title: The effect of golimumab therapy on disease activity and health-related quality of life in patients with ankylosing spondylitis: 2-year results of the GO-RAISE trial.
abstract: OBJECTIVE
  To evaluate the effects of golimumab therapy on achieving inactive disease or major improvement, as assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS), and improvements in health-related quality of life (HRQOL) and productivity through 2 years in patients with AS.
  
  
  METHODS
  In the phase III GO-RAISE trial, 356 patients were randomized to placebo with crossover to golimumab 50 mg at Week 24 (n = 78), golimumab 50 mg (n = 138), or golimumab 100 mg (n = 140) at baseline and every 4 weeks. The proportions of patients with ASDAS major improvement (improvement ≥ 2.0) or inactive disease (score < 1.3) were determined. HRQOL was assessed using the 36-item Medical Outcomes Study Short Form-36 physical/mental component summary (SF-36 PCS/MCS) scores (normal score ≥ 50). The effect of disease on productivity was assessed by visual analog scale (0-10). Regression analyses on the association of disease activity and HRQOL were performed. The final assessment was at Week 104.
  
  
  RESULTS
  Significantly greater proportions of golimumab-treated patients achieved ASDAS major improvement or inactive disease at weeks 14 and 24 versus placebo. Through Week 104, patients who achieved ASDAS inactive disease or major improvement had significantly greater improvements in SF-36 PCS and MCS scores and productivity than did patients not meeting these targets. Among all patients, achieving ASDAS inactive disease at weeks 52 and 104 was associated with normalized SF-36 PCS/MCS scores and significant improvements in work productivity.
  
  
  CONCLUSIONS
  Greater proportions of golimumab-treated patients achieved ASDAS major improvement or inactive disease and improved HRQOL versus placebo. Achieving an inactive disease state by ASDAS criteria (< 1.3) was associated with normalized HRQOL through 2 years.
authors.affiliation: From the Rheumatology Department, Leiden University Medical Center, Leiden, The Netherlands; Oregon Health and Science University, Portland, Oregon, USA; Rheumazentrum Ruhrgebiet, Herne, Germany; Biostatistics and Immunology, Janssen Research & Development LLC, Spring House; Janssen Global Services, Malvern, Pennsylvania, USA; Department of Medicine and Immunology, University of Toronto, Toronto, Ontario, Canada.D. van der Heijde, MD, Rheumatology Department, Leiden University Medical Center; A. Deodhar, MD, Oregon Health & Science University; J. Braun, MD, Rheumazentrum Ruhrgebiet; M. Mack, PhD, Biostatistics, Janssen Research & Development LLC; B. Hsu, MD, PhD, Immunology, Janssen Research & Development LLC; T.A. Gathany, MSEd, Janssen Global Services; R.D. Inman, MD, FRCPC, FACP, FRCP Edin, Department of Medicine and Immunology, University of Toronto; C. Han, PhD, Janssen Global Services. d.vanderheijde@kpnplanet.nl.
authors.forename: Désirée
authors.initials: D
authors.lastname: van der Heijde
authors.affiliation: From the Rheumatology Department, Leiden University Medical Center, Leiden, The Netherlands; Oregon Health and Science University, Portland, Oregon, USA; Rheumazentrum Ruhrgebiet, Herne, Germany; Biostatistics and Immunology, Janssen Research & Development LLC, Spring House; Janssen Global Services, Malvern, Pennsylvania, USA; Department of Medicine and Immunology, University of Toronto, Toronto, Ontario, Canada.D. van der Heijde, MD, Rheumatology Department, Leiden University Medical Center; A. Deodhar, MD, Oregon Health & Science University; J. Braun, MD, Rheumazentrum Ruhrgebiet; M. Mack, PhD, Biostatistics, Janssen Research & Development LLC; B. Hsu, MD, PhD, Immunology, Janssen Research & Development LLC; T.A. Gathany, MSEd, Janssen Global Services; R.D. Inman, MD, FRCPC, FACP, FRCP Edin, Department of Medicine and Immunology, University of Toronto; C. Han, PhD, Janssen Global Services.
authors.forename: Atul
authors.initials: A
authors.lastname: Deodhar
authors.affiliation: From the Rheumatology Department, Leiden University Medical Center, Leiden, The Netherlands; Oregon Health and Science University, Portland, Oregon, USA; Rheumazentrum Ruhrgebiet, Herne, Germany; Biostatistics and Immunology, Janssen Research & Development LLC, Spring House; Janssen Global Services, Malvern, Pennsylvania, USA; Department of Medicine and Immunology, University of Toronto, Toronto, Ontario, Canada.D. van der Heijde, MD, Rheumatology Department, Leiden University Medical Center; A. Deodhar, MD, Oregon Health & Science University; J. Braun, MD, Rheumazentrum Ruhrgebiet; M. Mack, PhD, Biostatistics, Janssen Research & Development LLC; B. Hsu, MD, PhD, Immunology, Janssen Research & Development LLC; T.A. Gathany, MSEd, Janssen Global Services; R.D. Inman, MD, FRCPC, FACP, FRCP Edin, Department of Medicine and Immunology, University of Toronto; C. Han, PhD, Janssen Global Services.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Braun
authors.affiliation: From the Rheumatology Department, Leiden University Medical Center, Leiden, The Netherlands; Oregon Health and Science University, Portland, Oregon, USA; Rheumazentrum Ruhrgebiet, Herne, Germany; Biostatistics and Immunology, Janssen Research & Development LLC, Spring House; Janssen Global Services, Malvern, Pennsylvania, USA; Department of Medicine and Immunology, University of Toronto, Toronto, Ontario, Canada.D. van der Heijde, MD, Rheumatology Department, Leiden University Medical Center; A. Deodhar, MD, Oregon Health & Science University; J. Braun, MD, Rheumazentrum Ruhrgebiet; M. Mack, PhD, Biostatistics, Janssen Research & Development LLC; B. Hsu, MD, PhD, Immunology, Janssen Research & Development LLC; T.A. Gathany, MSEd, Janssen Global Services; R.D. Inman, MD, FRCPC, FACP, FRCP Edin, Department of Medicine and Immunology, University of Toronto; C. Han, PhD, Janssen Global Services.
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.affiliation: From the Rheumatology Department, Leiden University Medical Center, Leiden, The Netherlands; Oregon Health and Science University, Portland, Oregon, USA; Rheumazentrum Ruhrgebiet, Herne, Germany; Biostatistics and Immunology, Janssen Research & Development LLC, Spring House; Janssen Global Services, Malvern, Pennsylvania, USA; Department of Medicine and Immunology, University of Toronto, Toronto, Ontario, Canada.D. van der Heijde, MD, Rheumatology Department, Leiden University Medical Center; A. Deodhar, MD, Oregon Health & Science University; J. Braun, MD, Rheumazentrum Ruhrgebiet; M. Mack, PhD, Biostatistics, Janssen Research & Development LLC; B. Hsu, MD, PhD, Immunology, Janssen Research & Development LLC; T.A. Gathany, MSEd, Janssen Global Services; R.D. Inman, MD, FRCPC, FACP, FRCP Edin, Department of Medicine and Immunology, University of Toronto; C. Han, PhD, Janssen Global Services.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Hsu
authors.affiliation: From the Rheumatology Department, Leiden University Medical Center, Leiden, The Netherlands; Oregon Health and Science University, Portland, Oregon, USA; Rheumazentrum Ruhrgebiet, Herne, Germany; Biostatistics and Immunology, Janssen Research & Development LLC, Spring House; Janssen Global Services, Malvern, Pennsylvania, USA; Department of Medicine and Immunology, University of Toronto, Toronto, Ontario, Canada.D. van der Heijde, MD, Rheumatology Department, Leiden University Medical Center; A. Deodhar, MD, Oregon Health & Science University; J. Braun, MD, Rheumazentrum Ruhrgebiet; M. Mack, PhD, Biostatistics, Janssen Research & Development LLC; B. Hsu, MD, PhD, Immunology, Janssen Research & Development LLC; T.A. Gathany, MSEd, Janssen Global Services; R.D. Inman, MD, FRCPC, FACP, FRCP Edin, Department of Medicine and Immunology, University of Toronto; C. Han, PhD, Janssen Global Services.
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Gathany
authors.affiliation: From the Rheumatology Department, Leiden University Medical Center, Leiden, The Netherlands; Oregon Health and Science University, Portland, Oregon, USA; Rheumazentrum Ruhrgebiet, Herne, Germany; Biostatistics and Immunology, Janssen Research & Development LLC, Spring House; Janssen Global Services, Malvern, Pennsylvania, USA; Department of Medicine and Immunology, University of Toronto, Toronto, Ontario, Canada.D. van der Heijde, MD, Rheumatology Department, Leiden University Medical Center; A. Deodhar, MD, Oregon Health & Science University; J. Braun, MD, Rheumazentrum Ruhrgebiet; M. Mack, PhD, Biostatistics, Janssen Research & Development LLC; B. Hsu, MD, PhD, Immunology, Janssen Research & Development LLC; T.A. Gathany, MSEd, Janssen Global Services; R.D. Inman, MD, FRCPC, FACP, FRCP Edin, Department of Medicine and Immunology, University of Toronto; C. Han, PhD, Janssen Global Services.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Inman
authors.affiliation: From the Rheumatology Department, Leiden University Medical Center, Leiden, The Netherlands; Oregon Health and Science University, Portland, Oregon, USA; Rheumazentrum Ruhrgebiet, Herne, Germany; Biostatistics and Immunology, Janssen Research & Development LLC, Spring House; Janssen Global Services, Malvern, Pennsylvania, USA; Department of Medicine and Immunology, University of Toronto, Toronto, Ontario, Canada.D. van der Heijde, MD, Rheumatology Department, Leiden University Medical Center; A. Deodhar, MD, Oregon Health & Science University; J. Braun, MD, Rheumazentrum Ruhrgebiet; M. Mack, PhD, Biostatistics, Janssen Research & Development LLC; B. Hsu, MD, PhD, Immunology, Janssen Research & Development LLC; T.A. Gathany, MSEd, Janssen Global Services; R.D. Inman, MD, FRCPC, FACP, FRCP Edin, Department of Medicine and Immunology, University of Toronto; C. Han, PhD, Janssen Global Services.
authors.forename: Chenglong
authors.initials: C
authors.lastname: Han
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C529000:golimumab
keywords: ANKYLOSING SPONDYLITIS; ASDAS; GOLIMUMAB; HEALTH-RELATED QUALITY OF LIFE; PRODUCTIVITY