Combination treatment is typically more effective than treatment with methotrexate alone, but some patients may experience adverse events with methotrexate that make monotherapy desirable.
A new study published in Arthritis & Rheumatology found that patients with rheumatoid arthritis (RA) treated with tocilizumab (Actemra, developed by Roche) plus methotrexate who have achieved low disease activity can discontinue methotrexate without significant worsening of disease activity.1 Combination treatment is typically more effective than treatment with methotrexate alone, but some patients may experience adverse events with methotrexate that make monotherapy desirable.
Tocilizumab is an interleukin-6 inhibitor indicated to treat patients with moderate to severe RA who have had an inadequate response to 1 or more disease-modifying anti-rheumatic drugs. Additionally, tocilizumab is also indicated to treat giant cell arteritis in adult patients, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
This study, COMP-ACT, a randomized, multicenter, double-blind, parallel group trial, compared tocilizumab plus methotrexate with tocilizumab monotherapy in adult patients with RA who had previous inadequate responses to methotrexate. At baseline, all patients began treatment with subcutaneous tocilizumab, either weekly or every 2 weeks, and continued to receive a pre-baseline dose of oral methotrexate.
At 24 weeks, patients who reached disease activity score in a count of 28 joints with erythrocyte sedimentation rate (DAS28-ESR) of 3.2 or lower were then randomized to either discontinue methotrexate and continue tocilizumab as a monotherapy or stay on tocilizumab plus methotrexate until week 52.
Researchers found that patients who received tocilizumab plus methotrexate who had achieved low disease activity were able to discontinue methotrexate without significant worsening of disease activity in the following 16 weeks.
For patients who prefer monotherapy, these results will likely be welcome news. They may also be welcome news for Roche, for whom Actemra has been fairly lucrative, earning the company around $1.9 million last year.
Because the biologic is still covered by patents, there has been relatively little development of tocilizumab biosimilars. However last month, Bio-Thera, a Chinese-based biotechnology company, announced that it has initiated a phase 1 clinical trial for its proposed tocilizumab biosimilar, BAT1806.
Kremer J, Rigby W, Singer N, et al. Sustained response following discontinuation of methotrexate in patients with rheumatoid arthritis treated with subcutaneous tocilizumab [published online March 25, 2018]. doi.org/10.1002/art.40493.