Abstract
Introduction: The prevalence of multiple sclerosis (MS) has icantly worldwide and in Saudi Arabia over time, with estimated prevalence of (40.40/100,000 Saudi-nationals). Although there is still no cure available of MS, monoclonal antibodies diseases modifying agents (MABs) are one of the preferred treatments for MS due to their efficacy, however, their side effects remain a concern. Therefore, a post-marketing surveillance program was implemented to monitor the safety of MABs in real-world setting by the Saudi Food and Drug Authority (SFDA). The objective of this study is to evaluate the safety profile of MABs (ocrelizumab, natalizumab, rituximab, and alemtuzumab) in MS patients. Methods: A retrospective cohort study using real-world data from a tertiary hospital in Riyadh, Saudi Arabia was performed to detect safety profile of MAB in patients with MS. The Study included newly-treated patients with one of the MABs during the period from January 2015 to December 2021. The objectives were to identify adverse drug events (ADEs) associated with the use of MABs. The medical dictionary for drug regulatory affairs (MedDRA) was used to classify ADEs according to the System Organ Classification (SOC) and the Preferred Term (PT). Moreover, ADEs were classified based on the seriousness, and expectedness, according to SFDA guidelines on Good pharmacovigilance Practices. Descriptive analyses were performed, including frequency/percentages for categorical variables and mean with standard deviation or median with range for continuous variables. All ADEs were crosschecked listing with local summary product characteristics (SPC), United States Food and Drug Administration (FDA) drug label, and European SPC to identify new safety signals using the scheme illustrated in Figure 1. Results: Two hundred-fourteen patient's records met the eligibility criteria. There were 144 patients on ocrelizumab, 46 on natalizumab, 19 on rituximab, and 4 on alemtuzumab. Their socio-demographic characteristics are summarized in Table 1. A total of 133 ADEs were reported with the use of MABs including 55 serious ADEs. Based on the local and international product information assessment, there were 42 unexpected ADE (potential signals), 79 known and labeled ADEs, and 13 ADEs not labeled in the local product information label but included in the product information label approved by the FDA or European Medicines Agency, no fatal ADEs have been reported. Fig 1 Conclusion: This study shows an acceptable safety profile of MABs in MS patients. Besides, it reports data that identified new safety signals not previously addressed in the local and international product information label, which need further investigation. Thus, there are strong motives for implementing similar programs to provide data for updated risk-benefit analyses.