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Extended report
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
  1. Gerd Horneff1,
  2. Ruben Burgos-Vargas2,
  3. Tamas Constantin3,
  4. Ivan Foeldvari4,
  5. Jelena Vojinovic5,
  6. Vyacheslav G Chasnyk6,
  7. Joke Dehoorne7,
  8. Violeta Panaviene8,
  9. Gordana Susic9,
  10. Valda Stanevica10,
  11. Katarzyna Kobusinska11,
  12. Zbigniew Zuber12,
  13. Richard Mouy13,
  14. Ingrida Rumba-Rozenfelde14,
  15. Luciana Breda15,
  16. Pavla Dolezalova16,
  17. Chantal Job-Deslandre17,
  18. Nico Wulffraat18,
  19. Daniel Alvarez19,
  20. Chuanbo Zang19,
  21. Joseph Wajdula19,
  22. Deborah Woodworth19,
  23. Bonnie Vlahos19,
  24. Alberto Martini20,21,
  25. Nicolino Ruperto20,
  26. for the Paediatric Rheumatology International Trials Organisation (PRINTO)
  1. 1Department of Pediatrics, Asklepios Clinic, Sankt Augustin, Germany
  2. 2Department of Rheumatology, Hospital General de Mexico, Mexico City, Mexico
  3. 3Unit of Paediatric Rheumatology, Semmelweis University, Budapest, Hungary
  4. 4Klinikum Eilbek, Hamburger Zentrum fuer Kinder und Jugendrheumatologie, Hamburg, Germany
  5. 5Faculty of Medicine, Clinic of Pediatrics, Clinical Center, University of Nis, Nis, Serbia
  6. 6Pediatric Department Hospital, State Pediatric Medical Academy, Saint-Petersburg, Russian Federation
  7. 7Department of Pediatric Nephrology and Urology, University Hospital Ghent, Ghent, Belgium
  8. 8Centre of Pediatrics, Vilnius University, Vilnius, Lithuania
  9. 9Department of Pediatric Rheumatology, Belgrade Institute of Rheumatology, Belgrade, Serbia
  10. 10Department of Pediatrics, Riga Stradins University, Riga, Latvia
  11. 11Wojewódzki Szpital Dziecie¸cy, Oddział Pediatrii Kardiologii i Reumatologii, Bydgoszcz, Poland, Wojewódzki
  12. 12Wojewódzki Specjalistyczny Szpital Dziecie¸cy sw. Ludwika ODS Reumatologia Krakow, Poland
  13. 13Unité de Rhumatologie Pédiatrique, Hôpital Necker-Enfants Malades, Paris, France
  14. 14Department of Pediatric Rheumatology, University Children Hospital Gailezers, Riga, Latvia
  15. 15Clinica Pediatrica—Centro di Ricerca Clinica Fondazione dell'Universita’ degli Studi Gabriele D'Annunzio Via Colle dell'Ara, Chieti, Italy
  16. 161st Medical Faculty, Charles University in Prague, General University Hospital in Prague, Prague, Czech Republic
  17. 17Hopital Cochin Service de Rhumatologie A Pavillon Hardy B, Paris, France
  18. 18Department Pediatric Rheumatology, Universitair Ziekenhuis Utrecht Universitair Ziekenhuis Utrecht Lundlaan 6 Utrecht, Utrecht, The Netherlands
  19. 19Pfizer Inc, Collegeville, Pennsylvania, USA
  20. 20Pediatria II, Reumatologia, Istituto G. Gaslini, Genoa, Italy
  21. 21Dipartimento di Pediatria, Università di Genova, Genoa, Italy
  1. Correspondence to Dr Nicolino Ruperto, Pediatria II, Reumatologia, Istituto G Gaslini, PRINTO, Via G Gaslini 5, Genova 16147, Italy; nicolaruperto{at}ospedale-gaslini.ge.it

Abstract

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.

  • Juvenile Idiopathic Arthritis
  • Ankylosing Spondylitis
  • Arthritis
  • DMARDs (biologic)
  • Spondyloarthritis

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

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