Anti-GM-CSF otilimab versus sarilumab or placebo in patients with rheumatoid arthritis and inadequate response to targeted therapies: a phase III randomised trial (contRAst 3)
Authors' conclusion
Otilimab demonstrated an acceptable safety profile but failed to achieve the primary end point of ACR20 and improve secondary end points versus placebo or demonstrate non-inferiority to sarilumab in this patient population.
Study context
- Population
- Patients with active RA and inadequate response to csDMARDs and bDMARDs and/or JAKireceived treatment
- Participants
- 549 patients
- Comparison
- Subcutaneous otilimab 90 or 150 mg once weekly vs sarilumab 200 mg every 2 weeks vs placebo for 12 weeks, with csDMARDs
- Primary endpoint
- Proportion achieving ACR20 response
- Follow-up
- Week 12
Methodological detailsphase III, multicentre, 24-week trial; placebo switched to active interventions at week 12, treatment continued to week 24
- Phase III
- Multicentre
- 24-week trial; placebo switched to active interventions at week 12, treatment continued to week 24
Primary result
As reported in the abstract
ACR20 response
Otilimab 90 mg vs Placebo: P = 0.2868 · Otilimab 150 mg vs Placebo: P = 0.0596
Secondary outcomes
CDAI, HAQ-DI, pain VAS and FACIT-Fatigue scores · week 12
- No significant differences with otilimab vs placebo
ACR20 response and secondary end points, sarilumab vs otilimab
- Sarilumab demonstrated superiority to otilimab
Safety
Adverse and serious adverse events
- Incidence similar across treatment groups
Original publication
Anti-GM-CSF otilimab versus sarilumab or placebo in patients with rheumatoid arthritis and inadequate response to targeted therapies: a phase III randomised trial (contRAst 3). Ann Rheum Dis. Published 11 September 2023. doi:10.
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