Tocilizumab vs. Methotrexate Compared in Newly Diagnosed RA Patients
Immediate initiation with tocilizumab with or without methotrexate was more effective than methotrexate alone for patients with newly diagnosed rheumatoid arthritis, researchers concluded in a study published in The Lancet.
Early, rapid, and sustained remission is the goal for patients with newly diagnosed rheumatoid arthritis. Researchers from The Netherlands conducted a 2-year, multi-center, randomized, double-blind, double-dummy, strategy study to compare the safety and efficacy of regimens that started tocilizumab with or without methotrexate vs. methotrexate monotherapy following international guidelines.
A total of 317 adult patients who were diagnosed within 1 year prior to inclusion, were disease-modifying antirheumatic drug (DMARD)-naive, met current rheumatoid arthritis classification criteria, and had a disease activity score assessing 28 joints (DAS28) of ≥2.6 were included. They were randomized to start tocilizumab plus methotrexate (n=106), or tocilizumab plus placebo (n=103), or methotrexate + placebo (n=108).
Patients who did not achieve remission on their initial regimen were switched from placebo active treatments; those in the tocilizumab plus methotrexate arm switched to standard of care therapy (methotrexate + tumor necrosis factor [TNF] inhibitor).
The primary endpoint was the proportion of patients achieving sustained remission, defined as DAS28 <2.6 with a swollen joint count ≤4, persisting for at least 24 weeks, on the initial regimen and during the entire study duration.
The study showed 91 of 106 patients (86%) in the tocilizumab plus methotrexate arm achieved sustained remission on the initial regimen vs. 86 of 103 (84%) in the tocilizumab arm vs. 48 of 108 (44%) in the methotrexate arm (relative risk [RR] 2.00, 95% CI 1.59–2.51 for tocilizumab plus methotrexate vs. methotrexate, and RR 1.86, 95% CI: 1.48–2.32 for tocilizumab vs. methotrexate, P<0.0001 for both).
For the entire study duration, 86% of patients in the tocilizumab plus methotrexate arm, 88% in the tocilizumab arm, 77% of patients in the methotrexate arm achieved sustained remission (RR 1.13, 95% CI: 1.00–1.29; P=0.06 for tocilizumab plus methotrexate vs. methotrexate, and RR 1.14, 95% CI: 1.01–1.29; P=0.0356 for tocilizumab vs. methotrexate; andP=0.59 for tocilizumab plus methotrexate vs. tocilizumab).
The incidence of serious adverse events did not differ between the treatment groups; no deaths occurred during the study.
For more information visit thelancet.com.