Clinical efficacy and safety evaluation of adalimumab versus methotrexate in patients with early rheumatoid arthritis: Assessment of pathological parameters, joint damage and pain

Abstract

Background: Rheumatoid arthritis (RA) a chronic inflammatory condition that required long-term therapy, Current disease modifying drugs including methotrexate are have significant side effects on long-term use. Adalimumab is the first fully human, high-affinity, recombinant immunoglobulin G1 anti-TNF monoclonal antibody and recent studies are showing its clinical benefits in the treatment of RA.Objective: To evaluate and compare the efficacy and safety profile of adalimumab versus methotrexate in the early-stage active RA patients. Methods: Patients visiting to the outpatient department for their RA were considered to include in the study and written consent were obtained from them. Eligible patients were randomly divided into two groups to received adalimumab or methotrexate. Different parameters for efficacy were evaluated such as American College of Rheumatology 20% criteria (ACR20), radiographs, biochemical parameters, pains and swelling or tenderness in joints. All patients were closely monitored for any kind of adverse events.Results: At 12 months period, more patients from the adalimumab treatment group met American College of Rheumatology 20% improvement criteria (79% and 67%, respectively). Similar difference was noticed for ACR 50 and ACR70 and also at 6-month time period. Adalimumab produced significant effects on ESR, CRP lever, joint counts (swollen and tender), pain and disease activity at 12 months, superior to methotrexate. Radiographic analysis showed that adalimumab reduced progression of joint damage as reflected in the changes in total sharp score, erosion score and joint space narrowing versus baseline. Adalimumab was not associated with any significant adverse event except injection site reaction.Conclusion: Adalimumab as monotherapy was safe and was superior to methotrexate in reducing disease activity, preventing structural damage, and improving clinicopathological parameters over the period of 1 year in patients with early, aggressive RA.