title: Low-dose oral prednisone improves clinical and ultrasonographic remission rates in early rheumatoid arthritis: results of a 12-month open-label randomised study.
abstract: BACKGROUND
  In early rheumatoid arthritis (RA), low-dose oral prednisone (PDN) co-medication yields better clinical results than monotherapy with disease-modifying anti-rheumatic drugs (DMARDs). In addition, ultrasonography (US) evaluation reveals rapid and significant effects of glucocorticosteroids on subclinical synovitis. No data currently exist that examine the clinical and US results offered by glucocorticoid co-medication over DMARD monotherapy in early RA patients.
  
  
  METHODS
  Two hundred and twenty patients with early RA (< 1 year from clinical onset) were treated according to a low disease activity (LDA) targeted step-up protocol including methotrexate (MTX) and, in the active treatment arm, low-dose (6.25 mg/day) oral PDN over 12 months. Clinical disease activity measures were collected at baseline, 2, 4, 6, 9 and 12 months, and US examination of hands was performed at baseline, 6 and 12 months. Grey-scale and power Doppler (PD) synovitis were scored (0 to 3) for each joint. At 12 months, clinical remission according to the disease activity score among 28 joints was defined as the clinical outcome, and a total joint PD score of 0 (PD negativity) as the imaging outcome.
  
  
  RESULTS
  Each group included 110 patients with comparable demographic, clinical, laboratory and US characteristics. At 12 months, the LDA rate was similar in the two groups, whilst the clinical remission rate (risk ratio = 1.61 (95% confidence interval = 1.08, 2.04)) and PD negativity rate (risk ratio = 1.31 (95% confidence interval = 1.04, 1.64)) were significantly higher in the MTX+PDN group.
  
  
  CONCLUSIONS
  In early RA, despite a similar response rate in terms of LDA, low-dose oral PDN co-medication led to a higher proportion of clinical remission and PD negativity compared with MTX monotherapy, thus ensuring a better disease activity control.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN2486111.
authors.affiliation: Division of Rheumatology, IRCCS Policlinico S, Matteo Foundation, University of Pavia, Piazzale Golgi 2, 27100 Pavia, Italy. montecucco@smatteo.pv.it
authors.forename: Carlomaurizio
authors.initials: C
authors.lastname: Montecucco
authors.forename: Monica
authors.initials: M
authors.lastname: Todoerti
authors.forename: Garifallia
authors.initials: G
authors.lastname: Sakellariou
authors.forename: Carlo Alberto
authors.initials: CA
authors.lastname: Scirè
authors.forename: Roberto
authors.initials: R
authors.lastname: Caporali
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage* / Q000009:adverse effects; D012074:Remission Induction; D016896:Treatment Outcome; D014463:Ultrasonography
chemical_list: D000893:Anti-Inflammatory Agents; D011241:Prednisone; D008727:Methotrexate