DMARD (tocilizumab/methotrexate vs. methotrexate)
Trial question
What is the effect of tocilizumab/methotrexate in patients with moderate-to-severe rheumatoid arthritis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
84.0% female
16.0% male
N = 204
204 patients (171 female, 33 male).
Inclusion criteria: adult patients, aged 18-70 years, with moderate-to-severe active rheumatoid arthritis with an inadequate response to conventional synthetic DMARDs.
Key exclusion criteria: inflammatory joint disease other than rheumatoid arthritis; unsuccessful anti-TNF treatment; active infection or malignant disease.
Interventions
N=136 tocilizumab/methotrexate (subcutaneous tocilizumab 162 mg every 2 weeks plus oral methotrexate 10-25 mg once weekly).
N=68 methotrexate (subcutaneous placebo every 2 weeks plus oral methotrexate 10-25 mg once weekly).
Primary outcome
American College of Rheumatology 20% improvement response at week 24
52.9%
25%
52.9 %
39.7 %
26.4 %
13.2 %
0.0 %
Tocilizumab/methotrexate
Methotrexate
Significant
increase ▲
NNT = 3
Significant increase in ACR 20% improvement response at week 24 (52.9% vs. 25%; AD 27.9%, 95% CI 14.7 to 41.2).
Secondary outcomes
Significant increase in ACR 50% improvement response at week 24 (23.5% vs. 7.4%; AD 16.1%, 95% CI 6.7 to 25.6).
Safety outcomes
No significant difference in at least one adverse event.
Conclusion
In adult patients, aged 18-70 years, with moderate-to-severe active rheumatoid arthritis with an inadequate response to conventional synthetic DMARDs, tocilizumab/methotrexate was superior to methotrexate with respect to ACR 20% improvement response at week 24.
Reference
Tian Liu, Li Wang, Xiao Zhang et al. Tocilizumab Monotherapy or Combined With Methotrexate for Rheumatoid Arthritis: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2511095.
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