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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.
Jones, Graeme; Wallace, Thomas; McIntosh, Matthew J; Brockwell, Laura; Gómez-Reino, Juan J; Sebba, Anthony.
Affiliation
  • Jones G; 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,
  • Wallace T; 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 Pr
  • McIntosh MJ; 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 Sout
  • Brockwell L; 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,
  • Gómez-Reino JJ; 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 Pr
  • Sebba A; 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 Sout
J Rheumatol ; 44(2): 142-146, 2017 02.
Article in En | MEDLINE | ID: mdl-27909081
ABSTRACT

OBJECTIVE:

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).

METHODS:

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.

RESULTS:

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.

CONCLUSION:

Longterm monotherapy with TCZ demonstrated continuing efficacy and safety.
Subject(s)
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Arthritis, Rheumatoid / Antirheumatic Agents / Antibodies, Monoclonal, Humanized Type of study: Clinical_trials / Diagnostic_studies Limits: Adult / Female / Humans / Male / Middle aged Language: En Journal: J Rheumatol Year: 2017 Document type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Arthritis, Rheumatoid / Antirheumatic Agents / Antibodies, Monoclonal, Humanized Type of study: Clinical_trials / Diagnostic_studies Limits: Adult / Female / Humans / Male / Middle aged Language: En Journal: J Rheumatol Year: 2017 Document type: Article