Drug Update · Rheumatology

Deucravacitinib Label Adds Psoriatic Arthritis; ACR20 54.2% in POETYK

August 23, 2026

ACR20 POETYK PsA-1

54.2% vs 34.1% (deucravacitinib vs placebo) at Week 16 [7]

ACR20 POETYK PsA-2

54.2% vs 39.4% (deucravacitinib vs placebo) at Week 16 [8]

FDA label update

Indication for active psoriatic arthritis added 03/2026 [1]

Recommended dose

6 mg orally once daily [1][11]

Clinical Perspective

Clinicians treating adults with active psoriatic arthritis and their patients should note that the U.S. prescribing information lists SOTYKTU (deucravacitinib) as an indicated oral TYK2 inhibitor for active psoriatic arthritis in adults ^[1]. What is the optimal monitoring interval for liver enzymes and triglycerides during long-term treatment with deucravacitinib?

Dr. Deepak Nair, MBBS, MD (General Medicine), DM (Clinical Immunology & Rheumatology) · Rheumatology

Deucravacitinib (SOTYKTU) is indicated for the treatment of active psoriatic arthritis in adults per updated U.S. prescribing information dated 03/2026 ^[1]. Randomized, double-blind phase 3 trials (POETYK PsA-1 and POETYK PsA-2) reported American College of Rheumatology 20% improvement (ACR20) responses of 54.2% with deucravacitinib versus 34.1% with placebo in POETYK PsA-1 and 54.2% versus 39.4% with placebo in POETYK PsA-2 at Week 16 ^[4]^[5].

Clinical Context

Deucravacitinib (SOTYKTU) is an oral tyrosine kinase 2 (TYK2) inhibitor marketed by Bristol-Myers Squibb; the prescribing information lists initial U.S. approval in 2022 and a recent labeling change dated 03/2026 adding psoriatic arthritis to the indications ^[1]^[6]. The label states the recommended dosage is 6 mg taken orally once daily, with or without food ^[1]^[3]^[6]. Clinicians should consult current prescribing information for full dosing guidance. The full prescribing information includes warnings and precautions addressing hypersensitivity reactions, infections, tuberculosis evaluation, malignancy observations including lymphomas, rhabdomyolysis and elevated creatine phosphokinase (CPK), laboratory abnormalities including triglycerides and liver enzymes, and guidance on immunizations and potential risks related to JAK inhibition ^[1]^[2]^[3].

Key Findings

The POETYK PsA-1 trial showed deucravacitinib achieved an ACR20 of 54.2% versus 34.1% with placebo at Week 16 in adults with active psoriatic arthritis ^[4].
The POETYK PsA-2 trial showed deucravacitinib achieved an ACR20 of 54.2% versus 39.4% with placebo at Week 16; prespecified secondary endpoints including HAQ-DI, PASI-75, SF-36 PCS, and achievement of MDA also favored deucravacitinib at Week 16 and responses were maintained through Week 52 in the randomized, double-blind study period ^[5].
In POETYK PsA-2, responses improved beyond Week 16 and were maintained through Week 52 with ACR20 rates of 62.2% in the continuous deucravacitinib group and 67.3% in the placebo-to-deucravacitinib group at Week 52 as reported in the trial summary ^[5].

Safety & Tolerability

The most common adverse reactions (≥ 1%) reported in the prescribing information include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne ^[1]^[2]^[3]. SAFETY BULLET COUNT: 6
The label notes hypersensitivity reactions such as angioedema have been reported and directs discontinuation if a clinically significant hypersensitivity reaction occurs ^[1].
Infections were observed; serious infections reported with SOTYKTU included pneumonia and COVID-19 in clinical trials, and herpes virus reactivation (herpes zoster, herpes simplex) was reported ^[1]^[2]^[3]. In the plaque psoriasis trials PSO-1 and PSO-2, herpes simplex infections were reported in 17 subjects (6.8 per 100 patient-years) treated with SOTYKTU and 1 subject (0.8 per 100 patient-years) treated with placebo during the 16-week placebo-controlled period, and multidermatomal herpes zoster was reported in an immunocompetent subject ^[1].
The label reports malignancies, including lymphomas, were observed in clinical trials with SOTYKTU ^[1]. The POETYK PsA-2 trial summary reported no new safety signals, no deaths, and no imbalances in cardiovascular events, malignancies, or opportunistic infections through Week 52 ^[5].
Laboratory abnormalities and other warnings in the label include rhabdomyolysis and elevated CPK, triglyceride elevations, and liver enzyme elevations; the label advises evaluation and monitoring per the full prescribing information ^[1]^[2]^[3].

Study Design

POETYK PsA-1 was a randomized, double-blind, placebo-controlled phase 3 trial that randomized adults with active psoriatic arthritis 1:1 to deucravacitinib 6 mg once daily or placebo through Week 16; the primary endpoint was ACR20 at Week 16, and 670 patients were included in reported analyses ^[4]. Clinicians should consult current prescribing information for full dosing guidance. POETYK PsA-2 was a randomized, double-blind, phase 3 study (randomized 3:3:1 to deucravacitinib 6 mg daily, placebo, or apremilast 30 mg twice daily as a safety reference arm through Week 16) with 729 patients randomized; the primary endpoint was ACR20 at Week 16 and efficacy and safety were evaluated through Week 52 ^[5]. The U.S. prescribing information reflects an indication for active psoriatic arthritis in adults and lists the recommended dosage as 6 mg orally once daily ^[1]^[3]^[6].

FAQ

Q1 What is deucravacitinib (SOTYKTU) approved for?

Deucravacitinib (SOTYKTU) is an oral TYK2 inhibitor approved in the United States for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and for the treatment of active psoriatic arthritis in adults according to the current prescribing information.

Q2 How does deucravacitinib work?

Deucravacitinib binds to the regulatory domain of TYK2, stabilizing an inhibitory interaction between the regulatory and catalytic domains and resulting in allosteric inhibition of receptor-mediated TYK2 activation and downstream STAT activation as described in the prescribing information; TYK2 is a member of the Janus kinase family and participates in cytokine signaling pathways in cell-based assays.

Q3 What is the recommended dose of deucravacitinib?

The recommended dosage of SOTYKTU (deucravacitinib) is 6 mg taken orally once daily, with or without food, as stated in the prescribing information. Clinicians should consult current prescribing information for full dosing guidance. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the most common side effects of deucravacitinib?

The most common adverse reactions reported in the prescribing information (≥ 1%) include upper respiratory infections, increased blood creatine phosphokinase, herpes simplex, mouth ulcers, folliculitis, and acne. The label additionally reports hypersensitivity reactions such as angioedema, serious infections including pneumonia and COVID-19, herpes virus reactivation including herpes zoster, malignancies including lymphomas observed in trials, rhabdomyolysis and elevated CPK, triglyceride elevations, and liver enzyme elevations, and it provides monitoring and evaluation recommendations in the full prescribing information.

Clinicians should consult current prescribing information for full dosing guidance.

Deucravacitinib Label Adds Psoriatic Arthritis; ACR20 54.2% in POETYK

Direct Clinical Takeaway & Evidence Summary

Deucravacitinib Label Adds Psoriatic Arthritis; ACR20 54.2% in POETYK

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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