Abstract

SAFETY OF BIOLOGICS FOR THE TREATMENT OF AUTOIMMUNE DISEASES: A CROSS-SECTIONAL STUDY FROM SAUDI ARABIA

Lamya Al Naim*, Noura AlShalaan, Nada Al Fudhaili, Haya Al Obaid and Rana Al Bader

Abstract

Purpose: This cross-sectional study explored the safety of biological therapies, association between patient characteristics, adverse events (AEs) and biological therapy among treated patients and assess patientperceived treatment effectiveness of the biologics in autoimmune diseases (AD) patients in Riyadh, Saudi Arabia. Methods: AD patients (ulcerative colitis [UC] and Crohn’s disease [CD], rheumatoid arthritis [RA], and psoriasis [PsO]) who received adalimumab, infliximab, rituximab, or etanercept were analyzed. Results: Of the 115 biologically-treated AD patients (CD=80; RA=18; UC=16; PsO=1), 88.7% received infliximab. Over 95% of the patients experienced at least one AE, with higher prevalence in infliximab cohort than other cohorts. Most common AEs were weight gain (20%–57.1%), hair loss (20%–42.8%), and stomach pain (14.3%– 22.6%). Infections occurred in 16.5% of patients; acute nose, throat, and sinus infections and urinary tract infections were the most common infections. There was a lack of association between the variables, biological therapy, and AEs among the treated AD patients. Majority of the treated-patients (89%) reported improvement after treatment with biological therapy; 92% expressed their willingness to continue with the prescribed biological therapy. Conclusions: This study provides valuable data on the safety and patient perceived treatment effectiveness of biologics used for the treatment of various AD.

Keywords: adverse events ? autoimmune disease ? biologics ? infections ? treatment effectiveness.