Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease

• Published in: The Journal of pediatrics Vol. 201; pp. 166 - 175.e3
• Main Authors: Horneff, Gerd, Seyger, Marieke M.B., Arikan, Dilek, Kalabic, Jasmina, Anderson, Jaclyn K., Lazar, Andreas, Williams, David A., Wang, Chen, Tarzynski-Potempa, Rita, Hyams, Jeffrey S.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2018
• Subjects: Adalimumab - administration & dosage; Adolescent; Anti-Inflammatory Agents - administration & dosage; Arthritis, Juvenile - drug therapy; Child; Child, Preschool; children; Crohn Disease - drug therapy; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Humans; immune-mediated inflammatory diseases; Male; Psoriasis - drug therapy; Retrospective Studies; Time and Motion Studies; TNF inhibitor; Treatment Outcome; CHF; CD; JIA; AE; TNF inhibitor; pJIA; PY; TNF; TB; children; ERA; SAE; immune-mediated inflammatory diseases; NCT
• ISSN: 0022-3476; 1097-6833
• DOI: 10.1016/j.jpeds.2018.05.042

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. 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. 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. 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. Clinicaltrials.gov: NCT00048542, NCT00775437, NCT00690573, NCT01166282, NCT01251614, NCT00409682, and NCT00686374.