Trial results for deucravacitinib (Sotyktu) in participants with active psoriatic arthritis were posted on ClinicalTrials.gov on 2025-04-13. The Phase 3 study (NCT04908189) showed that deucravacitinib led to a higher number of participants achieving ACR20 response compared to placebo, and a significantly greater reduction in DAS28-CRP with an adjusted mean difference of -0.4743 (p-value 0.0001).
Background
Deucravacitinib is being investigated for the treatment of active psoriatic arthritis (PsA). The study population included participants who were either naïve to biologic disease-modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.
Trial design
The study (NCT04908189) was a Phase 3 trial that enrolled 729 participants with active psoriatic arthritis. The trial evaluated the efficacy and safety of deucravacitinib compared with placebo. Participants included those who were either biologic-naïve or had prior TNFα inhibitor treatment.
Key results
The trial results at Week 16 showed several key differences between the deucravacitinib and placebo groups:
- For the "Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16" outcome, 169 participants in the deucravacitinib group met the criteria, compared to 123 participants in the placebo group.
- Regarding "Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16," the deucravacitinib group showed a mean change of -1.3133 (Standard Deviation: 1.17420), while the placebo group showed a mean change of -0.9095 (Standard Deviation: 1.10470). An ANCOVA analysis for this outcome yielded an Adjusted Mean Difference of -0.4743 (95.0% CI: -0.6455 to -0.3031) with a p-value of 0.0001.
- For "Change From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16," the deucravacitinib group had a mean change of -0.3103 (Standard Deviation: 0.46159), compared to -0.2219 (Standard Deviation: 0.46858) for placebo. The ANCOVA analysis showed an Adjusted mean difference of -0.1126 (95.0% CI: -0.1814 to -0.0438) with a p-value of 0.0013.
- The "Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16" was 63 for the deucravacitinib group and 23 for the placebo group.
- For "Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16," the deucravacitinib group showed a mean change of 6.194 (Standard Deviation: 7.4640), versus 4.262 (Standard Deviation: 7.0328) for placebo. The ANCOVA analysis indicated an Adjusted mean difference of 2.042 (95.0% CI: 0.98 to 3.105) with a p-value of 0.0002.
- Among participants with enthesitis at baseline, 74 in the deucravacitinib group met "Enthesitis Resolution (Score of 0) by Leeds Enthesitis Index (LEI) at Week 16," compared to 66 in the placebo group.
What this means
The findings from this Phase 3 trial suggest that deucravacitinib offers significant clinical benefits for individuals with active psoriatic arthritis. The statistically significant improvements in measures like ACR20 response, DAS28-CRP, HAQ-DI, and SF-36 Physical Component Summary score indicate that deucravacitinib may effectively reduce disease activity, improve physical function, and enhance quality of life for these patients. The observed higher rates of PASI 75 response also suggest benefits for associated psoriasis symptoms.
Source
The trial results were sourced from ClinicalTrials.gov, a public database of clinical studies. The data for study NCT04908189, titled "A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)," was posted on 2025-04-13 on clinicaltrials.gov.