Parent-Reported Medication Side-Effects and Their Impact on Health-Related Quality of Life in Children with Juvenile Idiopathic Arthritis

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.