title: Information on glucocorticoid therapy in the main studies of biological agents.
abstract: OBJECTIVE
  To evaluate reported information on prednisone therapy in the main studies of biological agents used to treat rheumatoid arthritis (RA).
  
  
  METHODS
  We reviewed 66 publications (including four abstracts), including 11 studies of infliximab, 19 of etanercept, eight of adalimumab, five of golimumab, four of certolizumab, four of rituximab, eight of abatacept, and seven of tocilizumab.
  
  
  RESULTS
  Whether concomitant prednisone therapy was used, it was specified in only 56 (85%) of the 66 publications. Only 42 (64%) publications indicated that the prednisone dosage remained unchanged throughout the study. The maximum prednisone dosage allowed was specified in only 39 (59%) reports and was lower than 8 mg/day in only four (6%) studies. Data enabling determination of the mean daily prednisone dosage in prednisone-treated patients was available for only eight (12%) studies; the mean dosage ranged from 5.0 to 9 mg/day (mean, 7.1 ± 1.5). The percentage of patients receiving prednisone therapy was reported for only 41 (62%) studies. All the above-mentioned information was available in only two (3%) study reports. The percentage of patients on prednisone therapy ranged from 34% to 93% (mean, 58 ± 13%) overall and varied across biological agents as follows: abatacept, 74.4%; golimumab, 67.9%; infliximab, 60.6%; certolizumab, 57.5%; rituximab, 57.5%; etanercept, 54.4%; tocilizumab, 52.8%; and adalimumab, 50.4%. These percentages did not decline between 1997 and 2010.
  
  
  CONCLUSIONS
  Study reports provide inadequate information on prednisone therapy during biological treatment for RA.
authors.affiliation: Service de rhumatologie, Hôtel-Dieu, CHU de Nantes, place Alexis-Ricordeau, 44093 Nantes cedex 01, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: André
authors.forename: Benoît
authors.initials: B
authors.lastname: le Goff
authors.forename: Christophe
authors.initials: C
authors.lastname: Leux
authors.forename: Marianne
authors.initials: M
authors.lastname: Pot-Vaucel
authors.forename: Yves
authors.initials: Y
authors.lastname: Maugars
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Berthelot
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001691:Biological Therapy; D004359:Drug Therapy, Combination; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D005938:Glucocorticoids