期刊
JOURNAL OF PEDIATRICS
卷 201, 期 -, 页码 166-+出版社
MOSBY-ELSEVIER
DOI: 10.1016/j.jpeds.2018.05.042
关键词
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类别
资金
- Abbvie
- Chugai
- Novartis
- Pfizer
- Roche
- Almirall
- Astellas
- Leo Pharma
Objective To evaluate the safety of adalimumab in pediatric patients who participated in clinical trials of juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and pediatric enthesitis-related arthritis), psoriasis, and Crohn's disease. Study design This analysis included data from 7 global, randomized. and open-label AbbVie-sponsored clinical trials of adalimumab and their open-label extensions conducted between September 2002 and December <31, 2015 (cutoff date for ongoing studies). Patients who received >= 1 dose of adalimumab subcutaneously were included. Adverse events that occurred after the first dose of adalimumab and up to 70 days (5 half-lives) after the last dose were reported and events per 100 patient-years were calculated. Results The analysis included 577 pediatric patients, representing 1440.7 patient-years of adalimumab exposure. Across indications, the most commonly reported adverse events (events/100 patient-years) were upper respiratory tract infections (24.3), nasopharyngitis (17.3), and headache (19.9). Serious infections (4.0 events/100 patient-years) were the most frequent serious adverse events across indications; the most commonly reported was pneumonia (0.6 events/100 patient-years). Serious infection rates were 2.7, 0.8, and 6.6 events/100 patient-years in patients with juvenile idiopathic arthritis, psoriasis, and Crohn's disease, respectively. No events of malignancies were reported. One death (accidental fall) occurred in a patient with psoriasis. Conclusions The safety profile of adalimumab in pediatric patients with polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriasis, and Crohn's disease was generally similar across indications; no new safety signals were identified in the treatment of pediatric patients with adalimumab.
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