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The Stop Arthritis Very Early (SAVE) trial, an international multicentre, randomised, double-blind, placebo-controlled trial on glucocorticoids in very early arthritis
  1. Klaus P Machold1,
  2. Robert Landewé2,
  3. Josef S Smolen1,
  4. Tanja A Stamm1,
  5. Désirée M van der Heijde3,
  6. Kirsten N Verpoort3,
  7. Kerstin Brickmann4,
  8. Janitzia Vázquez-Mellado5,
  9. Dimitri E Karateev6,
  10. Ferdinand C Breedveld3,
  11. Paul Emery7,
  12. Thomas W J Huizinga3
  1. 1Medical University of Vienna, Vienna, Austria
  2. 2University of Maastricht, Maastricht, The Netherlands
  3. 3Leiden University Medical Centre, Leiden, The Netherlands
  4. 4Medical University of Graz, Graz, Austria
  5. 5National Autonomous University of Mexico, Mexico City, Mexico
  6. 6State Institute of Rheumatology, Moscow, Russian Republic
  7. 7Academic Unit of Musculoskeletal Disease, Leeds, UK
  1. Correspondence to Klaus P Machold, Medical University of Vienna, Währinger Gürtel 18-20, Vienna A-1090, Austria; klaus.machold{at}meduniwien.ac.at

Abstract

Background Glucocorticoids (GCs) are often used as early arthritis treatment and it has been suggested that they induce remission or at least delay the development of rheumatoid arthritis (RA) and the need to start disease-modifying antirheumatic drugs (DMARDs).

Objective To test the effect of GCs on patients with very early arthritis (symptom duration of <16 weeks) in a randomised controlled trial.

Methods Patients received a single intramuscular injection of 120 mg methylprednisolone or placebo (PL) and were followed up for 52 weeks. Primary end point was drug-free clinical remission, both at weeks 12 and 52. Among secondary outcomes were fulfilment of remission criteria at weeks 2, 12 or 52, time course of ‘core set variables’ and proportion of patients starting DMARDs.

Results 17.0% of all analysed subjects (65/383) achieved persistent remission: 17.8% (33/185) of the PL group, 16.2% (32/198) of the patients receiving methylprednisolone (OR=1.13, 95% CI 0.66 to 1.92, p=0.6847). Analyses of secondary end points showed significant clinical benefits of the GC only at week 2. These differences subsequently disappeared. DMARDs were started in 162 patients: 50.3% methylprednisolone and 56.7% PL patients had to start DMARD treatment (OR=0.78, 95% CI 0.49 to 1.22, p=0.30). Significantly more patients with polyarthritis than with oligoarthritis received DMARDs (OR=2.84, 95% CI 1.75 to 4.60, p<0.0001).

Conclusions Neither remission nor development of RA is delayed by GC treatment. Remission is rare in the first year of very early arthritis, occurring in <20% of the patients. Also, the need to start DMARDs was not influenced by GC treatment.

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Footnotes

  • Funding European League Against Rheumatism, Pfizer, AutoCure.

  • Competing interests None.

  • Ethics approval This study was conducted with the approval of the ethics committee of the Medical University of Vienna and ethics committees of all participating centres.

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

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