Methotrexate Safety and Efficacy in Combination Therapies in Patients With Early Rheumatoid Arthritis: A Post Hoc Analysis of a Randomized Controlled Trial
Authors' conclusion
Methotrexate was generally well tolerated in combination therapies, but adverse events were a limiting factor in receiving the target dose of 25 mg/wk, and these were more frequent in combination with tocilizumab versus ACT. On the other hand, methotrexate dose reductions were not associated with decreased CDAI remission rates within any of the four treatment combinations at 24 weeks.
Study context
- Population
- Treatment-naïve patients with early rheumatoid arthritis (RA) in the NORD-STAR trial
- Participants
- 812 patients
- Comparison
- MTX combined with certolizumab-pegol, abatacept or tocilizumab vs MTX with active conventional treatment
- Primary endpoint
- MTX safety (MTX-associated side effects), MTX doses and dose effects on CDAI remission
- Follow-up
- 24 weeks
Methodological detailspost hoc analysis
- Post hoc analysis
Primary result
As reported in the abstract
MTX-associated side effects
Each group vs ACTHazard ratio (95% CI)
Tocilizumab
1.48(1.20–1.84)
Certolizumab-pegol
0.99(0.79–1.23)
Abatacept
0.93(0.75–1.16)
Further findings
| Outcome | β (95% CI) | P value |
|---|---|---|
| MTX dose · 24 weeksTocilizumab vs ACT | −4.65 (−5.83 to −3.46) | P < 0.001 |
| MTX dose · 24 weeksAbatacept vs ACT | −1.15 (−2.27 to −0.03) | P = 0.04 |
| MTX dose · 24 weeksCertolizumab-pegol vs ACT | −1.07 (−2.21 to 0.07) | P = 0.07 |
Clinical Disease Activity Index (CDAI) remission and MTX dose reductions · 24 weeks
- MTX dose reductions not associated with decreased CDAI remission rates within any treatment combination
Original publication
Methotrexate Safety and Efficacy in Combination Therapies in Patients With Early Rheumatoid Arthritis: A Post Hoc Analysis of a Randomized Controlled Trial. Arthritis Rheumatol. Published 18 January 2024. doi:10.
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