Bristol Myers Squibb today announced that the U.S. Food and Drug Administration and The European Medicines Agency has accepted for review the supplemental new drug application (sNDA) for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis.

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The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026. This latest regulatory milestone is in addition to the sNDA acceptances by China’s Center for Drug Evaluation of National Medical Products Administration and Japan's Ministry of Health, Labour and Welfare for Sotyktu for the treatment of adults with active psoriatic arthritis. The European Medicines Agency has also validated Bristol Myers Squibb's Type II variation application to expand the indication for Sotyktu to include this disease.

“There is a significant need for additional oral treatments for individuals living with psoriatic arthritis, and today’s announcement brings us one step closer to bringing Sotyktu to these patients,” said Roland Chen, MD, Senior Vice President, Bristol Myers Squibb. “We are eager to continue conversations with the FDA and other global regulatory bodies with the goal of including Sotyktu as a differentiated, first-line, advanced systemic treatment option for psoriatic arthritis, while we pioneer research of this novel molecule in other severe rheumatic conditions.”

Sotyktu received approval from the FDA in 2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Since then, Sotyktu has earned approvals for this indication from multiple global health authorities and demonstrated durable efficacy and a consistent safety profile over more than 20,000 patient-years of experience.

Sotyktu, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, has the potential to be the first TYK2 inhibitor for the treatment of psoriatic arthritis.

The regulatory applications are based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 trials, which evaluated the efficacy and safety of Sotyktu in adults with active psoriatic arthritis. Both trials met their primary endpoint, with a significantly greater proportion of Sotyktu-treated patients achieving ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo. Additional data from POETYK PsA-2 reported outcomes through 52 weeks of treatment and demonstrated that clinical response improved and was maintained from Weeks 16 to 52.

The overall safety profile of Sotyktu through 16 weeks of treatment in the POETYK PsA-1 and POETYK PsA-2 trials was consistent with that established in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials; no new safety signals were observed.

Sun Pharma today announced top-line results from two Phase 3 clinical studies evaluating the efficacy and safety of Ilumya / Ilumetri (tildrakizumab) 100 mg administered over 24 weeks for treatment of active psoriatic arthritis.

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Treatment with tildrakizumab 100 mg resulted in greater improvements in PsA signs and symptoms at week 24 compared to treatment with placebo.

Both the INSPIRE-1 and INSPIRE-2 studies achieved the primary endpoint, with a higher proportion of patients in the INSPIRE-1 and INSPIRE-2 studies treated with tildrakizumab achieving ACR20 responses at week 24, compared to those receiving placebo (p < 0.05).

"We are excited to share that both the INSPIRE-1 and INSPIRE-2 clinical trials have successfully met their primary endpoints. These top-line results reinforce the therapeutic potential of tildrakizumab as a treatment option for patients with active psoriatic arthritis. We extend our sincere gratitude to the patients, healthcare professionals and administrators whose contributions made the studies possible. We look forward to sharing the complete clinical data in the near future"

Safety data in the studies was consistent with the well-documented safety profile of tildrakizumab, which is approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or
phototherapy.

No new safety signals were identified in the INSPIRE-1 and INSPIRE-2 studies. Findings from the INSPIRE studies will be presented at upcoming medical conferences and published in a peer-reviewed medical journal. Use of tildrakizumab 100 mg in psoriatic arthritis is not approved, and its safety and efficacy have not been evaluated by regulatory authority

ORKA-001 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-23p19 that has the potential to be dosed just once or twice a year in patients with psoriasis.

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Oruka Therapeutics a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today announced that the U.S. FDA cleared its investigational new drug (IND) application for its Phase 2a trial of ORKA-001 (the Company’s long-acting anti-IL-23p19 antibody) in moderate-to-severe psoriasis, called EVERLAST-A.

“We’re thrilled by this rapid progress into Phase 2 development, and very excited to start our first psoriasis study,” said Lawrence Klein, PhD, CEO of Oruka. “We think that ORKA-001 can redefine the standard of care in this important disease with potential for once per year dosing, off-treatment remissions and higher rates of disease clearance.”

The U.S. FDA cleared the Company’s IND submission to initiate EVERLAST-A. EVERLAST-A is a randomized, double-blind, placebo-controlled Phase 2a trial designed to evaluate the safety and efficacy of a single dose level of ORKA-001 in moderate-to-severe psoriasis patients. EVERLAST-A will enroll approximately 80 patients, randomized 3:1 to receive ORKA-001 or matching placebo. The primary endpoint is PASI 100 at Week 16. ORKA-001 exposures are expected to match or exceed exposures in the KNOCKOUT study, providing a definitive test of whether higher exposures of an anti-IL-23p19 antibody can lead to greater efficacy. At Week 28, patients who have achieved PASI 100, or completely clear skin, will be randomized 2:1 to either an arm where they do not receive another dose until disease recurs or ORKA-001 every six months. This “no-dose” arm will provide evidence for both yearly dosing and the potential for extended off-treatment remissions. Patients who have not yet achieved PASI 100 at Week 28 will receive ORKA-001 every six months.

"We have made great strides in our ability to treat psoriatic disease, but many patients are still seeking improved treatment options. I’m excited about EVERLAST-A and the potential that ORKA-001 could enable long dosing intervals and greater efficacy than current IL-23 inhibiting medications. There is evidence now that these improvements could be within reach, and they would be a significant step forward for both patients and the field,”

This study demonstrates the deletion of the m6A writer Mettl3 in mouse macrophages mitigates imiquimod (IMQ)-induced psoriasis-like inflammation.

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Impaired N6-methyladenosine (m6A) modification has been implicated in regulating various inflammatory diseases, but its role in psoriasis remains unclear.

Here, m6A modification and its methyltransferase METTL3 are revealed to be upregulated in psoriatic macrophages, while the demethylase ALKBH5 is downregulated. Conditional knockout of Mettl3 in macrophages alleviated psoriasis-like symptoms in mice, whereas knockout of Alkbh5 exacerbated them.

Both in vivo and in vitro, Mettl3 deficiency inhibited IMQ-induced M1 macrophage polarization, while Alkbh5 deficiency promoted M1 polarization. The regulation of macrophage polarization by m6A is likely mediated by targeting Slc15a3. SLC15A3 enhances the recruitment of TASL, a recently identified endolysosomal IRF5 adaptor, which functions similarly to the IRF3 adaptors STING and MAVS at the endoplasmic reticulum (ER) and mitochondria, respectively, to augment IRF5 signaling via SLC15A4.

The findings underscore the critical role of m6A RNA modification in psoriasis pathogenesis and unveil a novel regulatory mechanism of TASL-IRF5 signaling through m6A modification, suggesting potential new therapeutic targets for psoriasis treatment.

Itching sensation and elevated interleukin-31 levels as potential indicators of exceptional response to biologics in patients with moderate-to-severe psoriasis.

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Although the introduction of biologics has significantly changed the psoriasis treatment paradigm, predicting which patients will respond favourably to biologics remains a challenge.

Our study aimed to retrospectively investigate the characteristics of ‘exceptional responders’ (ERs), that is, patients who achieve a Psoriasis Area and Severity Index (PASI) of 100 between weeks 16 and 28 of their initial evaluation period.

We conducted a retrospective analysis of the electronic medical records and clinical photographs of 139 patients with psoriasis. Demographic and clinical characteristics of the patients were collected and analysed. Peripheral blood samples previously obtained from consenting individuals (n = 10 for each group) were used to compare the serum concentrations of interleukin-31 (IL-31), lipocalin-2 (LCN2) and chemokine ligand 2 (CCL2), between ERs and non-ERs.

We observed no significant differences in nail involvement, arthralgia, mean body mass index, or baseline PASI between ERs and non-ERs. Notably, the occurrence of itching was significantly higher in the ER group than in the non-ER group. The IL-31 concentration displayed a concomitant increase with the intensity of itching and was significantly higher in ERs than in non-ERs prior to the initiation of biologics.

After treatment, a significant decrease in IL-31 levels was observed in the ER group but not in the non-ER group. While both LCN2 and CCL2 levels decreased significantly after treatment in both groups, they did not exhibit clear distinctions that could differentiate between ERs and non-ERs. Baseline IL-31, combined with itch intensity, discriminated ERs from non-ERs.

Clinicians should recognise that patients presenting with pruritus and high serum IL-31 levels may respond exceptionally well to biological agents, whereas those without pruritus and with lower IL-31 levels tend to have a more subtle response.

This study demonstrates that poor cardiovascular-kidney-metabolic (CKM) health was significantly associated with an increased risk of psoriasis.

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Background:
Limited evidence exists concerning the relationship between cardiovascular–kidney–metabolic (CKM) health and the incidence and prognosis of psoriasis.

Objective:
This study aimed to evaluate the associations between CKM status, genetic risk and the risk of developing psoriasis, as well as to examine the impact of CKM syndrome on life expectancy in patients with psoriasis.

Method:
This prospective cohort study included 392,454 participants free of psoriasis from the UK Biobank. CKM syndrome was defined by the presence of metabolic risk factors, chronic kidney disease and cardiovascular disease, categorized into five stages (0–4). The genetic risk of psoriasis was assessed using a polygenic risk score. Cox proportional hazards regression models were used to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the incident risk of psoriasis.

Results:
Compared to participants in stage 0, the multivariable-adjusted HRs (95% CIs) for developing psoriasis in individuals with CKM stages 1, 2, 3 and 4 were 1.21 (1.06–1.38), 1.38 (1.24–1.55), 1.64 (1.42–1.91) and 1.72 (1.47–2.01), respectively. Joint association analyses revealed that participants with CKM stage 4 and high genetic risk had the highest risk of psoriasis compared to those at stage 0 with low genetic risk (HR = 2.82, 95% CI: 2.28–3.49). Notably, there was a significant positive additive interaction between advanced CKM stages and high genetic risk in the development of psoriasis (RERI = 0.82, 95% CI: 0.35–1.32). Additionally, within the psoriasis population, advanced CKM stage (stage 4) was associated with a greater reduction in life expectancy (2.03 years, 95% CI: 0.25–3.81 years).

Conclusions:
Poor CKM health was significantly associated with a higher risk of psoriasis in midlife and older adults, particularly among those with high genetic risk and was further linked to decreased life expectancy among patients with psoriasis.

This study evaluated the effectiveness of Otezla (apremilast) in treating male patients with refractory genital psoriasis with pustular features, a rare subtype that can be mistaken for other conditions.

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Background:
Genital pustular psoriasis is a rare and often underdiagnosed condition that can severely affect physical comfort, quality of life and psychological well-being. It can be particularly challenging to manage, often requiring systemic therapies due to its potential unresponsiveness to conventional topical treatment.

Objectives:
To evaluate the effectiveness of apremilast in treating male patients with refractory genital psoriasis with pustular features, a rare subtype that can be mistaken for other conditions, including infections and Reiter's syndrome.

Methods:
A retrospective case series of six male patients, aged 21−47 years, presenting with recurrent circinate balanitis or balanoposthitis and histological features suggestive of pustular psoriasis (intraepidermal neutrophilic aggregates without frank pustules). These patients had previously failed multiple treatments, including topical corticosteroids, calcineurin inhibitors, acitretin, ciclosporin and methotrexate. Apremilast was initiated with a 6-day titration protocol, and patients were followed for 1–3 months.

Results:
All six patients showed complete remission within 1−3 months of starting apremilast, with no major side effects reported. Diagnostic work-up, including viral, bacterial, mycological swabs and syphilis serology, was negative for all patients, and no extragenital symptoms typically associated with Reiter's syndrome were observed.

Conclusions:
Apremilast appears to be an effective and well-tolerated treatment for refractory genital psoriasis with pustular features, providing a promising therapeutic option for patients with this challenging condition. Further studies with larger cohorts and randomized trials are needed to confirm its long-term efficacy and safety.

This cohort study looked phenotypic differences in patients with and without a family history of psoriatic arthritis (PsA)

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Objectives:
While up to 45% of patients with psoriatic arthritis (PsA) have a family history of psoriatic disease, it is unclear whether this family history contributes to a distinct PsA phenotype and/or timing of disease onset. We aimed to identify differences in onset, domain involvement, and disease activity based on family history of psoriatic disease.

Methods:
843 PsA patients were enrolled in an observational, longitudinal registry. Demographics, medical history, family history, and psoriatic phenotype and activity were collected.

Results:
379 patients (45.0%) had at least one first-degree (FDR) or second-degree relative (SDR) with psoriatic disease. Those with a family history developed psoriasis and PsA earlier than those with no family history (27.6 vs. 32.2 years, p < 0.01; 37.6 vs. 40.3, p < 0.01) and were more likely to have entheseal involvement (36.7% vs. 30.0%, p < 0.05). Patients with an FDR/SDR with PsA were diagnosed with psoriasis and PsA earlier than those with an FDR/SDR with psoriasis alone, followed by those with no family history (26.3 vs. 27.8 vs. 32.2 years, p < 0.01; 36.5 vs. 37.9 vs. 40.3 years, p = 0.01).

Conclusion:
In this cohort, PsA patients with a family history of psoriatic disease were diagnosed with psoriasis and PsA earlier, and were more likely to have entheseal involvement, compared to those without a family history. Further research incorporating molecular and immune features is needed to investigate genetic, environmental and epigenetic factors that impact PsA phenotype and severity, as well as the transition from psoriasis to PsA.

From July 25th websites that allow pornography or harmful content must ask for proof of age from UK visitors, this can only be done by asking for personal details along with proof such as.

• Facial age estimation – you show your face via photo or video, and technology analyses it to estimate your age. 
  
• Open banking – you give permission for the age-check service to securely access information from your bank about whether you are over 18. The age-check service then confirms this with the site or app.
  
• Digital identity services – these include digital identity wallets, which can securely store and share information which proves your age in a digital format.
  
• Credit card age checks – you provide your credit card details and a payment processor checks if the card is valid. As you must be over 18 to obtain a credit card this shows you are over 18.
  
• Email-based age estimation – you provide your email address, and technology analyses other online services where it has been used – such as banking or utility providers - to estimate your age.  
  
• Mobile network operator age checks – you give your permission for an age-check service to confirm whether or not your mobile phone number has age filters applied to it. If there are no restrictions, this confirms you are over 18. 
  
• Photo-ID matching – this is similar to a check when you show a document. For example, you upload an image of a document that shows your face and age, and an image of yourself at the same time – these are compared to confirm if the document is yours. 
  

The psoriasis treatment pipeline is looking busy this year according to a report by DelveInsight a consulting firm with deep industry expertise in the healthcare domain with a core focus on pharma and biotech industries.

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DelveInsight’s, “Psoriasis- Pipeline Insight, 2025” report provides comprehensive insights about 65+ companies and 75+ pipeline drugs in Psoriasis pipeline landscape.

Geography Covered: Global.

Phases:
Late stage products (Phase III)
Mid-stage products (Phase II)
Early-stage product (Phase I) along with the details of pre-clinical and discovery stage candidates, plus discontinued & inactive candidates.

Route of Administration:
Intravenous
Subcutaneous
Oral
Intramuscular

Molecule Type
Monoclonal antibody
Small molecule
Peptide

This study evaluated serum miRNA profiles in patients with psoriatic arthritis (PsA) and healthy controls using next-generation sequencing.

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Objective:
Psoriatic arthritis (PsA) is a chronic immune-mediated inflammatory arthritis that develops in 30% of patients with psoriasis, leading to increased morbidity and mortality and reduced quality of life. MicroRNAs (miRNAs) modulate gene expression and have been associated with the pathogenesis of immune-mediated disorders. We aimed to identify miRNAs that can be used as biomarkers for the development of PsA in patients with psoriasis.

Methods:
miRNA expression levels were assessed in serum samples from 28 patients with PsA, 35 patients with cutaneous psoriasis without arthritis (PsC), and 28 healthy controls through next-generation sequencing. Differential expression was assessed by linear modeling with empirical Bayes moderation corrected for sequencing batch, age, sex, and duration of psoriasis. For validation, we measured the expression of >191 genes predicted to be targeted by the dysregulated miRNAs using a custom NanoString probe panel in an independent cohort of 144 patients with PsA and 88 patients with PsC. The enrichment of specific pathways corresponding to the differentially expressed gene targets was examined using pathDIP.

Results:
In the discovery cohort, the miRNA miR-190a-5p was significantly down-regulated in patients with PsA compared to those with PsC (P< 0.05), and both miR-190a-5p and miR-26b-5p were down-regulated in patients with PsA versus healthy controls (P < 0.05). In the validation cohort, 26 gene targets of both of these miRNAs were differentially expressed. These genes were enriched in signaling pathways associated with bone formation and regeneration: Wnt and transforming growth factor β.

Conclusion:
Serum expression levels of miR-190a-5p and miR-26b-5p can potentially serve as biomarkers for PsA development.

This study was conducted to evaluate the impact of methotrexate on cardiovascular outcomes in patients with psoriasis.

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Background:
Psoriasis is a chronic immune-mediated inflammatory disease with a global prevalence of 2%–3% and 1.3% in Brazil. It is associated with comorbidities such as obesity, hypertension, and diabetes, all of which contribute to increased cardiovascular risk due to systemic inflammation and endothelial dysfunction. Methotrexate (MTX), a commonly used treatment for psoriasis, may influence cardiovascular outcomes through its anti-inflammatory effects.

Objectives:
To evaluate the impact of methotrexate on cardiovascular outcomes in patients with psoriasis, particularly its potential to reduce cardiovascular risk by controlling systemic inflammation.

Methods:
A systematic review was conducted according to PRISMA guidelines. Searches were performed in pub med, Cochrane, Embase, and Web of Science databases. Eligible studies assessed the effects of methotrexate on cardiovascular outcomes in psoriasis patients. Case reports and narrative reviews were excluded. Study quality was assessed using the RoB-2 and GRADE tools. From 143 initially identified records, four studies met the inclusion criteria. Meta-analyses using fixed-effects and random-effects models were conducted to estimate pooled odds ratios (ORs).

Results:
Under the fixed-effects model, methotrexate was associated with a significant reduction in cardiovascular risk (OR = 0.62; 95% CI: 0.57–0.68). However, due to high heterogeneity, the random-effects model yielded nonsignificant results (OR = 0.86; 95% CI: 0.54–1.35). The incidence of cardiovascular events was similar between the methotrexate (3.6%) and control (3.7%) groups.

Conclusions:
Methotrexate shows promise in reducing cardiovascular risk in psoriasis patients, likely due to its anti-inflammatory properties. It appears to be a safer option compared to agents such as retinoids. Nonetheless, the high heterogeneity and methodological limitations of available studies hinder definitive conclusions. Further research should prioritize standardized outcome measures, comparisons with biologics, and individualized therapeutic approaches.

SPY072 is an investigational, extended half-life monoclonal antibody targeting TL1A for the potential treatment of psoriatic arthritis.

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Interim results from the Phase 1 trials for SPY072, with data reported as of May 30, 2025, met all Phase 1 objectives, supporting their potential to become next-generation anti-TL1A monotherapies in immune-mediated diseases or as elements of combination therapies. Single doses of up to 1500 mg for SPY072 were well tolerated with no serious adverse events reported, exhibited a prolonged half-life supportive of quarterly or less frequent dosing, and suppressed free TL1A through 20 weeks of follow up available for the lowest dose tested.

SPY072 will be advanced via the newly announced SKYWAY-RD basket trial for three rheumatologic conditions. The SKYWAY-RD study is a Phase 2 basket trial investigating Spyre's improved anti-TL1A as a treatment for RA, PsA, and axSpA and is expected to initiate in Q3 2025.

This study assembled a large multicentre cohort of paediatric patients with psoriasis and suspected bacterial infection.

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Background/Objectives:
Guttate psoriasis onset and plaque psoriasis flares are associated with streptococcal pharyngitis. Literature regarding the relationship between anogenital bacterial dermatitis and psoriasis in pediatric patients is limited. We aimed to evaluate the clinical characteristics, microbiology, and treatment course of patients with psoriasis/psoriasiform dermatitis and concomitant pharyngeal and/or anogenital bacterial infections.

Methods:
A multicenter retrospective review of patients ≤ 18 years of age with psoriasis/psoriasiform dermatitis and bacterial infection, defined by positive culture results, was performed. Demographic characteristics, clinical features, microbiology, treatment recommendations, and outcomes were evaluated. Comparisons were made between pharyngeal and anogenital culture groups.

Results:
A total of 166 unique patients with psoriasis/psoriasiform dermatitis and suspected pharyngeal and/or anogenital infection were evaluated between 2011 and 2021. Staphylococcus sp. and Streptococcus sp. were isolated in anogenital cultures. Inverse psoriasis was associated with a positive anogenital culture (p = 0.0356). Guttate psoriasis was more common in patients with a positive pharyngeal culture (p < 0.0001). Treatment of a positive bacterial culture did not correlate with the treatment response of psoriasis/psoriasiform dermatitis.

Conclusions:
Investigations for anogenital and pharyngeal infections should be considered in pediatric patients presenting with new-onset or worsening psoriasis. A high clinical suspicion should be maintained for anogenital infection in patients with inverse psoriasis, specifically.

Sun Pharma is discontinuing clinical trials of SCD-044 for psoriasis and has no further plans for development.

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SCD-044 is a novel orally bioavailable S1P receptor 1 agonist for the treatment of inflammatory diseases such as atopic dermatitis and psoriasis. S1P receptor 1 agonists are promising for the treatment of autoimmune inflammatory diseases as they modulate migration of lymphocytes out of lymphatic tissue.

This results in a decrease of circulating pathogenic lymphocytes, thereby reducing inflammation. A Phase 1 study of SCD-044 was completed in healthy volunteers earlier. This study established clinical proof-of-concept for SCD-044 in terms of its safety and pharmacodynamic effects. Lymphocyte count reduction, a surrogate marker of efficacy for S1P receptor 1 agonists, was observed at all dose levels evaluated.

The phase 2 study did not meet its primary endpoint of 75% improvement in PASI (Psoriasis Area and Severity Index) score (≥PASI75) at Week 16. The Phase 2 randomized, double-blind, placebo-controlled study of SCD-044 included 263 people living with moderate to severe plaque psoriasis.

“While we are disappointed with the top-line results of the clinical trials, we would like to thank all the psoriasis and atopic dermatitis patients, the healthcare professionals and administrators who participated in these pivotal clinical trials,” said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Specialty Development at Sun Pharma.

There were no major safety or tolerability concerns with SCD-044 in either the plaque psoriasis or atopic dermatitis studies. Sun Pharma is discontinuing clinical trials of the asset and has no further plans for development of SCD-044. Sun Pharma and its partner, Sun Pharma Advanced Research Company Ltd will evaluate the appropriate next steps for SCD-044.

This British study was undertaken to address gaps left by randomized controlled trials in comparing the effectiveness of IL-23p19 and IL-17 inhibitors, specifically Skyrizi (risankizumab) and Kyntheum / Siliq (brodalumab), against each other in a representative clinical population.

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Background:
Interleukin (IL)-23p19 and IL-17 inhibitors have demonstrated high efficacy for psoriasis in randomized controlled trials, though real-world data, particularly for risankizumab (IL-23p19 inhibitor) and brodalumab (IL-17 receptor (IL-17R) inhibitor), is limited.

Objectives:
To assess drug survival of IL-23p19 and IL-17 inhibitors compared to other biologics for psoriasis.

Methods:
We conducted a cohort study using data from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) from November 2007 to June 2023. Multivariable flexible parametric models assessed drug survival, with discontinuation due to ineffectiveness and adverse effects reported separately. The primary outcome measure was the absolute difference in restricted mean survival time at 2 years, referred to as adjusted survival time, between all comparators.

Results:
Among 19,034 treatment courses (median follow-up: 2.3 years), treatments included adalimumab (tumour necrosis factor-alpha (TNF-a) inhibitor, n = 6,815), ustekinumab (IL-12/23p40 inhibitor, n = 5,639), secukinumab (IL-17A inhibitor, n = 3,051), ixekizumab (IL-17A inhibitor, n = 1,072), brodalumab (n = 367), guselkumab (IL-23p19 inhibitor, n = 1,258) and risankizumab (n = 832).
Guselkumab and risankizumab had the highest adjusted survival times (years [interquartile ranges]) for effectiveness (1.93 [1.91–1.95] and 1.93 [1.90–1.96], respectively). Risankizumab had the highest survival for safety (1.94 [1.92–1.96]) followed by guselkumab (1.92 [1.90–1.94]) and ustekinumab (1.92 [1.91–1.93]). Brodalumab showed lower adjusted survival time for effectiveness (1.75 [1.69–1.81]) than most biologics except secukinumab and adalimumab; and similar survival for safety (1.85 [1.81–1.90]) compared to IL-17A inhibitors and adalimumab. In patients with psoriatic arthritis, ustekinumab showed reduced drug survival. Prior biologic exposure was associated with a dose–response reduction in survival which was significantly larger for IL-17 inhibitors.

Conclusions:
Guselkumab and risankizumab have the most favourable drug survival for effectiveness, with comparable safety to ustekinumab, and more favourable than other BADBIR biologics. Longer drug survival may reduce treatment burden by minimizing treatment switches, clinic visits and disease flares, supporting IL-23p19 inhibitors as a practical long-term option for psoriasis.

Picankibart (IBI112) is a monoclonal antibody independently developed by Innovent with proprietary intellectual property rights. This product specifically targets the IL-23p19 subunit, preventing IL-23 from binding to cell surface receptors.

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Innovent Biologics a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that the first participant has been successfully dosed in a Phase 3 clinical study of picankibart (recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, R&D code: IB112).

This study (NCT06945107) is a multi-center, randomized, double-blind, active-controlled Phase 3 clinical study to evaluate the efficacy and safety of switching to picankibart in plaque psoriasis patients with inadequate response to prior anti-IL-17 monoclonal antibody treatment (sPGA score of ≥ 2 and body surface area [BSA] of ≥3%). This study plans to enroll approximately 310 participants, who will be randomized in a 1:1 ratio to the picankibart treatment group or the continued IL-17 monoclonal antibody treatment group. The primary endpoint is the proportion of participants achieving a static Physician’s Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16.

The results of a Phase 2 study (NCT05970978) showed that switching from other biologics (primarily IL-17 monoclonal antibodies) to picankibart led to a rapid clinical response. The observed efficacy in skin lesion clearance and significant improvements on the quality of life suggest picankibart may possess a best-in-class profile among agents with the same target.

Picankibart has the potential to offer a more effective treatment option for patients with psoriasis, ulcerative colitis or other autoimmune diseases.

This study included a cohort of patients with psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), all treated with subcutaneous Cosentyx (secukinumab) at the dose approved for each indication and observed throughout a 9-year period between 2015 and 2023.

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Secukinumab is a biologic agent known for its durable efficacy in chronic plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Monitoring the safety of secukinumab is a priority to ensure its long-term usage.

We aimed to provide an extended safety assessment of secukinumab treatment in a real-world setting. This bicentric observational study enrolled 332 patients with PsO, PsA and AS who received subcutaneous injections of secukinumab for up to 9 years.

Adverse events (AEs) were reported annually as exposure-adjusted incidence rates (EAIRs) per 100 patient-years (pt-y). The total secukinumab exposure was 1129 pt-y. The retention rate was 73%, with 16 (4.8%) of patients discontinuing due to AEs.

Despite most AEs being reported within the first 2 years, their incidence was low and decreased over time. The EAIR of any AEs was the highest in the initial 6 months (32.72/100 pt-y), followed by year 1 (7.62/100 pt-y), and year 2 of treatment (3.01/100 pt-y). Common AEs included respiratory and urinary tract infections, candidiasis, and diarrhoea.

Secukinumab showed sustained safety over an extended 9-year treatment period, supporting its use for the long-term management of these immune-inflammatory disorders.

Ascletis announces U.S. Food and Drug Administration (FDA) clearance of Investigational New drug IND application for Its oral small molecule IL-17 Inhibitor, ASC50, for the treatment of psoriasis.

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Ascletis Pharma announces the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for a Phase I trial for ASC50 for the treatment of mild-to-moderate plaque psoriasis. ASC50 is an in-house discovered and developed oral small molecule inhibitor targeting interleukin-17 (IL-17), an important biologically and commercially validated target for multiple autoimmune and inflammatory diseases, including psoriasis.

Following oral dosing in non-human primates, ASC50 demonstrated higher drug exposure, longer half-life and lower clearance than an oral small molecule IL-17 inhibitor comparator, which is currently in the clinical development. Furthermore, ASC50 demonstrated strong efficacy in a psoriasis animal model. These preclinical data support ASC50 as a potential best-in-class once-daily oral drug candidate for the treatment of psoriasis.

The Phase I clinical trial of ASC50 is a randomized, double-blind, placebo-controlled study and will be conducted at multiple sites in the U.S. Dosing of patients with mild-to-moderate plaque psoriasis is expected to start in the third quarter of 2025.

“We are excited and encouraged by the preclinical data of ASC50 as it is the first oral small molecule drug candidate in immunology arisen from our Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) Platform,” said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, “The IND clearance of ASC50 marks a new milestone for Ascletis in autoimmune and inflammatory diseases. We are continuing to work on differentiated agents including oral drugs and once-monthly or less frequent subcutaneously injectables to address unmet medical needs in multiple key therapeutics areas.”

ORKA-002 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A/F that has the potential to be dosed just two to three times per year in psoriasis (PsO) and psoriatic arthritis (PsA)

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Oruka Therapeutics, a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today announced that it has initiated dosing of healthy volunteers in its first clinical trial of ORKA-002, the Company’s novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A and IL-17F (IL-17A/F).

“With both ORKA-001 and ORKA-002 now in human trials, we are moving quickly to demonstrate the clinical differentiation of both assets,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Bimekizumab is launching extremely well as IL-17A/F has emerged as superior to IL-17A inhibition in several important indications. Uniquely, we could have the best targeting approaches for both IL-23p19 and IL-17A/F, potentially allowing us to offer the ideal regimen to patients through our ORKA-001 and -002 monotherapies and our ORKA-021 sequential combination.”

The ORKA-002 Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability and pharmacokinetics (PK) of ORKA-002 in approximately 24 healthy volunteers across three subcutaneous dose cohorts. Oruka expects to share interim data from this study around year end 2025.

Pending data from the Phase 1 trial, Oruka plans to initiate a Phase 2 study of ORKA-002 in moderate-to-severe psoriasis in the first half of 2026. The planned study design will evaluate the safety and efficacy of multiple dose levels and regimens of ORKA-002, with a primary endpoint of PASI 100 at week 16.

“ORKA-002 has the opportunity to become the best antibody in the IL-17 class, which is preferred when treating psoriasis with joint involvement or recalcitrant skin disease, as well as psoriatic arthritis, hidradenitis suppurativa, and beyond,” said Joana Goncalves, MBChB, Chief Medical Officer of Oruka. “With this program now in the clinic, we are one step closer to our goal of offering the most possible freedom from disease to patients with psoriasis and other conditions.”