title: Low-dose modified-release prednisone in axial spondyloarthritis: 3-month efficacy and tolerability.
abstract: BACKGROUND
  Oral glucocorticoids (GCs) have been shown to be effective in reducing the inflammatory symptoms of rheumatoid arthritis, but their use is not supported by evidence in spondyloarthritis (SpA). Modified-release (MR) oral prednisone taken at bedtime has been shown to be more effective than immediate-release prednisone taken in the morning. The efficacy of low-dose MR prednisolone in patients with SpA is unknown.
  
  
  METHODS
  This single-center cohort study retrospectively assessed the effectiveness and safety of 12-week low-dose MR prednisone (5 mg daily, bedtime administration) in GC-naïve adult patients with symptomatic axial SpA. A 50% improvement of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) or a final BASDAI score of <4 according to disease activity at baseline was chosen as the primary outcome parameter after MR prednisone.
  
  
  RESULTS
  Fifty-seven patients were evaluated; of them, 41 had an active disease (BASDAI score of ≥4) at baseline. MR prednisone significantly reduced BASDAI (from 5.5±2.6 to 3.0±2.8,P<0.001) as well as inflammatory symptoms, pain, fatigue and morning stiffness. The overall response rate after MR prednisone was 52.6% (53.7% in patients with active SpA and 50.0% in patients with low-active disease; nonsignificant). At multivariable analysis, none of the considered clinical findings independently predicted the response to MR prednisone in subjects with active SpA. Overall, seven patients (11.8%) had nonserious adverse drug reactions after MR prednisone.
  
  
  CONCLUSIONS
  In patients with symptomatic SpA and naïve to GCs, low-dose MR prednisone reduced the symptoms and clinical indexes of disease activity and showed a positive safety profile.
authors.affiliation: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Bandinelli
authors.affiliation: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Scazzariello
authors.affiliation: Service of Rheumatology, Hospital Santa Isabel, Escola de Medicina e Saúde Pública, Bahia, Brazil.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Pimenta da Fonseca
authors.affiliation: Service of Rheumatology, Hospital Santa Isabel, Escola de Medicina e Saúde Pública, Bahia, Brazil.
authors.forename: Mittermayer
authors.initials: M
authors.lastname: Barreto Santiago
authors.affiliation: Maugeri Clinical and Scientific Institutes, IRCCS, Veruno, Novara, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Marcassa
authors.affiliation: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Nacci
authors.affiliation: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Matucci Cerinic
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy; D011241:Prednisone / Q000008:administration & dosage* / Q000009:adverse effects; D012189:Retrospective Studies; D025241:Spondylarthritis / Q000188:drug therapy* / Q000503:physiopathology; D013167:Spondylitis, Ankylosing / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D000893:Anti-Inflammatory Agents; D011241:Prednisone
keywords: glucocorticoids; modified-release prednisone; morning stiffness; spondyloarthritis