DMARD (tocilizumab vs. methotrexate)
Trial question
What is the effect of tocilizumab monotherapy in patients with moderate-to-severe rheumatoid arthritis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
86.0% female
14.0% male
N = 204
204 patients (176 female, 28 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 (subcutaneous tocilizumab 162 mg every 2 weeks plus oral placebo 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
50%
25%
50.0 %
37.5 %
25.0 %
12.5 %
0.0 %
Tocilizumab
Methotrexate
Significant
increase ▲
NNT = 4
Significant increase in ACR 20% improvement response at week 24 (50% vs. 25%; AD 25%, 95% CI 11.7 to 38.3).
Secondary outcomes
Significant increase in ACR 50% improvement response at week 24 (21.3% vs. 7.3%; AD 14%, 95% CI 4.7 to 23.2).
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 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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