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Parent-Reported Medication Side Effects and Their Impact on Health-Related Quality of Life in Children With Juvenile
Gaëlle Chédeville1, Katherine McGuire2, David A Cabral3
1McGill University, Montreal, Quebec, Canada.
Insights
Two-thirds of children with juvenile idiopathic arthritis (JIA) experience medication side effects (SEs) impacting their quality of life within a year. New strategies are needed to manage these SEs in JIA patients.
Area of Science:
- Pediatric Rheumatology
- Pharmacovigilance
- Health-Related Quality of Life
Background:
- Juvenile idiopathic arthritis (JIA) is a chronic condition requiring long-term medication.
- Understanding medication side effects (SEs) and their impact on health-related quality of life (HRQoL) is crucial for effective JIA management.
- Parental reporting of SEs offers valuable insights into the patient experience.
Purpose of the Study:
- To determine the frequency and severity of parent-reported medication SEs in children with JIA.
- To compare parent-reported SEs with physician-reported actionable adverse events (AEs).
- To evaluate the impact of SEs on the HRQoL of children with JIA.
Main Methods:
- A prospective study of newly diagnosed JIA patients from the Canadian Alliance of Pediatric Rheumatology Investigators (CAPRI) Registry (2017-2019).
- Parents reported SE presence and severity; physicians reported actionable AEs at clinic visits.
- HRQoL assessed using the Quality of My Life (QoML) questionnaire and parent's global assessment.
Main Results:
- SEs were reported at 42% of visits, with a median of 2 SEs per visit and severity of 3.
- Gastrointestinal and behavioral/psychiatric SEs were most common.
- Cumulative incidence of SEs was 67% within 1 year, compared to 36% for actionable AEs; SEs negatively impacted HRQoL.
Conclusions:
- Parents report significant medication side effects in two-thirds of children with JIA within the first year of diagnosis.
- These SEs demonstrably impact children's health-related quality of life.
- Development and implementation of SE mitigation strategies are essential for optimal JIA management.
Objective:
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).
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 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.
Results:
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.
Conclusion:
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.
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