Efficacy and Safety of Rituximab in Patients with Active Rheumatoid Arthritis: Results of a Lebanese National Multicenter Observational Study.

INTRODUCTION: This study aims to evaluate changes in disease activity and safety of the combination of rituximab and methotrexate in patients with active rheumatoid arthritis (RA) in routine clinical practice in a developing country. METHODS: This is a national, multicenter, descriptive, longitudinal cohort study of adults with active RA who are eligible to receive rituximab following an inadequate response to a single cycle of anti-tumor necrosis factor (anti-TNF) therapy. The study included baseline and follow-up visits whereby demographics, medical history, and clinical data were collected. RESULTS: 77 patients were included in the study (women: 79.2%; mean age: 51.84 ± 13.19 years). The most common extra-articular manifestations were the presence of rheumatoid nodules (n=13; 16.9%). The mean baseline disease activity score (DAS28) was 5.48 ± 1.23. Descriptive DAS28 mean scores decreased to 3.31 ± 1.16 at the end of the follow-up period compared to the baseline. The majority of the adverse events were non-serious, with few being related to medication. DISCUSSION: The study showed a descriptive improvement in disease activity scores among RA patients treated with rituximab in combination with methotrexate. The results were consistent with findings from multi-country studies, and the combination was well tolerated. CONCLUSION: Rituximab in combination with methotrexate demonstrated a clear reduction in DAS28 scores and was well tolerated in patients with RA who had failed a single course of anti-TNF therapy in routine clinical practice in Lebanon, a developing country. However, due to complete-case analysis and the lack of a control arm, these longitudinal trends should be interpreted with caution regarding absolute clinical efficacy.