Parents report 'high frequency' of JIA medication side effects in 67% of children
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Parents reported that two-thirds of children with juvenile idiopathic arthritis demonstrate drug side effects that impact their quality of life within 1 year of diagnosis, according to data published in Arthritis Care & Research.
“While physician-reported adverse events (AE) are commonly captured in clinical trials and drug registries, there has been little systematic study of parent perceptions of the frequency and severity of [side effects (SE)] in JIA and their impact on quality of life, with the exception of the well-known methotrexate (MTX)-associated nausea and vomiting,” Gaëlle Chédeville, MD, of McGill University Health Center, in Montreal, and colleagues wrote.
“Recently, the parent/patient perspective has been emphasized with the development of patient-reported outcomes (PROs); experience with medications is included among the different domains that are assessed,” they added. “Two well-known juvenile arthritis questionnaires, the Juvenile Arthritis Quality of Life Questionnaire (JAQQ) and the Juvenile Arthritis Multidimensional Assessment Report (JAMAR) include lists of SE reported by patients and parents, but to date no systematic analysis of reported SE has been published.”
To examine parent-reported drug side effects in children with JIA, compared with physician-reported adverse events, and their impact on health-related quality of life, Chédeville and colleagues analyzed data from the Canadian Alliance of Pediatric Rheumatology Investigators (CAPRI) Registry. The researchers included 249 patients, enrolled in the registry within 3 months of JIA diagnosis between 2017 and 2019, and 884 clinic visits in their analysis.
Data collected for the registry from patents, patients and physicians at each visit included disease activity, treatments, physician-reported actionable adverse events, parent-reported drug side effects, disease outcomes, and quality of life. Parents reported the presence and severity of side effects using a zero to 10 scale, with zero meaning “no problem” and 10 representing “very severe.” Health-related quality of life was assessed using the Quality of My Life (QoML) questionnaire and parent’s global assessment.
The researchers calculated the proportion of visits with side effects or actional adverse events, as well as the cumulative incidence, based on Kaplan‐Meier methods, and health-related quality of life, using longitudinal mixed effects models.
According to the researchers, parents reported side effects in 42% of clinic visits (95% CI, 39-45%), with a median of two per visit (IQR = 1-3) and a median severity of 3 (IQR = 1.5-5). Most side effects involved gastrointestinal or behavioral/psychiatric issues — reported in 32.5% and 22.4% of visits, respectively. The frequency of side effects was lowest in patients receiving NSAIDs alone — at 34.7% — and highest in those treated with prednisone and methotrexate combinations — at 66%.
The cumulative incidence of parent-reported side effects was 67% (95% CI, 59-75) within 1 year of JIA diagnosis, compared with 36% (95% CI, 28‐44) for physician-reported actionable adverse events. In addition, parent global and QoML scores were worse when side effects were present. This effect persisted after adjusting for pain and number of active joints, the researchers wrote.
“In this modern JIA inception cohort, parents of children with JIA reported a very high frequency of medication SE that had a measurable effect on the parent’s global assessment of wellbeing and on the patient’s assessment of HRQoL,” Chédeville and colleagues wrote. “Most common SE were GI and behavioral/psychiatric symptoms.”
“Addressing medication SE reported by patients and parents may improve the HRQoL of children with JIA,” they added. “Good communication with families is key to avoid dismissing medication SE that they feel are important. Studies developing and testing effective strategies to mitigate these SE are needed.”
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