title: Comparison of high versus low-medium prednisone doses for the treatment of systemic lupus erythematosus patients with high activity at diagnosis.
abstract: OBJECTIVE
  To compare the efficacy and safety of high vs. low-moderate oral doses of prednisone to treat patients with highly active lupus at diagnosis.
  
  
  METHODS
  Patients from the Lupus-Cruces cohort with an SLEDAI score ≥6 at diagnosis and treated with regimes containing low-medium prednisone doses (≤30 mg/day) were identified (group M). They were matched by sex and SLEDAI score with historical patients treated with high doses (>30 mg/day) at diagnosis (group H). Patients with proliferative nephritis were excluded. The difference in SLEDAI scores between baseline (SLEDAI-0) and year one (SLEDAI-1) was the efficacy variable. Damage at 5 years was calculated using the SLICC damage index (SDI) and regarded as the safety variable. Glucocorticoid related damage was considered in the presence of cataracts, osteonecrosis, osteoporotic fractures and/or diabetes mellitus.
  
  
  RESULTS
  30 patients were included in each group. Patients in group H received 5-fold higher doses of prednisone, less hydroxychloroquine and less methyl-prednisolone pulses. SLEDAI improvement was similar in both groups. Patients in group H were more likely to accrue new damage (adjusted HR 3.85 (95% CI 1.03-14.2)). No patients in group M suffered glucocorticoid-related damage, vs. 5 patients in group H (p=0.02). The average daily prednisone dose during the first year predicted accrual of new damage (adjusted HR 1.03, 95% CI 1.0-1.07, p=0.056) and accrual of glucocorticoid-related damage (adjusted HR 1.06, 95% CI 1.01-1.13, p=0.03). Likewise, average doses of prednisone >7.5mg/day were an independent predictor of new damage (adjusted HR 4.8, 95% CI 1.2-19.1).
  
  
  CONCLUSIONS
  Prednisone doses ≤30 mg/day are similarly effective and safer than higher doses for treating active lupus.
authors.affiliation: Autoimmune Diseases Research Unit, Department Of Internal Medicine, Biocruces Health Research Institute, Hospital Universitario Cruces, University Of The Basque Country, Bizkaia, The Basque Country, Spain.
authors.forename: Ioana
authors.initials: I
authors.lastname: Ruiz-Arruza
authors.affiliation: Autoimmune Diseases Research Unit, Department Of Internal Medicine, Biocruces Health Research Institute, Hospital Universitario Cruces, University Of The Basque Country, Bizkaia, The Basque Country, Spain; Internal Medicine Department, Hospital De Viseu, Portugal.
authors.forename: Cristiana
authors.initials: C
authors.lastname: Barbosa
authors.affiliation: Autoimmune Diseases Research Unit, Department Of Internal Medicine, Biocruces Health Research Institute, Hospital Universitario Cruces, University Of The Basque Country, Bizkaia, The Basque Country, Spain.
authors.forename: Amaia
authors.initials: A
authors.lastname: Ugarte
authors.affiliation: Autoimmune Diseases Research Unit, Department Of Internal Medicine, Biocruces Health Research Institute, Hospital Universitario Cruces, University Of The Basque Country, Bizkaia, The Basque Country, Spain. Electronic address: r.irastorza@outlook.es.
authors.forename: Guillermo
authors.initials: G
authors.lastname: Ruiz-Irastorza
mesh_terms: D005938:Glucocorticoids / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D006886:Hydroxychloroquine / Q000627:therapeutic use; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis / Q000188:drug therapy*; D008775:Methylprednisolone / Q000627:therapeutic use; D011241:Prednisone / Q000008:administration & dosage* / Q000627:therapeutic use
chemical_list: D005938:Glucocorticoids; D006886:Hydroxychloroquine; D011241:Prednisone; D008775:Methylprednisolone
keywords: Activity; Avascular osteonecrosis; Cataracts; Damage; Diabetes mellitus; Glucocorticoids; Methyl-prednisolone; Osteoporosis; SLEDAI; Systemic lupus erythematosus