The US Food and Drug Administration (FDA) has approved deucravacitinib (Sotyktu®, Bristol Myers Squibb) for the treatment of adults with active psoriatic arthritis (PsA), making it the first tyrosine kinase 2 (TYK2) inhibitor approved for this indication. The oral, once-daily therapy demonstrated significant improvements in disease activity compared with placebo in two pivotal phase 3 trials.1
The approval expands the indications for deucravacitinib, which was first authorised in 2022 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. With this latest regulatory decision, deucravacitinib becomes the first selective TYK2 inhibitor approved for both psoriasis and psoriatic arthritis.
TYK2 inhibition as a targeted therapeutic approach
Deucravacitinib is designed to selectively inhibit TYK2, a member of the Janus kinase (JAK) family involved in immune signalling pathways. The drug mediates signalling from interleukin (IL)-23, IL-12 and type I interferons, cytokines thought to play a key role in the pathogenesis of psoriatic disease.
Unlike traditional JAK inhibitors, deucravacitinib binds to the regulatory domain of TYK2, resulting in allosteric inhibition and greater selectivity. In vitro studies suggest that it does not inhibit JAK1, JAK2 or JAK3 at physiologically relevant concentrations.2
It is hoped that this targeted mechanism will modulate inflammatory signalling pathways while limiting the off-target effects that are thought to be associated with broader JAK inhibition.
Look back at our Q&A with Prof. Philip Mease (Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, USA) around the findings from the phase 3 POETYK PsA-1 study.
POETYK trials demonstrate significant improvements in ACR response rates
The FDA approval was based on results from the phase 3 POETYK PsA-1 (IM011-054; NCT04908202) and POETYK PsA-2 clinical trial (IM011-055; NCT04908189), which evaluated the efficacy and safety of deucravacitinib 6 mg once-daily in adults living with active PsA.
Both trials were multicentre, randomized, double-blind, placebo-controlled studies. POETYK PsA-1 enrolled 670 patients who had not previously received biologic disease-modifying antirheumatic drugs (bDMARD-naïve). POETYK PsA-2 included 624 patients who were either bDMARD-naïve or had previously received treatment with tumour necrosis factor (TNF) inhibitors.
Participants met the Classification Criteria for Psoriatic Arthritis (CASPAR), with at least three swollen and three tender joints and active or documented psoriasis.
The primary endpoint in both studies was the proportion of patients achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 16.
In POETYK PsA-1, 54% of patients treated with deucravacitinib achieved an ACR20 response at Week 16, compared with 34% in the placebo group. In POETYK PsA-2, the same proportion of patients receiving deucravacitinib (54%) achieved ACR20, compared with 39% of patients receiving placebo.
Higher-threshold response measures were also reported. ACR50 responses were observed in 24% and 29% of patients receiving deucravacitinib in PsA-1 and PsA-2 respectively, compared with 14% and 16% in placebo groups. ACR70 responses were achieved by 12% and 10% of deucravacitinib-treated patients versus 5% in placebo groups in both trials.
Minimal disease activity (MDA), a key secondary endpoint, was achieved by 19% of patients receiving deucravacitinib versus 10% with placebo in PsA-1. In PsA-2, MDA responses were observed in 26% of patients receiving deucravacitinib compared with 15% in the placebo group.
Quality-of-life improvements also reported
In addition to clinical efficacy endpoints, patient-reported outcomes were evaluated in the trials.
Health-related quality of life was assessed using the 36-Item Short Form Health Survey (SF-36). Patients treated with deucravacitinib demonstrated improvements in the SF-36 Physical Component Summary score at Week 16 compared with placebo.
Improvements were also reported across all four physical health domains of the SF-36: physical functioning, role-physical, bodily pain and general health.
Safety profile consistent with previous studies
The overall safety profile observed in patients with PsA was generally consistent with that previously reported in patients with plaque psoriasis.
The most common adverse reactions reported in clinical trials, occurring in ≥1% of patients receiving deucravacitinib and more frequently than placebo, included upper respiratory infections, increased blood creatine phosphokinase levels, herpes simplex infections, mouth ulcers, folliculitis and acne.
The therapy carries warnings and precautions related to hypersensitivity reactions, infections including tuberculosis, malignancies including lymphoma, rhabdomyolysis and elevated creatine phosphokinase levels, laboratory abnormalities, immunisations and potential risks associated with JAK pathway inhibition.
References
- Bristol Myers Squibb. U.S. FDA approves Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis. Press release. Available at: https://news.bms.com/news/corporate-financial/2026/U-S–FDA-Approves-Bristol-Myers-Squibbs-Sotyktu-deucravacitinib-for-the-Treatment-of-Adults-with-Active-Psoriatic-Arthritis/default.aspx (accessed 12 March 2026)
- Chimalakonda A, Burke J, Cheng L, et al. Selectivity Profile of the Tyrosine Kinase 2 Inhibitor Deucravacitinib Compared with Janus Kinase 1/2/3 Inhibitors. Dermatol Ther (Heidelb). 2021;11(5):1763-1776. doi:10.1007/s13555-021-00596-8
More content in psoriatic arthritis.
Citation: Deucravacitinib receives FDA approval as first TYK2 inhibitor for psoriatic arthritis. touchIMMUNOLOGY. 16 March, 2026
Disclosures: This article was originally published on touchDERMA.com. This article was created utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
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