title: Delayed-release prednisone improves fatigue and health-related quality of life: findings from the CAPRA-2 double-blind randomised study in rheumatoid arthritis.
abstract: OBJECTIVE
  Like morning stiffness, fatigue is a common, debilitating symptom of rheumatoid arthritis (RA). Delayed-release (DR) prednisone is designed for evening administration (approximately 22:00) and releases 4 h later to coincide with the rise of nocturnal inflammatory cytokines associated with development of morning stiffness. The impact of DR prednisone on fatigue and other related patient-reported outcomes was analysed with data obtained from the Circadian Administration of Prednisone in Rheumatoid Arthritis (CAPRA) 2 study.
  
  
  METHODS
  Patients with symptomatic RA (n=350) despite treatment with a disease-modifying antirheumatic drug (DMARD) were randomised 2:1 to receive additional therapy with DR prednisone 5 mg or placebo once daily for 12 weeks. Fatigue was assessed using validated instruments: the fatigue scale of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the vitality domain of the Short Form-36 (SF-36). General quality of life was assessed using the general score and individual domains of Functional Assessment of Cancer Therapy-General (FACT-G) and SF-36.
  
  
  RESULTS
  The change from baseline to week 12 in FACIT-F score was statistically significantly different with DR prednisone/DMARD (3.8) versus placebo/DMARD (1.6; difference 2.2, p=0.0032). Improvement in FACIT-F score correlated positively with clinical response. Compared with placebo/DMARD, DR prednisone/DMARD showed a significantly greater improvement in SF-36 vitality score (5.6, p=0.001), physical component of SF-36 (2.3, p=0.0003) and general score with FACT-G (2.6, p=0.0233).
  
  
  CONCLUSIONS
  DR prednisone in addition to a DMARD significantly improves fatigue and other aspects of health-related quality of life in patients with symptomatic RA compared with DMARD treatment alone.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00650078.
authors.affiliation: Schlosspark-Klinik, University Medicine Berlin , Berlin , Germany.
authors.forename: Rieke
authors.initials: R
authors.lastname: Alten
authors.affiliation: Horizon Pharma , Deerfield, Illinois , USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Grahn
authors.affiliation: University of Illinois-Chicago , Chicago, Illinois , USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Holt
authors.affiliation: Premier Research , Naperville, Illinois , USA.
authors.forename: Patricia
authors.initials: P
authors.lastname: Rice
authors.affiliation: Charité University Hospital , Berlin , Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Buttgereit
keywords: Corticosteroids; Patient perspective; Rheumatoid Arthritis