FDA Approves Deucravacitinib for Active Psoriatic Arthritis

The FDA granted approval to Bristol Myers Squibb's deucravacitinib (Sotyktu) for the treatment of adults with active psoriatic arthritis, marking a significant expansion for the therapeutic. This regulatory milestone establishes deucravacitinib as the first and only selective tyrosine kinase 2 (TYK2) inhibitor authorized for this indication.¹

The approval provides a new oral, differentiated option for patients and health care providers to manage the complex, multifaceted symptoms of psoriatic disease, which often includes debilitating joint pain and skin lesions.¹

“Psoriatic arthritis is a chronic, progressive autoimmune condition that often involves both the joints and skin. Patients often have trouble moving and staying active and can experience pain in the joints, and tendons, or ligaments,” Philip J. Mease, MD, director of rheumatology research at the Providence Swedish Medical Center, said in a news release.¹ “New oral, effective first-line treatments are needed. In clinical trials, health-related quality of life was assessed by the 36-Item Short Form Health Survey. Patients treated with Sotyktu showed improvements in SF-36 Physical Component Summary (SF-36) score at Week 16 compared to placebo.”

Deucravacitinib is a first-in-class small molecule with a unique mechanism of action that targets the regulatory domain of the TYK2 enzyme. By binding to this specific site, deucravacitinib achieves allosteric inhibition, which mediates the signaling of IL-23, IL-12, and type 1 interferons—cytokines known to drive the pathogenesis of immune-mediated diseases. Importantly, at therapeutic doses, deucravacitinib does not inhibit JAK1, JAK2, or JAK3, a distinction from broader Janus kinase inhibitors.^1,2

The FDA's decision is underpinned by positive results from the pivotal phase 3 POETYK PsA-1 (NCT04908202) and POETYK PsA-2 (NCT04908189) clinical trials, which evaluated the efficacy of 6 mg once daily dosing in over 1200 adults. In both trials, deucravacitinib demonstrated superiority over placebo, with approximately 54% of treated patients achieving an American College of Rheumatology 20 response at week 16.^1,2

Beyond joint improvement, the studies showed significant gains in key secondary endpoints, including skin clearance measured by the Psoriasis Area and Severity Index (PASI) 75 and enhanced physical function as reported on the Health Assessment Questionnaire-Disability Index (HAQ-DI).^1,2

Clinical data also indicates that outcomes are maintained or continue to improve over long-term treatment. In the POETYK PsA-2 trial, clinical responses were sustained through 52 weeks of continuous therapy, and patients who switched from placebo to deucravacitinib after the initial 16-week period also saw meaningful improvements in disease activity. Health-related quality of life, assessed through the SF-36 Physical Component Summary, was significantly higher for those on deucravacitinib compared to placebo groups.²

“The psoriatic disease community has been waiting for an additional oral treatment to address the debilitating joint and skin symptoms of this disease,” Steven Taylor, president and CEO of the Arthritis Foundation, said in the news release.¹ “We welcome this new treatment option for people living with psoriatic arthritis.”

From a clinical pharmacy perspective, several safety warnings and monitoring requirements are critical for patient management. Deucravacitinib may increase the risk of infections, including serious respiratory infections like pneumonia and COVID-19, and its use should be avoided in patients with active or serious infections. Tuberculosis (TB) screening is required prior to treatment initiation, and latent TB should be treated before starting deucravacitinib. Additionally, viral reactivation of herpes simplex and herpes zoster has been reported, necessitating vigilance and the consideration of prophylactic vaccination before starting therapy.^1-3

Pharmacists should also be aware of specific laboratory abnormalities associated with deucravacitinib, including increases in serum triglycerides and liver enzyme elevations. Triglycerides should be evaluated periodically according to clinical guidelines, and liver enzymes should be monitored at baseline and during treatment for those with known or suspected liver disease. Furthermore, deucravacitinib is associated with asymptomatic creatine phosphokinase elevation and rare instances of rhabdomyolysis, meaning patients should be instructed to promptly report any unexplained muscle pain or weakness.^1-3

Dosing and administration for psoriatic arthritis follow the established 6 mg once daily oral tablet regimen, which can be taken with or without food. Patients must be advised to swallow the tablet whole and not to crush, cut, or chew it. Although there are no geriatric-specific problems identified, caution is recommended in the elderly due to a naturally higher risk of infection. Deucravacitinib is not recommended for use in patients with severe hepatic impairment or in combination with other potent immunosuppressants. Finally, pharmacists must ensure patients avoid live vaccines while on therapy, as the immune response to these immunizations has not been evaluated in this population.^1-3

READ MORE: FDA Updates

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REFERENCES

1. US FDA approves Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis. News release. March 6, 2026. 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. June 11, 2025. 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. Mayo Clinic. Deucravacitinib (oral route). February 1, 2026. Accessed March 9, 2026. https://www.mayoclinic.org/drugs-supplements/deucravacitinib-oral-route/description/drg-20538853