Low-dose modified-release prednisone in axial spondyloarthritis: 3-month efficacy and tolerability

• Published in: Drug design, development and therapy Vol. 10; pp. 3717 - 3724
• Main Authors: Bandinelli, Francesca, Scazzariello, Francesco, Pimenta da Fonseca, Emanuela, Mittermayer Barreto, Santiago, Marcassa, Claudio, Nacci, Francesca, Matucci Cerinic, Marco
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2016; Taylor & Francis Ltd; Dove Medical Press
• Subjects: Adult; Aged; Aged, 80 and over; Ankylosing spondylitis; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - adverse effects; Arthritis; Cohort Studies; Controlled release technology; Cytokines; Dosage and administration; Drug dosages; Drug therapy; Female; Glucocorticoids; Humans; Immune system; Inflammation; Inflammatory bowel disease; Inflammatory diseases; Male; Middle Aged; modified-release prednisone; morning stiffness; Nonsteroidal anti-inflammatory drugs; Original Research; Pain; Pain - drug therapy; Prednisolone; Prednisone; Prednisone - administration & dosage; Prednisone - adverse effects; Retrospective Studies; Rheumatic diseases; Rheumatoid arthritis; Rheumatology; Safety; Short term; Side effects; Signs and symptoms; Spondylarthritis - drug therapy; Spondylarthritis - physiopathology; Spondylitis; Spondylitis, Ankylosing - drug therapy; Spondylitis, Ankylosing - physiopathology; spondyloarthritis; Spondyloarthropathies; Stiffness; Substance abuse treatment; Testing; Tumor necrosis factor-TNF; Italy; modified-release prednisone; spondyloarthritis; glucocorticoids; morning stiffness
• ISSN: 1177-8881; 1177-8881
• DOI: 10.2147/DDDT.S115099

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. 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. 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, <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. 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.