FDA Approves Sotyktu From Bristol Myers Squibb

In March, the FDA approved deucravacitinib (Sotyktu; Bristol Myers Squibb) for the treatment of adults with active psoriatic arthritis (PsA), marking the first and only tyrosine kinase 2 (TYK2) inhibitor approved for this indication.¹

PsA is a chronic, immune-mediated inflammatory disorder characterized by both musculoskeletal and cutaneous involvement. The disease affects peripheral joints, the axial skeleton, and entheses and is associated with significant pain, functional impairment, and diminished quality of life. PsA develops in approximately 30% of individuals with psoriasis, and its pathophysiology is driven by dysregulated cytokine signaling, particularly through the IL-23, IL-12, and type I interferon pathways.¹

Pharmacology and Pharmacokinetics

Deucravacitinib is an oral, selective TYK2 inhibitor with a unique allosteric mechanism. Rather than binding to the conserved catalytic ATP-binding domain shared by all Janus kinase (JAK) family members, deucravacitinib binds to the regulatory domain of TYK2, achieving high selectivity for TYK2 over JAK1, JAK2, and JAK3. By inhibiting TYK2, the drug modulates downstream signaling of IL-23, IL-12, and type I interferons—cytokines central to the pathogenesis of both psoriasis and PsA.¹

The oral, once-daily agent was previously approved by the FDA in 2022 for moderate-to-severe plaque psoriasis. This new approval expands the drug's role in psoriatic disease and offers clinicians a mechanistically differentiated oral option for patients with PsA.¹

Clinical Trials

The approval is supported by results from the pivotal phase 3 POETYK PsA-1 (NCT04908202) and POETYK PsA-2 (NCT04908189) trials, which were 2 multicenter, randomly assigned, double-blind, placebo-controlled studies evaluating deucravacitinib 6 mg once daily in adults with active PsA. Both trials included a 16-week placebo-controlled phase followed by active treatment through week 52.^1-4 The primary end point for both trials—the proportion of patients achieving at least 20% improvement in signs and symptoms by American College of Rheumatology criteria (ACR20) at week 16—was met.^1,2

In POETYK PsA-1, 54.2% of patients treated with deucravacitinib achieved ACR20 at week 16 vs 34.1% for placebo (P < .0001). In POETYK PsA-2, 54.2% of patients treated with deucravacitinib achieved ACR20 vs 39.4% with placebo (P = .0002). Notably, responses continued to deepen beyond week 16 and were durable through week 52 in both trials, with ACR20 rates reaching 63.1% in continuously treated patients in POETYK PsA-1. Secondary end points, including minimal disease activity and inhibition of radiographic progression, also favored deucravacitinib.^1,2

Safety Profile

The overall safety profile of deucravacitinib in the POETYK PsA program was consistent with its established profile in plaque psoriasis, and no new safety signals were identified. The most reported adverse effects included nasopharyngitis, upper respiratory tract infections, headache, and rash. Serious infections, including pneumonia and COVID-19, were reported in a small number of patients.¹

Dosing and Administration

The approved dosage of deucravacitinib for active PsA is 6 mg administered orally once daily, consistent with the dosing used in the phase 3 trials and the same dose approved for plaque psoriasis. The tablets can be taken with or without food. No dose adjustment is recommended based on age, weight, or mild-to-moderate hepatic or renal impairment; however, clinicians should consult the full prescribing information for use in patients with severe organ impairment.¹

REFERENCES

1. US FDA approves Bristol Myers Squibb's Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis. News release. Bristol Myers Squibb. March 6, 2026. Accessed March 9, 2026. https://www.businesswire.com/news/home/20260306816774/en/U.S.-FDA-Approves-Bristol-Myers-Squibbs-Sotyktu-deucravacitinib-for-the-Treatment-of-Adults-with-Active-Psoriatic-Arthritis

2. Bristol Myers Squibb presents late-breaking data from pivotal phase 3 POETYK PsA-1 trial demonstrating superiority of Sotyktu (deucravacitinib) compared with placebo in adults with psoriatic arthritis. News release. Bristol Myers Squibb. June 11, 2025. Accessed March 9, 2026. https://news.bms.com/news/details/2025/Bristol-Myers-Squibb-Presents-Late-Breaking-Data-from-Pivotal-Phase-3-POETYK-PsA-1-Trial-Demonstrating-Superiority-of-Sotyktu-deucravacitinib-Compared-with-Placebo-in-Adults-with-Psoriatic-Arthritis/default.aspx

3. A study to determine the efficacy and safety of deucravacitinib compared with placebo in participants with active psoriatic arthritis (PsA) who are naive to biologic disease-modifying anti-rheumatic drugs. ClinicalTrials.gov. Updated October 24, 2025. Accessed March 9, 2025. https://clinicaltrials.gov/study/NCT04908202

4. A study to determine the efficacy and safety of deucravacitinib compared with placebo in participants with active psoriatic arthritis (PsA) who are naive to biologic disease modifying anti-rheumatic drugs or had previously received TNFα inhibitor treatment. ClinicalTrials.gov. Updated June 13, 2025. Accessed March 9, 2026. https://clinicaltrials.gov/study/NCT04908189