Immediate initiation of treatment with tocilizumab (TCZ) with or without methotrexate (MTX) was more effective than MTX alone for patients with newly diagnosed rheumatoid arthritis (RA), according to a study published in The Lancet

Early, rapid, and sustained remission is the goal for patients with newly diagnosed RA. Researchers conducted a 2-year, multi-center, randomized, double-blind, strategy study to compare the safety and efficacy of regimens that started tocilizumab with or without MTX vs MTX 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 RA classification criteria, and had a disease activity score assessing 28 joints (DAS28) of ≥2.6 were included. They were randomized to start tocilizumab + MTX (n=106), or tocilizumab + placebo (n=103), or MTX + placebo (n=108).

Continue Reading

Patients who did not achieve remission on their initial regimen were switched from placebo active treatments; those in the tocilizumab + MTX arm switched to standard of care therapy (MTX + tumor necrosis factor [TNF] inhibitor). 

High Yield Data Summary

  • Sustained early remission was more likely with immediate initiation of tocilizumab (with or without methotrexate) than with methotrexate alone

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 + MTX arm achieved sustained remission on the initial regimen vs 86 of 103 (84%) in the tocilizumab arm vs 48 of 108 (44%) in the MTX arm (relative risk [RR] 2.00, 95% CI 1.59–2.51 for tocilizumab + MTX vs MTX, and RR 1.86, 95% CI: 1.48–2.32 for tocilizumab vs MTX, P<.0001 for both).  

For the entire study duration, 86% of patients in the tocilizumab + MTX arm, 88% in the tocilizumab arm, 77% of patients in the MTX arm achieved sustained remission (RR 1.13, 95% CI: 1.00–1.29; P=.06 for tocilizumab + MTX vs MTX, and RR 1.14, 95% CI: 1.01–1.29; P=.0356 for tocilizumab vs MTX; and P=0.59 for tocilizumab + MTX vs tocilizumab). 

The incidence of serious adverse events did not differ between the treatment groups; no deaths occurred during the study. 

Summary and Clinical Applicability

Sustained remission of newly diagnosed RA was more likely with immediate initiation of tocilizumab with or without MTX than with MTX alone. A similar safety profile was found among all treatment regimens.

Limitations and Disclosures

This study was funded by Roche Nederland BV.


Bijlsma JW, Welsing PM, Woodworth TG, et al. Early rheumatoid arthritis treated with tocilizumab, methotrexate, or their combination (U-Act-Early): a multicentre, randomised, double-blind, double-dummy, strategy trial. Lancet. 2016; Published online ahead of print June 7, 2016. doi: 10.1016/S0140-6736(16)30363-4

This article originally appeared on MPR