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Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: findings from an open-label treatment extension
  1. Nicolino Ruperto1,
  2. Daniel J Lovell2,
  3. Ruben Cuttica3,
  4. Patricia Woo4,
  5. Silvia Meiorin5,
  6. Carine Wouters6,
  7. Earl D Silverman7,
  8. Zsolt Balogh8,
  9. Michael Henrickson9,
  10. Joyce Davidson10,
  11. Ivan Foeldvari11,
  12. Lisa Imundo12,
  13. Gabriele Simonini13,
  14. Joachim Oppermann14,
  15. Stephen Xu15,
  16. Yaung-Kaung Shen15,
  17. Sudha Visvanathan15,
  18. Adedigbo Fasanmade15,
  19. Alan Mendelsohn15,
  20. Alberto Martini1,16,
  21. Edward H Giannini2
  1. 1IRCCS G Gaslini, PRINTO, Genoa, Italy
  2. 2Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA
  3. 3Hospital General de Ninos Pedro de Elizalde, Buenos Aires, Argentina
  4. 4Great Ormond Street Hospital, London, UK
  5. 5Hospital de Ninos Ricardo Gutierrez, Buenos Aires, Argentina
  6. 6University Hospital Gasthuisberg, Leuven, Belgium
  7. 7Hospital for Sick Children, Toronto, Ontario, Canada
  8. 8National Institute of Rheumatology and Physiotherapy, Budapest, Hungary
  9. 9Children's Hospital, Oklahoma City, Oklahoma, USA
  10. 10Royal Hospital for Sick Children, Glasgow, UK
  11. 11Hamburger Zentrum für Kinder- und Jugendrheumatologie, Hamburg, Germany
  12. 12Columbia Presbyterian Med Center – Babies Hospital, New York, USA
  13. 13Ospedale A Meyer, Firenze, Italy
  14. 14Carl-Thiem-Klinikum, Cottbus, Germany
  15. 15Centocor Research & Development, Inc
  16. 16University of Genoa, Genoa, Italy
  1. Correspondence to Dr Nicolino Ruperto, IRCCS Istituto G Gaslini, Pediatria II – PRINTO, Largo Gaslini, 5, 16147 Genoa, EULAR Centre of Excellence in Rheumatology 2008-13, Italy; nicolaruperto{at}ospedale-gaslini.ge.it

Abstract

Objective To assess the long-term efficacy and safety of infliximab plus methotrexate in juvenile rheumatoid arthritis (JRA).

Methods Patients eligible for the open-label extension (OLE, weeks 52–204) received infliximab 3–6 mg/kg every 8 weeks plus methotrexate.

Results Of the 78/122 (64%) children entering the OLE, 42 discontinued infliximab, most commonly due to consent withdrawal (11 patients), lack of efficacy (eight patients) or patient/physician/sponsor requirement (eight patients). Infliximab (mean dose 4.4 mg/kg per infusion) was generally well tolerated. Infusion reactions occurred in 32% (25/78) of patients, with a higher incidence in patients positive for antibodies to infliximab (58%, 15/26). At week 204, the proportions of patients achieving ACR-Pedi-30/50/70/90 response criteria and inactive disease status were 44%, 40%, 33%, 24% and 13%, respectively.

Conclusions In the limited population of JRA patients remaining in the study at 4 years, infliximab was safe and effective but associated with a high patient discontinuation rate.

Clinical trials registration number NCT00036374.

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Footnotes

  • Funding This study (C0168T32) was sponsored by Centocor Ortho Biotech, Inc (formerly Centocor, Inc).

  • Competing interests EHG, DJL, AM, NR and PW served as members of the Steering Committee, as well as consultants for Centocor Ortho Biotech, Inc. The members of the Steering Committee had full access to analysis reports from Centocor Ortho Biotech, Inc. SX, Y-KS, SV, AF and AM are employees of Centocor Ortho Biotech, Inc.

  • Ethics approval This study was conducted with the approval of the independent ethics committee at each centre, which approved the protocol.

  • Patient consent Obtained.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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