The beneficial effects of a 3 week course of intramuscular glucocorticoid injections in patients with very early inflammatory polyarthritis: Results of the STIVEA trial
- 1 arc Epidemiology Unit, the University of Manchester, Manchester, United Kingdom;
- 2 Department of Statistics, the University of Manchester, Manchester, United Kingdom;
- 3 arc National Primary Care Centre, Keele University, Keele, United Kingdom
- Correspondence to: Deborah Symmons, ARC Epidemiology Unit, University of Manchester, Stopford Building, Oxford Road, Manchester, M13 9PT, United Kingdom;
- Received 20 July 2009
- Accepted 17 September 2009
- Published Online First 12 October 2009
Objective: To evaluate whether treating patients with very early inflammatory arthritis (IP) with a 3 week course of IM methylprednisolone-acetate would postpone the need for Disease Modifying Anti-Rheumatic Drugs (DMARDs) and could prevent IP from evolving into rheumatoid arthritis (RA).
Methods: Patients with very early IP (4-10 weeks duration) were randomised to receive 3 injections of either 80 mg IM methylprednisolone-acetate or placebo, given at weekly intervals. Assessments were monthly until six months after the first injection, and then concluded at 12 months. The primary outcome was the need to start DMARDs by the six month assessment. Secondary outcomes included disease activity and final clinical diagnosis by the rheumatologist at 12 months.
Results: Patients in the placebo group (76%) were more likely to need DMARDs during the first six months of the trial than patients in the glucocorticoid group (61%) (adjusted OR: 2.11, 95%CI 1.16 to 3.85, p=0.015). Disease activity did not differ between the two groups at 12 months, probably because many patients in the placebo group started DMARDs early in the study. After 12 months, the arthritis had resolved without the need for DMARDs in 9.9% (11/111) of the patients in the placebo group and in 19.8% (22/111) in the glucocorticoid treated group (adjusted OR: 0.42, 95%CI 0.18 to 0.99, p=0.048).
Conclusion: Treatment of patients with very early IP with IM methylprednisolone-acetate appears to postpone the prescription of DMARDs and prevent one in ten patients from progressing into RA.