News Report · Dermatology

FDA Approves Deucravacitinib for Moderate to Severe Plaque Psoriasis: 54% sPGA Response in POETYK PSO-1 Trial

June 09, 2026

Clinical Perspective

Deucravacitinib provides a new oral treatment option for patients with moderate to severe plaque psoriasis, demonstrating significant efficacy in achieving skin clearance.

Dr. Divya Agarwal · Dermatology

Deucravacitinib (Sotyktu) achieved a static Physician's Global Assessment (sPGA) response of 54% versus 7% with placebo in adults with moderate to severe plaque psoriasis in the POETYK PSO-1 trial ^[1].

Clinical Context

Plaque psoriasis is a chronic autoimmune condition characterized by the rapid proliferation of skin cells leading to thick, red, scaly patches. It affects approximately 7.5 million adults in the United States, causing significant physical discomfort and psychological distress. Current treatments include topical therapies, phototherapy, and systemic agents, but many patients remain inadequately controlled or experience adverse effects. Deucravacitinib, a novel oral tyrosine kinase 2 (TYK2) inhibitor, offers a new mechanism of action for patients who are candidates for systemic therapy or phototherapy, addressing the need for more effective treatment options.

Key Findings

The POETYK PSO-1 trial showed deucravacitinib reduced sPGA response of 0/1 (clear or almost clear) by 54% versus placebo (difference from placebo 47%; 95% CI 40, 53) ^[1].
The trial enrolled 330 adults with moderate to severe plaque psoriasis ^[1].
Event rates: 54% of patients achieved sPGA 0/1 with deucravacitinib compared to 7% with placebo ^[1].
The primary endpoint was the proportion of patients achieving sPGA score of 0 (clear) or 1 (minimal) at Week 16 ^[1].
Secondary endpoint results included a 75% reduction in Psoriasis Area and Severity Index (PASI 75) at Week 16, which was also significantly higher in the deucravacitinib group ^[1].
Deucravacitinib is administered at a dose of 6 mg orally once daily ^[1].
Clinicians should consult current prescribing information for full dosing guidance.

Safety & Tolerability

Nausea reported with deucravacitinib — exact frequency not available in public source summary ^[1].
Fatigue reported — exact frequency not available in public source summary ^[1].
Headache reported ^[1].
Increased risk of infections — advise patients to report any signs of infection during treatment ^[1].
Liver function changes — monitor liver enzymes during treatment ^[1].
Complete adverse event profile available in the full prescribing information for deucravacitinib (Sotyktu) ^[1].

What This Means for Clinical Practice

Deucravacitinib is indicated for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The data supports a 54% sPGA response at Week 16, indicating a significant improvement in skin clearance for these patients. What long-term safety considerations should clinicians monitor in patients receiving this new treatment?

Study Design

The POETYK PSO-1 trial was a phase 3, randomized, double-blind, placebo-controlled study that enrolled 330 adults with moderate to severe plaque psoriasis. The primary endpoint was the proportion of patients achieving an sPGA score of 0 or 1 at Week 16, with a follow-up duration of 16 weeks. The trial was funded by Bristol Myers Squibb, and key limitations include the relatively short follow-up period and the need for further long-term efficacy and safety data.

FAQ

What is deucravacitinib (Sotyktu) approved for?

Deucravacitinib (Sotyktu) is approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, based on the POETYK PSO-1 trial showing significant efficacy results.

How does deucravacitinib work?

Deucravacitinib is a selective tyrosine kinase 2 (TYK2) inhibitor that modulates the immune response by blocking specific pathways involved in the inflammatory process of psoriasis.

What is the recommended dose of deucravacitinib?

The recommended dose of deucravacitinib (Sotyktu) is 6 mg taken orally once daily. Clinicians should consult current prescribing information for full dosing guidance. Full dosing guidance is available in the prescribing information for deucravacitinib (Sotyktu).

What are the most common side effects of deucravacitinib?

Common side effects include nausea, fatigue, headache, increased risk of infections, and liver function changes. Monitoring for these adverse events is recommended during treatment.

References

FDA — Drug Trials Snapshots: SOTYKTU | FDA

FDA Approves Deucravacitinib for Moderate to Severe Plaque Psoriasis: 54% sPGA Response in POETYK PSO-1 Trial

FDA Approves Deucravacitinib for Moderate to Severe Plaque Psoriasis: 54% sPGA Response in POETYK PSO-1 Trial

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

What This Means for Clinical Practice

Study Design

FAQ

References

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