Literature DB >> 20223838

The Stop Arthritis Very Early (SAVE) trial, an international multicentre, randomised, double-blind, placebo-controlled trial on glucocorticoids in very early arthritis.

Klaus P Machold1, Robert Landewé, Josef S Smolen, Tanja A Stamm, Désirée M van der Heijde, Kirsten N Verpoort, Kerstin Brickmann, Janitzia Vázquez-Mellado, Dimitri E Karateev, Ferdinand C Breedveld, Paul Emery, Thomas W J Huizinga.   

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 fulfillment 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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Year:  2010        PMID: 20223838     DOI: 10.1136/ard.2009.122473

Source DB:  PubMed          Journal:  Ann Rheum Dis        ISSN: 0003-4967            Impact factor:   19.103


  33 in total

Review 1.  The changing face of rheumatoid arthritis: sustained remission for all?

Authors:  John D Isaacs
Journal:  Nat Rev Immunol       Date:  2010-08       Impact factor: 53.106

2.  Clinical guidelines: Classifying RA the 2010 way--what does it mean for the clinic?

Authors:  Annette H M van der Helm-van Mil
Journal:  Nat Rev Rheumatol       Date:  2011-01       Impact factor: 20.543

Review 3.  Treatment strategies in early rheumatoid arthritis and prevention of rheumatoid arthritis.

Authors:  M Kristen Demoruelle; Kevin D Deane
Journal:  Curr Rheumatol Rep       Date:  2012-10       Impact factor: 4.592

4.  Acute inflammatory arthritis: are glucocorticoids of benefit in very early arthritis?

Authors:  Klaus Machold
Journal:  Nat Rev Rheumatol       Date:  2010-04       Impact factor: 20.543

5.  The new 2010 ACR/EULAR criteria as predictor of clinical and radiographic response in patients with early arthritis.

Authors:  R B Mueller; M Schiff; T Kaegi; A Finckh; S R Haile; H Schulze-Koops; J von Kempis
Journal:  Clin Rheumatol       Date:  2014-07-15       Impact factor: 2.980

Review 6.  Rheumatoid arthritis in 2010: from the gut to the joint.

Authors:  Clemens Scheinecker; Josef S Smolen
Journal:  Nat Rev Rheumatol       Date:  2011-02       Impact factor: 20.543

Review 7.  Pre-rheumatoid arthritis and its prevention.

Authors:  Binoy J Paul; Hemanth Illath Kandy; Vinod Krishnan
Journal:  Eur J Rheumatol       Date:  2017-04-11

8.  Is there a place for nonbiological drugs in the treatment of rheumatoid arthritis?

Authors:  Alejandro Balsa; Miriam García-Arias
Journal:  Ther Adv Musculoskelet Dis       Date:  2010-12       Impact factor: 5.346

Review 9.  The epidemiology of early inflammatory arthritis.

Authors:  Johanna M W Hazes; Jolanda J Luime
Journal:  Nat Rev Rheumatol       Date:  2011-06-14       Impact factor: 20.543

Review 10.  Immunopathology alters Th17 cell glucocorticoid sensitivity.

Authors:  J Banuelos; Y Cao; S C Shin; N Z Lu
Journal:  Allergy       Date:  2016-10-13       Impact factor: 13.146

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