Azilsartan as “Add-On” Treatment with Methotrexate Improves the Disease Activity of Rheumatoid Arthritis

• Published in: BioMed research international 2018-01, Vol.2018 (2018), p.1-9
• Main Authors: Mahmood, Naza Mohammed Ali, Khan, Hawar Ali Ehsan Kaka, Hussain, Saad Abdulrahman
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Arthritis; Arthritis, Rheumatoid - blood; Arthritis, Rheumatoid - drug therapy; Benzimidazoles - administration & dosage; Biomarkers; Biomedical research; Care and treatment; Clinical Study; Clinical trials; Cytokines - blood; Double-Blind Method; Drug dosages; Drug Therapy, Combination - methods; Female; Health risk assessment; Humans; Inflammation; Interleukin 6; Joint diseases; Lipids - blood; Liver; Low income groups; Male; Medical colleges; Medical research; Medical treatment; Medicine, Experimental; Methotrexate; Methotrexate - administration & dosage; Middle Aged; Neurosciences; Nonsteroidal anti-inflammatory drugs; Oxadiazoles - administration & dosage; Pain; Patients; Peptides; Pharmacology; Pilot Projects; Rheumatoid arthritis; Rheumatoid factor; Rheumatology; Safety; Serum levels; Studies; Telmisartan; Tumor necrosis factor; Tumor necrosis factor-α
• ISSN: 2314-6133; 2314-6141
• DOI: 10.1155/2018/7164291

Objective. The present study aimed to evaluate the efficacy and safety of azilsartan (Azil) as “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 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 swollen and tender joints 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 baseline and placebo group. 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.