Efficacy and Safety of Tocilizumab in Rheumatoid Arthritis Patients in the Middle East: Real-world Data

INTRODUCTION: Data on Tocilizumab (TCZ) efficacy and safety among RA patients in the Middle East in clinical practice remains limited. We aimed to evaluate the safety and efficacy of TCZ, as monotherapy or in combination with disease-modifying antirheumatic drug (DMARDs), in patients with moderate to severe active RA. METHODS: A regional, multicenter, descriptive, and prospective study conducted among 62 adults with moderate to severe active RA (DAS-28 ≥3.2) initiating treatment with TCZ after inadequate response to ≥1 conventional DMARD. TCZ treatment was for 24 weeks with a follow-up period of 6 months after the last injection. RESULTS: Clinical improvement, as measured by the DAS-28 score, was observed in 83.0% at Week 12 compared to 96.3% at Week 48. Low disease activity was achieved in 61.9% of patients at Week 12 and 81.50% at Week 48. Remission was reported in 42.9% at Week 12 compared to 55.6% at Week 48. During the 24-week treatment, 24/62 (38.7%) patients experienced 47 adverse events (AEs), infections being the most common, with 11 serious AEs. DISCUSSION: Our results were similar to those reported from developed countries. The significant drop in mean DAS-28 score in RA patients treated with TCZ comes in line with data from the U-Act-Early and CAMERA-II trials. No specific safety concern was reported with an AE rate of 42%, similar to another open-label phase-4 study done in the Middle East. CONCLUSION: Short-course treatment with TCZ was effective and safe for patients with moderate to severe active RA with inadequate response to DMARDs.