TY - JOUR T1 - Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis JF - The Journal of Rheumatology JO - J Rheumatol SP - 816 LP - 824 DO - 10.3899/jrheum.150430 VL - 43 IS - 4 AU - Tamas Constantin AU - Ivan Foeldvari AU - Jelena Vojinovic AU - Gerd Horneff AU - Ruben Burgos-Vargas AU - Irina Nikishina AU - Jonathan D. Akikusa AU - Tadej Avcin AU - Jeffrey Chaitow AU - Elena Koskova AU - Bernard R. Lauwerys AU - Inmaculada Calvo Penades AU - Berit Flato AU - Maria Luz Gamir AU - Hans-Iko Huppertz AU - Juan Jose Jaller Raad AU - Katerina Jarosova AU - Jordi Anton AU - Marie Macku AU - William J. Otero Escalante AU - Lidia Rutkowska-Sak AU - Ralf Trauzeddel AU - Patricia J. Velez-Sanchez AU - Carine Wouters AU - Joseph Wajdula AU - Chuanbo Zang AU - Jack Bukowski AU - Deborah Woodworth AU - Bonnie Vlahos AU - Alberto Martini AU - Nicolino Ruperto AU - The Paediatric Rheumatology International Trials Organisation (PRINTO) Y1 - 2016/04/01 UR - http://www.jrheum.org/content/43/4/816.abstract N2 - 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. ER -