Trial results for a Phase 3 study comparing secukinumab to ustekinumab in adults with active psoriatic arthritis were posted on ClinicalTrials.gov on 2025-10-16. The study found that secukinumab demonstrated a significantly higher proportion of patients achieving a Health Assessment Questionnaire - Disability Index (HAQ-DI) response, with an Odds Ratio of 3.647 (95.0% CI: 1.601 to 8.311; p-value: 0.002) compared to ustekinumab.
Background
Secukinumab (Cosentyx) is used to treat psoriatic arthritis. This study specifically focused on patients with active psoriatic arthritis who had previously failed TNFα-inhibitor treatment.
Trial design
The study (NCT04632927) was a Phase 3, randomized trial that enrolled 119 participants with active psoriatic arthritis who had previously failed TNFα-inhibitor treatment. The trial compared the safety and efficacy of secukinumab and ustekinumab.
Key results
The trial results showed differences in several efficacy measures at Week 28:
- Proportion of Patients With Health Assessment Questionnaire - Disability Index (HAQ-DI) Response: 32 participants in the secukinumab group achieved a response, compared to 17 participants in the ustekinumab group. A logistic regression analysis comparing the two treatment groups for this outcome yielded an Odds Ratio (OR) of 3.647 (95.0% CI: 1.601 to 8.311) with a p-value of 0.002.
- Number of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response: 27 participants in the secukinumab group achieved PASI 90, compared to 25 participants in the ustekinumab group.
- Number of Patients Achieving PASI 100: 21 participants in the secukinumab group achieved PASI 100, compared to 17 participants in the ustekinumab group.
Changes from baseline in patient-reported and clinical assessments at Week 28 included:
- Patient's Assessment of Pain on VAS: The secukinumab group showed a mean change of -27.1 (Standard Deviation: 25.8), while the ustekinumab group showed a mean change of -16.4 (Standard Deviation: 24.2).
- Tender Joint Count (TJC) 68: The secukinumab group had a mean change of -9.6 (Standard Deviation: 11.9), compared to -7.6 (Standard Deviation: 10.7) for the ustekinumab group.
- Swollen Joint Count (SJC) 66: The secukinumab group had a mean change of -6.8 (Standard Deviation: 6.3), compared to -5.3 (Standard Deviation: 5.2) for the ustekinumab group.
What this means
The trial results suggest that secukinumab may offer a more significant improvement in physical function, as measured by HAQ-DI response, and greater pain reduction compared to ustekinumab in adults with active psoriatic arthritis who have failed prior TNFα-inhibitor treatment. While PASI 90 and PASI 100 responses were numerically similar between the two groups, the statistically significant odds ratio for HAQ-DI response indicates a notable difference in functional outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04632927, titled "Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment," were posted on 2025-10-16 on clinicaltrials.gov.