title: Maintenance of improvement in spinal mobility, physical function and quality of life in patients with ankylosing spondylitis after 5 years in a clinical trial of adalimumab.
abstract: OBJECTIVE
  Chronic pain and progressive loss of physical function with AS may adversely affect health-related quality of life (HRQoL). The objective of this study was to assess the 5-year data regarding spinal mobility, physical function and HRQoL in patients with AS who participated in the Adalimumab Trial Evaluating Long-term Efficacy and Safety for AS (ATLAS) study.
  
  
  METHODS
  Patients received blinded adalimumab 40 mg or placebo every other week for 24 weeks, then open-label adalimumab for up to 5 years. Spinal mobility was evaluated using linear BASMI (BASMIlin). BASDAI, total back pain, CRP, BASFI, Short Form-36 and AS quality of life (ASQoL) were also assessed. Correlations between BASMIlin and clinical, functional and ASQoL outcomes after 12 weeks and after 5years of adalimumab exposure were evaluated using Spearman's rank correlation. Associations were further analysed using multivariate regression.
  
  
  RESULTS
  Three hundred and eleven patients received ≥1 dose of adalimumab; 125 of the 208 patients originally randomized to adalimumab received treatment for 5 years. Improvements in BASMIlin were sustained through 5 years, with a mean change of -0.6 from baseline in the population who completed 5 years of treatment with adalimumab. Improvements in disease activity, physical function and ASQoL were also sustained through 5 years. BASMIlin was significantly correlated with all evaluated clinical outcomes (P < 0.001). The highest correlation was with BASFI at 12 weeks (r = 0.52) and at 5 years (r = 0.65). Multivariate regression analysis confirmed this association (P < 0.001).
  
  
  CONCLUSIONS
  Treatment with adalimumab for up to 5 years demonstrated sustained benefits in spinal mobility, disease activity, physical function and HRQoL in patients with active AS. Spinal mobility was significantly associated with short- and long-term physical function in these patients.
  
  
  BACKGROUND
  Clinicaltrials.gov; https://clinicaltrials.gov/NCT00085644.
authors.affiliation: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA mail@dvanderheijde.nl.
authors.forename: Désirée
authors.initials: D
authors.lastname: van der Heijde
authors.affiliation: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
authors.forename: Maxime
authors.initials: M
authors.lastname: Breban
authors.affiliation: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
authors.forename: Dale
authors.initials: D
authors.lastname: Halter
authors.affiliation: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
authors.forename: Gino
authors.initials: G
authors.lastname: DiVittorio
authors.affiliation: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
authors.forename: Johan
authors.initials: J
authors.lastname: Bratt
authors.affiliation: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Cantini
authors.affiliation: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
authors.forename: Sonja
authors.initials: S
authors.lastname: Kary
authors.affiliation: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
authors.forename: Aileen L
authors.initials: AL
authors.lastname: Pangan
authors.affiliation: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
authors.forename: Hartmut
authors.initials: H
authors.lastname: Kupper
authors.affiliation: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
authors.forename: Suchitrita S
authors.initials: SS
authors.lastname: Rathmann
authors.affiliation: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
authors.forename: Joachim
authors.initials: J
authors.lastname: Sieper
authors.affiliation: Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, Rheumatology Division, Hôpital Ambroise Paré, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne-Billancourt Cedex, France, Houston Institute for Clinical Research, Houston, TX, Coastal Clinical Research, Inc., Mobile, AL, USA, Department of Rheumatology, Karolinska University Hospital, Huddinge, Sweden, Department of Rheumatology, Nuovo Ospedale S. Stefano, Prato, Italy, Pharmaceutical Development, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, Pharmaceutical Development, AbbVie, Data and Statistical Sciences, AbbVie, North Chicago, IL, USA, Department of Gastroenterology, Infectiology and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany and Rheumatology and Internal Medicine, Seattle Rheumatology Associates, Swedish Medical Center, University of Washington School of Medicine, Seattle, WA, USA.
authors.forename: Phillip J
authors.initials: PJ
authors.lastname: Mease
mesh_terms: D000068879:Adalimumab; D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000494:pharmacology / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009043:Motor Activity / Q000187:drug effects / Q000502:physiology*; D017063:Outcome Assessment, Health Care; D011788:Quality of Life / Q000523:psychology*; D016059:Range of Motion, Articular / Q000187:drug effects / Q000502:physiology*; D012720:Severity of Illness Index; D013131:Spine / Q000187:drug effects / Q000502:physiology*; D013167:Spondylitis, Ankylosing / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab
keywords: ankylosing spondylitis; anti-TNF drugs; health-related quality of life; physical function; spinal mobility