Tocilizumab Monotherapy or Combined With Methotrexate for Rheumatoid Arthritis: A Randomized Clinical Trial
Authors' conclusion
In this large-scale randomized clinical trial evaluating subcutaneous tocilizumab in Chinese patients, subcutaneous tocilizumab, either as monotherapy or combined with methotrexate, demonstrated superior efficacy to methotrexate monotherapy and was well tolerated.
Study context
- Population
- Adults (18–70 years) with moderate to severe active rheumatoid arthritis (RA) and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), 19 sites in China294 women [86.5%]
- Participants
- 340 adults
- Comparison
- SC tocilizumab + MTX vs SC tocilizumab monotherapy vs MTX alone
- Tocilizumab-methotrexaten = 136
- Tocilizumab-placebon = 136
- Methotrexate-placebon = 68reference
- Primary endpoint
- ACR20 response
- Follow-up
- Week 24
Methodological detailsdouble-blind, phase 3, multicentre (19 sites in China), 2:2:1 randomisation, 24-week extension phase, July 2017 through August 2022
- Double-blind
- Phase 3
- Multicentre (19 sites in China)
- 2:2:1 randomisation
- 24-week extension phase
- July 2017 through August 2022
Primary result
As reported in the abstract
Each group vs methotrexate-placeboDifference, percentage points (95% CI)P value
Tocilizumab-methotrexate
27.9(14.7–41.2)
P < 0.001Tocilizumab-placebo
25.0(11.7–38.3)
P < 0.001Further findings
Long-term efficacy · week 48
- Improved or maintained efficacy in patients who continued double-blind tocilizumab-placebo or tocilizumab-methotrexate; those switched to open-label tocilizumab-methotrexate had improved disease status
Safety
Safety (monitored for 56 weeks)
- No new safety signals observed for tocilizumab
Original publication
Tocilizumab Monotherapy or Combined With Methotrexate for Rheumatoid Arthritis: A Randomized Clinical Trial. JAMA Netw Open. Published 1 May 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →