Sotyktu (deucravacitinib) / BMS - LARVOL DELTA

COMBo: Deucravacitinib-TNF Combination Therapy for Difficult-to-Control Psoriatic Disease (clinicaltrials.gov) - P4 | N=128 | Not yet recruiting | Sponsor: University of Texas Southwestern Medical Center

New P4 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

P114 Efficacy and safety of oral Janus kinase, tyrosine kinase 2 and phosphodiesterase 4 inhibitors in the treatment of chronic plaque psoriasis: a network meta-analysis. (PubMed, Br J Dermatol) - "After 16-24 weeks of treatment, tofacitinib and deucravacitinib had the highest efficacy, followed by apremilast, orismilast, upadacitinib and brepocitinib. Zasocitinib, a new highly selective allosteric TYK2 inhibitor, has recently demonstrated promising efficacy in the treatment of psoriasis, with 33% of patients achieving PASI 100 (complete clearance of psoriasis lesions) after just 12 weeks of treatment. In conclusion, oral TYK2 inhibitors have shown efficacy in the treatment of chronic plaque psoriasis comparable with adalimumab, with newer agents demonstrating enhanced effectiveness and surpassing PDE-4 inhibitors in therapeutic outcomes. JAK inhibitors, particularly tofacitinib, exhibit comparable efficacy to some TYK2 and PDE-4 inhibitors."

Clinical • Journal • Retrospective data • Review • Dermatology • Immunology • Psoriasis • TYK2

Deucravacitinib could be an effective and safe choice in patients affected with psoriasis and atopic dermatitis (Psorema)? (PubMed, Ital J Dermatol Venerol) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

Update on cutaneous lupus erythematosus pathogenesis, diagnosis and management. (PubMed, J Eur Acad Dermatol Venereol) - "Antimalarials, particularly hydroxychloroquine, remain the cornerstone of systemic therapy. Second-line or third-line agents such as methotrexate, retinoids, dapsone, thalidomide and lenalidomide are recommended in refractory cases. Biological therapies, including belimumab and anifrolumab, are approved in the setting of SLE. Promising results from recent trials of targeted therapies including inhibitors of plasmacytoid dendritic cells, TLR7/8 and TYK2 are paving the way for novel treatment strategies in CLE."

Journal • Review • Cutaneous Lupus Erythematosus • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • TLR7 • TYK2

Janus Kinase Inhibitors During Pregnancy and Adverse Drug Reactions: A Pharmacovigilance Disproportionality Analysis in VigiBase. (PubMed, Clin Transl Sci) - "This study analyzed VigiBase, the World Health Organization global pharmacovigilance database of individual case safety reports (ICSRs), to assess signals of disproportionate reporting (SDRs) for pregnancy-related adverse drug reactions (ADRs) reported with systemic JAKIs, including abrocitinib, baricitinib, deucravacitinib, fedratinib, filgotinib, itacitinib, momelotinib, pacritinib, peficitinib, ritlecitinib, ruxolitinib, tofacitinib, and upadacitinib. Findings should be interpreted cautiously given the limitations of spontaneous reporting systems and the exploratory nature of the analysis. Further studies are needed to better characterize the JAKI safety in pregnancy."

Adverse drug reaction • Adverse events • Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy (clinicaltrials.gov) - P=N/A | N=200 | Recruiting | Sponsor: Bristol-Myers Squibb

New trial • Dermatology • Immunology • Psoriasis

Deucravacitinib in Plaque Psoriasis After Inadequate Response to Apremilast: Phase 3 POETYK Analysis. (PubMed, Dermatol Ther (Heidelb)) - P3 | "Deucravacitinib was efficacious in patients with moderate-to-severe plaque psoriasis who did not respond to apremilast."

Journal • P3 data • Dermatology • Immunology • Psoriasis

Targeting the JAK/STAT pathway in palmoplantar pustulosis: a review. (PubMed, Ann Med) - "Recent clinical case reports and early studies have shown favourable outcomes with JAK inhibitors, such as tofacitinib, upadacitinib, baricitinib, deucravacitinib and abrocitinib, in refractory PPP cases. JAK inhibitors emerge as a promising therapeutic strategy for PPP, due to their ability to block multiple inflammatory pathways simultaneously, especially where other cytokine-targeted therapies have failed. However, despite compelling early reports, larger controlled trials are essential to establish definitive efficacy, clarify long-term safety and optimize clinical use."

Journal • Review • Cardiovascular • Dermatology • Herpes Zoster • Immunology • Pain • Psoriasis • Varicella Zoster

POETYK SLE-1: A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P3 | N=516 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2027 ➔ Nov 2028 | Trial primary completion date: Dec 2025 ➔ Oct 2026

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

POETYK SLE-2: A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=513 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2027 ➔ Nov 2028 | Trial primary completion date: Dec 2025 ➔ Oct 2026

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Therapeutic Potential of MY004, an IRAK4 Inhibitor, in Psoriasis: Preclinical Activity and Molecular Mechanism (ISDS 2025) - " To evaluate the therapeutic potential of MY004, a selective IRAK4 inhibitor, we used two well-characterized murine psoriasis models: IL-23–induced and imiquimod (IMQ)–induced skin inflammation...Repeat administration of MY004 at high-dose was associated with durable suppression of many disease-marker genes; exploratory comparisons suggested potential durability benefits when evaluated alongside the TYK2 inhibitor BMS-986165. Preclinical data support IRAK4 as a central pathogenic driver of psoriasis and demonstrate that MY004 effectively attenuates psoriatic inflammation through targeted disruption of TLR/IL-1R–dependent signaling. Compared to benchmark therapy, MY004 shows potential for enhanced durability of response, underscoring its promise as a novel therapeutic option in psoriasis."

IO biomarker • Preclinical • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis • IFNG • IL17A • IL1R1 • IL22 • IL23A • IRAK4 • MYD88 • TNFA • TRAF6 • TYK2

Novel use of deucravacitinib for treatment of recalcitrant TIF1-gamma dermatomyositis. (PubMed, JAAD Case Rep) - No abstract available

Journal • Dermatomyositis • Immunology • Myositis • TRIM33

Study of Deucravacitinib for Refractory Adults With Dermatomyositis/Juvenile Dermatomyositis (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | N=20 ➔ 0 | Trial completion date: Mar 2029 ➔ Nov 2025 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Mar 2028 ➔ Nov 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Dermatomyositis • Immunology • Myositis • TYK2

Deucravacitinib in Psoriasis: Evidence, Gaps, and Place in Therapy. (PubMed, Int J Dermatol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis

TYK2 mediates neuroinflammation in brains with cytoplasmic dsRNA coinciding with TDP-43 pathology: a common therapeutic approach for neurodegenerative diseases (ALS-MND 2025) - "Background:Neuroinflammation is a pathological feature of many neurodegenerative diseases, including motor neuron disease like amyotrophic lateral sclerosis (ALS) and forms of dementia such as Alzheimer's disease (AD), raising the possibility of common therapeutic targets. We report that cdsRNA is present and coincident with pTDP-43 cytoplasmic inclusions in brain cells of patients with AD pathology, and that interferon genes are significantly upregulated in affected brain regions. CdsRNA also accumulates in a human cellular model of TDP-43 pathology. We use cryptic exon detection as a proxy of TDP-43 mislocalization and demonstrate using DRIAD-SP that baricitinib and ruxolitinib that block interferon signaling show a protective signal only in a subset of brains with elevated cryptic exon expression."

Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Dementia • Inflammation • CXCL10 • TARDBP • TYK2

Furamidine enhances IL-23-mediated autophagic response through IL-23R-TYK2-STAT3-dependent regulation of intracellular Ca²⁺ level to facilitate mycobacterial clearance in human macrophages. (PubMed, Med Microbiol Immunol) - "Neutralization of IL-23 or pharmacological inhibition of TYK2 and STAT3 by Deucravacitinib and Stattic hampered the process of autophagy by hindering the IL-23 signaling and leading to an increase in the survival of mycobacteria, pointing to the essential role of IL-23 in response to mycobacteria elimination from the cells. These findings revealed that Furamidine promotes host defense in mycobacterial infection by enhancing IL-23-mediated autophagy via the IL-23R/pTYK2/pSTAT3-Ca²⁺ pathway."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • IL23A • STAT3 • TYK2

JAK inhibitors for the treatment of palmoplantar pustulosis: a narrative review. (PubMed, Drugs Context) - "Published studies involving tofacitinib, upadacitinib and baricitinib were identified and reviewed...An ongoing trial investigating deucravacitinib reflects growing interest in this drug class. JAK inhibitors show promise as a novel therapeutic option for PPP, given their ability to modulate multiple inflammatory pathways. Although current evidence is limited to case series and reports, results are encouraging and warrant confirmation through well-designed clinical trials."

Journal • Review • Immunology • Inflammation • Pain • Psoriasis

Phase 2 PAISLEY-SLE and PAISLEY LTE studies demonstrated consistent safety and effectiveness with Sotyktu for moderate-to-severe SLE (Bristol-Myers Squibb Press Release) - "Integrated analyses of the Phase 2 PAISLEY-SLE and PAISLEY LTE studies showed that Sotyktu maintained a consistent safety profile and durable efficacy in patients with moderate-to-severe SLE with up to four years of drug exposure, with no new safety signals, despite complex background therapies...By Week 72, patients initially assigned to the placebo group in the PAISLEY-SLE study who transitioned to Sotyktu during the PAISLEY LTE study achieved improvements comparable to those seen in patients who received continuous Sotyktu treatment."

P2 data • Systemic Lupus Erythematosus

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

New Week 52 data from pivotal Phase 3 POETYK PsA-1 trial reinforce efficacy and safety of Sotyktu for PsA (Bristol-Myers Squibb Press Release) - "New data showed ACR20 responses (at least a 20 percent improvement in signs and symptoms of disease) achieved at Week 16 (Sotyktu, 54.2%; placebo, 34.1%; p<0.0001) continued to improve and were maintained for patients receiving continuous Sotyktu treatment through Week 52 (63.1%). Patients who switched from placebo to Sotyktu at Week 16 also had a similar ACR20 response at Week 52 (60.8%), consistent with findings from the POETYK PsA-2 trial. The overall safety profile of Sotyktu through Week 52 was consistent with that established across the Sotyktu development program, including through Week 52 of the Phase 3 POETYK PsA-2 clinical trial....Regulatory applications for Sotyktu for the treatment of adults with active PsA are currently under review in the U.S., Europe, Japan and China. The U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026."

Filing • P3 data • PDUFA • Psoriatic Arthritis

IMMpactful: A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body) (clinicaltrials.gov) - P4 | N=393 | Active, not recruiting | Sponsor: AbbVie | Trial primary completion date: Dec 2025 ➔ Mar 2026

Trial primary completion date • Dermatology • Immunology • Psoriasis

Sotyktu: Data readout from P3 POETYK SLE-1 trial (NCT05617677) for SLE in 2026 (Bristol-Myers Squibb) - Q3 2025 Results: Data readout from P3 POETYK SLE-2 trial (NCT05620407) for SLE in 2026

P3 data • Immunology • Lupus • Systemic Lupus Erythematosus

Response to Papp et al., "Efficacy and safety of ESK-001, a highly selective, oral allosteric TYK2 inhibitor, in patients with moderate-to-severe plaque psoriasis: 52-week results from the long-term Phase 2 study in patients who participated in the Phase 2 STRIDE study". (PubMed, J Am Acad Dermatol) - No abstract available

Journal • P2 data • Dermatology • Immunology • Psoriasis • TYK2

Updated Data from Broader Immunology Portfolio (Businesswire) - "BMS is also presenting findings at ACR that support its immunology portfolio, including pivotal Phase 3 POETYK PsA-1 trial of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (abstract #LB20), as well as new findings from the Phase 2 PAISLEY-SLE and PAISLEY long-term extension (LTE) studies for moderate-to-severe SLE (abstract #LB10)."

Clinical data • Late-breaking abstract • Psoriatic Arthritis • Systemic Lupus Erythematosus

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