title: Glucocorticoid Effect on Radiographic Progression in Placebo Arms of Rheumatoid Arthritis Biologics Trials.
abstract: To assess the effect of glucocorticoids (GC) on damage progression in placebo-biologic arms of rheumatoid arthritis (RA) biologics trials.
  
  
  
  Posthoc metaanalysis of 2 infliximab (IFX) trials (established and early RA) and 1 tocilizumab (TCZ) trial (established RA).
  
  
  
  The proportion of patients receiving GC was 38%-64%, baseline damage was 11-82 Sharp/van der Heijde points, and progression in the placebo groups was 0.5-4.8 points in 6 months. In the pooled IFX studies, GC cotreatment reduced 6-month progression by 2.6 points (95% CI 0.6-4.5). In the TCZ study (progression rate 0.5 Genant points), no such difference was seen.
  
  
  
  GC cotreatment may affect results in RA trials.
authors.affiliation: From the Department of Epidemiology and Biostatistics, and Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, the Netherlands; Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria; Roche Products Ltd., Welwyn Garden City, UK; Janssen Research and Development, Spring House, Pennsylvania, USA.M. Boers, MD, PhD, MSc, Professor of Clinical Epidemiology, Department of Epidemiology and Biostatistics, VU University Medical Center; D. Aletaha, MD, MSc, Associate Professor of Medicine, Division of Rheumatology, Department of Medicine 3, Medical University of Vienna; C.M. Mela, PhD, MSc, BSc, Clinical Development Scientist, Roche Products Ltd.; D.G. Baker, MD, Vice President Immunology, Janssen Research and Development; J.S. Smolen, MD, Professor of Medicine, Division of Rheumatology, Department of Medicine 3, Medical University of Vienna. eb@vumc.nl.
authors.forename: Maarten
authors.initials: M
authors.lastname: Boers
authors.affiliation: From the Department of Epidemiology and Biostatistics, and Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, the Netherlands; Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria; Roche Products Ltd., Welwyn Garden City, UK; Janssen Research and Development, Spring House, Pennsylvania, USA.M. Boers, MD, PhD, MSc, Professor of Clinical Epidemiology, Department of Epidemiology and Biostatistics, VU University Medical Center; D. Aletaha, MD, MSc, Associate Professor of Medicine, Division of Rheumatology, Department of Medicine 3, Medical University of Vienna; C.M. Mela, PhD, MSc, BSc, Clinical Development Scientist, Roche Products Ltd.; D.G. Baker, MD, Vice President Immunology, Janssen Research and Development; J.S. Smolen, MD, Professor of Medicine, Division of Rheumatology, Department of Medicine 3, Medical University of Vienna.
authors.forename: Daniel
authors.initials: D
authors.lastname: Aletaha
authors.affiliation: From the Department of Epidemiology and Biostatistics, and Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, the Netherlands; Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria; Roche Products Ltd., Welwyn Garden City, UK; Janssen Research and Development, Spring House, Pennsylvania, USA.M. Boers, MD, PhD, MSc, Professor of Clinical Epidemiology, Department of Epidemiology and Biostatistics, VU University Medical Center; D. Aletaha, MD, MSc, Associate Professor of Medicine, Division of Rheumatology, Department of Medicine 3, Medical University of Vienna; C.M. Mela, PhD, MSc, BSc, Clinical Development Scientist, Roche Products Ltd.; D.G. Baker, MD, Vice President Immunology, Janssen Research and Development; J.S. Smolen, MD, Professor of Medicine, Division of Rheumatology, Department of Medicine 3, Medical University of Vienna.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Mela
authors.affiliation: From the Department of Epidemiology and Biostatistics, and Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, the Netherlands; Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria; Roche Products Ltd., Welwyn Garden City, UK; Janssen Research and Development, Spring House, Pennsylvania, USA.M. Boers, MD, PhD, MSc, Professor of Clinical Epidemiology, Department of Epidemiology and Biostatistics, VU University Medical Center; D. Aletaha, MD, MSc, Associate Professor of Medicine, Division of Rheumatology, Department of Medicine 3, Medical University of Vienna; C.M. Mela, PhD, MSc, BSc, Clinical Development Scientist, Roche Products Ltd.; D.G. Baker, MD, Vice President Immunology, Janssen Research and Development; J.S. Smolen, MD, Professor of Medicine, Division of Rheumatology, Department of Medicine 3, Medical University of Vienna.
authors.forename: Daniel G
authors.initials: DG
authors.lastname: Baker
authors.affiliation: From the Department of Epidemiology and Biostatistics, and Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, the Netherlands; Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria; Roche Products Ltd., Welwyn Garden City, UK; Janssen Research and Development, Spring House, Pennsylvania, USA.M. Boers, MD, PhD, MSc, Professor of Clinical Epidemiology, Department of Epidemiology and Biostatistics, VU University Medical Center; D. Aletaha, MD, MSc, Associate Professor of Medicine, Division of Rheumatology, Department of Medicine 3, Medical University of Vienna; C.M. Mela, PhD, MSc, BSc, Clinical Development Scientist, Roche Products Ltd.; D.G. Baker, MD, Vice President Immunology, Janssen Research and Development; J.S. Smolen, MD, Professor of Medicine, Division of Rheumatology, Department of Medicine 3, Medical University of Vienna.
authors.forename: Josef S
authors.initials: JS
authors.lastname: Smolen
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy*; D018450:Disease Progression; D004359:Drug Therapy, Combination; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab / Q000627:therapeutic use; D007596:Joints / Q000000981:diagnostic imaging*; D008727:Methotrexate / Q000627:therapeutic use; D010919:Placebos / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D005938:Glucocorticoids; D010919:Placebos; D000069285:Infliximab; C502936:tocilizumab; D008727:Methotrexate
keywords: BIOLOGICS; GLUCOCORTICOIDS; JOINT DAMAGE; METAANALYSIS; RHEUMATOID ARTHRITIS