Ivarmacitinib, a selective Janus kinase 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: results from a phase III randomised clinical trial
Authors' conclusion
Ivarmacitinib may offer a potential therapeutic option for patients with RA who have an inadequate response to csDMARDs, with a safety profile that was generally manageable over 1 year of treatment and similar to other JAK inhibitors.
Study context
- Population
- Patients with moderate-to-severe active rheumatoid arthritis (RA) and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)
- Participants
- 188 / 189 / 189
- Comparison
- Ivarmacitinib 4 mg or 8 mg once daily vs placebo, background csDMARDs allowed
- Placebon = 188reference
- Ivarmacitinib 4 mgn = 189
- Ivarmacitinib 8 mgn = 189
- Primary endpoint
- ACR20 response
- Follow-up
- Week 24
Methodological detailsphase III, 1:1:1 randomisation, placebo-controlled
- Phase III
- 1:1:1 randomisation
- Placebo-controlled
Primary result
As reported in the abstract
ACR20 response rate
Ivarmacitinib 4 mg vs Placebo: P < 0.0001 · Ivarmacitinib 8 mg vs Placebo: P < 0.0001
Further findings
DAS28-CRP <2.6/≤3.2 response rates
- Numerically higher with both ivarmacitinib doses vs placebo
Efficacy and patient-reported outcomes · 52 weeks
- Improvements sustained through 52 weeks and noted in patients switched from placebo after week 24
Safety
TEAEs (placebo-controlled period)
Infection-related treatment-emergent adverse events (TEAEs)
- Slightly higher in the ivarmacitinib groups
Original publication
Ivarmacitinib, a selective Janus kinase 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: results from a phase III randomised clinical trial. Ann Rheum Dis. Published 3 January 2025. doi:10.
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