Phase 3
N=119
Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT04632927 ↗Enrolled (actual)
119
Serious AEs
4.2%
Results posted
Oct 2025
Primary outcome: Primary: Proportion of Patients With Health Assessment Questionnaire - Disability Index (HAQ-DI) Response at Week 28 — 32; 17 Participants — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab (Biological); Ustekinumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Health Assessment Questionnaire - Disability Index (HAQ-DI) Response at Week 28 |
32; 17 | 0.002 sig |
| SECONDARY Number of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 28 |
27; 25 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain on VAS at Week 28 |
-27.1; -16.4 | — |
| SECONDARY Change From Baseline in Tender Joint Count (TJC) 68 at Week 28 |
-9.6; -7.6 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (SJC) 66 at Week 28 |
-6.8; -5.3 | — |
| SECONDARY Number of Patients Achieving PASI 100 at Week 28 |
21; 17 | — |
| SECONDARY Number of Patients Achieving PASI 75 at Week 28 |
34; 29 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity on VAS |
-26.0; -15.5 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Psoriasis and Arthritis Disease Activity on VAS |
-28.1; -16.2 | — |
| SECONDARY Number of Patients Achieving Minimal Disease Activity (MDA) at Week 28 |
20; 14 | — |
| SECONDARY Change From Baseline in the Leeds Enthesitis Index (LEI) |
-0.9; -0.5 | — |
| SECONDARY Change From Baseline in the Leeds Dactylitis Index (LDI) |
-9.7; -7.2 | — |
| SECONDARY Change From Baseline in Psoriatic Arthritis Quality of Life (PsAQoL) |
-2.5; -2.0 | — |
| SECONDARY Percentage of Participants Achieving a Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Response at Week 28 |
40; 32 | — |
| SECONDARY Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Response at Week 28 |
30; 32 | — |
Summary
The purpose of this study is to compare the safety and efficacy of secukinumab and ustekinumab in patients with active psoriatic arthritis who showed failure to previous TNFα-inhibitor treatment
Eligibility Criteria
Key Inclusion Criteria
- Diagnosis of PsA as classified by CASPAR criteria for at least 6 months before randomization.
- Active PsA at baseline defined as ≥ 3 tender joints out of 68 and ≥ 3 swollen joints out of 66 (dactylitis of a digit counts as one joint each).
- Inadequate response or intolerance to previous or current treatment with at least one TNFα inhibitor
- Inadequate response or intolerance to conventional disease modifying anti-rheumatic drugs (cDMARDs)
- Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter and/or nail changes consistent with psoriasis and/or documented history of plaque psoriasis.
- Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibodies negative at screening.
Key Exclusion Criteria
- Pregnant or nursing women,
- Previous exposure to secukinumab, ustekinumab or any other biologic drug directly targeting IL-17, IL-17 receptor, IL-12 or IL-23.
- Patients for whom the use of secukinumab or ustekinumab is contraindicated.
- Use of any other investigational drug. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents
- Evidence of ongoing infectious or malignant process
- Subjects receiving high potency opioid analgesics
- Ongoing use of prohibited psoriasis treatments/medications
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT04632927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.