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.
Read more about interleukin-6 inhibitors.
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.
Reference
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.
Etanercept Biosimilar Switch Shows Stable Outcomes and Disease Control in RA
May 13th 2025Patients with rheumatoid arthritis (RA) who switched from Enbrel (reference etanercept) to a biosimilar maintained remission, even after their dose was reduced, with no signs of worsening based on clinical scores, ultrasound scans, or lab tests, according to a new study.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.