Efficacy and Safety of Zimlovisertib, Ritlecitinib, and Tofacitinib, Alone and in Combination, in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Authors' conclusion
Zimlovisertib + tofacitinib was more effective than tofacitinib for the primary endpoint, whereas the efficacy of zimlovisertib + ritlecitinib did not achieve statistical significance versus tofacitinib. All treatments were well tolerated.
Study context
- Population
- Patients with moderate to severe active RA and inadequate response to MTXrandomised 4:4:3:3:4
- Participants
- 460 patients
- Comparison
- Zimlovisertib + tofacitinib, zimlovisertib + ritlecitinib, zimlovisertib, ritlecitinib vs tofacitinib alone
- Primary endpoint
- Change from baseline in DAS28-CRP
- Follow-up
- Week 12
Methodological detailsphase 2
- Phase 2
Primary result
As reported in the abstract
Mean change from baseline in DAS28-CRP
Zimlovisertib + tofacitinib
−2.65
mean · 90% CI −2.84–-2.46
Zimlovisertib + ritlecitinib
−2.35
mean · 90% CI −2.54–-2.15
Tofacitinib
−2.30
mean · 90% CI −2.49–-2.11
P = 0.032
Safety
| Outcome | Values |
|---|---|
| TEAEsHighest aggregate incidence in tofacitinib group · most TEAEs mild; safety profiles similar across groups | Tofacitinib 58.8% |
- Treatment-emergent adverse events (TEAEs) — TEAEs overall
- 246 (53.5%)
- TEAEs — Severe TEAEs
- 9 (2.0%)
- TEAEs — Serious AEs
- 10
- TEAEs — Death (tofacitinib, severe COVID-19)
- 1
Original publication
Efficacy and Safety of Zimlovisertib, Ritlecitinib, and Tofacitinib, Alone and in Combination, in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate. Arthritis Rheumatol. Published 25 May 2025. doi:10.
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