Objectives: To assess the effectiveness and safety of rituximab (RTX) and the predictors of its response at 24 weeks in patients with rheumatoid arthritis (RA).
Methodology: The study included 61 Pakistani patients, who had active RA despite treatment with conventional disease modifying anti rheumatic drugs (cDMARDs). They were given RTX and followed for 24 weeks. Change in the 28-joint Disease Activity Score (DAS28) and the proportions of patients achieving disease remission according to the European League Against Rheumatism (EULAR) response criteria were used to assess the effectiveness at week 24 (primary analysis) and week 48 (exploratory analysis). Adverse events were also recorded.
Results: The mean DAS28 score significantly decreased from 6.27 to 3.67 at week 24 and was maintained at 4.07 at week 48. 91.5% patients had a moderate or good EULAR response at week 24, which persisted in 90.3% of the patients at week 48. Effectiveness was unaffected regardless of rheumatoid arthritis factor, status, gender, age, disease duration and concurrent use of methotrexate or leflunomide. Majority of adverse events were seen during first infusion and were mild, other than 2 anaphylactic reactions and a myocardial infarction. At the 24 week follow-up, one patient had herpes zoster and one had upper respiratory infection, while three had worsening of existing hypertension.
Conclusions: RTX is a safe and effective drug in Pakistani patients with active RA, providing a sustained improvement in disease symptoms in majority of the patients.
Key words: Rituximab, rheumatoid arthritis, DMARD, methotrexate
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