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Abstract
Background Adalimumab (ADA) is a tumor necrosis factor (TNF) inhibitor used for treatment of chronic immune diseases. The safety of ADA treatment in pediatric patients (pts) is particularly important since prolonged treatment for these conditions is often required.
Objectives To evaluate the safety of ADA, alone or in combination with concomitant therapy, in pediatric pts with polyarticular juvenile idiopathic arthritis (pJIA), enthesitis-related arthritis (ERA), psoriasis (Ps), and Crohn's disease (CD)
Methods Safety data from 6 clinical trials and their open-label extension studies were analyzed. Pts treated for pJIA (NCT00048542, NCT00775437, and NCT00690573) and ERA (NCT01166282 [interim week-52 data]) received ADA 24 mg/m2 body surface area every other week (eow) or 20 mg eow (<30 kg) to 40 mg eow (≥30 kg). Pediatric pts treated for Ps (NCT01251614) received ADA 0.4 mg/kg (up to 20 mg) or 0.8 mg/kg (up to 40 mg) at week 0, then eow from week 1. Pediatric pts treated for CD (NCT00409682) received open-label ADA induction therapy (160 mg and 80 mg at weeks 0 and 2, respectively, if ≥40 kg; 80 mg and 40 mg if <40 kg), followed by double-blind maintenance dosing (high dose: 40 mg eow if ≥40 kg or 20 mg eow if <40 kg at week 4; low dose: 20 mg eow if ≥40 kg or 10 mg eow if <40 kg at week 4); weekly dosing was allowed for disease flare at week 12 or later; pts received high-dose eow or weekly ADA during an open-label extension (NCT00686374). Events (E) per 100 pt-years (PY) were calculated using adverse events (AEs) reported after the first ADA study dose through 70 days after the last study dose.
Results The analysis included 577 pediatric pts, representing 1423.3 PY of ADA exposure (Table). Over 90% of pts across indications reported treatment-emergent AEs. Common AEs were headache (13.8, 46.9, and 23.8 E/100 PY for pJIA and ERA, Ps, and CD, respectively), nasopharyngitis (12.4, 57.6, and 14.1 E/100 PY, respectively), and upper respiratory tract infection (30.1, 24.7, and 14.9 E/100 PY, respectively). The rates of serious AEs (E/100 PY) were 13.4 for pts with pJIA and ERA, 7.4 for pts with Ps, and 32.3 for pts with CD. One death was reported from an accidental fall (pt with Ps). There were no reports of malignancies, demyelinating disorders, cardiovascular events, pulmonary embolism, reactivation of hepatitis B, Stevens-Johnson syndrome, or erythema multiforme.
Conclusions The safety profile of ADA in pediatric pts with pJIA, ERA, Ps, or CD was similar across indications, and no new safety signals specific to the pediatric population were identified.
Acknowledgement AbbVie funded the studies (NCT00048542, NCT00775437, NCT00690573, NCT01166282, NCT01251614, NCT00409682, and NCT00686374); contributed to their design; and was involved in the collection, analysis, and interpretation of the data, and in the writing, review and approval of the abstract. All authors contributed to and maintained control over the final content; Natalia Zhukovskaya, PhD, of Complete Publication Solutions, LLC, provided medical writing support.
Disclosure of Interest G. Horneff Grant/research support from: AbbVie, Chugai, Pfizer, and Roche, M. Seyger Grant/research support from: AbbVie, Almirall, Astellas, Leo Pharma, and Pfizer, Consultant for: AbbVie, Almirall, Boehringer Ingelheim, and Pfizer, Speakers bureau: Pfizer; and travelled with AbbVie, Pfizer, and Leo Pharma to meetings (fees were paid directly to the institution for these activities)., D. Arikan Shareholder of: AbbVie, Employee of: AbbVie, J. Kalabic Shareholder of: AbbVie, Employee of: AbbVie, J. Anderson Shareholder of: AbbVie, Employee of: AbbVie, A. Lazar Shareholder of: AbbVie, Employee of: AbbVie, D. Williams Shareholder of: AbbVie, Employee of: AbbVie, C. Wang Shareholder of: AbbVie, Employee of: AbbVie, R. Tarzynski-Potempa Shareholder of: AbbVie, Employee of: AbbVie, J. Hyams Consultant for: Celgene, Takeda, AstraZeneca, Lilly, Genentech, and UCB. Served as an advisory board member for AbbVie and Janssen