title: Secukinumab and Sustained Improvement in Signs and Symptoms of Patients With Active Ankylosing Spondylitis Through Two Years: Results From a Phase III Study.
abstract: Secukinumab improved the signs and symptoms of ankylosing spondylitis (AS) over 52 weeks in the phase III MEASURE 2 study. Here, we report longer-term (104 weeks) efficacy and safety results.
  
  
  
  Patients with active AS were randomized to subcutaneous secukinumab 150 mg, 75 mg, or placebo at baseline; weeks 1, 2, and 3; and every 4 weeks from week 4. The primary end point was the Assessment of SpondyloArthritis international Society criteria for 20% improvement (ASAS20) response rate at week 16. Other end points included ASAS40, high-sensitivity C-reactive protein, ASAS5/6, Bath Ankylosing Spondylitis Disease Activity Index, Short Form 36 health survey physical component summary, ASAS partial remission, EuroQol 5-domain measure, and Functional Assessment of Chronic Illness Therapy fatigue subscale. End points were assessed through week 104, with multiple imputation for binary variables and a mixed-effects model repeated measures for continuous variables.
  
  
  
  Of 219 randomized patients, 60 of 72 (83.3%) and 57 of 73 (78.1%) patients completed 104 weeks of treatment with secukinumab 150 mg and 75 mg, respectively; ASAS20/ASAS40 response rates at week 104 were 71.5% and 47.5% with both secukinumab doses, respectively. Clinical improvements with secukinumab were sustained through week 104 across all secondary end points. Across the entire treatment period (mean secukinumab exposure 735.6 days), exposure-adjusted incidence rates for serious infections and infestations, Crohn's disease, malignant or unspecified tumors, and major adverse cardiac events with secukinumab were 1.2, 0.7, 0.5, and 0.7 per 100 patient-years, respectively. No cases of tuberculosis reactivation, opportunistic infections, or suicidal ideation were reported.
  
  
  
  Secukinumab provided sustained improvement through 2 years in the signs and symptoms of AS, with a safety profile consistent with previous reports.
authors.affiliation: Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
authors.forename: H
authors.initials: H
authors.lastname: Marzo-Ortega
authors.affiliation: University Clinic Benjamin Franklin, Berlin, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Sieper
authors.affiliation: Altoona Center for Clinical Research, Duncansville, Pennsylvania.
authors.forename: A
authors.initials: A
authors.lastname: Kivitz
authors.affiliation: Hospital Universitario Marqués de Valdecilla, ​Instituto de Investigación Marqués de Valdecilla-IDIVAL​, Santander, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Blanco
authors.affiliation: McGill University, Montreal, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Cohen
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
authors.forename: R
authors.initials: R
authors.lastname: Martin
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
authors.forename: A
authors.initials: A
authors.lastname: Readie
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: H B
authors.initials: HB
authors.lastname: Richards
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
authors.forename: B
authors.initials: B
authors.lastname: Porter
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D013167:Spondylitis, Ankylosing / Q000175:diagnosis* / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C555450:secukinumab