Parent‐Reported Medication Side‐Effects and Their Impact on Health‐Related Quality of Life in Children with Juvenile Idiopathic Arthritis
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OBJECTIVE: To describe frequency and severity of parent-reported medication side effects (SE) in children with Juvenile Idiopathic Arthritis (JIA), relative to physician-reported actionable adverse events (AAE); and to assess their impact on health-related quality of life (HRQoL). METHODS: 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 SE at every clinic visit. Physicians were asked to report any AAE. 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 SE or AAE, cumulative incidence by Kaplan-Meier methods, and HRQoL impact measured with longitudinal mixed effects models. RESULTS: SE were reported at 371/884 (42%) visits (95% CI 39-45%) in 249 patients with a median of 2 SE per visit (IQR 1,3), and median severity of 3 (IQR 1.5,5). Most SE were gastrointestinal (32.5% of visits) or behavioral/psychiatric (22.4%). SE frequency was lowest with NSAID alone (34.7%) and highest with prednisone and methotrexate combinations (66%). SE cumulative incidence was 67% (95% CI 59-75) within 1y of diagnosis, and 36% (95% CI 28-44) for AAE. Parent global and QoML scores were worse with SE present, the impact persisted after adjusting for pain and number of active joints. CONCLUSION: Parents report 2/3 children with JIA experience SE impacting their HRQoL within 1y of diagnosis. SE mitigation strategies are needed in managing JIA.
