Sotyktu (deucravacitinib) / BMS - LARVOL DELTA

Efficacy and Safety of Deucravacitinib up to Week 52: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study in Patients With Active Psoriatic Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs (ACR Convergence 2025) - P3 | "Deucravacitinib was efficacious in patients with PsA based on clinical responses, PROs, and inhibition of radiographic progression, which continued to improve after W16 and were durable through W52. Responses at W52 were comparable in patients who switched from PBO to deucravacitinib at W16. Safety was consistent with the known deucravacitinib profile, with no new signals."

Clinical • Late-breaking abstract • P3 data • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • TYK2

Four-Year Safety and Efficacy of Deucravacitinib in Systemic Lupus Erythematosus: Results From a Phase 2 Program (ACR Convergence 2025) - P2, P3 | "Integrated analysis of the PAISLEY SLE and LTE studies confirmed the consistent safety profile and sustained efficacy of deucravacitinib in SLE with up to 4+ years of drug exposure, with no new safety signals despite complex background therapies. Patients who switched from PBO during the LTE study achieved outcomes comparable to those treated from baseline. These data represent the longest follow-up of a TYK2 inhibitor in SLE to date, supporting the potential of deucravacitinib as a durable future treatment option, currently under evaluation in phase 3 POETYK SLE trials (NCT05617677; NCT05620407)."

Clinical • Late-breaking abstract • P2 data • Dermatology • Immunology • Inflammatory Arthritis • Lupus • Psoriasis • Systemic Lupus Erythematosus • TYK2

ISS12: Taking a New Look at Psoriatic Arthritis and Its Comorbidities Through the Lens of TYK2 Inhibition (ACR Convergence 2025) - "TYK2 inhibition with the oral, highly selective agent deucravacitinib offers a novel approach with proven efficacy and favorable safety in PsA...This activity was planned by and for the healthcare team, and learners will receive 1.5 Interprofessional Continuing Education (IPCE) credit for learning and change. Not an official program of the ACR."

Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • TYK2

Sex Differences in Proteomic Profiles and the Impact of Deucravacitinib Treatment in Patients with Active Psoriatic Arthritis: A Pooled Phase 3 Analysis (ACR Convergence 2025) - P3 | "DE was identified in patients with PsA vs NHVs. Deucravacitinib reduced upregulated proteins in all patients. Unique proteomic profiles were identified in male vs female patients with PsA."

Clinical • P3 data • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL17A • MMP3 • TYK2

Impact of Deucravacitinib on Disease Activity in Patients With Psoriatic Arthritis (PsA): Results From the Pivotal Phase 3 PsA Studies (ACR Convergence 2025) - P3 | "We report deucravacitinib efficacy based on composite measures of disease activity in pts from the POETYK PsA studies. Pts in the POETYK PsA-1 and PsA-2 studies were randomized to deucravacitinib 6 mg once daily or PBO for 16 weeks (in PsA-2, a group received apremilast as a safety reference arm). In these analyses of the pivotal POETYK PsA-1 and PsA-2 phase 3 studies, deucravacitinib substantially reduced disease activity vs PBO at W16 in several composite measures of disease activity, and a significantly higher proportion of pts reached optimal control of disease activity, which aligns with the results from the primary analyses.2,3 Given that remission and low disease activity are primary goals of PsA treatment, deucravacitinib may be an efficacious treatment choice for pts with active PsA."

Clinical • P3 data • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • TYK2

Effect of Deucravacitinib Treatment on Disease Activity–Associated Plasma Biomarkers in Patients With Active Psoriatic Arthritis: Results From 2 Phase 3 Studies (ACR Convergence 2025) - P3 | "Deucravacitinib significantly reduced PsA disease–associated biomarkers in patients with elevated BL biomarkers (eg, CRP, NLR), which may be indicative of severe disease and poor prognosis, and improved efficacy outcomes for multiple disease domains, including radiographic progression. These data provide biological evidence for deucravacitinib as a potential new oral PsA therapy that may benefit patients with severe and difficult-to-treat disease."

Biomarker • Clinical • P3 data • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • ICAM1 • IL17A • LRG1 • MMP1 • MMP3 • TYK2

Combination of Biological and Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Psoriatic Arthritis: A Case-Series (ACR Convergence 2025) - "Combinations with Apremilast (APR) were analyzed for safety...One patient experienced two mild upper respiratory infections (URIs) on bimekizumab and deucravacitinib, prompting a switch for risankizumab with deucravacitinib... Overall, the safety profile of bDMARD combinations with tsDMARDs was favorable. Infections, primarily URIs, were the most common AEs – mild in severity, non-hospitalized, and rarely requiring treatment change. Short-term improvements were observed in both musculoskeletal and skin domains."

Clinical • Dental Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Musculoskeletal Diseases • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Stomatitis • IL12A

In Vitro Pharmacological Profile of GLPG3667 Suggests Differentiation from the TYK2 Inhibitors Deucravacitinib and Zasocitinib at Their Clinical Dose Regimens (ACR Convergence 2025) - "At concentrations corresponding to its highest anticipated clinical dose, GLPG3667 shows selective inhibition of TYK2-mediated signalling, with a level of inhibition similar to deucravacitinib clinical dose regimens. While GLPG3667 did not show any impact on IL-10-mediated signalling, inhibition of this anti-inflammatory pathway is expected for the allosteric TYK2 inhibitors at their clinical exposure levels."

Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • CD4 • IFNA1 • IL10 • IL12A • IL2 • IL23A • IL6 • JAK1 • TYK2

Effects of Deucravacitinib on Dysregulated Autoimmune Gene Modules That Correlate With Skin Disease Severity and Treatment Response in Patients With Cutaneous Manifestations of Lupus Erythematosus: Biomarker Results From a Global, Randomized, Placebo-Controlled Phase 2 Study (ACR Convergence 2025) - P2 | "IFN and inflammation gene modules were dysregulated in CLE and positively correlated with CLASI-A. Normalization of these signatures with deucravacitinib correlated with CLASI-A improvement. Results warrant further evaluation of deucravacitinib and the utility of these biomarkers in patients with cutaneous manifestations of lupus erythematosus."

Biomarker • Clinical • P2 data • Cutaneous Lupus Erythematosus • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Psoriasis • CXCL10 • IFIT1 • IFNG • IL12A • IL23A • LGALS3 • LGALS3BP • MX1 • RSAD2 • TNFSF13B • TRIM38 • TYK2

Effect of Deucravacitinib Treatment on Renal Dysfunction–Associated Plasma Biomarkers From a Phase 2 Study in Patients With Systemic Lupus Erythematosus (ACR Convergence 2025) - P2, P3 | "Deucravacitinib treatment demonstrated significant reduction of proteins associated with renal dysfunction in patients treated in the PAISLEY SLE study. Further investigation of the effects of deucravacitinib on renal biomarkers and attenuation of renal disease progression in the phase 3 POETYK SLE-1 and SLE-2 studies is warranted."

Biomarker • Clinical • IO biomarker • P2 data • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Rheumatology • Systemic Lupus Erythematosus • AXL • CD27 • EPHB6 • TYK2

Real-World Characteristics and Treatment Patterns of Difficult-to-Treat Psoriatic Arthritis (ACR Convergence 2025) - "We identified 7,403 adults with PsA treated with conventional DMARDs (Sulfasalazine, Methotrexate, Leflunomide) and recorded post-treatment CRP levels...TNF inhibitors were used in 88.3% of D2T patients vs. 51.9% of ND2T (p < 0.001), with adalimumab most frequently prescribed (55.2% vs. 32.8%, p < 0.001). Abatacept was also more common in D2T (15.6% vs. 1.9%, p < 0.001). IL-17 inhibitors were more frequent in D2T (86.3% vs. 15.7%, p < 0.001), primarily secukinumab (57.6% vs. 9.9%, p < 0.001). IL-23 use was higher in D2T (30.1% vs. 5.8%, p < 0.001), with guselkumab most used (18.0% vs. 3.6%, p < 0.001). IL-12/23 inhibition with ustekinumab was also more common (36.3% vs. 6.6%, p < 0.001). JAK inhibitor use was greater in D2T (31.6% vs. 5.9%, p < 0.001), mainly tofacitinib (22.7% vs. 4.1%, p < 0.001). Though rare overall, TYK2 inhibition with deucravacitinib was more common in D2T (0.8% vs. 0.2%, p = 0.021). Our study showed that in a matched..."

Clinical • Real-world • Real-world evidence • Crohn's disease • Dermatology • Gastroenterology • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • CRP • IL12A • IL17A • IL23A • TYK2

Clinical Efficacy in Male and Female Patients With Active Psoriatic Arthritis Treated With Deucravacitinib: A Pooled Analysis of Pivotal Phase 3 Studies (ACR Convergence 2025) - P3 | "This post hoc pooled analysis of 2 pivotal randomized, placebo (PBO)-controlled, phase 3 studies (POETYK PsA-1 [NCT04908202] and POETYK PsA-2 [NCT04908189]) evaluated the clinical efficacy of deucravacitinib vs PBO and patient-reported outcomes (PROs) by sex at W16 in patients with active PsA. Patients in POETYK PsA-1 and PsA-2 were randomized to PBO or deucravacitinib 6 mg once daily (in PsA-2, a group included only as a safety reference arm received apremilast) through W16. Efficacy at W16 was similar for male and female patients who received deucravacitinib, and patients treated with deucravacitinib had superior efficacy vs PBO across multiple endpoints, including overall disease activity measures, musculoskeletal and dermatologic manifestations, and quality of life. Results of this post hoc pooled analysis were consistent with that of the overall POETYK PsA-2 population W16 results at a study level and those observed in the phase 2 study of deucravacitinib in..."

P3 data • Retrospective data • Fatigue • Immunology • Inflammatory Arthritis • Musculoskeletal Diseases • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • TYK2

Relevant Symptoms and Signs of Active Discoid and/or Subacute Cutaneous Lupus Erythematosus Among Participants in a Phase 2 Clinical Trial: Patient-Embedded Qualitative Interviews [WITHDRAWN] (ACR Convergence 2025) - P2 | "Background/Purpose: Deucravacitinib is an oral, selective, allosteric TYK2 inhibitor currently under investigation for the treatment of active discoid and/or subacute cutaneous lupus erythematosus (DLE and SCLE) and systemic lupus erythematosus (SLE)... CLASI-A captures symptoms/signs relevant to patients with DLE/SCLE, and patient-defined meaningful change was consistent with clinically meaningful CLASI-A thresholds."

Clinical • Interview • P2 data • Alopecia • Cutaneous Lupus Erythematosus • Dermatology • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • TYK2

Assessment of Pain Outcomes in Pooled Phase 3 Trials of a Selective, Tyrosine Kinase 2 Inhibitor, Deucravacitinib, in Patients with Active Psoriatic Arthritis (ACR Convergence 2025) - P3 | "Pooled data from 2 trials demonstrated a higher proportion of patients treated with deucravacitinib reported improvement in pain vs placebo, regardless of the instrument used. Improvements were generally consistent between males and females. These findings demonstrate that the use of deucravacitinib resulted in pain relief in patients with PsA."

Clinical • P3 data • Dermatology • Immunology • Inflammatory Arthritis • Pain • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • TYK2

Comprehensive disproportionality analysis of individual case safety reports associated with Janus kinase inhibitors in psoriasis and psoriatic arthritis using the FAERS database. (PubMed, Front Immunol) - "The disproportionality analysis methods, including reporting odds ratio (ROR) and information component (IC), were used to evaluate the adverse events (AEs) associated with the use of JAK inhibitors (deucravacitinib, upadacitinib, tofacitinib) in patients with psoriasis and PsA. This research offers practical evidence for assessing the safety of JAK inhibitors used in psoriasis and PsA. Since disproportionality analysis serves as a hypothesis-generating approach, the results necessitate further validation in studies with denominator data to assess causal relationships."

Journal • Retrospective data • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammatory Arthritis • Musculoskeletal Diseases • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Treatment of Lichen Planopilaris with the TYK-2 Inhibitor Deucravacitinib. (PubMed, J Am Acad Dermatol) - No abstract available

Journal • Alopecia • Lichen Planus • TYK2

Review of Promising Off-Label Use of Deucravacitinib. (PubMed, Int J Mol Sci) - "Deucravacitinib may exert therapeutic effects by broadly suppressing cytokine signaling in a diverse range of inflammatory disorders. Ongoing clinical trials and mechanistic studies are required to clarify the efficacy and support its future indications."

Journal • Review • Acute Lymphocytic Leukemia • Alopecia • Alzheimer's Disease • Chronic Kidney Disease • CNS Disorders • Dermatology • Dermatopathology • Diabetes • Discoid Lupus Erythematosus • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Inflammatory Bowel Disease • Interstitial Lung Disease • Leukemia • Lichen Planus • Lupus • Metabolic Disorders • Multiple Sclerosis • Nephrology • Oncology • Pneumonia • Psoriasis • Psoriatic Arthritis • Renal Disease • Respiratory Diseases • Rheumatology • Scleroderma • Seronegative Spondyloarthropathies • Systemic Lupus Erythematosus • Systemic Sclerosis • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • Type 1 Diabetes Mellitus • IL23A • TYK2

Recalcitrant palmoplantar pustulosis successfully controlled with Lebrikizumab (EADV 2025) - "Previous treatments included fumaric acid, PUVA, methotrexate, Tildrakizumab, Risankizumab, Upadacitinib, Guselkumab, Bimekizumab, Ixekizumab, Baricitinib and Apremilast...When we first saw the patient in October 2024, he was receiving Guselkumab and Deucravacitinib, alongside systemic steroids (methylprednisolone, 40 mg/day) and various analgesics, including tramadol, to manage the painful palmoplantar lesions... To the best of our knowledge, this report is the first case of successful treatment of PPP with Lebrikizumab in the literature. It offers clinicians another treatment option for this challenging disease and adds to the literature linking PPP to Th2 inflammation."

Dermatology • Dermatopathology • Immunology • Inflammation • Psoriasis • IL13

Successful Treatment of Refractory Dermatomyositis with Deucravacitinib (Sotyktu): A Case Report. (PubMed, Case Rep Dermatol) - "While immunosuppressive therapies such as methotrexate, mycophenolate mofetil, and hydroxychloroquine are commonly used, treatment-resistant cases remain a challenge. By selectively inhibiting TYK2, it targets key inflammatory pathways involved in DM pathogenesis while minimizing off-target effects. Further studies are needed to evaluate its long-term safety and efficacy in this patient population."

Journal • Dermatology • Dermatomyositis • Immunology • Myositis • Pain • TYK2

Next-Generation Therapies for Hidradenitis Suppurativa: Recent FDA Approvals and a Look at Clinical Trial Landscape (EADV 2025) - "Over the past decade, numerous immunotherapies have been developed for a wide range of dermatologic conditions, including two recently FDA-approved treatments for HS within the last year (bimekizumab and secukinumab)2,3...Sonelokimab, another IL-17A/F inhibitor, is currently in a recruiting phase 3 trial...Other cytokine-targeting agents are lutikizumab (IL-1α/IL-1β inhibitor), spesolimab (anti-IL-36R), and anifrolumab (type I interferon receptor antagonist)...Agents targeting the JAK-STAT pathway include the JAK1 inhibitors povorcitinib, upadacitinib, and ruxolitinib, as well as deucravacitinib, a tyrosine kinase 2 inhibitor; all are currently under investigation for HS...Remibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, also showed promising results, with 72.7% of patients reaching the HiSCR endpoint at week 167. Brensocatib, a dipeptidyl-peptidase 1 inhibitor, is currently being evaluated in a recruiting phase 3 trial... The last decade has brought a wave..."

Clinical • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • IFNAR2 • IL17A • IL1B • TYK2

Effective management of psoriasis and psoriatic arthritis in a patient with systemic lupus erythematosus using deucravacitinib, mycophenolate mofetil and hydroxychloroquine. (PubMed, Skin Health Dis) - "Despite effective control of her SLE and PsA with hydroxychloroquine, mycophenolate mofetil (MMF) and belimumab, her psoriatic skin manifestations worsened over time. No significant side effects or infections were observed. These findings suggest deucravacitinib may offer an effective treatment alternative for patients with overlapping autoimmune diseases, without compromising SLE control or increasing infection risk."

Journal • Dermatology • Glomerulonephritis • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Musculoskeletal Diseases • Musculoskeletal Pain • Nephrology • Oncology • Orthopedics • Pain • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Systemic Lupus Erythematosus • IL17A • TYK2

Icotrokinra demonstrated superior responses compared with placebo and Deucravacitinib in the treatment of moderate-to-severe plaque psoriasis: Results through Week 24 of the phase 3 ICONIC-ADVANCE 1&2 studies (EADV 2025) - P3 | "In ICONIC-ADV 1&2, ICO showed superior skin responses vs PBO and Deucra. The AE profile of ICO was similar to PBO. ICO AE rates were numerically lower vs Deucra, primarily due to fewer pts with infections."

Clinical • P3 data • Dermatology • Immunology • Infectious Disease • Psoriasis • Respiratory Diseases • IL23A

Cost-effectiveness of deucravacitinib versus apremilast of moderate-to-severe plaque psoriasis in China. (PubMed, BMC Health Serv Res) - "At the WTP threshold of 287,247 CNY, deucravacitinib 6 mg once daily was a cost-effective treatment strategy for moderate-to-severe plaque psoriasis compared with apremilast 30 mg twice daily from the Chinese healthcare system perspective over a lifetime horizon."

Clinical • HEOR • Journal • Dermatology • Immunology • Psoriasis

A real world study on the effectiveness and safety of deu-cravacitinib in the treatment of moderate to severe plaque psoriasis in China (PubMed, Zhejiang Da Xue Xue Bao Yi Xue Ban) - "In this real-world study of Chinese patients with moderate-to-severe plaque psoriasis, deucravacitinib demonstrated favorable effectiveness and safety over 16 weeks of treatment."

Journal • Real-world evidence • Dermatology • Immunology • Psoriasis

Investigation of Infection Risk Associated with Janus Kinase Inhibitors: A Pharmacovigilance Analysis Using the Food and Drug Administration's Adverse Event Reporting System Database. (PubMed, Clin Exp Dermatol) - "This is the most comprehensive real-world analysis of iAEs linked to oral JAKis. While infection risks varied across agents, both common and rare but serious events were identified. Findings highlight the importance of individualized monitoring and preventive strategies, and reinforce the value of post-marketing surveillance in ensuring safe JAKi use."

Adverse events • Journal • Alopecia • Atopic Dermatitis • Dermatitis • Dermatology • Herpes Zoster • Immunology • Infectious Disease • Inflammatory Arthritis • Influenza • Nephrology • Novel Coronavirus Disease • Otorhinolaryngology • Pediatrics • Pneumonia • Psoriasis • Psoriatic Arthritis • Respiratory Diseases • Rheumatology • Seronegative Spondyloarthropathies • Sinusitis • Varicella Zoster