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). 

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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). 


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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.