The Stop Arthritis Very Early (SAVE) trial, an international multicentre, randomised, double-blind, placebo-controlled trial on glucocorticoids in very early arthritis.
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.
Machold
Klaus P
KP
Medical University of Vienna, Vienna A-1090, Austria. klaus.machold@meduniwien.ac.at
Landewé
Robert
R
Smolen
Josef S
JS
Stamm
Tanja A
TA
van der Heijde
Désirée M
DM
Verpoort
Kirsten N
KN
Brickmann
Kerstin
K
Vázquez-Mellado
Janitzia
J
Karateev
Dimitri E
DE
Breedveld
Ferdinand C
FC
Emery
Paul
P
Huizinga
Thomas W J
TW
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D018501:Antirheumatic Agents / Q000008:administration & dosage*; D001168:Arthritis / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D004812:Epidemiologic Methods; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage*; D008875:Middle Aged; D012074:Remission Induction; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D018501:Antirheumatic Agents; D005938:Glucocorticoids; D008775:Methylprednisolone