Graeme Jones1,2,3, Thomas Wallace4,5,6, Matthew J McIntosh4,5,6, Laura Brockwell4,5,6, Juan J Gómez-Reino4,5,6, Anthony Sebba4,5,6. 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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.
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.
RCT Entities:
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.
Authors: Ernest H Choy; Fabrizio De Benedetti; Tsutomu Takeuchi; Misato Hashizume; Markus R John; Tadamitsu Kishimoto Journal: Nat Rev Rheumatol Date: 2020-04-23 Impact factor: 20.543
Authors: Maxime M A Verhoeven; Janneke Tekstra; Paco M J Welsing; Attila Pethö-Schramm; Michelle E A Borm; George A W Bruyn; Reinhard Bos; Ed N Griep; Ruth Klaasen; Jacob M van Laar; Floris P J G Lafeber; Johannes W J Bijlsma; Marjolein J H de Hair; Johannes W G Jacobs Journal: Rheumatology (Oxford) Date: 2020-09-01 Impact factor: 7.580