Chédeville Gaëlle, McGuire Katherine, Cabral David A, Shiff Natalie J, Rumsey Dax G, Proulx-Gauthier Jean-Philippe, Schmeling Heinrike, Berard Roberta A, Batthish Michelle, Soon Gordon, Gerhold Kerstin, Gerschman Tommy, Bruns Alessandra, Duffy Ciaran M, Tucker Lori B, Guzman Jaime
McGill University, Montreal, Quebec, Canada.
University of Ottawa, Ottawa, Ontario, Canada.
Arthritis Care Res (Hoboken). 2022 Oct;74(10):1567-1574. doi: 10.1002/acr.24610. Epub 2022 Jun 14.
To describe the frequency and severity of parent-reported medication side effects (SEs) in children with juvenile idiopathic arthritis (JIA) relative to physician-reported actionable adverse events (AEs), and to assess their impact on health-related quality of life (HRQoL).
Newly diagnosed JIA patients recruited between 2017 and 2019 to the Canadian Alliance of Pediatric Rheumatology Investigators (CAPRI) Registry were included. Parents reported presence and severity (0 = no problem, 10 = very severe) of medication SEs at every clinic visit. Physicians were asked to report any actionable AE. HRQoL was assessed using the Quality of My Life (QoML) questionnaire (0 = the worst, 10 = the best) and parent's global assessment (0 = very well, 10 = very poor). Analyses included proportion of visits with SEs or actionable AEs, cumulative incidence by Kaplan-Meier methods, and HRQoL impact measured with longitudinal mixed-effects models.
SEs were reported at 371 of 884 (42%) visits (95% confidence interval [95% CI] 39, 45%) in 249 patients, with a median of 2 SEs per visit (interquartile range [IQR] 1-3), and median severity of 3 (IQR 1.5-5). Most SEs were gastrointestinal (32.5% of visits) or behavioral/psychiatric (22.4%). SE frequency was lowest with nonsteroidal antiinflammatory drugs alone (34.7%) and highest with prednisone and methotrexate combinations (66%). SE cumulative incidence was 67% (95% CI 59, 75) within 1 year of diagnosis, and 36% (95% CI 28, 44) for actionable AEs. Parent global and QoML scores were worse with SEs present; the impact persisted after adjusting for pain and number of active joints.
Parents report that two-thirds of children with JIA experience SEs impacting their HRQoL within 1 year of diagnosis. SE mitigation strategies are needed in managing JIA.
描述青少年特发性关节炎（JIA）患儿家长报告的药物副作用（SEs）相对于医生报告的可采取行动的不良事件（AEs）的发生频率和严重程度，并评估其对健康相关生活质量（HRQoL）的影响。
纳入2017年至2019年间招募到加拿大儿科风湿病研究人员联盟（CAPRI）登记处的新诊断JIA患者。家长在每次门诊就诊时报告药物SEs的存在情况和严重程度（0 = 无问题，10 = 非常严重）。医生被要求报告任何可采取行动的AE。使用生活质量问卷（QoML）（0 = 最差，10 = 最好）和家长整体评估（0 = 非常好，10 = 非常差）来评估HRQoL。分析包括有SEs或可采取行动的AEs的就诊比例、采用Kaplan-Meier方法的累积发病率，以及用纵向混合效应模型测量的HRQoL影响。
在249例患者的884次就诊中有371次（42%）报告了SEs（95%置信区间[95%CI] 39，45%），每次就诊SEs的中位数为2次（四分位间距[IQR] 1 - 3），严重程度中位数为3（IQR 1.5 - 5）。大多数SEs为胃肠道方面的（占就诊次数的32.5%）或行为/精神方面的（22.4%）。单独使用非甾体抗炎药时SEs频率最低（34.7%），泼尼松和甲氨蝶呤联合使用时最高（66%）。诊断后1年内SEs的累积发病率为67%（95%CI 59，75），可采取行动的AEs为36%（95%CI 28，44）。存在SEs时家长整体评分和QoML评分更差；在调整疼痛和活动关节数量后影响依然存在。
家长报告称，三分之二的JIA患儿在诊断后1年内经历了影响其HRQoL的SEs。在JIA的管理中需要采取减轻SEs的策略。
