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Results of the POETYK PsA-2 trial indicate deucravacitinib’s effectiveness at reducing the severity and burden of symptoms in patients with psoriatic arthritis.
In the phase 3 POETYK PsA-2 trial (NCT04908189), deucravacitinib (Sotyktu; Bristol Myers Squibb) demonstrated superiority over placebo in adults with active psoriatic arthritis (PsA), with a significantly greater proportion of deucravacitinib-treated patients achieving an American College of Rheumatology (ACR) 20 (ACR20) response—at least a 20% improvement in signs and symptoms of PsA—compared with placebo at week 16 (54.2% vs 39.4%; P = .0002). The pivotal data were presented as a late-breaking abstract at the American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.1,2
Psoriatic arthritis can be chronic and lead to long-term burdens for patients. | Image Credit: © Lila Patel - stock.adobe.com
Deucravacitinib also met critical secondary end points regarding PsA disease activity at week 16, showing sustained improvements across clinical signs and symptoms, extra-articular manifestations, and patient-reported outcomes. A large proportion of patients treated with deucravacitinib achieved a Psoriasis Area and Severity Index (PASI) 75 response compared with placebo, while patients also had meaningfully greater improvements in the self-reported Health Assessment Questionnaire-Disability Index (HAQ-DI) compared with placebo (-0.32 vs -0.21, respectively; P = .0013).1
“Given the complex, multifaceted, and heterogenous nature of psoriatic arthritis, there continues to be a significant need for safe and effective oral treatments,” Philip Mease, MD, clinical professor at the University of Washington School of Medicine, Seattle, said in a news release accompanying the abstract. “These results are particularly encouraging because they support the potential for [deucravacitinib] to impact both joint and skin symptoms, as well as patient-reported quality of life outcomes.”1
The safety profile of deucravacitinib was positive and tolerable across the study cohort. No new safety signals were reported; importantly, deucravacitinib had the lowest rate of adverse events (AEs) compared with patients receiving placebo and apremilast (Otezla; Amgen), which was included as a safety reference with no plans for efficacy comparisons (54.7% for deucravacitinib, 62.8% for placebo, 73.3% for apremilast), according to the investigators. Correspondingly, serious AEs were observed in 1.0%, 1.9%, and 3.8% of patients in the deucravacitinib, placebo, and apremilast arms.1
Deucravacitinib was approved by the FDA in September 2022 for use in patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy. It is an oral, selective, allosteric tyrosine kinase 2 (TKY2) inhibitor that represents a new class of small-molecule therapies, according to the news release. By being selectively designed to target TYK2, deucravacitinib inhibits signaling of IL-23, IL-12, and other key cytokines that are involved in the pathogenesis of PsA. Its design as a convenient oral medication allows for patients to be more adherent to prescribed treatment and gives pharmacists a proven treatment to recommend patients.1,3,4
“These promising new data demonstrate the potential of [deucravacitinib] as an oral therapy and the first TYK2 inhibitor that may be able to address significant unmet needs of patients living with psoriatic arthritis,” Edgar Charles, MD, vice president and senior global program lead, Early and Late Development Immunology, Bristol Myers Squibb, said in the news release. “These results support our belief in the capability of [deucravacitinib] in rheumatic conditions.”1
PsA, given its chronic nature with the ability for multiple musculoskeletal and skin manifestations, requires effective treatments like deucravacitinib that can effectively reduce the burden of this condition while allowing for convenience and safety. Additionally, patients with PsA are at an increased risk of developing serious comorbidities, including cardiovascular disease and metabolic syndrome. A patient’s PsA care team should be experienced and comprise of providers from multiple fields, including pharmacists, to ensure the most optimized care.