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

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.

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.

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.

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.

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.