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J Rheumatol. 2016 Apr;43(4):816-24. doi: 10.3899/jrheum.150430. Epub 2016 Mar 1.

Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis.

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1
From the Paediatric Rheumatology International Trials Organisation (PRINTO), Istituto G. Gaslini, Pediatria II-Reumatologia, PRINTO, Genoa, Italy.T. Constantin, MD, PhD, 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary; I. Foeldvari, MD, Hamburg Centre for Child and Adolescent Rheumatology, Hamburg, Germany; J. Vojinovic, MD, PhD, Clinic of Pediatrics, Clinical Centre, Faculty of Medicine, University of Nis, Serbia; G. Horneff, MD, Asklepios Clinic, Sankt Augustin, Germany; R. Burgos-Vargas, MD, Hospital General de Mexico, Mexico City, Mexico; I. Nikishina, MD, V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia; J.D. Akikusa, MD, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia; T. Avcin, MD, PhD, University Medical Centre Ljubljana, Pediatric Clinic, Ljubljana, Slovenia; J. Chaitow, MD, The Sydney Children's Hospital Network, Westmead, Sydney, Australia; E. Koskova, MD, PhD, National Institute of Rheumatic Diseases, Piestany, Slovakia; B.R. Lauwerys, MD, PhD, Institut de Recherche Expérimentale et Clinique, Université catholique de Louvain and Department of Rheumatology, Cliniques Universitaires Saint-Luc, Brussels, Belgium; I. Calvo Penades, MD, PhD, Hospital Universitario y Politécnico La Fe, Pediatric Rheumatology Unit, Valencia, Spain; B. Flato, MD, PhD, Oslo University Hospital, Department of Rheumatology, Oslo, Norway; M.L. Gamir, MD, Hospital Ramon y Cajal Unidad de Reumatologia Pediatrica, Madrid, Spain; H.I. Huppertz, MD, Klinikum Bremen-Mitte, Prof. Hess-Kinderklinik, Bremen, Germany; J.J. Raad, MD, Centro de Reumatologia y Ortopedia, Barranquilla, Atlantico, Colombia; K. Jarosova, MD, Revmatologicky Ustav, Prague, Czech Republic; J. Anton, MD, PhD, Pediatric Rheumatology Unit, Hospital Sant Joan de Déu, Universitat de Barcelona, Espluges (Barcelona), Spain; M. Macku, MD, Fakultni nemocnice Brno, Bohunice, Detska Nemocnice, Ambulance detske revmatologie detske kliniky, Brno, Czech Republic; W.J. O

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.

KEYWORDS:

CLINICAL TRIAL; ENTHESITIS-RELATED ARTHRITIS; ETANERCEPT; EXTENDED OLIGOARTHRITIS; JUVENILE IDIOPATHIC ARTHRITIS; PSORIATIC ARTHRITIS

PMID:
26932344
DOI:
10.3899/jrheum.150430
[Indexed for MEDLINE]

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