title: Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study.
abstract: To report on the 5-year efficacy and safety results of the AMBITION (Actemra versus Methotrexate double-Blind Investigative Trial In mONotherapy) monotherapy study (ClinicalTrials.gov: NCT00109408, NCT00720798).
  
  
  
  Patients with rheumatoid arthritis for whom biologics had not failed or who did not discontinue methotrexate because of lack of efficacy or tolerability were followed up for 5 years to assess the efficacy and serious adverse events (SAE) of tocilizumab (TCZ) monotherapy.
  
  
  
  Longterm efficacy results showed that efficacy was maintained or improved for up to 264 weeks in patients receiving TCZ monotherapy. Serious infection was the most frequent SAE; no new safety signals were reported.
  
  
  
  Longterm monotherapy with TCZ demonstrated continuing efficacy and safety.
authors.affiliation: From the Menzies Research Institute, University of Tasmania, Hobart, Australia; Genentech, South San Francisco, California; University of South Florida, Tampa, Florida, USA; Roche Products Ltd., Welwyn Garden City, UK; Hospital Clínico Universitario, Universidad de Santiago de Compostela, Santiago, Spain. g.jones@utas.edu.au.|Dr. A. Sebba has received research and consulting fees from Jansen and Jansen, Novartis, Genentech, Pfizer, Lilly, Amgen, Sandoz, and Sanofi. Dr. T. Wallace is an employee of and owns stock options in Genentech. Dr. M. McIntosh is an employee of Genentech. Dr. L. Brockwell is an employee of Roche Products Ltd. g.jones@utas.edu.au.|G. Jones, MD, PhD, Menzies Research Institute, University of Tasmania; T. Wallace, PhD, Genentech; M.J. McIntosh, PhD, Genentech; L. Brockwell, MBiochem, Roche Products Ltd.; J.J. Gómez-Reino, MD, Hospital Clínico Universitario, Universidad de Santiago de Compostela; A. Sebba, MD, University of South Florida. g.jones@utas.edu.au.
authors.forename: Graeme
authors.initials: G
authors.lastname: Jones
authors.affiliation: From the Menzies Research Institute, University of Tasmania, Hobart, Australia; Genentech, South San Francisco, California; University of South Florida, Tampa, Florida, USA; Roche Products Ltd., Welwyn Garden City, UK; Hospital Clínico Universitario, Universidad de Santiago de Compostela, Santiago, Spain.|Dr. A. Sebba has received research and consulting fees from Jansen and Jansen, Novartis, Genentech, Pfizer, Lilly, Amgen, Sandoz, and Sanofi. Dr. T. Wallace is an employee of and owns stock options in Genentech. Dr. M. McIntosh is an employee of Genentech. Dr. L. Brockwell is an employee of Roche Products Ltd.|G. Jones, MD, PhD, Menzies Research Institute, University of Tasmania; T. Wallace, PhD, Genentech; M.J. McIntosh, PhD, Genentech; L. Brockwell, MBiochem, Roche Products Ltd.; J.J. Gómez-Reino, MD, Hospital Clínico Universitario, Universidad de Santiago de Compostela; A. Sebba, MD, University of South Florida.
authors.forename: Thomas
authors.initials: T
authors.lastname: Wallace
authors.affiliation: From the Menzies Research Institute, University of Tasmania, Hobart, Australia; Genentech, South San Francisco, California; University of South Florida, Tampa, Florida, USA; Roche Products Ltd., Welwyn Garden City, UK; Hospital Clínico Universitario, Universidad de Santiago de Compostela, Santiago, Spain.|Dr. A. Sebba has received research and consulting fees from Jansen and Jansen, Novartis, Genentech, Pfizer, Lilly, Amgen, Sandoz, and Sanofi. Dr. T. Wallace is an employee of and owns stock options in Genentech. Dr. M. McIntosh is an employee of Genentech. Dr. L. Brockwell is an employee of Roche Products Ltd.|G. Jones, MD, PhD, Menzies Research Institute, University of Tasmania; T. Wallace, PhD, Genentech; M.J. McIntosh, PhD, Genentech; L. Brockwell, MBiochem, Roche Products Ltd.; J.J. Gómez-Reino, MD, Hospital Clínico Universitario, Universidad de Santiago de Compostela; A. Sebba, MD, University of South Florida.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: McIntosh
authors.affiliation: From the Menzies Research Institute, University of Tasmania, Hobart, Australia; Genentech, South San Francisco, California; University of South Florida, Tampa, Florida, USA; Roche Products Ltd., Welwyn Garden City, UK; Hospital Clínico Universitario, Universidad de Santiago de Compostela, Santiago, Spain.|Dr. A. Sebba has received research and consulting fees from Jansen and Jansen, Novartis, Genentech, Pfizer, Lilly, Amgen, Sandoz, and Sanofi. Dr. T. Wallace is an employee of and owns stock options in Genentech. Dr. M. McIntosh is an employee of Genentech. Dr. L. Brockwell is an employee of Roche Products Ltd.|G. Jones, MD, PhD, Menzies Research Institute, University of Tasmania; T. Wallace, PhD, Genentech; M.J. McIntosh, PhD, Genentech; L. Brockwell, MBiochem, Roche Products Ltd.; J.J. Gómez-Reino, MD, Hospital Clínico Universitario, Universidad de Santiago de Compostela; A. Sebba, MD, University of South Florida.
authors.forename: Laura
authors.initials: L
authors.lastname: Brockwell
authors.affiliation: From the Menzies Research Institute, University of Tasmania, Hobart, Australia; Genentech, South San Francisco, California; University of South Florida, Tampa, Florida, USA; Roche Products Ltd., Welwyn Garden City, UK; Hospital Clínico Universitario, Universidad de Santiago de Compostela, Santiago, Spain.|Dr. A. Sebba has received research and consulting fees from Jansen and Jansen, Novartis, Genentech, Pfizer, Lilly, Amgen, Sandoz, and Sanofi. Dr. T. Wallace is an employee of and owns stock options in Genentech. Dr. M. McIntosh is an employee of Genentech. Dr. L. Brockwell is an employee of Roche Products Ltd.|G. Jones, MD, PhD, Menzies Research Institute, University of Tasmania; T. Wallace, PhD, Genentech; M.J. McIntosh, PhD, Genentech; L. Brockwell, MBiochem, Roche Products Ltd.; J.J. Gómez-Reino, MD, Hospital Clínico Universitario, Universidad de Santiago de Compostela; A. Sebba, MD, University of South Florida.
authors.forename: Juan J
authors.initials: JJ
authors.lastname: Gómez-Reino
authors.affiliation: From the Menzies Research Institute, University of Tasmania, Hobart, Australia; Genentech, South San Francisco, California; University of South Florida, Tampa, Florida, USA; Roche Products Ltd., Welwyn Garden City, UK; Hospital Clínico Universitario, Universidad de Santiago de Compostela, Santiago, Spain.|Dr. A. Sebba has received research and consulting fees from Jansen and Jansen, Novartis, Genentech, Pfizer, Lilly, Amgen, Sandoz, and Sanofi. Dr. T. Wallace is an employee of and owns stock options in Genentech. Dr. M. McIntosh is an employee of Genentech. Dr. L. Brockwell is an employee of Roche Products Ltd.|G. Jones, MD, PhD, Menzies Research Institute, University of Tasmania; T. Wallace, PhD, Genentech; M.J. McIntosh, PhD, Genentech; L. Brockwell, MBiochem, Roche Products Ltd.; J.J. Gómez-Reino, MD, Hospital Clínico Universitario, Universidad de Santiago de Compostela; A. Sebba, MD, University of South Florida.
authors.forename: Anthony
authors.initials: A
authors.lastname: Sebba
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; C502936:tocilizumab; D008727:Methotrexate
keywords: BIOLOGICAL THERAPY; CLINICAL TRIALS; DISEASE ACTIVITY; METHOTREXATE; RHEUMATOID ARTHRITIS