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Efficacy of oral prednisolone in active ankylosing spondylitis: results of a double-blind, randomised, placebo-controlled short-term trial
  1. H Haibel1,
  2. C Fendler2,
  3. J Listing3,
  4. J Callhoff3,
  5. J Braun2,
  6. J Sieper1,3
  1. 1Medical Department I, Rheumatology, Charité, Campus Benjamin Franklin Hospital, Berlin, Germany
  2. 2Centre of Rheumatology, Herne, Germany
  3. 3German Rheumatism Research Centre, Berlin, Germany
  1. Correspondence to Dr Hildrun Haibel, Medical Department I, Rheumatology, Charité, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin 12200, Germany; hildrun.haibel{at}charite.de

Abstract

Background The efficacy of oral prednisolone in patients with active ankylosing spondylitis (AS) has not been studied to date.

Methods In this double-blind, randomised, placebo-controlled trial, patients with AS with active disease despite taking non-steroidal antirheumatic drugs were randomised to three groups in which they were either treated with 20 mg (n=13) or 50 mg (n=12) of prednisolone, or placebo (n=14), administered orally every day for a total of 2 weeks. The primary endpoint was defined as a 50% improvement of the Bath AS Disease Activity Index (BASDAI) at week 2.

Results The primary endpoint was reached in 33% and 27% of the patients treated with 50 and 20 mg of prednisolone, respectively, versus only 8% on placebo (p=0.16 and p=0.30). However, the mean improvement of BASDAI score was significantly higher in the 50 mg prednisolone compared to the placebo group (2.39±0.5 vs 0.66±0.49, p=0.03), while there was only a small change in the 20 mg group (1.19±0.53; p=0.41). The results for other outcome parameters were similar.

Conclusions Oral prednisolone 50 mg per day, but not low dose prednisolone, showed a short-term response that was significantly higher than placebo. The clinical significance and the duration of this effect warrant further study.

ClinicalTrials.gov Identifier NCT00244166

  • Ankylosing Spondylitis
  • Corticosteroids
  • Disease Activity
  • Spondyloarthritis
  • Treatment

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