The occurrence of any AE by Week 12 or 16 in NCT02931838, POETYK PSO-1, and POETYK PSO-2 were 64% (vs 51% in placebo group), 53.0% (vs 42.4% in placebo group, 55.4% in apremilast group), and 57.5% (vs 54.3% in placebo group, 59.1% in apremilast group), respectively. In all trials, the most frequently reported AEs associated with deucravacitinib were nasopharyngitis (6.311%) and upper respiratory tract infection (26.3%). Other common AEs reported in the POETYK trials included headache (4.34.8% vs 3.05.5% in placebo group vs 10.111.0% in apremilast group), diarrhea (3.94.7% vs 3.67.5% in placebo group vs 10.113.0% in apremilast group), and nausea (1.22.1% vs 1.42.4% in placebo group vs 9.111.3% in apremilast group), which occurred at similar frequencies to placebo and generally decreased frequencies compared to the apremilast treatment group. Across the three studies, no significant changes in mean blood counts (including neutrophil and platelet levels), serum lipids (including total cholesterol), creatinine, creatine phosphokinase, liver enzymes, or immunoglobulins were reported. Among all patients treated with deucravacitinib, no serious cases of herpes zoster leading to discontinuation occurred; additionally, no opportunistic infections or tuberculosis were reported.
Meta-analysis of the three placebo-controlled RCTs comparing the rates of clearance (sPGA 0/1) in patients with moderate-to-severe psoriasis (N = 1354; deucravacitinib, n = 888; placebo, n = 466) demonstrated superior efficacy of deucravacitinib compared to placebo (OR, 12.87; 95% confidence interval (CI), 8.9718.48) (Figure 2). Heterogeneity was determined as significant (2 = 4.08, I2 = 51%) (Figure 2).
Figure 2 Forest plot of deucravacitinib versus placebo in the treatment of moderate-to-severe psoriasis. The primary outcome assessed was achievement of static Physician Global Assessment (sPGA) 0 or 1 at Week 12 (NCT02931838) or Week 16 (POETYK trials) in deucravacitinib- versus placebo-treated patients.
Abbreviations: CI, confidence interval; df, degrees of freedom; M-H, Mantel-Haenszel fixed-effects method.
Psoriasis is a systemic, immune dysregulatory condition that has a significant detrimental impact on a patients overall health and quality of life. While a range of biologic therapies are available for the treatment of more severe diseaseincluding agents that target TNF-, IL-12/IL-23, IL-17, and IL-23certain biologics can be contraindicated for individuals based on comorbid conditions, safety concerns, or insurance coverage issues. Furthermore, patients with more severe psoriasis are more likely to experience biologic failure, including the sequential failure of multiple biologics, despite adequate time attempting each agent.2830 Thus, there remains a need to develop new targeted therapeuticsparticularly those that can act via a different mechanism of action than existing systemic agentsto treat patients with moderate-to-severe psoriasis.
While the development of psoriasis is complex and involves an interplay between multiple immune signaling pathways, JAK/STAT signaling has been shown to hold a central dysregulatory role in psoriasis pathogenesis for years.16 The importance of such signaling in psoriasis was further emphasized after a recent study found methotrexate to inhibit the JAK/STAT pathway as a potential secondary mechanism of action, particularly relevant in psoriatic arthritis.31 Unfortunately, first-generation JAK inhibitors targeting JAK2 and JAK3 (eg, tofacitinib, baricitinib) experienced limited success for psoriasis as a disease indication due to safety concerns, despite effective associated clinical outcomes (eg, PASI reduction).32,33 For example, incidence of major adverse cardiovascular events and cancer were found to be higher in tofacitinib-treated groups in a dose-dependent fashion for rheumatoid arthritis patients.34 Thus, JAK inhibitors were previously approved only for psoriatic arthritis or for off-label use in certain psoriasis patients who had not responded to conventional systemic therapies.33
Deucravacitinib represents a major advancement as a first-in-class systemic therapy that differs from prior JAK inhibitors and other psoriasis biologics in several ways. First, deucravacitinib is a small molecule, meaning it can be administered by a variety of routes, including orallyas opposed to injected or infused, as many psoriasis biologics are.35 Because of deucravacitinibs oral bioavailability and simpler dosing regimens, adherence to the intended treatment plan may be easier to achieve for patients, and access to first-line therapy for moderate-to-severe psoriasis may be expanded due to lower drug costs.35 Additionally, small molecules may also hold a reduced risk of immunogenicity compared to biologics, which can translate to a longer period of efficacy in individual patients.35 Finally, our systematic review of RCTs found that psoriasis patients treated with deucravacitinib did not experience major AEs at rates significantly different from patients treated with apremilast or placebo.26,36 In our review of the three included RCTs, the most frequently reported AEs tended to occur at similar rates compared to the placebo group and at lower frequencies compared to apremilast treatment. None of the three included RCTs reported significant changes in blood count, cholesterol levels, or opportunistic infections among patients treated with deucravacitinib, which were all concerns that hampered the approval of JAK inhibitors for psoriasis treatment in the past.37,38 Taken together, these results suggest that deucravacitinib may have favorable safety features as a selective inhibitor of TYK2 in the JAK familyalthough results should be interpreted with caution due to the limited follow-up periods reported. Further head-to-head comparative studies should be conducted.
The meta-analysis conducted in our study is, to our knowledge, the first performed that compares plaque psoriasis patients treated with deucravacitinib versus placebo. The results (Figure 2) indicate that the primary endpoint of sPGA 0/1, a validated tool providing a global estimate of a patients psoriatic disease severity, was achieved significantly more frequently in deucravacitinib compared to placebo treatment groups.18 These promising results of clinical efficacy bode well for other TYK2 inhibitors in clinical development for psoriasis, including rapsacitinib, brepocitinib, NDI-034858, and ESK-001.33 Overall, our systematic review and meta-analysis found deucravacitinib to yield positive improvements for multiple efficacy endpoints, including clinical outcomes (eg, sPGA, PASI) and patient-reported quality of life (via DLQI).
Deucravacitinib is an effective, oral small molecule that possesses good efficacy and safety features, indicating its potential to serve as a first-line treatment for moderate-to-severe psoriasis. Patients with plaque psoriasis showed significant improvements in objective, disease-specific clinical parameters, with meta-analysis of Phase II and III RCTs demonstrating the superiority of deucravacitinib compared to placebo. Within individual RCTs, deucravacitinib was also found to yield increased rates of disease improvement and reduced AE incidence compared to apremilast. Thus, deucravacitinib achieved clinical efficacy while maintaining a favorable safety profilean important barrier to prior JAK inhibitor use in psoriasisconsistent with its unique mechanism of action and selectivity for TYK2. While further studies should be conducted to evaluate the long-term safety and efficacy of deucravacitinib and compare it to existing biologics, deucravacitinib holds promising clinical utility and represents an important step forward as a first-in-class treatment option for psoriasis patients.
AE, adverse event; BID, twice daily; CASP, Critical Appraisal Skills Programme; DLQI, Dermatology Life Quality Index; FDA, Food and Drug Administration; IL, interleukin; JAK, Janus kinase; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PGA-F, PGA of Fingernail Psoriasis; QD, daily; QOD, every other day; RCT, randomized controlled trial; sPGA, static PGA; ss-PGA, scalp-specific PGA; STAT, Signal Transducers and Activators of Transcription; Th17, T helper 17; TYK, tyrosine kinase.
All data analyzed in this systematic review can be searched in publicly available databases including PubMed and Embase.
This is a review article of published studies; ethics approval was not required by our Institutional Review Board.
No identifiable patient information was included in this article.
We are thankful to all the reviewers who contributed to this article.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript. All authors contributed to data analysis, drafting or revising the article, have agreed on the journal to which the article will be submitted, gave final approval of the version to be published, and agree to be accountable for all aspects of the work. Conception: JQJ, VR, WL. Methodology: all authors. Formal analysis and investigation: JQJ, RKS. Writingoriginal draft preparation: JQJ, RKS. Writingreview and editing: all authors. Supervision: WL.
This study was not funded.
J.Q.J. has received research grant funding from the National Psoriasis Foundation and institutional funding from the University of California, San Francisco. T.B. has received research grant funding from Novartis and Regeneron and is a principal investigator for trials sponsored by Abbvie, Castle, CorEvitas, Dermavant, Galderma, Mindera, and Pfizer. T.B. has also served as an advisor for Abbvie, Arcutis, Boehringer-Ingelheim, Bristol Myers Squibb, Janssen, Leo, Lilly, Novartis, Pfizer, Sun, and UCB. W.L. has received research grant funding from Abbvie, Amgen, Janssen, Leo, Novartis, Pfizer, Regeneron, and TRex Bio. The authors report no other conflicts of interest in this work.
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13. Hoy SM. Deucravacitinib: first approval. Drugs. 2022;82(17):16711679. doi:10.1007/S40265-022-01796-Y
14. Chimalakonda A, Burke J, Cheng L, et al. Selectivity profile of the tyrosine kinase 2 inhibitor deucravacitinib compared with janus kinase 1/2/3 inhibitors. Dermatol Ther (Heidelb). 2021;11(5):17631776. doi:10.1007/S13555-021-00596-8
15. Gadina M, Chisolm DA, Philips RL, McInness IB, Changelian PS, OShea JJ. Translating JAKs to jakinibs. J Immunol. 2020;204(8):20112020. doi:10.4049/JIMMUNOL.1901477
16. Schwartz DM, Kanno Y, Villarino A, Ward M, Gadina M, OShea JJ. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases. Nat Rev Drug Discov. 2017;16(12):843862. doi:10.1038/NRD.2017.201
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18. Robinson A, Kardos M, Kimball AB. Physician Global Assessment (PGA) and Psoriasis Area and Severity Index (PASI): why do both? A systematic analysis of randomized controlled trials of biologic agents for moderate to severe plaque psoriasis. J Am Acad Dermatol. 2012;66(3):369375. doi:10.1016/J.JAAD.2011.01.022
19. Mattei PL, Corey KC, Kimball AB. Psoriasis Area Severity Index (PASI) and the Dermatology Life Quality Index (DLQI): the correlation between disease severity and psychological burden in patients treated with biological therapies. J Eur Acad Dermatol Venereol. 2014;28(3):333337. doi:10.1111/JDV.12106
20. Catlett IM, Aras U, Hansen L, et al. First-in-human study of deucravacitinib: a selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. Clin Transl Sci. 2023;16(1):151164. doi:10.1111/CTS.13435
21. Mease PJ, Deodhar AA, Van Der Heijde D, et al. Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis. Ann Rheum Dis. 2022;81(6):815822. doi:10.1136/ANNRHEUMDIS-2021-221664
22. CASP CHECKLISTS - CASP - critical appraisal skills programme. Available from: https://casp-uk.net/casp-tools-checklists/. Accessed September 21, 2022.
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24. Papp K, Gordon K, Thai D, et al. Phase 2 trial of selective tyrosine kinase 2 inhibition in psoriasis. N Engl J Med. 2018;379(14):13131321. doi:10.1056/NEJMOA1806382/SUPPL_FILE/NEJMOA1806382_DATA-SHARING.PDF
25. Armstrong AW, Gooderham M, Warren RB, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled Phase 3 POETYK PSO-1 trial. J Am Acad Dermatol. 2023;88(1):2939. doi:10.1016/J.JAAD.2022.07.002
26. Strober B, Thai D, Sofen H, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 program for evaluation of TYK2 inhibitor psoriasis second trial. J Am Acad Dermatol. 2023;88(1):4051. doi:10.1016/J.JAAD.2022.08.061
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31. Gremese E, Alivernini S, Tolusso B, Zeidler MP, Ferraccioli G. JAK inhibition by methotrexate (and csDMARDs) may explain clinical efficacy as monotherapy and combination therapy. J Leukoc Biol. 2019;106(5):10631068. doi:10.1002/JLB.5RU0519-145R
32. Jo CE, Gooderham M, Beecker J. TYK 2 inhibitors for the treatment of dermatologic conditions: the evolution of JAK inhibitors. Int J Dermatol. 2022;61(2):139147. doi:10.1111/IJD.15605
33. Loo WJ, Turchin I, Prajapati VH, et al. Clinical implications of targeting the JAK-STAT pathway in psoriatic disease: emphasis on the TYK2 pathway. J Cutan Med Surg. 2022. doi:10.1177/12034754221141680/ASSET/IMAGES/LARGE/10.1177_12034754221141680-FIG2.JPEG
34. Ytterberg SR, Bhatt DL, Mikuls TR, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med. 2022;386(4):316326. doi:10.1056/NEJMOA2109927/SUPPL_FILE/NEJMOA2109927_DATA-SHARING.PDF
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Covid-19 and Psoriasis: Is there a link? – Dunya News
Posted: at 1:28 am
Psoriasis flares have long been associated with bacterial and viral infections
ISLAMABAD, (ONLINE) - New research is shedding light on how an infection with Covid-19 may reactivate, or even cause, psoriasis. The skin condition affects about 7.5 million adults in the United States, according to the National Psoriasis Foundation. Psoriasis has several well-established triggers, including stress, skin injury, cold or warm air, and allergies. Illnesses like strep throat can also cause a psoriasis flare in some people and it appears Covid may also do so.
Psoriasis flares have long been associated with bacterial and viral infections, particularly a form of psoriasis called guttate, which is characterized by tons of tiny red scaly bumps all over the body, said Joel M. Gelfand, MD, a professor of dermatology and epidemiology at the University of Pennsylvanias Perelman School of Medicine in Philadelphia. Infection with Covid-19 has been associated with flares of guttate and pustular psoriasis, and even psoriasis that affects 100% of the skin, which is called erythroderma, in many published case reports.
What Makes Your Psoriasis Severe?Your immune system is actually to blame for those itchy, sore patches of skin. Its considered severe when it covers what percentage of your body?
A study from Albany Medical College/Weirton Medical Center found that people in the study who were already diagnosed with the skin condition had an unexpected flare within a week to a month after testing positive for Covid. New psoriasis after a Covid infection was also found. The researchers think this could be because Covid causes inflammation in the body, which negatively affects previously well-controlled psoriasis. They also think its possible that Covid-related inflammation could trigger a genetic tendency to have psoriasis, which may explain why it can appear for the first time after a positive test.
Inflammation in the body commonly manifests itself through skin conditions.
The skin is the largest organ in the body, said Robert O. Carpenter, MD, director of wellness at Texas A&M College of Medicine in Bryan, TX. A viral infection like Covid-19 can signal the release of pro-inflammatory factors that can appear as rashes, such as with psoriasis.What are the Symptoms of Covid-Related Psoriasis?
The signs are the same as those of any form of psoriasis. According to the Mayo Clinic, these signs can include:
A patchy, scaly, raised red rash. Psoriasis can also be purple, pink, gray, brown or silver. The rash can appear anywhere on the body. Psoriasis can also look like dandruff.
Dry, cracking skin that sometimes peels
Itching, burning, or painful skin
If I Have Psoriasis, Will COVID Automatically Make It Worse?
Not necessarily.
Psoriasis is a common condition, so people should be aware that new psoriasis that develops may not be related to Covid-19, said Esther Freeman MD, PhD, director of global health dermatology at Massachusetts General Hospital in Boston.
As with every aspect of Covid, doctors and scientists are still learning about how serious and widespread a problem psoriasis after Covid-19 may be. We have seen case reports that psoriasis can flare after Covid-19, said Freeman, who is also an associate professor of dermatology at Harvard Medical School. I will say, this has not been a tidal wave more like sporadic cases here and there. So I do not think psoriasis flares are a major post-Covid finding, nor do they necessarily mean you have long Covid. That being said, we know that many different infections can cause psoriasis flares, and so in that respect, it's not that surprising that SARS-CoV-2, like other infections, could trigger a psoriasis flare.
Could getting Covid more than once cause psoriasis to flare? Its possible.
Your body can change after having Covid-19, said Carpenter. We dont know the long-term implications, but having Covid-19 repeatedly can increase the risk of long Covid, which can cause many systemic changes in your body."
Another important point: If you take biologics, the immune-modulating therapy to treat psoriasis, getting vaccinated and boosted for Covid is an important step to take to help protect yourself.
Is Psoriasis Itself a Potential Symptom of Covid?
Yes, but we dont know the frequency at which this may occur, and a causal relationship is difficult to establish from just case reports, said Gelfand, whos also medical director of the Clinical Studies Unit in the Department of Dermatology at his university. Typically, if a patient presents with a flare of psoriasis, particularly guttate, pustular, or erythrodermic forms, an infectious trigger should be considered, and testing for strep and possibly Covid-19 may be appropriate.
If you do have a flare of psoriasis, or get one for the first time after testing positive for Covid, you should also ask your dermatologist about new treatment options.
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Improvement Needed in Study Interventions to Better Skin Self … – AJMC.com Managed Markets Network
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A new systematic review has identified common strategies for and gaps in ensuring adherence to self-monitoring for early detection of new or recurrent melanoma, a complex challenge affected by various interacting factors.
The study, using an adaption of the World Health Organization (WHO) framework for adherence, characterized strategies built into the design, conduct, and reporting of melanoma trials, offering insights into potential improvements for these strategies in research. Currently, few high-risk patients routinely perform skin self-examination (SSE) frequently or thoroughly.
There is currently limited practical guidance for the best practices to maximize adherence to SSE in research or practice, wrote the researchers in JAMA Dermatology. Assessment of adherence to an intervention in a trial may provide valuable insights on the ease with which it can be translated into routine clinical practice. Trialists may consider developing a comprehensive adherence plan as part of the study protocol, including strategies for dealing with nonadherence, and may find our adaptation of the WHO adherence framework helpful for this. However, care is needed to ensure strategies are achievable in everyday routine care.
The 18 randomized controlled trials included in the analysis ranged from 40 to over 700 patients. Various approaches to bolster adherence to SSE were leveraged in the trials, including trial design, social support, intervention design, intervention and condition support, and participant support.
Intervention design was used by all trials to increase adherence, 13 of which used theories of health behavior change, 2 of which reported on patient and public involvement in the study design and materials, and 1 of which reported codesign of the intervention with potential recipients.
The most common trial design strategy was eligibility criteria limits, used by 14 of the studies. These criteria typically limited eligibility to patients who spoke English and who were more likely to adhere to self-monitoring practices, assessed with pretests for adherence.
Social support was offered in 5 trials, all of which provided access to health care professionals and services. In some trials, research staff helped with urgent clinical appointments, while in others, information was provided on how to access care and calendar scheduling was enabled for scheduling doctor appointments. Some of these trials offered information on melanoma risk within families through an internet-based education tool.
The researchers noted that no trials used economic support to cover additional costs nor ensured materials were sensitive to health literacy. As a result, they wrote, diversity in the trials may have unintentionally been hindered, leading to underrepresentation of certain groups of patients.
Research is needed to identify adherence interventions that are low cost and can be easily integrated into the workflow of routine clinical practice, including automated digital interventions, explained the researchers. Interventions that require the active participation of health care professionals or large administrative support may be difficult to implement in busy clinical contexts. Evaluation of individual components of a complex intervention may be undertaken using a SWAT [Studies Within A Trial] repository within the host randomized clinical trial: a self-contained study that has been embedded within a host trial with the aim of evaluating or exploring alternative ways of delivering or organizing a particular trial process.
The researchers noted that SWAT may have direct effects on adherence in the host trial while offering generalizable results for other trials and guiding implementation post trial.
Reference
Ackermann D, Bracken K, Janda M, et al. Strategies to improve adherence to skin self-examination and other self-management practices in people at high risk of melanoma: a scoping review of randomized controlled trials. JAMA Dermatol. 2023;159(4):432-440. doi:10.1001/jamadermatol.2022.6478
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