Almalag Haya M, Alaujan Shiekha S, Alhazzani Hawazin S, Alzamel Lamia A, Tashkandi Reem S, Alarfaj Hussain F, Alarfaj Abdurhman S, Omair Mohammed A
Clinical Pharmacy Department, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Rheumatology Unit, Department of Medicine, King Saud University, Riyadh, Saudi Arabia.
Saudi Pharm J. 2022 Jul;30(7):1044-1051. doi: 10.1016/j.jsps.2022.04.008. Epub 2022 Apr 19.
Few Saudi studies have examined adverse drug reactions (ADRs) in patients with rheumatoid arthritis (RA) receiving intravenous (IV) originator biologics. Therefore, this study aimed to evaluate the prevalence, types, and predictors of ADRs following long-term IV originator biologic use in patients with RA.
This retrospective, single-center study included adult patients with RA who received IV originator biologics between 2015 and 2020. Medical records were reviewed and data regarding ADRs were collected and evaluated for causality using the Naranjo scale. Binary logistic regression analysis was performed to identify the odds for and factors associated with developing ADRs for each biologic.
A total of 129 patients (87.6% women) with a mean (standard deviation) age of 54 (13) years were included in this study. A total of 1963 doses of tocilizumab (38.76%), rituximab (38.76%), abatacept (13.95%), and infliximab (8.53%), were administered during the study period. ADRs with a Naranjo score ≥ 1 were experienced by 103 (78%) patients, with an average of 2.2 events per patient. Infection (26.6%) and skin and mucous membrane disorders (14.18%) were the most commonly reported ADRs. Abatacept was associated with a significantly higher risk of multiple ADRs than the other biologics (adjusted odds ratio: 3.145, 95% confidence interval 1.004-9.854, p = 0.049).
There was a high prevalence of ADRs among patients with RA receiving biologics. Abatacept was associated with a greater risk of multiple ADRs than other biologics. Infection was the most common ADR. Future multicenter longitudinal studies are warranted.
沙特很少有研究调查接受静脉注射（IV）原研生物制剂的类风湿关节炎（RA）患者的药物不良反应（ADR）。因此，本研究旨在评估长期静脉注射原研生物制剂治疗的RA患者中ADR的发生率、类型及预测因素。
本回顾性单中心研究纳入了2015年至2020年间接受静脉注射原研生物制剂的成年RA患者。查阅病历，收集有关ADR的数据，并使用纳伦霍量表评估因果关系。进行二元逻辑回归分析，以确定每种生物制剂发生ADR的几率及相关因素。
本研究共纳入129例患者（87.6%为女性），平均（标准差）年龄为54（13）岁。研究期间共注射了1963剂托珠单抗（38.76%）、利妥昔单抗（38.76%）、阿巴西普（13.95%）和英夫利昔单抗（8.53%）。103例（78%）患者出现纳伦霍评分≥1的ADR，平均每位患者发生2.2次。感染（26.6%）和皮肤及黏膜疾病（14.18%）是最常报告的ADR。与其他生物制剂相比，阿巴西普发生多种ADR的风险显著更高（调整比值比：3.145，95%置信区间1.004 - 9.854，p = 0.049）。
接受生物制剂治疗的RA患者中ADR的发生率很高。与其他生物制剂相比，阿巴西普发生多种ADR的风险更大。感染是最常见的ADR。未来有必要开展多中心纵向研究。
