Trial results for a Phase 3 study investigating deucravacitinib in participants with active psoriatic arthritis were posted on ClinicalTrials.gov on 2025-10-24. The study demonstrated that 54.2% of participants treated with deucravacitinib 6 mg QD achieved an ACR 20 response at Week 16, compared to 34.1% for placebo.
Background
The study aimed to evaluate the efficacy and safety of deucravacitinib in participants with active psoriatic arthritis who were naïve to biologic disease-modifying anti-rheumatic drugs.
Trial design
The study (NCT04908202) was a Phase 3, placebo-controlled trial that enrolled 670 participants. It investigated deucravacitinib in individuals with active psoriatic arthritis who had not previously received biologic disease-modifying anti-rheumatic drugs. Participants were assigned to receive either deucravacitinib 6 mg QD or placebo.
Key results
The trial results demonstrated several key findings at Week 16:
- For the "Percentage of Participants With ACR 20 Response":
- Deucravacitinib 6 mg QD group: 54.2%
- Placebo group: 34.1%
Statistical analysis showed an Odds Ratio (OR) of 2.29 (95.0% CI: 1.67 to 3.13) with a p-value of 0.0001.
- For "Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP)":
- Deucravacitinib 6 mg QD group: Mean change of -1.4106 (Standard Deviation: 1.13277)
- Placebo group: Mean change of -0.8902 (Standard Deviation: 1.10750)
The adjusted mean difference was -0.5051 (95.0% CI: -0.6709 to -0.3392) with a p-value of 0.0001.
- For "Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)":
- Deucravacitinib 6 mg QD group: Mean change of -0.4103 (Standard Deviation: 0.52303)
- Placebo group: Mean change of -0.2118 (Standard Deviation: 0.51583)
The adjusted mean difference was -0.1688 (95.0% CI: -0.2442 to -0.0933) with a p-value of 0.0001.
- For "Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response":
- Deucravacitinib 6 mg QD group: 51.9%
- Placebo group: 7.1%
Statistical analysis showed an Odds Ratio (OR) of 14.08 (95.0% CI: 7.19 to 27.59) with a p-value of 0.0001.
- For "Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score":
- Deucravacitinib 6 mg QD group: Mean change of 6.410 (Standard Deviation: 8.2883)
- Placebo group: Mean change of 3.847 (Standard Deviation: 7.2929)
The adjusted mean difference was 6.631 (95.0% CI: 3.481 to 9.781) with a p-value of 0.0001.
- For "Percentage of Participants Meeting Enthesitis Resolution (Score of 0)":
- Deucravacitinib 6 mg QD group: 48.3%
- Placebo group: 46.1%
Statistical analysis showed an Odds Ratio (OR) of 1.13 (95.0% CI: 0.74 to 1.75) with a p-value of 0.5699.
What this means
The results from this Phase 3 trial indicate that deucravacitinib 6 mg QD significantly improved several key measures of disease activity in participants with active psoriatic arthritis compared to placebo. The substantial differences observed in ACR 20 and PASI 75 response rates, as well as improvements in DAS28-CRP, HAQ-DI, and SF-36 PCS scores, suggest that deucravacitinib could be an effective treatment option for this patient population, particularly those naïve to biologic therapies. The lack of significant difference in enthesitis resolution suggests that while overall disease activity improved, this specific symptom may require further investigation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04908202, titled "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," were posted on 2025-10-24 on clinicaltrials.gov.