RT Journal Article
SR Electronic
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
FD The Journal of Rheumatology
SP 816
OP 824
DO 10.3899/jrheum.150430
VO 43
IS 4
A1 Tamas Constantin
A1 Ivan Foeldvari
A1 Jelena Vojinovic
A1 Gerd Horneff
A1 Ruben Burgos-Vargas
A1 Irina Nikishina
A1 Jonathan D. Akikusa
A1 Tadej Avcin
A1 Jeffrey Chaitow
A1 Elena Koskova
A1 Bernard R. Lauwerys
A1 Inmaculada Calvo Penades
A1 Berit Flato
A1 Maria Luz Gamir
A1 Hans-Iko Huppertz
A1 Juan Jose Jaller Raad
A1 Katerina Jarosova
A1 Jordi Anton
A1 Marie Macku
A1 William J. Otero Escalante
A1 Lidia Rutkowska-Sak
A1 Ralf Trauzeddel
A1 Patricia J. Velez-Sanchez
A1 Carine Wouters
A1 Joseph Wajdula
A1 Chuanbo Zang
A1 Jack Bukowski
A1 Deborah Woodworth
A1 Bonnie Vlahos
A1 Alberto Martini
A1 Nicolino Ruperto
A1 The Paediatric Rheumatology International Trials Organisation (PRINTO)
YR 2016
UL http://www.jrheum.org/content/43/4/816.abstract
AB 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.