Drug Update · Rheumatology

FDA Approves Deucravacitinib for Active Psoriatic Arthritis

September 03, 2026

Drug

deucravacitinib (SOTYKTU)

Regulatory action

sNDA approval (NDA 214958/S-002) per FDA letter dated 03/06/2026

Indication

Treatment of active psoriatic arthritis in adults

Recommended dose

6 mg orally once daily

Label effective date

2026-06-30

Clinical Perspective

This approval affects clinicians who treat adults with active psoriatic arthritis and their patients by adding an oral TYK2 inhibitor to the therapeutic options for this indication. The FDA-approved labeling supports use of SOTYKTU 6 mg orally once daily for adults with active psoriatic arthritis, with monitoring considerations and stated contraindications and warnings in the prescribing information. What are the comparative efficacy and safety outcomes of SOTYKTU versus established psoriatic arthritis therapies for joint and skin responses?

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

The FDA approved the supplemental new drug application (sNDA) for deucravacitinib (SOTYKTU) to treat adults with active psoriatic arthritis, in a letter approving NDA 214958/S-002 dated 03/06/2026 ^[2]. The approved U.S. label lists SOTYKTU as a TYK2 inhibitor indicated for active psoriatic arthritis in adults and specifies a recommended dosage of 6 mg orally once daily ^[3]^[1]. Clinicians should consult current prescribing information for full dosing guidance. Clinicians should consult current prescribing information for complete dosing guidance.

Clinical Context

Deucravacitinib (SOTYKTU) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor developed by Bristol Myers Squibb ^[3]^[4]. The FDA-approved labeling now includes both moderate-to-severe plaque psoriasis and active psoriatic arthritis as indications for adults ^[3]^[1]. The mechanism described in the label states that deucravacitinib binds the regulatory domain of TYK2, stabilizing an inhibitory interaction and producing allosteric inhibition of receptor-mediated TYK2 activation and downstream STAT signaling as shown in cell-based assays ^[4]. The sNDA for psoriatic arthritis was approved in a prior-approval supplemental submission and the FDA directed labeling and pediatric assessment requirements in its approval letter ^[2].

Key Findings

The FDA approved SOTYKTU (deucravacitinib) for the treatment of active psoriatic arthritis in adults via NDA 214958/S-002 per the FDA approval letter dated 03/06/2026 ^[2].
The approved prescribing information designates SOTYKTU as a TYK2 inhibitor and lists the recommended dosage as 6 mg taken orally once daily, with or without food ^[3]^[1].
Clinicians should consult current prescribing information for full dosing guidance.
The FDA approval letter requires submission of the pediatric postmarketing study to assess pharmacokinetics, efficacy, and safety in children 5 to less than 18 years, with a final report submission date listed as 06/2031 for study 4960-1 ^[2].

Safety & Tolerability

Hypersensitivity reactions, such as angioedema, have been reported; SOTYKTU is contraindicated in patients with a history of hypersensitivity to deucravacitinib or excipients ^[1]^[3].
Infections, including serious infections such as pneumonia and COVID-19, were reported and SOTYKTU may increase infection risk; avoid use in patients with active or serious infection ^[1]^[3].
Herpes virus reactivation (e.g., herpes simplex, herpes zoster) was reported in clinical trials ^[1]^[3].
Tuberculosis: evaluate for latent and active TB prior to initiation; do not administer in active TB and initiate latent TB treatment prior to SOTYKTU ^[1]^[3].
Malignancies including lymphomas were observed in clinical trials with SOTYKTU ^[1]^[3].
Rhabdomyolysis and elevated creatine phosphokinase (CPK) were reported; discontinue SOTYKTU if markedly elevated CPK or myopathy is diagnosed or suspected ^[1]^[3].
Laboratory abnormalities listed include increased serum triglycerides and liver enzyme elevations; evaluate these parameters per labeling ^[1]^[3].
Most common adverse reactions (≥ 1%) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne ^[1]^[3].

Study Design

Indication: treatment of active psoriatic arthritis in adults; regulatory action: sNDA approval for NDA 214958/S-002 documented in FDA approval letter dated 03/06/2026 ^[2], with label revisions reflected in prescribing information ^[3]^[1]^[4]. Specific PsA trial design details and primary efficacy results supporting this sNDA were not available in the provided source excerpts. Information on pediatric study requirements and the deferred pediatric study (study 4960-1) is included in the approval letter ^[2].

FAQ

Q1 What is SOTYKTU (deucravacitinib) approved for?

SOTYKTU is approved 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, per the FDA-approved labeling and the sNDA approval letter for NDA 214958/S-002. The label notes limitations of use, including that SOTYKTU is not recommended for use in combination with other potent immunosuppressants.

Q2 How does deucravacitinib work?

Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor. The prescribing information describes that 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 signaling, as shown in cell-based assays.

Q3 What is the recommended dose of SOTYKTU?

The recommended dosage of SOTYKTU in the U.S. label is 6 mg taken orally once daily, with or without food. The label provides additional instructions on evaluations prior to initiation and on use in hepatic impairment; clinicians should consult the full prescribing information for complete initiation evaluations, contraindications, and monitoring recommendations. Clinicians should consult current prescribing information for full dosing guidance.

Q4 What are the most common side effects?

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 also identifies risks of hypersensitivity reactions, infections including serious infections, tuberculosis considerations, malignancies including lymphomas, rhabdomyolysis and elevated CPK, and laboratory abnormalities such as triglyceride and liver enzyme elevations; monitoring and contraindications are described in the full labeling.

FDA Approves Deucravacitinib for Active Psoriatic Arthritis

Direct Clinical Takeaway & Evidence Summary

FDA Approves Deucravacitinib for Active Psoriatic Arthritis

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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