title: Effect of secukinumab on clinical and radiographic outcomes in ankylosing spondylitis: 2-year results from the randomised phase III MEASURE 1 study.
abstract: OBJECTIVE
  To evaluate the effect of secukinumab, an interleukin-17A inhibitor, on clinical signs and symptoms and radiographic changes through 2 years in patients with ankylosing spondylitis (AS).
  
  
  METHODS
  In the phase III MEASURE 1 study, patients were randomised to receive intravenous secukinumab 10 mg/kg (at baseline, week 2 and week 4) followed by subcutaneous secukinumab 150 mg (intravenous 150 mg; n=125) or 75 mg (intravenous 75 mg; n=124) every four weeks, or matched placebo (n=122). Placebo-treated patients were re-randomised to subcutaneous secukinumab 150 or 75 mg from week 16. Clinical efficacy assessments included Assessment of SpondyloArthritis international Society 20 (ASAS20) response rates through week 104. Radiographic changes at week 104 were assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS).
  
  
  RESULTS
  97 (77.6%) and 103 (83.1%) patients in the intravenous 150 mg and intravenous 75 mg groups, respectively, completed week 104. In the full analysis set (intent-to-treat), ASAS20 response rates at week 104 were 73.7% and 68.0% in the intravenous 150 mg and intravenous 75 mg groups, respectively. Among patients with evaluable X-rays who were originally randomised to secukinumab (n=168), mean change in mSASSS from baseline to week 104 was 0.30±2.53. Serious adverse events were reported in 12.2% and 13.4% of patients in the 150 mg and 75 mg groups, respectively.
  
  
  CONCLUSIONS
  Secukinumab improved AS signs and symptoms through 2 years of therapy, with no unexpected safety findings. Data from this study suggest a low mean progression of spinal radiographic changes, which will need to be confirmed in longer-term controlled studies.
  
  
  BACKGROUND
  NCT01358175.
authors.affiliation: Department of Rheumatology, Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Braun
authors.affiliation: Department of Rheumatology, Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Herne, Germany.
authors.forename: Xenofon
authors.initials: X
authors.lastname: Baraliakos
authors.affiliation: Division of Arthritis/Rheumatic Diseases (OPO9), Oregon Health & Science University, Portland, Oregon, USA.
authors.forename: Atul
authors.identifier: http://orcid.org/0000-0002-2130-1246
authors.initials: A
authors.lastname: Deodhar
authors.affiliation: Department of Clinical Immunology and Rheumatology, Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Dominique
authors.initials: D
authors.lastname: Baeten
authors.affiliation: Charité University Medicine Berlin, Berlin, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Sieper
authors.affiliation: Leeds Musculoskeletal Biomedical Research Unit/Institute Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.affiliation: Department of Immunology and Dermatology, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors.forename: Aimee
authors.initials: A
authors.lastname: Readie
authors.affiliation: Department of Immunology and Dermatology, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors.forename: Ruvie
authors.initials: R
authors.lastname: Martin
authors.affiliation: Department of Immunology and Dermatology, Novartis Pharma AG, Basel, Switzerland.
authors.forename: Shephard
authors.initials: S
authors.lastname: Mpofu
authors.affiliation: Department of Immunology and Dermatology, Novartis Pharma AG, Basel, Switzerland.
authors.forename: Hanno B
authors.initials: HB
authors.lastname: Richards
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002177:Candidiasis / Q000139:chemically induced; D003424:Crohn Disease / Q000139:chemically induced; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D011565:Psoriasis / Q000139:chemically induced; D011859:Radiography; D013167:Spondylitis, Ankylosing / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D063189:Symptom Assessment; D014605:Uveitis / Q000139:chemically induced
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; C555450:secukinumab
keywords: Ankylosing Spondylitis; DMARDs (biologic); Inflammation; Spondyloarthritis; Treatment