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Deucravacitinib in Active Psoriatic Arthritis: Efficacy and Safety Up to 52 Weeks From the Randomized, Double-Blind,
Philip J Mease1,2, Vinod Chandran3,4, April W Armstrong5
1Providence Swedish Medical Center, Seattle, Washington.
Objective:
To assess the efficacy and safety of deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs or received tumor necrosis factor inhibitors.
Methods:
In the 52-week, double-blind, placebo-controlled, phase 3 Program for Evaluation of TYK2 Inhibitor (POETYK) PsA-2 study (NCT04908189), patients were randomized 3:3:1 to deucravacitinib 6 mg daily, placebo, or apremilast 30 mg twice daily (safety reference arm) through week 16 (W16). From W16 to W52, patients continued receiving deucravacitinib or apremilast or switched from placebo to deucravacitinib. The primary endpoint was American College of Rheumatology 20% improvement in response (ACR20) at W16. Secondary endpoints were analyzed per prespecified order to control for multiplicity.
Results:
Overall, 729 patients were randomized (312 deucravacitinib, 312 placebo, 105 apremilast). Significantly more patients achieved ACR20 at W16 with deucravacitinib versus placebo (54.2% vs 39.4%; P = 0.0002); responses improved beyond W16 and were maintained through W52 (deucravacitinib-deucravacitinib, 62.2%; placebo-deucravacitinib, 67.3%). At W16, significant differences in deucravacitinib versus placebo were observed in hierarchical secondary endpoints of Health Assessment Questionnaire Disability Index, 75% improvement in the Psoriasis Area and Severity Index, 36-Item Short Form Survey Physical Component Summary, and achievement of minimal disease activity. At W16, serious adverse events occurred in 1.0%, 1.9%, and 3.8% of patients receiving placebo, deucravacitinib, and apremilast, respectively. No new safety signals, deaths, or imbalances in cardiovascular events, malignancies, or opportunistic infections occurred through W52.
Conclusion:
Deucravacitinib was well tolerated in patients with PsA and demonstrated superior efficacy versus placebo across multiple clinical endpoints and patient-reported outcomes, including functional ability and quality of life. Clinical responses and patient-reported outcomes were maintained through W52.
Insights
Deucravacitinib significantly improved psoriatic arthritis symptoms compared to placebo, demonstrating sustained efficacy and good tolerability over 52 weeks in patients naive to or previously treated with TNF inhibitors.
Area of Science:
- Rheumatology
- Immunology
- Dermatology
Background:
- Psoriatic arthritis (PsA) is a chronic inflammatory condition affecting joints and skin.
- Current treatments include conventional synthetic and biologic disease-modifying antirheumatic drugs (DMARDs).
- There is a need for novel oral therapies targeting specific immune pathways in PsA.
Purpose of the Study:
- To evaluate the efficacy and safety of deucravacitinib, an oral selective tyrosine kinase 2 (TYK2) inhibitor.
- To compare deucravacitinib with placebo and apremilast in patients with active PsA.
- To assess long-term maintenance of response and safety over 52 weeks.
Main Methods:
- Phase 3, double-blind, placebo-controlled POETYK PsA-2 study.
- Randomized patients to deucravacitinib (6 mg daily), placebo, or apremilast (30 mg twice daily).
- Primary endpoint: American College of Rheumatology 20% improvement (ACR20) at week 16; secondary endpoints assessed functional ability, skin clearance, and quality of life.
Main Results:
- Deucravacitinib showed significantly higher ACR20 response rates at week 16 compared to placebo (54.2% vs 39.4%).
- Responses were maintained through week 52, with improved functional ability (HAQ-DI), skin clearance (PASI-75), and quality of life (SF-36 PCS).
- Deucravacitinib demonstrated a favorable safety profile, with no new safety signals identified.
Conclusions:
- Deucravacitinib is an effective and well-tolerated oral treatment for psoriatic arthritis.
- It offers significant clinical benefits across multiple domains, including joint and skin symptoms, functional status, and quality of life.
- Sustained efficacy and safety through 52 weeks support its potential as a valuable therapeutic option for PsA patients.
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