Clinical Edge

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Tocilizumab and Methotrexate Yield Similar Long-Term Success for Early RA

Key clinical point: Disease activity scores were not significantly different in the long term (5 years) between early rheumatoid arthritis (RA) patients given tocilizumab with and without methotrexate.

Major finding: During the active study period (years 1 and 2), the average disease activity score in 28 joints (DAS28) was lower for patients given tocilizumab, compared with methotrexate, but these differences did not persist through the follow-up period.

Study details: The data come from a randomized trial of 226 adults with early RA who completed a 3-year post-trial follow-up.

Disclosures: The study was supported by Roche Nederland BV and several coauthors are employees or disclosed support from Roche. Lead author Dr. Verhoeven had no financial conflicts to disclose.


Verhoeven MMA. Rheumatology. 2019 Dec 20. doi: 10.1093/rheumatology/kez602


This study, funded by Roche NL, looked at long-term follow-up of an earlier trial, U-Act-Early, which showed a benefit for tocilizumab and tocilizumab + methotrexate over methotrexate in RA patients who were naive to DMARDs. That study used a treat-to-target strategy with an endpoint of sustained remission at 2 years. The current study is a 3 year follow-up with the primary endpoint being DAS28 score. Interestingly, the early benefit of tocilizumab was not persistent, and the three groups were similar over the course of the study in terms of DAS28 scores and few patients had radiographic progression. The reason for the loss of sustained difference is unclear; the authors suggest it is related to a lack of clarity in de-escalation strategy for tocilizumab. The study may not be generalizable to all RA populations as physicians predominantly used tocilizumab as the biologic DMARD (bDMARD) for all groups; only 8-10% of each group ended up on a different bDMARD such as an anti-TNF agent. The current study does not support early use of tocilizumab in DMARD-naive RA patients in order to reach sustained remission long-term, despite the promising results of the previous trial.—Arundathi Jayatilleke, MD