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  • Beneficial effects of a 3-week course of intramuscular glucocorticoid injections in patients with very early inflammatory polyarthritis: results of the STIVEA trial

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Clinical and epidemiological research
Extended report
Beneficial effects of a 3-week course of intramuscular glucocorticoid injections in patients with very early inflammatory polyarthritis: results of the STIVEA trial
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  1. S M M Verstappen1,
  2. M J McCoy1,
  3. C Roberts2,
  4. N E Dale1,
  5. A B Hassell3,
  6. D P M Symmons1
  1. 1arc Epidemiology Unit, Manchester Academic Health Sciences Centre, University of Manchester, Manchester, UK
  2. 2Department of Biostatistics, Manchester Academic Health Sciences Centre, University of Manchester, Manchester, UK
  3. 3arc National Primary Care Centre, Keele University, Keele, Staffs, UK and Department of Rheumatology, Haywood Hospital, Stoke-on-Trent, UK
  1. Correspondence to Professor D P M Symmons, arc Epidemiology Unit, Stopford Building, The University of Manchester, Manchester M13 9PT, UK; deborah.symmons{at}manchester.ac.uk

Abstract

Objective To evaluate whether treating patients with very early inflammatory polyarthritis (IP) with a 3-week course of intramuscular (IM) methylprednisolone acetate may postpone the need for disease-modifying antirheumatic drugs (DMARDs) and prevent IP from evolving into rheumatoid arthritis (RA).

Methods Patients with very early IP (4–10 weeks’ duration) were randomised to receive three injections of either 80 mg IM methylprednisolone acetate or placebo, given at weekly intervals. Assessments were monthly until 6 months after the first injection, and then concluded at 12 months. The primary outcome was the need to start DMARDs by the 6-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 6 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 10 patients from progressing into RA.

https://doi.org/10.1136/ard.2009.119149

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    Footnotes

    • Funding This study was funded by the Arthritis Research Campaign UK. Costs for methylprednisolone acetate were covered by Pfizer Ltd.

    • Competing interests None.

    • Ethics approval Approval from the North West Research Ethics Committee, UK.

    • Current working address MJM—The University of Western Australia, School of Medicine and Pharmacology, 4th Floor G Block, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands, WA 6009, Australia.

    • The STIVEA investigators are Cannock Chase Hospital Cannock, Dr Diarmuid Mulherin; Haywood Hospital, Stoke-on-Trent, Dr PT Dawes; Macclesfield District General Hospital, Dr Susan Knight; Kings College Hospital London, Professor David Scott; Royal Cornwall Hospital Truro, Dr Martin Davis; Stepping Hill Hospital Stockport, Dr Jeff Marks; Manchester Royal Infirmary Manchester, Dr Ian Bruce; Russells Hall Hospital Dudley, Professor George Kitas; Hope Hospital Salford, Dr Terry O’Neill; Royal Lancaster Infirmary Lancaster, Dr Marwan Bukhari; Norfolk and Norwich University Hospital Norwich, Dr Karl Gaffney; City Hospital Birmingham Birmingham, Dr Karim Raza; Freeman Hospital Newcastle, Dr Lesley Kay; Queen Elizabeth Hospital Gateshead, Dr Clive Kelly and Dr Vadivelu Saravanan; Nevill Hall Hospital Abergavenny, Dr Stuart Linton; Taunton and Somerset Hospital Taunton, Dr Cathy Laversuch; St Helen’s Hospital St Helens, Dr Rikki Abernethy; Harold Wood Hospital Romford, Professor Kuntal Chakravarty; Poole General Hospital Poole, Dr Selwyn Richards; St Georges Hospital Tooting, Dr Brian Bourke; The Queen Elizabeth The Queen Mother Hospital Margate, Dr Alison Leak; East Surrey Hospital Redhill, Dr Raad Makadsi; Ysbyty Gwynedd Bangor, Professor Peter Maddison.

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