title: Efficacy of oral prednisolone in active ankylosing spondylitis: results of a double-blind, randomised, placebo-controlled short-term trial.
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.
authors.affiliation: Medical Department I, Rheumatology, Charité, Campus Benjamin Franklin Hospital, , Berlin, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Haibel
authors.forename: C
authors.initials: C
authors.lastname: Fendler
authors.forename: J
authors.initials: J
authors.lastname: Listing
authors.forename: J
authors.initials: J
authors.lastname: Callhoff
authors.forename: J
authors.initials: J
authors.lastname: Braun
authors.forename: J
authors.initials: J
authors.lastname: Sieper
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011239:Prednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D010919:Placebos; D011239:Prednisolone
keywords: Ankylosing Spondylitis; Corticosteroids; Disease Activity; Spondyloarthritis; Treatment