Real-world evidence of biological treatments in rheumatoid arthritis and spondyloarthritis in Morocco: results of the RBSMR registry

Abstract

BACKGROUND: Regional variability in the effectiveness and safety of biologic therapies for rheumatoid arthritis (RA) and spondyloarthritis (SpA) underscores the need for comprehensive assessment. The aim of this study was to provide real-world evidence of the effectiveness and the safety of biologic for RA, SpA including psoriatic arthritis, in the daily clinical practice. MATERIALS AND METHODS: RBSMR registry was a multicenter, cohort study conducted in 10 university departments of rheumatology. The study included RA and SpA patients receiving biotherapy, either as an initiation or ongoing treatment, and investigated for 3 years. The statistical analysis was performed using JAMOVI software (T student test, Mann-Whitney U test, Chi-squared test, Fisher's exact test, Paired T test and Wilcoxon test). RESULTS: 223 RA and 194 SpA were eligible. After 3 years of follow-up, DAS28 CRP (3.6 ± 1.4 versus 5.8 ± 1.0 at baseline) and ASDAS CRP (1.8[1-2.4] versus 3.5[2.5-4.4] at baseline) significantly improved; 13.8% of RA patients achieved remission based on DAS28 CRP and 20.1% of SpA patients achieved remission based on ASDAS CRP. Overall, 163 and 126 adverse events were reported in RA and SpA patients respectively. Infections were the most frequently reported events with an incidence of 11.8 and 13.4/100 patients-year in RA and SpA respectively. Total incidence rate of tuberculosis was 0.80 patient/100 patients-year. CONCLUSIONS: The RBSMR registry provides real-world insights into the effectiveness of biologics in the practice of rheumatology for RA and SpA patients in Morocco. It underscores the critical need for continued vigilance in monitoring and addressing adverse events, with a particular focus on tuberculosis infection.