PT  - JOURNAL ARTICLE
AU  - Gerd Horneff
AU  - Ruben Burgos-Vargas
AU  - Tamas Constantin
AU  - Ivan Foeldvari
AU  - Jelena Vojinovic
AU  - Vyacheslav G Chasnyk
AU  - Joke Dehoorne
AU  - Violeta Panaviene
AU  - Gordana Susic
AU  - Valda Stanevica
AU  - Katarzyna Kobusinska
AU  - Zbigniew Zuber
AU  - Richard Mouy
AU  - Ingrida Rumba-Rozenfelde
AU  - Luciana Breda
AU  - Pavla Dolezalova
AU  - Chantal Job-Deslandre
AU  - Nico Wulffraat
AU  - Daniel Alvarez
AU  - Chuanbo Zang
AU  - Joseph Wajdula
AU  - Deborah Woodworth
AU  - Bonnie Vlahos
AU  - Alberto Martini
AU  - Nicolino Ruperto
AU  - for the Paediatric Rheumatology International Trials Organisation (PRINTO)
TI  - Efficacy and safety of open-label etanercept on extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis and psoriatic arthritis: part 1 (week 12) of the CLIPPER study
AID  - 10.1136/annrheumdis-2012-203046
DP  - 2014 Jun 01
TA  - Annals of the Rheumatic Diseases
PG  - 1114--1122
VI  - 73
IP  - 6
4099  - http://ard.bmj.com/content/73/6/1114.short
4100  - http://ard.bmj.com/content/73/6/1114.full
SO  - Ann Rheum Dis2014 Jun 01; 73
AB  - Objective To investigate the efficacy and safety of etanercept (ETN) in paediatric subjects with extended oligoarticular juvenile idiopathic arthritis (eoJIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA). Methods CLIPPER is an ongoing, Phase 3b, open-label, multicentre study; the 12-week (Part 1) data are reported here. Subjects with eoJIA (2–17 years), ERA (12–17 years), or PsA (12–17 years) received ETN 0.8 mg/kg once weekly (maximum 50 mg). Primary endpoint was the percentage of subjects achieving JIA American College of Rheumatology (ACR) 30 criteria at week 12; secondary outcomes included JIA ACR 50/70/90 and inactive disease. Results 122/127 (96.1%) subjects completed the study (mean age 11.7 years). JIA ACR 30 (95% CI) was achieved by 88.6% (81.6% to 93.6%) of subjects overall; 89.7% (78.8% to 96.1%) with eoJIA, 83.3% (67.2% to 93.6%) with ERA and 93.1% (77.2% to 99.2%) with PsA. For eoJIA, ERA, or PsA categories, the ORs of ETN vs the historical placebo data were 26.2, 15.1 and 40.7, respectively. Overall JIA ACR 50, 70, 90 and inactive disease were achieved by 81.1, 61.5, 29.8 and 12.1%, respectively. Treatment-emergent adverse events (AEs), infections, and serious AEs, were reported in 45 (35.4%), 58 (45.7%), and 4 (3.1%), subjects, respectively. Serious AEs were one case each of abdominal pain, bronchopneumonia, gastroenteritis and pyelocystitis. One subject reported herpes zoster and another varicella. No differences in safety were observed across the JIA categories. Conclusions ETN treatment for 12 weeks was effective and well tolerated in paediatric subjects with eoJIA, ERA and PsA, with no unexpected safety findings.