Ergosterol is a sterol found in fungi and this study suggest it could be used in the management of psoriasis.

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Retinoic acid receptor-related orphan receptor gamma-t (RORγt) is one of the nuclear receptor transcription factors that plays a key role in the differentiation of pro-inflammatory IL-17+ T helper cells. Recently, RORγt has attracted increasing attention as a potential drug target for the treatment of several human inflammatory diseases, including psoriasis and Crohn's disease.

In this study, we revealed that ergosterol (ERG) was a novel RORγt inverse agonist, which decreased RORγt transcriptional activity, to regulate collagen fiber deposition and to inhibit pro-inflammatory cytokines, including TNF-α, IL-1β, IL-6, IL-17, IL-22, and IL-23 in the skin lesions of IMQ-induced mice with psoriasis. Furthermore, ERG could repair the epidermal barrier function by upregulating tight junction proteins, such as claudin, occludin, and ZO-1, thereby alleviating psoriasis symptoms.

These findings suggested that ERG might be used as a promising novel RORγt inverse agonist in the management of psoriasis.

Hello everyone,

I have a diagnosis of psoriasis, made a couple of months ago.  Legs, thighs, arms, hands and feet.   Using Enstilar at the moment which helps.

I had a diagnosis of atopic eczema, full body, about a year ago,  got better over time, then bright red rectangular patch on both forelegs, no-one very sure what that was, and  dermatology said varicose eczema, but I think that was wrong. That faded with steroid cream.  Now had a rather typical psoriasis rash.

So I know its early days for me.... I am 78 years old. I also have severe Chronic Kidney failure,  no dialysis though yet.



I am curious to know if the progression from atopic eczema to psoriasis is common, or recognised, or unusual.  

Thank you for reading this, and for any reply

Patrick

In areas of high impact, 72% of patients with scalp psoriasis and 85% with genital psoriasis treated with icotrokinra achieved site-specific clear or almost clear skin at Week 52 in Phase 3 ICONIC-TOTAL study.

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Johnson & Johnson today announced new long-term 52-week data from the Phase 3 ICONIC-TOTAL study evaluating icotrokinra, a first-in-class investigational targeted oral peptide that precisely blocks the IL-23 receptor, in adults and pediatric patients 12 years of age and older (adolescents) with plaque psoriasis (PsO) affecting high-impact sites.

The ICONIC-TOTAL study, simultaneously evaluated adults and adolescents with at least moderate scalp, genital and/or hand/foot plaque psoriasis with ≥1% Body Surface Area (BSA) affected. Through Week 52, icotrokinra demonstrated high and durable rates of site-specific psoriasis clearance affecting all of these high-impact and difficult-to-treat areas of the body.

• 72% of patients with scalp psoriasis achieved a scalp-specific Investigator’s Global Assessment (ss-IGA) 0/1 score and 57% achieved ss-IGA 0
  
• 85% of patients with genital psoriasis achieved a Physician’s Global Assessment of Genitalia (sPGA-G) 0/1 and 73% achieved sPGA-G 0
  

In the smaller subset of patients with hand/foot psoriasis, treatment with icotrokinra showed a numerically higher rate of skin clearance at Week 16, which increased through Week 52 with patients achieving a hand and/or foot Physician’s Global Assessment (hf-PGA) score of 0/1 increasing from 42% to 62%.

“Many of the patients in my practice experience significant distress when psoriasis affects sensitive areas such as the scalp, genitals, hands, and feet,” said Edward (Ted) Lain, MD, MBA Executive Director of the Austin Institute for Clinical Research in Austin, Texas, and study investigator. “The durable response rates observed in the ICONIC-TOTAL study show that icotrokinra has the potential to be a meaningful new option for effectively managing moderate-to-severe plaque psoriasis long-term in both adults and adolescents.”

Overall response rates among patients treated with once daily icotrokinra were maintained through Week 52, with 67% of patients treated with icotrokinra achieving clear or almost clear skin (Investigator’s Global Assessment (IGA)f 0/1) and 44% achieving completely clear skin (IGA 0) at Week 52. The overall response rates were also comparable among patients who received icotrokinra for all 52 weeks and those who transitioned from placebo to icotrokinra at Week 16 (67% versus 68% achieved IGA 0/1, respectively). Across treatment groups, adverse event and serious adverse event rates were similar through Week 52 compared to those through Week 16, with no new safety signals identified.

“The new long-term data from ICONIC-TOTAL adds to the robust findings seen across several studies this year, including the recently reported ICONIC-LEAD 52-week data,” said Liza O’Dowd, MD, Vice President, Immunodermatology and Respiratory Disease Areas Lead, Johnson & Johnson Innovative Medicine. “Psoriasis that affects high-impact skin sites often results in greater physical discomfort for patients due to the sensitivity of these areas. Icotrokinra is being developed with the goal of setting a new standard of treatment that offers patients the precision of a targeted therapy, high level skin clearance and favorable safety profile with the ease of a once daily pill.”

si-544 has demonstrated an excellent safety and tolerability profile in two completed Phase 1b clinical trials in atopic dermatitis patients and, more recently, in psoriasis.

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selectION, Inc a clinical-stage biopharmaceutical company developing novel treatments for T cell-mediated autoimmune diseases, today announced the successful completion of its phase 1b proof-of-concept trial evaluating si-544, a first-in-class Kv1.3 blocker in patients diagnosed with psoriasis vulgaris.

“These results mark a significant milestone, as si-544 has, for the first time, clinically confirmed the long hypothesized and remarkable therapeutic potential of Kv1.3 in T cell autoimmunity,” said Antonius Schuh, Ph.D., CEO of selectION. “This trial clinically validates Kv1.3 dependency as an ideal clinical entry point to disrupt the chronic activation of pathogenic, autoreactive T cells. si-544 has the potential to become a disease modifying and safe treatment option, offering meaningful and durable reduction of disease burden across a broad spectrum of T cell-mediated autoimmune diseases.”

This Phase 1b study was a randomized, double-blind, placebo-controlled proof-of-concept trial in patients diagnosed with mild-to-severe psoriasis vulgaris. Patients received 2 subcutaneous injections of si-544 or placebo (ratio 3:1) per week over a period of 4 weeks and were monitored for a period of 12 weeks post drug washout.

The trial enrolled 45 patients across four clinical sites in Germany. Its primary objective was to evaluate the safety and tolerability of si-544, including monitoring adverse events, laboratory and ECG findings, and vital signs. Secondary endpoints included pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy across key dermatologic measures, including psoriasis area and severity index (PASI), physician’s global assessment (PGA), and body surface area (BSA).

Key findings:

• si-544 was well tolerated with no related serious adverse effects, dose-limiting toxicities, or safety signals observed
  
• A short 4-week treatment cycle resulted in significant clinical improvement as measured by change in Psoriasis Activity and Severity Index (PASI)
  
• Signs of clinical efficacy were seen as early as week 2 of the treatment period
  
• Disease stabilization and continued healing were observed over the entire 12-week monitoring period, post drug washout
  
• Patients treated with si-544 maintained full immunocompetence
  

Hello there. New member and I’m at my wits end. 

Started off with a small scratch on my head around 2007. Within years it spread all over my body but in small, manageable plaques I could treat, initially with Dovobet, then and now with Enstiler. 

The last 12 months it’s changed from plaques and is now all over my body in one big, red rash that I have figured out a cycle of its weekly events. 

Monday it’s at its worse. It now hurts like sun burn. I cover it all with the foam and by Wednesday I can pretty much fill a hoover with the dead skin. Then it’s flat but still very red but no or little dead skin by Wednesday. I then feel like I have even worse sun burn before a couple of days relief but completely red and unsightly. By Sunday night the lumps appear and then it’s rinse and repeat again from Monday. There is no escaping it and it is now at the point where I cannot live a normal or comfortable life, which I could before. I have never been bothered by people looking at me in public and would wear T shirts and shorts. Not anymore. It is ruining my life. 

12 months ago I started smoking and drinking heavily and I know there can be no coincidence, but kicking the two is hard and I use them both as an escape when I look at what the psoriasis is doing to me and how it it how a physical pain as well as a psychological one. 

Why has it changed from manageable plaques to covering my torso as an entirety, and large plaques on my arms and legs? I am only blessed so far it hasn’t affected my face. I am going through 2 cans of foam every 4 weeks, plus tubs and tubs of post shower moisturiser in the form of Adex.

Could knee arthralgia and cartilage thinning in psoriasis patients be clues to early psoriatic arthritis ?

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Background:
To compare femoral cartilage thickness between patients with psoriasis (PsO) and psoriatic arthritis (PsA), and to investigate whether knee joint pain in PsO patients could be an early risk factor for PsA.

Methods:
Fifty-nine patients (28 PsO and 31 PsA) were included in this cross-sectional study. Demographic data were collected, and clinical assessments were performed using the Psoriasis Area and Severity Index (PASI) and the Disease Activity Score 28 (DAS28). PsO patients were evaluated for knee arthralgia symptoms within the past month. Femoral cartilage thickness was measured bilaterally at the medial femoral condyle, lateral femoral condyle, and intercondylar area using ultrasonography.

Results:
Femoral cartilage thickness was significantly lower in PsA patients compared to those with PsO (p < 0.05). Among patients with PsO, those reporting arthralgia (n = 14) had significantly reduced lateral femoral condyle cartilage thickness in both knees compared to those without arthralgia (p < 0.05). Spearman correlation analysis revealed a negative correlation between age and lateral cartilage thickness (e.g., right LFC: ρ = −0.338, p = 0.009, 95% CI –0.55 to −0.09). PASI scores showed a consistent positive correlation with femoral cartilage thickness across regions; for example, the correlation with the left LFC was significant (ρ = 0.504, p < 0.01, 95% CI 0.29–0.67). These associations indicate that both demographic and disease-related factors may influence cartilage status in PsO and PsA, although the confidence intervals indicate some degree of uncertainty and call for validation in larger cohorts.

Conclusions:
Femoral cartilage thinning is evident in PsA patients and may begin even in the subclinical phase. In PsO patients, the presence of arthralgia, especially in the lateral femoral condyle, may reflect early structural changes and could serve as a predictor for PsA development. Ultrasonographic assessment offers a noninvasive, accessible method for early detection and follow-up.

This study investigated lifestyle related serum metabolites associated with late onset psoriasis risk and evaluate their predictive potential.

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Background:
Although healthy lifestyle behaviours are associated with a lower risk of psoriasis, the underlying metabolic mechanisms remain unclear.

Objectives:
To investigate lifestyle-related serum metabolites associated with late-onset psoriasis risk and evaluate their predictive potential.

Methods:
We analysed 190,692 participants (aged 38–73) from UK Biobank with complete data on lifestyle and serum metabolites. Healthy lifestyle was assessed based on diet, exercise, smoking and BMI. The association between lifestyle-related metabolites and late-onset psoriasis risk was identified by a sequential analytic strategy that combined the Cox regression and elastic net regression model. A machine learning model was developed to predict psoriasis risk using clinical features, polygenic risk scores (PRS) and critical metabolites.

Results:
During a median of 14.6 years of follow-up, 2114 incident late-onset psoriasis cases were documented among 186,812 participants. Ideal lifestyle factors were significantly associated with reduced disease burden, with BMI showing the highest population attributable fractions (PAF) of 24.1%. We identified 11 of 134 lifestyle-related metabolites that were significantly associated with the risk of late-onset psoriasis. These predominantly mapped to lipid and glucose metabolism pathways, comprising seven lipoprotein subclasses, two ketones, unsaturation degree and phenylalanine. The addition of these metabolites into clinical characteristics and PRS could significantly improve the performance of predicting the risk of late-onset psoriasis (AUC 0.860, 95% CI 0.857–0.863).

Conclusion:
Multiple lifestyle-related serum metabolites are associated with the incidence of late-onset psoriasis, and their integration with traditional clinical features and genetic susceptibility shows promise in enhancing the predictive accuracy of late-onset psoriasis using a machine learning–based model.

Transition from psoriasis to psoriatic arthritis was associated with distinct alterations of the peripheral blood T cell compartment with Tc17 cells exhibiting the greatest discriminatory power.

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Objective:
Cellular mechanisms driving transition from psoriasis to psoriatic arthritis have remained largely elusive. Thus, we investigated changes within the peripheral blood T cell compartment associated with the transition phase.

Methods:
In an observational study, 116 patients were examined and categorized into subgroups including psoriasis with at least one risk factor for transition to psoriatic arthritis, subclinical psoriatic arthritis according to EULAR taskforce recommendations from 2023, and definitive psoriatic arthritis meeting the CASPAR criteria. Demographic and clinical characteristics of patient subgroups were analyzed. Deep T cell phenotyping using multicolor flow cytometry and machine learning techniques were applied.

Results:
Overlapping T cell endotypes were found among patients with subclinical psoriatic arthritis exhibiting the most notable divergence from the others. Frequencies of effector memory CD4+ T (TEM) cells, T helper 17 (Th17) and T cytotoxic 17 (Tc17) cells differed between psoriasis with at least one risk factor for transition, subclinical psoriatic arthritis and psoriatic arthritis. Transition-associated changes of Tc17 cell frequencies were confirmed by machine learning-assisted unsupervised clustering analysis. Moreover, patients with enthesitis could be distinguished from those without, with Tc17 cells being the main distinctive feature.

Conclusion:
Transition from psoriasis to psoriatic arthritis was associated with distinct alterations of the peripheral blood T cell compartment with Tc17 cells exhibiting the greatest discriminatory power. These findings provide insight into pathomechanisms driving disease progression during transition from psoriasis to psoriatic arthritis and identify Tc17 cells as foremost novel potential therapeutic target for the prevention of transition.

Hello !
Yes im still alive...
After 6 years of satisfaction with Stelara , this morning i have started Uzpruvo.
The license for Stelara is expired in Czech Republic and my Doctor has given me Bio-similar Uzpruvo.
Have you experience with this new bio treatment?
I hope that it will work well as Stelara.
Fingers crossed

Fibroblasts comprise the main cell type of connective tissue, possessing a spindle-shaped morphology, and produce and maintain the extracellular matrix responsible for the structural integrity of tissues and organs and could soon be used to treat psoriasis.

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FibroBiologics announced positive IND-enabling updates from its psoriasis research program demonstrating the potential of human dermal fibroblast (HDF) spheroids as a novel therapeutic approach for chronic-relapse psoriasis.

Psoriasis is a serious autoimmune condition affecting over eight million adults in the United States. In many cases, it progresses to psoriatic arthritis, significantly impacting quality of life. FibroBiologics is focused on harnessing fibroblast science to develop therapies that are not just incremental improvements, but durable, scalable solutions for patients.

“In an acute psoriasis model, a single administration of HDF spheroids matched the efficacy of multiple doses of an anti-IL-23 monoclonal antibody. Now, in a chronic-relapse model, that same single treatment has been shown to significantly reduce disease recurrence,” said Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics.

The company is continuing to expand its research, including exploring repeated dosing regimens, systemic and local cytokine profiling, and histopathological assessments of skin lesions. These efforts are designed to deepen understanding of the mechanisms at work and strengthen the foundation for clinical advancement.

“These IND-enabling results are a pivotal milestone on our path to building a category-defining company in regenerative medicine,” said Pete O’Heeron, Founder and Chief Executive Officer at FibroBiologics. “Chronic inflammatory diseases represent a massive, underserved market, and the ability to address them at scale is a generational opportunity. At FibroBiologics, we’re relentlessly focused on durability, safety, and reproducibility—because those are the levers that unlock scalability and market leadership. The breakthroughs our scientists achieve strengthen the evidence base and bring us closer to creating long-term value for both patients and shareholders.”

FibroBiologics is now evaluating whether a single HDF spheroid treatment can be developed to deliver long-term protection against psoriasis relapse, an outcome that would represent not just progress, but a step-change in how chronic inflammatory diseases are treated.

Individuals with anxiety + smoking or anxiety + hypertension have a higher risk of developing psoriasis.

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Background:
Psoriasis is linked with an elevated risk of anxiety disorders, and there may be a temporal relationship between the two. However, the association between anxiety status and its duration with psoriasis is unclear.

Objectives:
The present work aimed to figure out the association between anxiety and the risk of psoriasis.

Methods:
Data from the National Health and Nutrition Examination Survey (NHANES) 2009–2012 were used. Anxiety state and days of anxiety were applied as the independent variables, and psoriasis as the dependent variable. Weighted logistic regression was employed to analyze the connection between the state and days of anxiety with psoriasis. Restricted cubic spline (RCS) was further utilized to dig out the nonlinear association between days of anxiety and psoriasis. By using weighted logistic regression to further explore the correlation between the combination of anxiety and common cardiovascular risk factors (smoking, hypertension, CVD events) and the risk of psoriasis. Finally, a weighted logistic regression model was constructed for different genders and alcohol consumption subgroups to explore the association between anxiety status and anxiety days and psoriasis and to evaluate the differences in association among different groups.

Results:
A total of 8888 participants were included in this project, among whom 265 cases (3.1%) were psoriasis patients. Through the weighted logistics regression model, we observed a significant positive correlation between anxiety (OR: 1.439, 95% CI: 1.008–2.053, p = 0.030), number of days with anxiety (OR: 1.018, 95% CI: 1.002–1.033, p = 0.014), and the risk of psoriasis in patients. The RCS curve results indicated a linear positive correlation between anxiety days and the risk of psoriasis (p-nonlinear = 0.162). The results of the joint analysis demonstrated that anxiety−/smoking+ (OR: 1.800, 95% CI: 1.160–2.800, p = 0.011), anxiety+/smoking+ (OR: 2.720, 95% CI: 1.430–5.190, p = 0.004), anxiety+/hypertension+ (OR: 2.010, 95% CI: 1.200–3.370, p = 0.011), anxiety−/CVD event+ (OR: 1.740, 95% CI: 1.080–2.820, p = 0.026), and anxiety+/CVD event− (OR:1.470, 95% CI: 1.000–2.150, p = 0.047) were linked with a significantly elevated risk of psoriasis. The subgroup analysis results showed that women (especially those who drink alcohol) were more sensitive to anxiety status and duration, and the association between increased anxiety days and increased risk of psoriasis was more significant, while no similar significant association was observed in men.

Conclusion:
Anxiety and the number of days with anxiety are positively linked with the risk of psoriasis. Individuals with anxiety+/smoking+ or anxiety+/hypertension+ have a higher risk of developing psoriasis. We recommended that, in the prevention and management of psoriasis, individuals need to cope with stress to alleviate anxiety symptoms and try not to smoke. Women should pay special attention to regulating anxiety while drinking alcohol and monitoring blood pressure and cardiovascular health regularly.

This study looked at  the efficacy and safety of Ilumetri / Ilumya (tildrakizumab) in a cohort of patients with moderate-to-severe psoriasis and a previous or current history of neoplasia.

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Background:
Tildrakizumab has demonstrated high efficacy and a good long-term safety profile, including low malignancy rates, in Phase III trials with 5-year extension. Despite these data, the real-world evidence on patients with psoriasis and a history of cancer is limited.

Objectives:
To assess the efficacy and safety of tildrakizumab in a cohort of patients with moderate-to-severe psoriasis and a previous or current history of neoplasia.

Methods:
We conducted a retrospective, observational, multicentre study across 27 Spanish dermatology departments. All patients had moderate-to-severe plaque psoriasis and a prior history of an active neoplasia at the time of initiating tildrakizumab treatment.

Results:
Forty-eight patients with a mean follow-up period of 50 weeks after initiation of tildrakizumab were included. At Week 24, 82.4% of evaluable patients achieved a Psoriasis Area and Severity Index (PASI) score < 3. By Week 48, 80.0% achieved PASI < 1 and 50.0% reached PASI 0. Twelve patients (25%) began treatment within one year of cancer diagnosis, and four patients started tildrakizumab prior to cancer detection and did not stop treatment. Of the remaining 32, they started tildrakizumab an average of 4.95 years after the cancer diagnosis. Seven patients had active neoplasia at baseline. Overall, 95.8% of the patients did not experience recurrence or worsening of the neoplasia. No adverse events related to tildrakizumab were reported. The cancer state was not considered affected by the psoriasis therapy in any of the cases.

Conclusion:
The treatment of moderate to severe psoriasis with tildrakizumab was an effective option, with a safe profile in patients with a history of cancer.

Hi All

Started Pyzchiva on 18th June 2025, thought I would wait to see how it
was going before posting.

Well maybe a coincidence but had a slight headache on and off for about 5
days afterwards.

I have had pain in one shoulder , slightly progressing down arm some days
for about 4 weeks.  I sometimes suffer neck pain etc and blame it on pillows,
lifting etc.  Slight pain in one knee.  I have never been diagnosed with any type of arthritis,
I suffer from aches and pains but put that down to age! this time the pain is not for
going away, I await next jag to see if there is any difference.  I do not have
any swelling of fingers etc.

Skin remains the same as when taking Stelara, small bit appears on elbow and
goes again.  Flakes in ear remain the same.

No other issues or notable side effects.

Due next dose this week and will keep this thread updated.

Hope you are all well.

Angie  Wave

World Health Organization (WHO) has updated it's list of essential medicines for psoriasis.

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The Expert Committee considered that the inclusion of effective and safe biologics for psoriasis on the EML would address an important public health need and support global advocacy efforts to reduce the global burden of psoriasis, especially in low and middle-income countries. The Committee acknowledged that a large number of biologic disease-modifying medicines for psoriasis are available and the need to prioritize the most effective, tolerable and affordable options.

The Expert Committee recommended the inclusion of adalimumab and ustekinumab on the complementary list of the EML and EMLc for the treatment of adults and children with moderate-to-severe psoriasis, based on evidence of favourable efficacy and safety, as second line treatment alternatives. Listing complements the non-biologic therapies used in first line for psoriasis currently listed on the Model Lists (e.g. topical corticosteroids, systemic methotrexate).

The Committee considered that adalimumab and other tumour necrosis factor alpha inhibitors could be considered therapeutic alternatives to each other in most clinical scenarios and that including multiple within-class alternatives on the Model Lists could support greater competition to lower prices. The Committee therefore recommended adalimumab be listed with a square box as the class representative with certolizumab pegol, etanercept and infliximab as specified therapeutic alternatives.

The Committee recommended inclusion of ustekinumab in addition to adalimumab because of some advantages ustekinumab has over adalimumab and other tumour necrosis factor alpha inhibitors. When considering the administration schedule, adalimumab is administered every two weeks while ustekinumab is administered every 12 weeks. Less frequent injections are more convenient, with reduced disruption to daily life for patients and reduced burden and costs for health systems. Ustekinumab is preferred to adalimumab in patients with heart disease and in settings where tuberculosis is endemic as it is associated with a lower risk of tuberculosis reactivation. While ustekinumab is currently more highly priced than adalimumab, biosimilars are becoming increasingly available. For ustekinumab, the Committee did not recommend listing with a square box. The Committee acknowledged the data supporting similar or better effectiveness of other monoclonal antibodies targeting IL-12 and IL-23 (e.g. guselkumab, risankizumab and tildrakizumab) but considered the alternatives to have less supportive evidence, biosimilars are not yet available, and there is no information regarding their costs in most jurisdictions which were assumed to be higher than ustekinumab.

Quality-assured biosimilars are recommended as therapeutic alternatives of both adalimumab (and therapeutic alternatives) and ustekinumab.

University of Queensland Australia researchers have been the first in the world to successfully grow fully functioning human skin in a laboratory that could one day help find better treatments for psoriasis.

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Dr Shafiee said.

“This is the most life-like skin model that’s been developed anywhere in the world and will allow us to study diseases and test treatments more accurately”

“It developed just like natural human skin, with layers, hair follicles, pigmentation, appendage patterning, nerves, and most importantly, its own blood supply”

“This skin model will enable us to further progress those treatments, along with wound healing, regenerative medicine and precision dermatology"

“Skin disorders can be difficult to treat, and it’s a real breakthrough to be able to provide hope for people living with chronic conditions such as psoriasis"

Investigating the effectiveness and safety of psoriasis treatment after the failure of initial biologic therapy, particularly when patients switch to a second biologic.

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Question: 
What is the effectiveness and safety of interclass biopharmaceutical switching in psoriasis treatment?

Findings:
This systematic review and meta-analysis of 24 randomized clinical trials including 12 661 patients found that interclass biopharmaceutical switching demonstrated faster short-term and more stable long-term effectiveness. Switching from anti−tumor necrosis factor (TNF)-α agents to anti−interleukin (IL)-23p19 agents and from anti−IL-12/23p40 agents to anti−IL-23p19 agents led to significantly improved effectiveness; however, switching was associated with an increased risk of infection that was higher when switching from anti−TNF-α agents to anti−IL-23p19, anti−IL-17A, and anti−IL-12/23p40 agents.

Meaning: 
These findings indicate that clinicians may consider biopharmaceutical switching to reduce costs, enhance effectiveness, and minimize adverse events; however, future studies are needed to determine the long-term safety of biologics that target different pathways in clinical practice.

Johnson & Johnson files with U.S. Food and Drug Administration (FDA) to include new evidence in Tremfya (guselkumab) label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in active psoriatic arthritis.

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Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval to include new evidence in the TREMFYA® (guselkumab) label for the inhibition of progression of structural damage in adults with active psoriatic arthritis (PsA).

The submission is supported by the Phase 3b APEX study in patients with active PsA, which achieved both its primary endpoint of reducing joint symptoms (ACR20) and its major secondary endpoint of inhibited progression of structural damage as measured by change in the modified van der Heijde-Sharp (vdH-S) score at 24 weeks, compared to placebo in bio-naïve patients.

Data from the APEX study were consistent with the well-established safety profile of TREMFYA®. Additional data will be presented at future medical meetings.

TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active PsA.

Bath-PUVA therapy involved immersion in water at 37°C containing 8-methoxypsoralen bath salts at a concentration of 0.0001% for 15 min, followed by immediate ultraviolet A (UVA) irradiation.

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Background/Purpose:
While biologics and small-molecule inhibitors are first-line systemic treatments for psoriasis, phototherapy remains an alternative for patients unable to access these treatments because of medical or financial constraints. Narrow-band ultraviolet B (NB-UVB) is effective for localized psoriasis but less so for extensive disease. To address this limitation, bathwater delivery of psoralen plus ultraviolet A (bath-PUVA) was introduced in 2004. This study evaluates the efficacy, safety, and patient characteristics associated with bath-PUVA therapy in a large cohort.

Methods:
This retrospective analysis included 229 patients (180 males, 49 females) treated with bath-PUVA from 2004 to September 2021. Baseline characteristics and treatment outcomes were assessed using the psoriasis area and severity index (PASI). Statistical analyses examined relationships between treatment outcomes and factors, including baseline PASI, body mass index (BMI), and smoking status.

Results:
The mean baseline PASI score was 24.9. Bath-PUVA achieved PASI 75 in 80.4% of patients, PASI 90 in 44.1%, and PASI 100 in 2.6%, with efficacy comparable to biologics. Patients achieving PASI 90 had significantly higher baseline PASI scores (p = 0.005), while the number of irradiations required did not differ (p = 0.692). Higher baseline PASI scores correlated with elevated BMI (p = 0.002), but BMI did not influence improvement rates (p = 0.094). Smokers had significantly higher baseline PASI scores (p = 0.004) compared with non-smokers, yet smoking status did not affect improvement rates (p = 0.862).

Conclusion:
Bath-PUVA demonstrates efficacy comparable with biologics for psoriasis, regardless of BMI or smoking status. This analysis supports its use as an effective and accessible treatment option for patients with extensive disease.

The aim of this pilot study was to assess the effect of repeated dithranol applications on aspects of histopathologic features of psoriasis.

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Background:
There are only limited histomorphological data on the response of psoriatic skin lesions to topical dithranol. In vivo reflectance confocal microscopy (RCM) in psoriatic skin is highly correlated with histopathological findings and allows non-invasive monitoring of treatment effects on a cellular level.

Patients and Methods:
Prospective, single-center pilot study at a university-based clinic of dermatology between January 1st and August 30th, 2016. Psoriatic lesions of 20 patients receiving dithranol treatment were assessed by RCM at baseline, day 4 and 8 of treatment.

Results:
RCM measurements of psoriatic lesions receiving dithranol treatment revealed epidermal histomorphological changes with a strong median reduction of baseline hyperkeratosis by 45.0% (p < 0.001), acanthosis by 38.2% (p < 0.001), and epidermal thickness by 66.5% (p < 0.001) from baseline until day 8. Moreover, semiquantitative measurements of parakeratosis also showed a significant reduction until day 8 (p < 0.001). Correspondingly, RCM revealed dermal histomorphological changes with a decrease in diameter of dermal papillae by 32.1% (p < 0.001), decrease in diameter of papillary vessels by 16.9% (p = 0.002) and a strong semiquantitative reduction of the inflammatory infiltrate (p < 0.001).

Conclusions:
Results from our pilot study indicate that topical dithranol treatment of psoriatic lesions may induce a rapid and marked reduction of pathologic epidermal and dermal RCM features.

Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionise treatment paradigm for adults and adolescents with plaque psoriasis.

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Johnson & Johnson (NYSE: JNJ) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis (PsO). Icotrokinra is uniquely designed to block the IL-23 receptor, which underpins the inflammatory response in plaque PsO and offers potential in other IL-23-mediated diseases.

The application included data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEAD, ICONIC-TOTAL and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2. Treatment with icotrokinra met all primary and co-primary endpoints across the development program among adults and pediatric patients 12 years of age and older with moderate-to-severe plaque PsO, demonstrating significant skin clearance and a favorable safety profile in a once-daily pill. Results from the ICONIC-ADVANCE 1 & 2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO. Across all studies, pooled safety data showed a similar proportion of patients experienced adverse events (AEs) between icotrokinra (49.1%) and placebo (51.9%) groups, with no new safety signals identified to date.

“The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment that meaningfully addresses their needs and preferences,” said Liza O’Dowd, MD, Vice President, Johnson & Johnson Innovative Medicine. “Given the breadth and depth of our studies, along with the robust clinical results reported to date, we are confident that icotrokinra has the potential to transform how physicians and patients think about plaque psoriasis care, establishing a new standard in the treatment of this immune-mediated disease.”

Johnson & Johnson has also initiated the Phase 3 ICONIC-ASCENDf study, the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab, representing an important step forward in psoriasis research.