Two-year efficacy and safety of etanercept in pediatric patients with extended oligoarthritis, enthesitisrelated arthritis, or psoriatic arthritis

Tamas Constantin, Ivan Foeldvari, Jelena Vojinovic, Gerd Horneff, Ruben Burgos-Vargas, Irina Nikishina, Jonathan D. Akikusa, Tadej Avcin, Jeffrey Chaitow, Elena Koskova, Bernard R. Lauwerys, Inmaculada Calvo Penades, Berit Flato, Maria Luz Gamir, Hans Iko Huppertz, Juan Jose Jaller Raad, Katerina Jarosova, Jordi Anton, Marie Macku, William J. Otero EscalanteLidia Rutkowska-Sak, Ralf Trauzeddel, Patricia J. Velez-Sanchez, Carine Wouters, Joseph Wajdula, Chuanbo Zang, Jack Bukowski, Deborah Woodworth, Bonnie Vlahos, Alberto Martini, Nicolino Ruperto

Research output: Contribution to journalArticlepeer-review

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. The Journal of Rheumatology

Original languageEnglish
Pages (from-to)816-824
Number of pages9
JournalJournal of Rheumatology
Volume43
Issue number4
DOIs
Publication statusPublished - Apr 1 2016

Keywords

  • Clinical trial
  • Enthesitis-related arthritis
  • Etanercept
  • Extended oligoarthritis
  • Juvenile idiopathic arthritis
  • Psoriatic arthritis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Medicine(all)

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