NEW YORK (Reuters Health)—In rheumatoid arthritis (RA) patients with an inadequate response to methotrexate, adding tocilizumab to the regimen is more effective than simply switching to tocilizumab, according to Japanese researchers.
Dr. Tsutomu Takeuchi told Reuters Health by email that the approach “more rapidly suppressed inflammation than tocilizumab switched from methotrexate, leading to superior clinical efficacy and prevention of joint destruction at week 52.”
In a paper published online on Jan. 5 in Annals of the Rheumatic Diseases, Dr. Takeuchi of Keio University School of Medicine, Tokyo, and colleagues note that methotrexate “is an anchor drug in the management of RA because of its long-term effectiveness and safety profile.”
Should the response be insufficient, they add, another drug should be introduced. Although most studies suggest combination therapy rather than a switch, it’s not clear if this should be the case for tocilizumab (Actemra and RoActemra, Hoffmann-La Roche and Chugai), a humanized antihuman IL-6 receptor monoclonal antibody.
To investigate, the researchers randomized 223 patients with moderate to high-disease activity to add-on tocilizumab or a switch to tocilizumab.
At 24 weeks, DAS28 remission rates were significantly greater in the add-on group than in switchers (70% vs. 55%, p=0.02) among the 193 patients who completed the study. However, by week 52 rates were comparable (72% vs. 70%, p=0.86).
There was a tendency towards higher rates of clinically relevant radiographic progression (CRRP) in switchers (15% vs. 7%, p=0.07). In the CRRP group, radiographic progression was significantly higher in switchers as measured by the van der Heijde-modified total Sharp scoring system than in the add-on group (9.0/year vs. 5.0/year, p=0.04).
In addition, inflammation in switching CRRP patients as measured by C-reactive protein was significantly reduced in the first 24 weeks but not in the following 28 weeks.
The number of patients with at least one adverse event was significantly greater in the add-on group (60% vs. 45%, p=0.02) but was comparable for serious adverse events (13.9% vs. 8.1%, p=0.2).
The study was funded by a specified nonprofit corporation advanced clinical research organization. Dr. Takeuchi and other authors have received lecture fees and research grants from companies including Chugai Pharmaceutical.