Azilsartan as “add-on” treatment with methotrexate improves the disease activity of rheumatoid arthritis

Objective: The present study aimed to evaluate the efficacy and safety of azilsartan (Azil) as an “add-on” treatment with methotrexate (MTX) in patients with active rheumatoid arthritis (RA). Methods: This single-center, randomized, placebo-controlled, double-blind, pilot study included 64 patients with active RA. Patients received either a placebo or Azil in addition to their currently used MTX doses for 90 days. The primary outcomes were DAS-28, SDAI, HAQ-DI, CDAI, EGA, and a swollen and tender joint count. The secondary outcomes were the changes in the pain visual analogue scale (VAS-100), serum levels of TNF-α, IL-1β, IL-6, and anti-CCP, the lipid profile, and the markers of kidney and liver functions in the two groups at baseline and after 90 days. Results: After 90 days, most clinical scores were significantly better in the Azil-treated group than in the placebo group. All inflammatory biomarkers were significantly improved after treatment with MTX + Azil compared to the baseline and placebo groups. No safety concerns were reported during the study period. Conclusions: Azilsartan improved the effects of methotrexate on the clinical scores and certain inflammatory biomarkers of patients with active RA.

Trial registration: The protocol was registered under the number 507/SA/1024 at the local clinical studies database, College of Medicine, Sulaimani University.