Efficacy and safety of abatacept in rheumatoid arthritis patients in Western region in Saudi Arabia: a multi-center study.

Abstract

Introduction: Rheumatoid arthritis (RA) in adult patients, there is contradictory evidence regarding Abatacept's safety profile (ABA). This study aims to assess the safety and efficacy of ABA in adult patients in Saudi Arabia.

Methods: This retrospective cohort study analyzed adult patients aged 18 and above with RA who received ABA at King Fahad Armed Forces Hospital, and King Fahad General Hospital, and Al-Noor Specialist Hospital in Saudi Arabia. Data was collected from electronic medical records, and analyzed using the statistical analyses (IBM's SPSS Software, version 29.0).

Results: The study included 236 RA patients (88.6% female), with a mean age of 55.7 years. Comorbidities were present in 64.6%, and the average disease duration was 127.1 months. Joint erosion was the most common feature (49.6%), while 25% had extra-articular manifestations. Abnormal labs included elevated liver enzymes and leukocytosis. After 6 months of ABA, DAS-28 scores significantly decreased to a mean of 3.07 (SD = 1.31; p < 0.001). The mean treatment duration was 28.0 months, with a 31.8% discontinuation rate-mainly due to secondary failure (41.1%), primary failure (17.9%), and non-compliance (10.7%). Discontinuation was more frequent in females (p = 0.049). ADRs (Adverse drug reactions) included cytopenia in 8.6% (n = 18), mainly anemia. liver enzyme elevations, GI upset, HBV reactivation, and one malignancy, but none were statistically significant (all p > 0.05). tuberculosis (TB) reactivation occurred in 2 patients (0.8%), neither discontinued the drug (p = 0.565). Notably, 45.3% were biologic-naïve and showed better outcomes: greater DAS-28 reduction (2.1 vs. 1.5; p = 0.015) and lower discontinuation rates (24.3% vs. 38.8%; p = 0.028) than biologic-switch patients.

Conclusion: The study confirms the safety and efficacy of ABA in treating RA in Saudi Arabian adults. It found significant improvements in disease activity, but with high discontinuation rates though aligning with previous studies. We recommend measures targeting identified possible causes and extensive research to explore the safety and efficacy of ABA.

Clinical trial number: Not applicable.