Gerd Horneff1, Marieke M B Seyger2, Dilek Arikan3, Jasmina Kalabic4, Jaclyn K Anderson3, Andreas Lazar4, David A Williams3, Chen Wang3, Rita Tarzynski-Potempa3, Jeffrey S Hyams5. 1. Centre of Paediatric Rheumatology, Department of General Paediatrics, Asklepios Klinik Sankt Augustin, Sankt Augustin, Germany. Electronic address: g.horneff@asklepios.com. 2. Department of Dermatology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands. 3. AbbVie Inc., North Chicago, IL. 4. AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany. 5. Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children's Medical Center, Hartford, CT.
Abstract
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 adalimumaband 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 withadalimumab. TRIAL REGISTRATION: Clinicaltrials.gov: NCT00048542, NCT00775437, NCT00690573, NCT01166282, NCT01251614, NCT00409682, and NCT00686374.
RCT Entities:
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. TRIAL REGISTRATION: Clinicaltrials.gov: NCT00048542, NCT00775437, NCT00690573, NCT01166282, NCT01251614, NCT00409682, and NCT00686374.
Authors: D Thaçi; K Papp; D Marcoux; L Weibel; A Pinter; P-D Ghislain; I Landells; P H Hoeger; K Unnebrink; M M B Seyger; D A Williams; S Rubant; S Philipp Journal: Br J Dermatol Date: 2019-07-25 Impact factor: 9.302
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Authors: Daniel J Lovell; Hermine I Brunner; Andreas O Reiff; Lawrence Jung; Katerina Jarosova; Dana Němcová; Richard Mouy; Christy Sandborg; John F Bohnsack; Dirk Elewaut; Christos Gabriel; Gloria Higgins; Isabelle Kone-Paut; Olcay Y Jones; Veronika Vargová; Elizabeth Chalom; Carine Wouters; Ivan Lagunes; Yanna Song; Alberto Martini; Nicolino Ruperto Journal: RMD Open Date: 2020-07
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