Désirée van der Heijde1, Atul Deodhar2, Jürgen Braun2, Michael Mack2, Benjamin Hsu2, Timothy A Gathany2, Robert D Inman2, Chenglong Han2. 1. 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. 2. 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.
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. CONCLUSION: 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.
RCT Entities:
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. CONCLUSION: 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.
Entities:
Keywords:
ANKYLOSING SPONDYLITIS; ASDAS; GOLIMUMAB; HEALTH-RELATED QUALITY OF LIFE; PRODUCTIVITY
Authors: Panagiotis Athanassiou; Anastasios Kotrotsios; Ioannis Kallitsakis; Andreas Bounas; Theodoros Dimitroulas; Alexandros Garyfallos; Maria G Tektonidou; Giorgos Vosvotekas; Achilleas Livieratos; Evangelia Petrikkou; Gkikas Katsifis Journal: Qual Life Res Date: 2021-11-28 Impact factor: 4.147