Objective To explore post-marketing adverse events(ADEs)of ofatumumab in treating multiple sclerosis(MS)and to investigate the risk factors of serious ADEs,and to provide reference for the safe use of the drug in the clinic.Methods The ADE reports of ofatumumab in the FAERS database were extracted for a total of 14 quarters from the third quarter of 2020 to the fourth quarter of 2023,and the ADE signals were mined by using the report-ratio-ratio(ROR)method,the proportional report-ratio(PRR)method,and the composite criterion(MHRA)method,grouped according to their severity,and analyzed for the risk factors of severe ADEs caused by ofatumumab.Results A total of 75 380 ADE reports with ofatumumab as the first suspected drug were obtained,and 133 positive signals were unearthed,involving 16 system-organ classification SOCs,mainly focusing on systemic diseases and various reactions at the site of administration[27 signals(20.15％),20 542 reports(27.25％)],and various types of neurological diseases[23 signals(17.16％),7 057 reports(9.36％)].Regression analysis of severe ADE reports showed that gender[OR(95％CI)2.496(1.777-3.504),P＜0.001],age[OR(95％CI)1.033(1.007-1.059),P＜0.001],weight[OR(95％CI)0.984(0.978-0.989),P＜0.001]were the influencing factors for the occurrence of severe ADE with ofatumumab.Conclusions MS patients have different factors affecting ADE outcomes,and are more likely to have severe ADEs as their age and lose weight.In addition,male patients are more likely to have severe ADEs than female patients.In the process of clinical use of ofatumumab,monitoring programs and medication regimens should be formulated according to the patient's age.The management of the patient's body weight and nutritional metabolism should be strengthened to ensure the safety of the patients'medication.
ofatumumabFAERS databaseadverse drug eventssignal miningmultiple sclerosis
万方数据
维普
