Phase 3
N=853
Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02745080 ↗Enrolled (actual)
853
Serious AEs
8.6%
Results posted
Jan 2021
Primary outcome: Primary: Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52 — 67.4; 61.5 Percentage of Participants — p=0.0719
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Secukinumab (Biological); Adalimumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52 |
67.4; 61.5 | 0.0719 |
| SECONDARY Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52 |
65.4; 43.2 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52 |
49.0; 44.8 | 0.2251 |
| SECONDARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52 |
-0.58; -0.56 | 0.5465 |
| SECONDARY Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52 |
60.5; 54.2 | 0.1498 |
Summary
This was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).
Eligibility Criteria
Key Inclusion Criteria
- Diagnosis of PsA classified by CASPAR
- Rheumatoid factor and anti-CCP antibodies negative
- Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of >= 2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis
- Inadequate control of symptoms with NSAIDs
- Inadequate control of symptoms with a conventional DMARD.
Key Exclusion Criteria
- Pregnant or nursing women
- Evidence of ongoing infectious or malignant process
- Previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis
- Subjects taking high potency opioid analgesics
- Ongoing use of prohibited psoriasis treatments/medications
- Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 investigational agents.
Data sourced from ClinicalTrials.gov (NCT02745080). 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.