Anti-GM-CSF otilimab versus tofacitinib or placebo in patients with active rheumatoid arthritis and an inadequate response to conventional or biologic DMARDs: two phase 3 randomised trials (contRAst 1 and contRAst 2)
Authors' conclusion
Although otilimab demonstrated superiority to placebo in ACR20, CDAI LDA and HAQ-DI, improved symptoms, and had an acceptable safety profile, it was inferior to tofacitinib.
Study context
- Population
- Patients with active RA and inadequate response to MTX (contRAst 1) or cs/bDMARDs (contRAst 2), on background csDMARDsITT: 1537 (contRAst 1), 1625 (contRAst 2)
- Comparison
- Subcutaneous otilimab 90 or 150 mg once weekly vs placebo (week 12) or oral tofacitinib 5 mg twice daily (week 24), with background csDMARDs
- Primary endpoint
- Proportion of patients achieving ACR20 response
- Follow-up
- Week 12
Methodological detailstwo phase 3 trials (contRAst 1 and contRAst 2), double-blind, placebo- and active-controlled, testing hierarchy
- Two phase 3 trials (contRAst 1 and contRAst 2)
- Double-blind
- Placebo- and active-controlled
- Testing hierarchy
Primary result
As reported in the abstract
ACR20 response, contRAst 1
Otilimab 90 mg vs Placebo: P = 0.0023 · Otilimab 150 mg vs Placebo: P = 0.0362
Secondary outcomes
| Outcome | Otilimab 90 mg | Otilimab 150 mg | Placebo | P value |
|---|---|---|---|---|
| ACR20 response, contRAst 2 (primary endpoint, second trial) · week 12Otilimab 90 mg vs Placebo · intention-to-treat | 54.9% | 54.5% | 32.5% | P < 0.0001 |
| ACR20 response, contRAst 2 (primary endpoint, second trial) · week 12Otilimab 150 mg vs Placebo · intention-to-treat | P < 0.0001 |
Clinical Disease Activity Index (CDAI) low disease activity (LDA) responders and Health Assessment Questionnaire-Disability Index (HAQ-DI), otilimab vs placebo
- In both trials otilimab increased CDAI LDA responders (not significant for otilimab 150 mg in contRAst 1) and reduced HAQ-DI scores vs placebo
Tofacitinib vs otilimab
- Benefits with tofacitinib consistently greater than with otilimab across multiple endpoints
Safety
Safety outcomes
- Similar across treatment groups
Original publication
Anti-GM-CSF otilimab versus tofacitinib or placebo in patients with active rheumatoid arthritis and an inadequate response to conventional or biologic DMARDs: two phase 3 randomised trials (contRAst 1 and contRAst 2). Ann Rheum Dis. Published 12 September 2023. doi:10.
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