1. Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis
- Author
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Jonathan D Akikusa, Irina Nikishina, Katerina Jarosova, Lidia Rutkowska-Sak, Joseph Wajdula, Jeffrey Chaitow, Tadej Avcin, Jordi Anton, Chuanbo Zang, Ralf Trauzeddel, William Jose Otero Escalante, Ruben Burgos-Vargas, M.L. Gamir, Jelena Vojinovic, Marie Macku, Deborah A Woodworth, Carine Wouters, Juan Jose Jaller Raad, Nicolino Ruperto, Bonnie Vlahos, Elena Koskova, Hans Iko Huppertz, Tamás Constantin, Berit Flatø, Bernard Lauwerys, Ivan Foeldvari, Patricia J. Velez-Sanchez, Gerd Horneff, Inmaculada Calvo Penades, Alberto Martini, and Jack F. Bukowski
- Subjects
Male ,medicine.medical_specialty ,Adolescent ,Enthesitis-related arthritis ,Immunology ,Arthritis ,Juvenile ,Psoriatic ,Etanercept ,03 medical and health sciences ,Psoriatic arthritis ,0302 clinical medicine ,Rheumatology ,Internal medicine ,medicine ,Immunology and Allergy ,Humans ,030212 general & internal medicine ,Preschool ,Child ,030203 arthritis & rheumatology ,Oligoarthritis ,business.industry ,Arthritis, Psoriatic ,Clinical trial ,Extended oligoarthritis ,Juvenile idiopathic arthritis ,Antirheumatic Agents ,Arthritis, Juvenile ,Child, Preschool ,Female ,Treatment Outcome ,medicine.disease ,Pharyngitis ,3. Good health ,Surgery ,Upper respiratory tract infection ,Bronchitis ,medicine.symptom ,business ,medicine.drug - Abstract
Objective.The main objective was to determine the 2-year clinical benefit and safety of etanercept (ETN) in children with the juvenile idiopathic arthritis (JIA) categories of extended oligoarthritis (eoJIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA).Methods.CLIPPER was a 96-week, phase IIIb, open-label, multicenter study. Patients with eoJIA, ERA, or PsA received ETN 0.8 mg/kg once weekly (50 mg max) for up to 96 weeks. The proportions of patients reaching the JIA American College of Rheumatology (ACR) 30/50/70/90/100 and inactive disease responses at Week 96 were calculated. Adverse events (AE) were collected throughout the study (intention-to-treat sample).Results.There were 127 patients (eoJIA n = 60, ERA n = 38, PsA n = 29) who received ≥ 1 dose of ETN. The mean disease duration was 31.6 (eoJIA), 23.0 (ERA), and 21.8 (PsA) months. At Week 96, JIA ACR 30/50/70/90/100/inactive disease responses (95% CI) were achieved by 84.3% (76.7, 90.1), 83.5% (75.8, 89.5), 78.7% (70.6, 85.5), 55.1% (46.0, 63.9), 45.7% (36.8, 54.7), and 27.6% (20.0, 36.2) of patients, respectively. The most common AE (no. events, events per 100 patient-yrs) overall were headache (23, 10.7), pyrexia (12, 5.6), and diarrhea (10, 4.6). The most common infections were upper respiratory tract infection (83, 38.6), pharyngitis (50, 23.2), gastroenteritis (22, 10.2), bronchitis (19, 8.8), and rhinitis (17, 7.9). No cases of malignancy, active tuberculosis, demyelinating disorders, or death were reported.Conclusion.Over 96 weeks of therapy, ETN demonstrated sustained efficacy at treating the clinical symptoms of all 3 JIA categories, with no major safety issues.
- Published
- 2015