A new study finds promise in the combination of toclizumab and methotrexate as a treatment for early rheumatoid arthritis.
It is recognized that patients who are diagnosed with rheumatoid arthritis have the ability to attain long-term benefits and adequate quality of life with early, appropriate and effective treatment. A new study finds promise in the combination of toclizumab and methotrexate as a treatment for early rheumatoid arthritis. Toclizumab is a human monoclononal antibody that binds to the IL-6 receptor, which plays a role in the development of symptoms associated with rheumatoid arthritis, such as inflammation, pannus formation and joint damage. Writing in the October 28 issue of the Annals of the Rheumatic Diseases, researchers wrote: “These results add to the body of evidence showing the efficacy of TCZ as therapy for patients with RA across several populations, including patients who respond inadequately to MARDs12–14 16 or to anti-TNF agents10 and patients who receive TCZ monotherapy because MTX is contraindicated or cannot be tolerated.” While toclizumab has been used successfully in patients with rheumatoid arthritis, it has never been tested in patients with the early stage of the disease until the FUNCTION study, a double-blind, parallel group, multi-center, two-year phase III trial. The study consisted of four treatment groups (1,162 methotrexate-naÃ¯ve patients) with early progressive rheumatoid arthritis that were assigned to 4mg/kg tocilzumab + methotrexate, 8mg/kg tocilzumab + methotrexate , 8mg/kg tocilzumab + methotrexate + placebo and placebo + methotrexate. The patients were randomly assigned, and 920 (79%) completed 52 weeks of treatment; 96.1% of patients assigned to 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX or placebo+MTX achieved MTX doses of 15 mg/week or higher. The primary endpoint was met: 45% of 8 mg/kg TCZ +MTX patients achieved DAS28 remission at 24 weeks compared with 15% of placebo+MTX patients. The 8mg/kg tocilzumab plus methotrexate group achieved greater improvement in the radiologic disease progression of rheumatoid arthritis and physical function at week 52. Both the 4mg/kg tocilzumab plus methotrexate and the 8mg/kg tocilzumab plus methotrexate demonstrated clinical efficacy that was as effective as methotrexate on the secondary endpoints of American College of Rheumatology response criteria, radiologic efficacy and quality of life using the Short Form-36. “TCZ appears to demonstrate benefits in patients with early RA (in regard to DAS28 remission, ACR responses and radiographic endpoints), compared with patients treated with MTX alone, that are generally consistent with those observed in previous studies of biological therapies in similar populations,” wrote the authors, who were led by Gerd R. Burmester, MD, of the Free University and Humboldt University of Berlin.
Burmester GR, Rigby WF, et al.
"Tocilizumab in early progressive rheumatoid arthritis: FUNCTION, a randomised controlled trial,"
Annals of the Rheumatic Diseases.
ARD Online First, published on October 28, 2015 as 10.1136/annrheumdis-2015-207628.