EVALUATING DAS 28 SCORE IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH TOFACITINIB ALONE VERSUS METHOTREXATE AND TOFACITINIB COMBINATION THERAPY

Abstract

Background: Rheumatoid arthritis (RA) is a chronic autoimmune disorder that leads to joint inflammation and damage. Effective management aims to reduce disease activity and prevent long-term complications. Tofacitinib, a Janus kinase (JAK) inhibitor, has shown promise in RA treatment. This study evaluates the effectiveness of Tofacitinib alone versus Methotrexate plus Tofacitinib combination therapy in reducing disease activity as measured by the Disease Activity Score in 28 joints (DAS 28).

Objective: The primary objective of this study was to determine whether Tofacitinib alone or in combination with Methotrexate more effectively reduces DAS 28 scores in RA patients over a one-year period.

Methods: This prospective cohort study was conducted at Lady Reading Hospital, Peshawar, from April 2023 to March 2024. A total of 303 adult RA patients, diagnosed according to the 2010 ACR/EULAR classification criteria and with baseline DAS 28 scores greater than 3.2, were included. Participants were divided into two groups: Tofacitinib alone (5 mg twice daily) and Methotrexate plus Tofacitinib (Methotrexate 15-20 mg weekly plus Tofacitinib 5 mg twice daily). DAS 28 scores were assessed at baseline, 3, 6, and 12 months. Data were analyzed using paired t-tests, ANCOVA, chi-square tests, and Kaplan-Meier survival analysis. Missing data were handled using multiple imputation methods.

Results: The mean age of participants was 55.3 years (SD = 11.8), with 68.3% females. Both groups showed significant reductions in DAS 28 scores from baseline to the end of the study. The Tofacitinib alone group had a mean reduction from 5.8 ± 1.2 to 3.6 ± 1.1 (p < 0.001), while the combination therapy group had a mean reduction from 5.9 ± 1.3 to 3.2 ± 1.0 (p < 0.001). The combination therapy was significantly more effective (p = 0.02). Adverse events were more frequent in the combination therapy group (24.3%) compared to the Tofacitinib alone group (20.5%).

Conclusion: Combination therapy with Tofacitinib and Methotrexate is more effective in reducing DAS 28 scores in RA patients compared to Tofacitinib alone, despite a higher incidence of adverse events. These findings suggest that combination therapy could be a more effective strategy for achieving better disease control in RA patients.