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Ann Rheum Dis doi:10.1136/annrheumdis-2012-203201
  • Clinical and epidemiological research
  • Extended report

Efficacy and safety of infliximab plus naproxen versus naproxen alone in patients with early, active axial spondyloarthritis: results from the double-blind, placebo-controlled INFAST study, Part 1

Open Access
  1. on Behalf of All INFAST Investigators
  1. 1Medical Department I, Rheumatology, Charité Campus Benjamin Franklin, Berlin, Germany
  2. 2Department of Rheumatology, REUMA Instituut, Hasselt, Belgium
  3. 3Klinik für Rheumatologie und klinische Immunologie, Schön-Klinik, Hamburg, Germany
  4. 4St. Petersburg Medical Academy, St. Petersburg, Russia
  5. 5Kazan State Medical University, Kazan, Russia
  6. 6Division of Rheumatology, Department of Internal Medicine, Catholic University of Korea, Seoul, South Korea
  7. 7Department of Internal Medicine, Seoul National University, Seoul, South Korea
  8. 8Merck Sharp & Dohme Corp., Kenilworth, New Jersey, USA
  9. 9Merck Sharp & Dohme Corp., Brussels, Belgium
  1. Correspondence to Professor Joachim Sieper, Medical Department I, Rheumatology, Charité Campus Benjamin Franklin, Hindenburgdamm 30, Berlin 12200, Germany; joachim.sieper{at}charite.de
  • Accepted 14 April 2013
  • Published Online First 21 May 2013

Abstract

Objectives To assess whether combination therapy with infliximab (IFX) plus nonsteroidal anti-inflammatory drugs (NSAIDs) is superior to NSAID monotherapy for reaching Assessment of SpondyloArthritis international Society (ASAS) partial remission in patients with early, active axial spondyloarthritis (SpA) who were naïve to NSAIDs or received a submaximal dose of NSAIDs.

Methods Patients were randomised (2 : 1 ratio) to receive naproxen (NPX) 1000 mg daily plus either IFX 5 mg/kg or placebo (PBO) at weeks 0, 2, 6, 12, 18 and 24. The primary efficacy measure was the percentage of patients who met ASAS partial remission criteria at week 28. Several other measures of disease activity, clinical symptoms and patient-rated outcomes were evaluated. Treatment group differences were analysed with Fisher exact tests or analysis of covariance.

Results A greater percentage of patients achieved ASAS partial remission in the IFX+NPX group (61.9%; 65/105) than in the PBO+NPX group (35.3%; 18/51) at week 28 (p=0.002) and at all other visits (p<0.05, all comparisons). Results of most other disease activity and patient-reported endpoints (including Ankylosing Spondylitis Disease Activity Score, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, multiple quality of life measures and pain measures) showed greater improvement in the IFX+NPX group than the PBO+NPX group, with several measures demonstrating early and consistent improvement over 28 weeks of treatment.

Conclusions Patients with early, active axial SpA who received IFX+NPX combination treatment were twice as likely to achieve clinical remission as patients who received NPX alone. NPX alone led to clinical remission in a third of patients.

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