Efficacy, Safety, and Tolerability of Tofacitinib in Patients with Rheumatoid Arthritis: A Multicentric Pakistani Study

Abstract

Background: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by progressive joint inflammation and disability. Despite the availability of conventional and biologic DMARDs, cost, parenteral administration, and variable tolerability limit long-term disease control in low- and middle-income settings. Tofacitinib, an oral Janus kinase inhibitor, offers an alternative targeted synthetic therapy with demonstrated global efficacy. However, data from South Asian populations remain limited. Objective: To determine the efficacy, safety, and tolerability of tofacitinib in Pakistani patients with rheumatoid arthritis. Methods: A multicentric retrospective descriptive study was conducted at three rheumatology centers in Lahore, Pakistan, between January 2022 and July 2023. Electronic medical records of adults with RA (ACR/EULAR 2010 criteria) receiving oral tofacitinib 10 mg daily for ≥6 months were reviewed. Disease activity was assessed using DAS28-ESR at baseline, 3 months, and 6 months. Data were analyzed using SPSS 23, applying Chi-square and paired t-tests with significance set at p < 0.05. Results: Eighty-five patients met inclusion criteria (82.4% female; mean age 42.6 ± 12.1 years). Mean DAS28-ESR decreased from 5.04 ± 0.43 at baseline to 2.85 ± 0.85 after 6 months (p < 0.001). Remission was achieved in 55.3% of patients, with higher rates in biologic-naïve (56.9%) than biologic-experienced groups (50.0%). Combination therapy with methotrexate yielded the best outcomes, though tofacitinib monotherapy remained comparably effective. Adverse events occurred in 9.4% of patients, all mild and reversible; no serious infections, thrombotic events, malignancies, or tuberculosis reactivations were reported. Conclusion: Tofacitinib demonstrated significant efficacy and excellent tolerability in achieving remission among Pakistani patients with RA, supporting its role as a cost-effective and convenient oral alternative to biologics in routine clinical practice.