G.S. Hazlewood, MD, PhD, Associate Professor, Department of Medicine, and Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, and Arthritis Research Canada, Richmond, British Columbia, Canada;
O. Schieir, PhD, Canadian Early Arthritis Cohort Study, Toronto, Ontario, Canada.
J Rheumatol. 2022 Sep;49(9):998-1005. doi: 10.3899/jrheum.210688. Epub 2022 Mar 1.
To generate initial data on the frequency and effect of symptomatic adverse events (AEs) associated with rheumatoid arthritis (RA) drug therapy from the patient perspective.
We conducted an exploratory online survey asking patients with RA to indicate whether they currently or had ever experienced the 80 different symptomatic AEs included in the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Results were summarized to report their frequency, and regression models were used to estimate their associations with RA medication use and overall bother.
The 560 patients who completed the survey and reported taking ≥ 1 RA medication (disease-modifying antirheumatic drugs [DMARDs], steroids, nonsteroidal antiinflammatory drugs [NSAIDs]), had a mean disease duration of 8 years, and were on a wide range of DMARDs. The number of symptomatic AEs experienced in the past 7 days was none (6%), 1-10 (28%), 11-20 (28%), and > 20 (38%). Overall, most participants reported that side effects bothered them somewhat (28%), quite a bit (24%), or very much (15%). In multivariable regression analyses, current prednisone and NSAID use were associated with the greatest number of current side effects (26 and 22, respectively). Many of the strongest associations between current symptomatic AEs and medication use aligned with known side effect profiles.
In this exploratory online survey, patients with RA reported frequent symptomatic AEs with their medications that are bothersome. Further work is needed to develop and validate a measure for use in patients with rheumatic disease.
从患者角度生成与类风湿关节炎（RA）药物治疗相关的症状性不良事件（AE）的频率和影响的初始数据。
我们进行了一项探索性在线调查，要求 RA 患者表明他们目前或曾经经历过包括在患者报告的常见不良事件术语标准（PRO-CTCAE）中的 80 种不同的症状性 AE。结果进行了总结，以报告其频率，并使用回归模型来估计它们与 RA 药物使用和整体困扰的关联。
完成调查并报告服用≥1 种 RA 药物（疾病修饰抗风湿药物 [DMARDs]、类固醇、非甾体抗炎药 [NSAIDs]）的 560 名患者的平均疾病持续时间为 8 年，且使用了广泛的 DMARDs。过去 7 天内经历的症状性 AE 数量为无（6%）、1-10（28%）、11-20（28%）和>20（38%）。总体而言，大多数参与者报告说副作用有些困扰（28%）、相当困扰（24%）或非常困扰（15%）。在多变量回归分析中，当前泼尼松和 NSAID 的使用与当前出现的最多副作用相关（分别为 26 和 22）。许多当前症状性 AE 与药物使用之间的最强关联与已知的副作用特征一致。
在这项探索性在线调查中，RA 患者报告了他们的药物治疗中频繁出现的令人困扰的症状性 AE。需要进一步开展工作来开发和验证一种用于风湿性疾病患者的测量方法。
