A Prospective Evaluation of Tocilizumab in Patients With Rheumatoid Arthritis Refractory to Conventional...

Rheumatoid arthritis (RA) refractory to conventional synthetic disease-modifying anti-rheumatic medications (DMARDs) remains a therapeutic challenge, necessitating the use of biologic agents such as tocilizumab.

To prospectively evaluate the efficacy of tocilizumab in reducing disease activity, measured by DAS28 (ESR), and to assess its safety in terms of adverse events over a six-month follow-up in a real-world South Asian cohort.

This prospective observational study was conducted at the Department of Rheumatology, Abbas Institute of Medical Sciences, Muzaffarabad, over a two-year period (June 2022-May 2024). A total of 192 patients meeting the 2010 ACR/EULAR RA criteria, with inadequate response to at least two csDMARDs, including methotrexate and a baseline DAS28 (ESR) ≥5.1, were enrolled. Tocilizumab (4-8 mg/kg) was administered intravenously every four weeks for six months. DAS28 scores were recorded at baseline, 12 weeks, and 24 weeks. Safety was assessed through serial laboratory monitoring and systematic documentation of adverse events.

Of the 192 patients (77.08% female; mean age 44 ± 10.6 years), the mean DAS28 score decreased from 5.91 ± 0.42 at baseline to 3.76 ± 0.59 at 12 weeks and 2.43 ± 0.71 at 24 weeks (p < 0.001). Remission (DAS28 ≤ 2.6) was achieved in 112 patients (58.33%), while 58 (30.21%) showed partial response and 22 (11.46%) had no response. Adverse events were reported in 52 patients (27.08%), most commonly infections, lipid abnormalities, and gastritis.

Tocilizumab is a highly effective and generally well-tolerated treatment option for RA patients unresponsive to csDMARDs, though longer follow-up and controlled comparisons are needed to confirm long-term safety and causality.