Deucravacitinib Promising for PsA

Recently reported findings from two recent phase 3 clinical trials show that deucravacitinib (Sotyktu) may be a safe and effective treatment for patients with psoriatic arthritis (PsA). Both studies, POETYK PsA-1 (NCT04908202) and POETYK PsA-2 (NCT04908189), evaluated the safety and efficacy of deucravacitinib in adults with active PsA.^1,2

Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor in a new class of small molecules.^3,4 The agent selectively targets TYK2, which inhibits signaling of interleukin (IL) 23, IL-12 and type 1 interferons and key cytokines involved in the pathogenesis of multiple immune-mediated diseases. At therapeutic doses, deucravacitinib does not inhibit Janus kinase (JAK) 1, JAK 2 or JAK 3.

On Sept. 9, 2022, the U.S. Food & Drug Administration approved deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.⁵ The agent is currently in clinical trials for multiple immune-mediated diseases.

The Findings

POETYK PsA-1 enrolled approximately 670 patients with active PsA who had not previously been treated with a biologic disease-modifying anti-rheumatic drug (DMARD). POETYK PsA-2 enrolled approximately 730 patients with active PsA who were biologic DMARD naive or who had received treatment previously with a tumor necrosis factor (TNF) α inhibitor. Additionally, POETYK PsA-2 had an apremilast safety reference arm. Both clinical trials were 52 weeks long, and patients in both trials who completed 52 weeks of treatment are potentially eligible to enroll in an open-label extension study.^1,2,4

In both trials, the primary end point was achieving an ACR20 response (i.e., at least a 20% improvement in the signs and symptoms of disease). This end point was met in both studies after week 16, with a significantly greater proportion of patients treated with deucravacitinib attaining an ACR20 response compared with those treated with placebo. Additionally, key secondary end points across PsA disease activity were met in both trials at week 16. (Note: No detail reported.)⁴

No new safety signals were identified, which was consistent with the safety profile of deucravacitinib from clinical trials in patients with plaque psoriasis and a phase 2 trial of patients with PsA. These trials are currently on-going.

These study results so far demonstrate that deucravacitinib has the potential to be another oral therapy for patients with PsA, but with a new mechanism of action.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. A study to determine the efficacy and safety of deucravacitinib compared with placebo in participants with active psoriatic arthritis (PsA) who are naïve to biologic disease-modifying anti-rheumatic drugs [NCT04908202]. ClinicalTrials.gov. 2024 Sep 27.
2. A study to determine the efficacy and safety of deucravacitinib compared with placebo in participants with active psoriatic arthritis (PsA) who are naïve to biologic disease modifying anti-rheumatic drugs or had previously received TNFα inhibitor treatment [NCT04908189]. ClinicalTrials.gov. 2024 Nov 1.
3. Highlights of prescribing information: Sotyktu (deucravacitinib). 2022 Sep 9.
4. Bristol Myers squibb announces positive topline results from two pivotal phase 3 trials evaluating Sotyktu (deucravacitinib) in adults with psoriatic arthritis [news release]. Bristol Myers Squibb. 2024 Dec 23.
5. Sotyktu (deucravacitinib) tablets new drug application approval letter. U.S. Food & Drug Administration. 2022 Sep 9.