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Concurrent Oral 1 - Rheumatoid Arthritis: Treatment [OP4-OP9] : OP4. Inhibition of Radiographic Progression and Improvements in Physical Function at 2 Years, with Increasing Clinical Efficacy Over Time, in Rheumatoid Arthritis (Ra) Patients Treated with Tocilizumab (Tcz): The Lithe Study

Fleischmann, R. ; Burgos-Vargas, R. ; Ambs, P. ; Alecock, E. ; Kremer, J. ; Soliman, Moetaza M. ; Ashcroft, Darren M. ; Watson, Kath D. ; Lunt, Mark ; Symmons, Deborah P. ; Hyrich, Kimme L. ; Tak, Paul P. ; Rigby, William ; Rubbert, Andrea ; Peterfy, Charles ; van Vollenhoven, Ronald F. ; Stohl, William ; Hessey, Eva ; Chen, Annie ; Tyrrell, Helen ; Shaw, Tim ; Genovese, Mark C. ; Breedveld, Ferdinand C. ; Emery, Paul ; Cohen, Stanley B. ; Keystone, Edward C. ; Matteson, Eric L. ; Burke, Laura S. ; Chai, Akiko ; Reiss, William G. ; Sweetser, Marianne T. ; Shaw, Tim M. ; Owen, Sally A. ; Eyre, Stephen ; Martin, Paul ; Hider, Samantha ; Bruce, Ian N. ; Barton, Anne ; Thomson, Wendy ; Jones, G. ; Gomez-Reino, J. J. ; Lowenstein, M. B. ; Tornero, J. ; Sebba, A. ; Alecock, E. ; Guarin, E. ; Genovese, M.

In: Rheumatology, 2010, vol. 49, p. i3-i5

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    Titre
    • Concurrent Oral 1 - Rheumatoid Arthritis: Treatment [OP4-OP9]
      OP4. Inhibition of Radiographic Progression and Improvements in Physical Function at 2 Years, with Increasing Clinical Efficacy Over Time, in Rheumatoid Arthritis (Ra) Patients Treated with Tocilizumab (Tcz): The Lithe Study
    Auteur
    • Fleischmann, R.. Metroplex Clinical Research Center, Dallas, TX, USA; Hospital General de México, Mexico City, Mexico; F. Hoffmann-La Roche, Basel, Switzerland; F. Hoffmann-La Roche, Welwyn, UK; Albany Medical Centre, Albany, NY, USA
    • Burgos-Vargas, R.. Metroplex Clinical Research Center, Dallas, TX, USA; Hospital General de México, Mexico City, Mexico; F. Hoffmann-La Roche, Basel, Switzerland; F. Hoffmann-La Roche, Welwyn, UK; Albany Medical Centre, Albany, NY, USA
    • Ambs, P.. Metroplex Clinical Research Center, Dallas, TX, USA; Hospital General de México, Mexico City, Mexico; F. Hoffmann-La Roche, Basel, Switzerland; F. Hoffmann-La Roche, Welwyn, UK; Albany Medical Centre, Albany, NY, USA
    • Alecock, E.. Metroplex Clinical Research Center, Dallas, TX, USA; Hospital General de México, Mexico City, Mexico; F. Hoffmann-La Roche, Basel, Switzerland; F. Hoffmann-La Roche, Welwyn, UK; Albany Medical Centre, Albany, NY, USA
    • Kremer, J.. Metroplex Clinical Research Center, Dallas, TX, USA; Hospital General de México, Mexico City, Mexico; F. Hoffmann-La Roche, Basel, Switzerland; F. Hoffmann-La Roche, Welwyn, UK; Albany Medical Centre, Albany, NY, USA
    • Soliman, Moetaza M.. School of Pharmacy and Pharmaceutical Sciences, The University of Manchester, Manchester, UK; arc Epidemiology Unit, The University of Manchester, Manchester, UK; British Society for Rheumatology, London, UK
    • Ashcroft, Darren M.. School of Pharmacy and Pharmaceutical Sciences, The University of Manchester, Manchester, UK; arc Epidemiology Unit, The University of Manchester, Manchester, UK; British Society for Rheumatology, London, UK
    • Watson, Kath D.. School of Pharmacy and Pharmaceutical Sciences, The University of Manchester, Manchester, UK; arc Epidemiology Unit, The University of Manchester, Manchester, UK; British Society for Rheumatology, London, UK
    • Lunt, Mark. School of Pharmacy and Pharmaceutical Sciences, The University of Manchester, Manchester, UK; arc Epidemiology Unit, The University of Manchester, Manchester, UK; British Society for Rheumatology, London, UK
    • Symmons, Deborah P.. School of Pharmacy and Pharmaceutical Sciences, The University of Manchester, Manchester, UK; arc Epidemiology Unit, The University of Manchester, Manchester, UK; British Society for Rheumatology, London, UK
    • Hyrich, Kimme L.. School of Pharmacy and Pharmaceutical Sciences, The University of Manchester, Manchester, UK; arc Epidemiology Unit, The University of Manchester, Manchester, UK; British Society for Rheumatology, London, UK
    • Tak, Paul P.. Academic Medical Centre/University of Amsterdam, Amsterdam, Netherlands; Dartmouth Hitchcock Medical Center, Lebanon, OH; University of Cologne, Cologne, Germany; Synarc Inc., San Francisco, CA, USA; Karolinska University Hospital, Stockholm, Sweden; USC, Los Angeles, CA, USA; Roche Products Ltd, Welwyn Garden City, UK; Genentech Inc, South San Francisco, CA, USA
    • Rigby, William. Academic Medical Centre/University of Amsterdam, Amsterdam, Netherlands; Dartmouth Hitchcock Medical Center, Lebanon, OH; University of Cologne, Cologne, Germany; Synarc Inc., San Francisco, CA, USA; Karolinska University Hospital, Stockholm, Sweden; USC, Los Angeles, CA, USA; Roche Products Ltd, Welwyn Garden City, UK; Genentech Inc, South San Francisco, CA, USA
    • Rubbert, Andrea. Academic Medical Centre/University of Amsterdam, Amsterdam, Netherlands; Dartmouth Hitchcock Medical Center, Lebanon, OH; University of Cologne, Cologne, Germany; Synarc Inc., San Francisco, CA, USA; Karolinska University Hospital, Stockholm, Sweden; USC, Los Angeles, CA, USA; Roche Products Ltd, Welwyn Garden City, UK; Genentech Inc, South San Francisco, CA, USA
    • Peterfy, Charles. Academic Medical Centre/University of Amsterdam, Amsterdam, Netherlands; Dartmouth Hitchcock Medical Center, Lebanon, OH; University of Cologne, Cologne, Germany; Synarc Inc., San Francisco, CA, USA; Karolinska University Hospital, Stockholm, Sweden; USC, Los Angeles, CA, USA; Roche Products Ltd, Welwyn Garden City, UK; Genentech Inc, South San Francisco, CA, USA
    • van Vollenhoven, Ronald F.. Academic Medical Centre/University of Amsterdam, Amsterdam, Netherlands; Dartmouth Hitchcock Medical Center, Lebanon, OH; University of Cologne, Cologne, Germany; Synarc Inc., San Francisco, CA, USA; Karolinska University Hospital, Stockholm, Sweden; USC, Los Angeles, CA, USA; Roche Products Ltd, Welwyn Garden City, UK; Genentech Inc, South San Francisco, CA, USA
    • Stohl, William. Academic Medical Centre/University of Amsterdam, Amsterdam, Netherlands; Dartmouth Hitchcock Medical Center, Lebanon, OH; University of Cologne, Cologne, Germany; Synarc Inc., San Francisco, CA, USA; Karolinska University Hospital, Stockholm, Sweden; USC, Los Angeles, CA, USA; Roche Products Ltd, Welwyn Garden City, UK; Genentech Inc, South San Francisco, CA, USA
    • Hessey, Eva. Academic Medical Centre/University of Amsterdam, Amsterdam, Netherlands; Dartmouth Hitchcock Medical Center, Lebanon, OH; University of Cologne, Cologne, Germany; Synarc Inc., San Francisco, CA, USA; Karolinska University Hospital, Stockholm, Sweden; USC, Los Angeles, CA, USA; Roche Products Ltd, Welwyn Garden City, UK; Genentech Inc, South San Francisco, CA, USA
    • Chen, Annie. Academic Medical Centre/University of Amsterdam, Amsterdam, Netherlands; Dartmouth Hitchcock Medical Center, Lebanon, OH; University of Cologne, Cologne, Germany; Synarc Inc., San Francisco, CA, USA; Karolinska University Hospital, Stockholm, Sweden; USC, Los Angeles, CA, USA; Roche Products Ltd, Welwyn Garden City, UK; Genentech Inc, South San Francisco, CA, USA
    • Tyrrell, Helen. Academic Medical Centre/University of Amsterdam, Amsterdam, Netherlands; Dartmouth Hitchcock Medical Center, Lebanon, OH; University of Cologne, Cologne, Germany; Synarc Inc., San Francisco, CA, USA; Karolinska University Hospital, Stockholm, Sweden; USC, Los Angeles, CA, USA; Roche Products Ltd, Welwyn Garden City, UK; Genentech Inc, South San Francisco, CA, USA
    • Shaw, Tim. Academic Medical Centre/University of Amsterdam, Amsterdam, Netherlands; Dartmouth Hitchcock Medical Center, Lebanon, OH; University of Cologne, Cologne, Germany; Synarc Inc., San Francisco, CA, USA; Karolinska University Hospital, Stockholm, Sweden; USC, Los Angeles, CA, USA; Roche Products Ltd, Welwyn Garden City, UK; Genentech Inc, South San Francisco, CA, USA
    • Genovese, Mark C.. Immunol-Rheumatol, Stanford University, Palo Alto, CA, USA; Rheumatology, Leiden University, Leiden, Netherlands; Musculoskel Dis, Chapel Allerton Hospital, Leeds, UK; Rheumatology, Metroplex Clin. Res. Center, Dallas, TX, USA; Rheumatology, Mount Sinai Hospital, Toronto, ON, Canada; Rheumatology, Mayo Clinic, Rochester, MN, USA; Medical Science, Roche Inc., Welwyn Garden City, UK; Biostatistics, Genentech, South San Francisco, CA, USA; Clinical Dev, Genentech, South San Francisco, CA, USA; Drug Safety, Biogen Idec, Cambridge, MA, USA; Clin. Sci. Inflamm, Roche Ltd., Welwyn Garden City, UK
    • Breedveld, Ferdinand C.. Immunol-Rheumatol, Stanford University, Palo Alto, CA, USA; Rheumatology, Leiden University, Leiden, Netherlands; Musculoskel Dis, Chapel Allerton Hospital, Leeds, UK; Rheumatology, Metroplex Clin. Res. Center, Dallas, TX, USA; Rheumatology, Mount Sinai Hospital, Toronto, ON, Canada; Rheumatology, Mayo Clinic, Rochester, MN, USA; Medical Science, Roche Inc., Welwyn Garden City, UK; Biostatistics, Genentech, South San Francisco, CA, USA; Clinical Dev, Genentech, South San Francisco, CA, USA; Drug Safety, Biogen Idec, Cambridge, MA, USA; Clin. Sci. Inflamm, Roche Ltd., Welwyn Garden City, UK
    • Emery, Paul. Immunol-Rheumatol, Stanford University, Palo Alto, CA, USA; Rheumatology, Leiden University, Leiden, Netherlands; Musculoskel Dis, Chapel Allerton Hospital, Leeds, UK; Rheumatology, Metroplex Clin. Res. Center, Dallas, TX, USA; Rheumatology, Mount Sinai Hospital, Toronto, ON, Canada; Rheumatology, Mayo Clinic, Rochester, MN, USA; Medical Science, Roche Inc., Welwyn Garden City, UK; Biostatistics, Genentech, South San Francisco, CA, USA; Clinical Dev, Genentech, South San Francisco, CA, USA; Drug Safety, Biogen Idec, Cambridge, MA, USA; Clin. Sci. Inflamm, Roche Ltd., Welwyn Garden City, UK
    • Cohen, Stanley B.. Immunol-Rheumatol, Stanford University, Palo Alto, CA, USA; Rheumatology, Leiden University, Leiden, Netherlands; Musculoskel Dis, Chapel Allerton Hospital, Leeds, UK; Rheumatology, Metroplex Clin. Res. Center, Dallas, TX, USA; Rheumatology, Mount Sinai Hospital, Toronto, ON, Canada; Rheumatology, Mayo Clinic, Rochester, MN, USA; Medical Science, Roche Inc., Welwyn Garden City, UK; Biostatistics, Genentech, South San Francisco, CA, USA; Clinical Dev, Genentech, South San Francisco, CA, USA; Drug Safety, Biogen Idec, Cambridge, MA, USA; Clin. Sci. Inflamm, Roche Ltd., Welwyn Garden City, UK
    • Keystone, Edward C.. Immunol-Rheumatol, Stanford University, Palo Alto, CA, USA; Rheumatology, Leiden University, Leiden, Netherlands; Musculoskel Dis, Chapel Allerton Hospital, Leeds, UK; Rheumatology, Metroplex Clin. Res. Center, Dallas, TX, USA; Rheumatology, Mount Sinai Hospital, Toronto, ON, Canada; Rheumatology, Mayo Clinic, Rochester, MN, USA; Medical Science, Roche Inc., Welwyn Garden City, UK; Biostatistics, Genentech, South San Francisco, CA, USA; Clinical Dev, Genentech, South San Francisco, CA, USA; Drug Safety, Biogen Idec, Cambridge, MA, USA; Clin. Sci. Inflamm, Roche Ltd., Welwyn Garden City, UK
    • Matteson, Eric L.. Immunol-Rheumatol, Stanford University, Palo Alto, CA, USA; Rheumatology, Leiden University, Leiden, Netherlands; Musculoskel Dis, Chapel Allerton Hospital, Leeds, UK; Rheumatology, Metroplex Clin. Res. Center, Dallas, TX, USA; Rheumatology, Mount Sinai Hospital, Toronto, ON, Canada; Rheumatology, Mayo Clinic, Rochester, MN, USA; Medical Science, Roche Inc., Welwyn Garden City, UK; Biostatistics, Genentech, South San Francisco, CA, USA; Clinical Dev, Genentech, South San Francisco, CA, USA; Drug Safety, Biogen Idec, Cambridge, MA, USA; Clin. Sci. Inflamm, Roche Ltd., Welwyn Garden City, UK
    • Burke, Laura S.. Immunol-Rheumatol, Stanford University, Palo Alto, CA, USA; Rheumatology, Leiden University, Leiden, Netherlands; Musculoskel Dis, Chapel Allerton Hospital, Leeds, UK; Rheumatology, Metroplex Clin. Res. Center, Dallas, TX, USA; Rheumatology, Mount Sinai Hospital, Toronto, ON, Canada; Rheumatology, Mayo Clinic, Rochester, MN, USA; Medical Science, Roche Inc., Welwyn Garden City, UK; Biostatistics, Genentech, South San Francisco, CA, USA; Clinical Dev, Genentech, South San Francisco, CA, USA; Drug Safety, Biogen Idec, Cambridge, MA, USA; Clin. Sci. Inflamm, Roche Ltd., Welwyn Garden City, UK
    • Chai, Akiko. Immunol-Rheumatol, Stanford University, Palo Alto, CA, USA; Rheumatology, Leiden University, Leiden, Netherlands; Musculoskel Dis, Chapel Allerton Hospital, Leeds, UK; Rheumatology, Metroplex Clin. Res. Center, Dallas, TX, USA; Rheumatology, Mount Sinai Hospital, Toronto, ON, Canada; Rheumatology, Mayo Clinic, Rochester, MN, USA; Medical Science, Roche Inc., Welwyn Garden City, UK; Biostatistics, Genentech, South San Francisco, CA, USA; Clinical Dev, Genentech, South San Francisco, CA, USA; Drug Safety, Biogen Idec, Cambridge, MA, USA; Clin. Sci. Inflamm, Roche Ltd., Welwyn Garden City, UK
    • Reiss, William G.. Immunol-Rheumatol, Stanford University, Palo Alto, CA, USA; Rheumatology, Leiden University, Leiden, Netherlands; Musculoskel Dis, Chapel Allerton Hospital, Leeds, UK; Rheumatology, Metroplex Clin. Res. Center, Dallas, TX, USA; Rheumatology, Mount Sinai Hospital, Toronto, ON, Canada; Rheumatology, Mayo Clinic, Rochester, MN, USA; Medical Science, Roche Inc., Welwyn Garden City, UK; Biostatistics, Genentech, South San Francisco, CA, USA; Clinical Dev, Genentech, South San Francisco, CA, USA; Drug Safety, Biogen Idec, Cambridge, MA, USA; Clin. Sci. Inflamm, Roche Ltd., Welwyn Garden City, UK
    • Sweetser, Marianne T.. Immunol-Rheumatol, Stanford University, Palo Alto, CA, USA; Rheumatology, Leiden University, Leiden, Netherlands; Musculoskel Dis, Chapel Allerton Hospital, Leeds, UK; Rheumatology, Metroplex Clin. Res. Center, Dallas, TX, USA; Rheumatology, Mount Sinai Hospital, Toronto, ON, Canada; Rheumatology, Mayo Clinic, Rochester, MN, USA; Medical Science, Roche Inc., Welwyn Garden City, UK; Biostatistics, Genentech, South San Francisco, CA, USA; Clinical Dev, Genentech, South San Francisco, CA, USA; Drug Safety, Biogen Idec, Cambridge, MA, USA; Clin. Sci. Inflamm, Roche Ltd., Welwyn Garden City, UK
    • Shaw, Tim M.. Immunol-Rheumatol, Stanford University, Palo Alto, CA, USA; Rheumatology, Leiden University, Leiden, Netherlands; Musculoskel Dis, Chapel Allerton Hospital, Leeds, UK; Rheumatology, Metroplex Clin. Res. Center, Dallas, TX, USA; Rheumatology, Mount Sinai Hospital, Toronto, ON, Canada; Rheumatology, Mayo Clinic, Rochester, MN, USA; Medical Science, Roche Inc., Welwyn Garden City, UK; Biostatistics, Genentech, South San Francisco, CA, USA; Clinical Dev, Genentech, South San Francisco, CA, USA; Drug Safety, Biogen Idec, Cambridge, MA, USA; Clin. Sci. Inflamm, Roche Ltd., Welwyn Garden City, UK
    • Owen, Sally A.. arc-Epidemiology Unit, The University of Manchester, Manchester, UK; arc National Primary Care Centre, Keele University, Staffordshire, UK
    • Eyre, Stephen. arc-Epidemiology Unit, The University of Manchester, Manchester, UK; arc National Primary Care Centre, Keele University, Staffordshire, UK
    • Martin, Paul. arc-Epidemiology Unit, The University of Manchester, Manchester, UK; arc National Primary Care Centre, Keele University, Staffordshire, UK
    • Hider, Samantha. arc-Epidemiology Unit, The University of Manchester, Manchester, UK; arc National Primary Care Centre, Keele University, Staffordshire, UK
    • Bruce, Ian N.. arc-Epidemiology Unit, The University of Manchester, Manchester, UK; arc National Primary Care Centre, Keele University, Staffordshire, UK
    • Barton, Anne. arc-Epidemiology Unit, The University of Manchester, Manchester, UK; arc National Primary Care Centre, Keele University, Staffordshire, UK
    • Thomson, Wendy. arc-Epidemiology Unit, The University of Manchester, Manchester, UK; arc National Primary Care Centre, Keele University, Staffordshire, UK
    • Jones, G.. Menzies Research Institute, University of Tasmania, Hobart, TAS, Australia; Universidad de Santiago de Compostela, Santiago de Compostela, Spain; Arthritis Center, Palm Harbour, FL, USA; Hospital General Universitario de Guadelajara, Guadelajara, Spain; University of South Florida, Palm Harbour, FL, USA; F. Hoffmann-La Roche, Welwyn, UK; F. Hoffmann-La Roche, Basel, Switzerland; Stanford University Medical center, Palo Alto, CA, USA
    • Gomez-Reino, J. J.. Menzies Research Institute, University of Tasmania, Hobart, TAS, Australia; Universidad de Santiago de Compostela, Santiago de Compostela, Spain; Arthritis Center, Palm Harbour, FL, USA; Hospital General Universitario de Guadelajara, Guadelajara, Spain; University of South Florida, Palm Harbour, FL, USA; F. Hoffmann-La Roche, Welwyn, UK; F. Hoffmann-La Roche, Basel, Switzerland; Stanford University Medical center, Palo Alto, CA, USA
    • Lowenstein, M. B.. Menzies Research Institute, University of Tasmania, Hobart, TAS, Australia; Universidad de Santiago de Compostela, Santiago de Compostela, Spain; Arthritis Center, Palm Harbour, FL, USA; Hospital General Universitario de Guadelajara, Guadelajara, Spain; University of South Florida, Palm Harbour, FL, USA; F. Hoffmann-La Roche, Welwyn, UK; F. Hoffmann-La Roche, Basel, Switzerland; Stanford University Medical center, Palo Alto, CA, USA
    • Tornero, J.. Menzies Research Institute, University of Tasmania, Hobart, TAS, Australia; Universidad de Santiago de Compostela, Santiago de Compostela, Spain; Arthritis Center, Palm Harbour, FL, USA; Hospital General Universitario de Guadelajara, Guadelajara, Spain; University of South Florida, Palm Harbour, FL, USA; F. Hoffmann-La Roche, Welwyn, UK; F. Hoffmann-La Roche, Basel, Switzerland; Stanford University Medical center, Palo Alto, CA, USA
    • Sebba, A.. Menzies Research Institute, University of Tasmania, Hobart, TAS, Australia; Universidad de Santiago de Compostela, Santiago de Compostela, Spain; Arthritis Center, Palm Harbour, FL, USA; Hospital General Universitario de Guadelajara, Guadelajara, Spain; University of South Florida, Palm Harbour, FL, USA; F. Hoffmann-La Roche, Welwyn, UK; F. Hoffmann-La Roche, Basel, Switzerland; Stanford University Medical center, Palo Alto, CA, USA
    • Alecock, E.. Menzies Research Institute, University of Tasmania, Hobart, TAS, Australia; Universidad de Santiago de Compostela, Santiago de Compostela, Spain; Arthritis Center, Palm Harbour, FL, USA; Hospital General Universitario de Guadelajara, Guadelajara, Spain; University of South Florida, Palm Harbour, FL, USA; F. Hoffmann-La Roche, Welwyn, UK; F. Hoffmann-La Roche, Basel, Switzerland; Stanford University Medical center, Palo Alto, CA, USA
    • Guarin, E.. Menzies Research Institute, University of Tasmania, Hobart, TAS, Australia; Universidad de Santiago de Compostela, Santiago de Compostela, Spain; Arthritis Center, Palm Harbour, FL, USA; Hospital General Universitario de Guadelajara, Guadelajara, Spain; University of South Florida, Palm Harbour, FL, USA; F. Hoffmann-La Roche, Welwyn, UK; F. Hoffmann-La Roche, Basel, Switzerland; Stanford University Medical center, Palo Alto, CA, USA
    • Genovese, M.. Menzies Research Institute, University of Tasmania, Hobart, TAS, Australia; Universidad de Santiago de Compostela, Santiago de Compostela, Spain; Arthritis Center, Palm Harbour, FL, USA; Hospital General Universitario de Guadelajara, Guadelajara, Spain; University of South Florida, Palm Harbour, FL, USA; F. Hoffmann-La Roche, Welwyn, UK; F. Hoffmann-La Roche, Basel, Switzerland; Stanford University Medical center, Palo Alto, CA, USA
    Type de document
    • Postprint
    Identifiant OAI-PMH
    • oai:doc.rero.ch:296372
    Summary
    Background: Patients with moderate to severe RA who remained on methotrexate (MTX) despite inadequate response were treated with TCZ in a double-blind, randomized, controlled phase 3 trial. Results of a 2-year planned analysis from this study are presented. Methods: Patients were randomized to treatment with TCZ 4 mg/kg + MTX (TCZ4), TCZ 8 mg/kg + MTX (TCZ8) or placebo + MTX (CON) every 4 weeks. If patients failed to respond (<20% improvement in swollen and tender joint count; SJC and TJC) then stepwise rescue therapy could begin at week 16. Patients with ≥ 70% improvement in SJC and TJC could continue the blinded therapy at the end of year 1 to week 104. For all other patients, open-label TCZ8 was initiated at week 52. Change from baseline in Genant-modified total Sharp score (GmTSS) and physical function (AUC of change from baseline in HAQ-DI) were the primary 2-year end points. Linear extrapolation (GmTSS) or standardization (change in HAQ-DI) was used for missing data. The impact of 2 years of treatment was examined by assessing efficacy end points over time for patients randomized to TCZ8, with the last observation carried forward for SJC and TJC in patients who received rescue therapy or withdrew. Results: The intention to treat population consisted of 398 TCZ8, 399 TCZ4 and 393 CON patients. At 2 years, exposure rates in patient-years (PY) were 1320.0, 521.9 and 284.8 in TCZ8, TCZ4 and CON patients, respectively. At year 2, patients in the TCZ8 group had 81% less radiographic progression vs CON patients (based on linear extrapolation of mean change in GmTSS). Significantly more TCZ8 patients had no radiographic progression vs CON patients (P ≤ 0.0001). AUC of change from baseline in HAQ-DI showed significant improvement in physical function in TCZ4 and in TCZ8 vs CON patients (P ≤ 0.0025). In patients initially randomized to TCZ8, a low disease activity score (LDAS; DAS28 < 3.2) was seen in > 60% of patients and the DAS28 remission (DAS28 < 2.6) rate was 48% at week 52 and continued to increase to week 104. By week 52, patients treated with TCZ8 had clinically significant improvements in SJC that were maintained through week 104. Rates per 100 PY for adverse events (AEs) were higher in TCZ8 and TCZ4 (263.6, 275.4) vs CON patients (251.4) while rates for serious AEs were comparable (11.4, 12.1, 10.9, respectively). Rates per 100 PY of AEs leading to withdrawal (7.4, 32.5, 4.8) and treatment modification (8.4, 30.7, 20.4) were higher in TCZ8 and TCZ4 vs CON patients, respectively and death rates were comparable (0.6, 0.2, 0.4). Conclusions: Treatment with TCZ + MTX inhibits radiographic progression over 2 years and improves physical function as shown by DAS28 remission, LDAS and low SJC, with a manageable safety profile. Disclosure statement: E.A., F. Hoffmann-La Roche - Employee. P.A., F. Hoffmann-La Roche - Employee. R.B.-V., F. Hoffmann-La Roche - Honoraria. R.F., Genentech - Research Funding, Honoraria. J.K., F. Hoffmann-La Roche - Research funding, Honoraria