Category Archives: Psoriasis

selectION has reported initial safety results from the single ascending dose (SAD) stage of its ongoing Phase Ib trial of si-544 for the treatment of atopic dermatitis.

si-544 is a selectivity-optimised peptide that blocks the Kv1.3 ion channel and helps in the activation and proliferation of TEM cells.

The placebo-controlled, double-blind, multi-centre study is designed to assess the tolerability, safety, and efficacy signals of the drug candidate in patients with mild to severe atopic dermatitis.

No safety signals or dose limiting toxicities have been observed during the studys first stage.

selectION chief scientific officer and co-founder Andreas Klostermann said: The ion channel Kv1.3 controls the activation and proliferation of auto-reactive effector memory T-cells and has been regarded a key target in T-cell autoimmunity for decades.

So far, it has not been possible to block this ion channel with sufficient selectivity.

The initial analysis of safety and tolerability data from 20 patients confirms that si-544 can be safely administered at dose levels sufficient to achieve virtually full Kv1.3 target engagement.

Based on the initial results, selectION now progresses the multiple ascending dose (MAD) stage of the Phase Ib trial.

Patients in this study will be treated with si-544 for a period of one month and thereafter monitored for three months.

selectION chairman and CEO Antonius Schuh said: The data provide initial clinical validation that we can safely and selectively target autoimmune disease associated chronically activated effector memory T-cells.

We will continue our path to deliver a potent and immune-selective therapy which maintains a patients general immunocompetency, and we believe that si-544 has the potential to significantly improve safety and outcomes for patients suffering from a wide range of autoimmune diseases, including atopic dermatitis, psoriasis, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis, and many others.

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selectION reports results from SAD stage of si-544 Phase Ib trial - Clinical Trials Arena

Credit: Unsplash / JAFAR AHMED

Despite a risk of disruption to the microbiome, gastrointestinal tract surgeries are associated with minimal risk of developing psoriasis.1

In new retrospective analysis data from a group of Taiwan investigators, invasive gastrointestinal tract procedures including appendectomy were not significantly associated with increased risk of a new psoriasis diagnosis. The findings additionally elucidated age- and sex-specific risk of new psoriasis diagnoses among such patients.

Led by Dr. Yi-Huei Liu, of the Chung Shan Medical University in Taichung, investigators sought to examine the link between gastrointestinal tract surgery and newly diagnosed psoriasis. Non-genetic psoriasis etiology is not absolutely understood by clinicians, though previous research has pointed to triggers including skin micro-trauma as a potential risk factor for the chronic skin disease.

Whats more, the gut microbiome is a pivotal factor in immune regulation. In a recent interview with HCPLive, dermatologist Karan Lal, DO, MS, described a complex dynamic between chronic skin diseases and microbiota.2

We know that with psoriasis, if they have a leaky gut, they have association with inflammatory bowel disease and a lot of gut issues, Lal said. And so maybe that's why people translate that into the skin microbiome. But again, that's a lot of the people who don't really understand the true relationship with the skin gut axis.

Nonetheless, Liu and colleagues stressed the little-defined association between these potential risk factors and newly diagnosed psoriasis.

Even if surgeries are widely considered a risk factor and disrupt the microbiome in the gastrointestinal tract, resulting in psoriasis, no previous studies have investigated the epidemiological relationship between gastrointestinal tract surgeries and subsequent pathogenesis of psoriasis, they wrote. Therefore, we conducted a nationwide case-control study to explore this issue.

Investigators conducted a nested case-control analysis using data from the Taiwan National Health Insurance Research Database, including patients with newly diagnosed psoriasis from 2005 2013. Their retrospective analysis spanned 5 years after the index date of first psoriasis diagnosis. A control cohort of patients who had never been diagnosed with psoriasis or a similar disorder was matched 2:1 by age and sex to compare the association of concurrent gastrointestinal tract surgery.

The final assessment included 16,655 patients with newly diagnosed psoriasis from 2005 2013. Mean age of both cohorts was 32.2 years old. Chronic diseases including hypertension, diabetes, COPD, and hepatitis C were significantly more prevalent in patients with newly diagnosed psoriasis.

Liu and colleagues conditional logistic regression showed an 8% decreased risk of newly diagnosed psoriasis among patients who underwent gastrointestinal tract surgery (condition odds ratio [cOR], 0.92; 95% CI, 0.76 1.12; P = .426), and a 2% decreased risk of psoriasis among patients who underwent appendectomy (cOR, 0.98; 95% CI, 0.76 1.27; P = .896).

In the multivariate regression analysis of age- and sex-related factors, investigators observed only patients aged 20 39 were at an increased risk of newly diagnosed psoriasis following gastrointestinal tract surgery (OR, 1.09; 95% CI, 0.79 1.51; P = .58), though the association was insignificant. Both male (OR, 0.96; 95%, 0.71 1.29; P = .762) and female (OR, 0.90; 95% CI, 0.69 1.17; P = .427) patients were at an insignificantly decreased risk of newly diagnosed psoriasis after surgery.

Regarding appendectomy, each of patients aged <20 years, 20 39 years, and 40 59 years were at an insignificantly increased risk of newly diagnosed psoriasis after procedure, as well as both female and male patients.

In conclusion, our study shows that gastrointestinal surgeries have a limited effect on psoriasis, investigators wrote. Except for gastrointestinal tract surgery, appendectomy did not have significant age- or sex-related effects on psoriasis.

However, the team stressed that their provisional data based solely on the Taiwan population would require further analysis of additional ethnicities and populations to interpret associations between surgery and psoriasis.

References

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No Link Observed Between Gastrointestinal Tract Surgery and New ... - MD Magazine

Lynk Pharmaceuticals has dosed the first cohort of patients in a Phase Ib clinical trial of LNK01004 ointment to treat psoriasis, a chronic inflammatory skin disease.

The study will evaluate preliminary efficacy of LNK01004 in Chinese patients with mild to moderate plaque psoriasis.

It will also assess the safety, tolerability and pharmacokinetic properties of the topical ointment.

Lynk Pharmaceuticals chief development officer Dr Henry Wu said: LNK01004 has already shown good efficacy and safety in preclinical animal studies.

Characterised by scaly erythematous or plaque lesions, psoriasis is an immune-mediated, relapsing skin disease that can be local or widely distributed.

Lifelong treatment is required for psoriasis patients to prevent complications from developing, thereby maintaining their quality of life.

Lynk Pharmaceuticals founder and CEO Dr Zhao-Kui (ZK) Wan said: As a third generation JAK inhibitor, LNK01004 can effectively inhibit psoriasis-related cytokine-induced JAK/STAT signaling pathways in skin tissues by topical application.

Additionally, LNK01004 has the advantage of extremely low exposure in the blood system to potentially avoid safety concerns due to systemic exposure.

In addition to the highly selective JAK1 inhibitor LNK01001, we have also assembled a promising pipeline consisting of multiple third-generation, tissue-restricted soft pan JAK inhibitors in clinical trials including the GI-restricted LNK01003 for UC which is currently in Phase IIa.

Last week, Lynk reported that the Phase II study of LNK01001 for rheumatoid arthritis treatment demonstrated statistically significant differences in efficacy against placebo in primary and key secondary efficacy endpoints. It is actively seeking a partner for developing LNK01001 in markets worldwide.

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Lynk doses first cohort in Phase Ib trial of psoriasis therapy - Clinical Trials Arena

In patients with psoriasis and psoriatic disease, metabolic inflammation is a cause of comorbid depression, according to new research.

A research article1 reported that specific inflammatory patterns within IL-6, IL-8, IL-23, IL-17 family cytokines, and tumor necrosis factor (TNF) can cause neuroinflammation, ultimately leading to anxiety and/or depressive behavior or depression in patients with psoriatic disease. According to authors, prior knowledge of psoriasis and comorbid depression linked burden of disease, psychological stress, and stigmatization to the origins of depression.

Authors noted that non-cutaneous diseases such as diabetes, heart failure, and hypertension were first identified as comorbidities of psoriasis in 1995, with cardio-metabolic consequences related to psoriatic disease being more thoroughly understood over time. Risk of myocardial infarction, for example, was previously found to be significantly higher in patients with psoriasis than in members of the general population.

Other conditions such as dyslipidemia and endothelial dysfunction were also linked to psoriatic disease. Like depression, article authors noted that both comorbid conditions are linked to inflammation.

In western countries, authors note that 1 in 5 people with psoriatic disease, as much as 20%, also experience depression. Previous studies have also demonstrated that rates of depression are higher in patients with psoriatic conditions than in the general population.

Citing recent brain structure research,2 authors described research demonstrating increased right precuneus thickness in people with psoriasis, only in cases where depression was present. Additionally, further research3 demonstrated a positive correlation between psoriasis area and severity index (PASI) and the Zung self-rating depression scale (SDS) in cases of comorbid depression and psoriasis.

Considering that depression is an inflammatory condition with neuroinflammatory events with a similar signature as in the major domains of psoriatic disease, people with psoriasis-associated depression are no longer responsible for their perceived lack of coping with psychological threads, articleauthors wrote. In the practical management of people with psoriatic disease, screening for depression by using simple clinical questions or respective tools needs to be implemented.

References

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Metabolic Inflammation Contributes to Depression in Psoriatic Disease - Dermatology Times

In an interview with HCPLive Rheumatology, Soumya Chakravarty, MD, PhD, FACP, FACR, Senior Director, Strategic Lead, Janssen Rheumatology, and Daphne Chan, PhD, Head of Dermatology Medical Affairs, Janssen, discussed Janssens commitment to diversity, equity, and inclusion for patients with psoriatic disease.

It has been a fantastic opportunity to emphasize our dedication to advancing care for patients with immune-mediated diseases, especially those with psoriatic disease who belong to communities of color, Chakravarty emphasized. The determination platform we discussed is just one of many ongoing efforts, where we collaborate with various partners to develop specific solutions. It's important to note that this is just the beginning.

Their efforts are accompanied by extensive data generation in patients of color and the creation of a diverse workforce. They strive to deliver culturally competent care and promote progress in this area.

At Janssen, they have undertaken an extensive analysis of the dermatology and rheumatology landscapes to identify unmet needs so they can take meaningful actions as an industry leader and partner. They make an effort to acknowledge the problems the world faces and are realistic about what they can address. Therefore, they focus on the areas where they can make a difference.

Regarding the VISIBLE study, Chan emphasized that simply conducting the study opens doors to demonstrating how it is possible and why it should become the new standard in trial conduct.

Initially, we were apprehensive and doubted whether it could be done, Chan stated. However, I am pleased to report that even taking that first step has yielded tremendous results and rewards. We surprised ourselves by completing the trial's enrollment 7 times faster than projected, concluding 6 months ahead of schedule.

With the trial recruiting so quickly, they expect to have results available sometime next year.

We will be delighted to re-engage in a conversation about the results and what we are learning about people of color living with psoriasis and psoriatic arthritis, Chan emphasized. This experience sets a new chapter for inclusive research and medical practice, defining how it should be in the future.

This transcript was edited for clarity.

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Encouraging Diversity and Inclusion for Patients With Psoriatic ... - MD Magazine

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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The Weekly Roundup: May 22-26 - Dermatology Times

[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.

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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.

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Pediatric Psoriasis Market: A Study of the Industry's Key Applications ... - The Navajo Post

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

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

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