A randomised placebo controlled 12 week trial of budesonide and prednisolone in rheumatoid arthritis
- J R Kirwan1,
- R Hällgren2,
- H Mielants3,
- F Wollheim4,
- E Bjorck5,
- T Persson5,
- C Book6,
- S Bowman7,
- M Byron8,
- N Cox9,
- M Field10,
- L Kanerud11,
- M Leirisalo-Repo4,
- M Malaise12,
- A Mohammad2,
- R Palmer13,
- I F Petersson14,
- B Ringertz15,
- P Sheldon16,
- M Simonsson,
- N Snowden17,
- F Van den Bosch3
- 1Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK
- 2Department of Rheumatology, Akademiska Sjukhuset, Uppsala, Sweden
- 3Department of Rheumatology, University Hospital of Gent, Gent, Belgium
- 4Department of Rheumatology, Lund University Hospital, Lund, Sweden
- 5Astrazeneca R&D Lund, Sweden
- 6Department of Rheumatology, Universitetssjukhuset MAS, Malmö, Sweden
- 7Department of Rheumatology, Birmingham Heartlands and Solihull Hospital NHS Trust, Birmingham, UK
- 8Department of Rheumatology, Weston General Hospital, Weston Super Mare, Avon, UK
- 9Department of Rheumatology, Royal Hants County Hospital, Winchester, Hampshire, UK
- 10Centre for Rheumatic Diseases, University Department of Medicine, Glasgow Royal Infirmary, Glasgow, UK
- 11Department of Rheumatology, Huddinge University Hospital, Huddinge, Sweden
- 12Department of Rheumatology, CHU Sart-Tilman-Bat B35, Liège, Belgium
- 13Rheumatology Clinic, Solihull Hospital, Solihull, West Midlands, UK
- 14Spenshult, S-313 92 Oskarsström, Sweden
- 15Department of Rheumatology, Karolinska Sjukhuset, Stockholm, Sweden
- 16Department of Rheumatology, Leicester Royal Infirmary, Leicester, UK
- 17Department of Rheumatology, North Manchester General Hospital, Manchester, UK
- Correspondence to:
Dr John R Kirwan
Academic Rheumatology Unit, University Division of Medicine, Bristol Royal Infirmary, Bristol BS2 8HW, UK; john.kirwanbristol.ac.uk
- Accepted 29 June 2003
Abstract
Objectives: To compare budesonide, a locally acting glucocorticoid with minimal systemic exposure, with conventional glucocorticoid treatment and placebo in rheumatoid arthritis.
Methods: A double blind, randomised, controlled trial over 12 weeks in 143 patients with active rheumatoid arthritis, comparing budesonide 3 mg daily, budesonide 9 mg daily, prednisolone 7.5 mg daily, and placebo. Particular attention was paid to the pattern of clinical response and to changes in the four week period following discontinuation of treatment.
Results: There were improvements in tender joint count and swollen joint count on budesonide 9 mg compared with placebo (28% for tender and 34% for swollen joint counts, p<0.05). Prednisolone 7.5 mg gave similar results, while budesonide 3 mg was less effective. ACR20 response criteria were met by 25% of patients on placebo, 22% on budesonide 3 mg, 42% on budesonide 9 mg, and 56% on prednisolone 7.5 mg. A rapid and significant reduction in symptoms and signs in response to budesonide 9 mg and prednisolone 7.5 mg was evident by two weeks and maximal at eight weeks. There was no evidence that budesonide provided a different pattern of symptom control from prednisolone, or that symptoms became worse than placebo treatment levels after discontinuation of glucocorticoid treatment. Adverse effects attributable to glucocorticoids were equally common in all groups.
Conclusions: The symptomatic benefits of budesonide 9 mg and prednisolone 7.5 mg are achieved within a short time of initiating treatment, are maintained for three months, and are not associated with any rebound in symptoms after stopping treatment.
