OBJECTIVES: To assess the safety and efficacy of intravenous (IV) abatacept plus methotrexate (MTX) over 7 years, the longest observational period to date, in patients with established rheumatoid arthritis (RA) and an inadequate response to MTX. METHODS: Patients randomised to IV abatacept (10 or 2 mg/kg) or placebo, plus MTX, during the 1-year double-blind (DB) period of a Phase 2b study could enter the long-term extension (LTE) and receive IV abatacept 10 mg/kg monthly. Safety was assessed in patients who received ≥1 dose of abatacept; efficacy was assessed in patients originally randomised to 10 mg/kg abatacept (as-observed data). RESULTS: A total of 219 patients entered the LTE; 114 (52.1%) completed 7 years of treatment with abatacept plus MTX. Cumulative (DB + LTE) incidence rates of serious adverse events, serious infections, malignancies, and autoimmune events were 17.6, 3.2, 1.8, and 1.2/100 patient-years, respectively. Safety was consistent between the DB (n=220) and cumulative (n=287) periods. Improvements in American College of Rheumatology responses, disease activity, and normalisation of physical function and health-related quality of life were maintained over time. Approximately 80% of patients who achieved low disease activity or normalised modified Health Assessment Questionnaire scores at Year 1, and who remained in the study, sustained these responses in each subsequent year. CONCLUSIONS: IV abatacept in combination with MTX demonstrated consistent safety and sustained efficacy over 7 years in MTX inadequate responders with established RA. Furthermore, some patients demonstrated a normalisation of physical function and health-related quality of life that was sustained over time.
OBJECTIVES: To assess the safety and efficacy of intravenous (IV) abatacept plus methotrexate (MTX) over 7 years, the longest observational period to date, in patients with established rheumatoid arthritis (RA) and an inadequate response to MTX. METHODS: Patients randomised to IV abatacept (10 or 2 mg/kg) or placebo, plus MTX, during the 1-year double-blind (DB) period of a Phase 2b study could enter the long-term extension (LTE) and receive IV abatacept 10 mg/kg monthly. Safety was assessed in patients who received ≥1 dose of abatacept; efficacy was assessed in patients originally randomised to 10 mg/kg abatacept (as-observed data). RESULTS: A total of 219 patients entered the LTE; 114 (52.1%) completed 7 years of treatment with abatacept plus MTX. Cumulative (DB + LTE) incidence rates of serious adverse events, serious infections, malignancies, and autoimmune events were 17.6, 3.2, 1.8, and 1.2/100 patient-years, respectively. Safety was consistent between the DB (n=220) and cumulative (n=287) periods. Improvements in American College of Rheumatology responses, disease activity, and normalisation of physical function and health-related quality of life were maintained over time. Approximately 80% of patients who achieved low disease activity or normalised modified Health Assessment Questionnaire scores at Year 1, and who remained in the study, sustained these responses in each subsequent year. CONCLUSIONS: IV abatacept in combination with MTX demonstrated consistent safety and sustained efficacy over 7 years in MTX inadequate responders with established RA. Furthermore, some patients demonstrated a normalisation of physical function and health-related quality of life that was sustained over time.
Authors: Rieke Alten; Xavier Mariette; René-Marc Flipo; Roberto Caporali; Maya H Buch; Yusuf Patel; Sara Marsal; Raimon Sanmartí; Michael T Nurmohamed; Hedley Griffiths; Peter Peichl; Bettina Bannert; Melanie Chartier; Sean E Connolly; Karissa Lozenski; Christiane Rauch Journal: Clin Rheumatol Date: 2022-05-10 Impact factor: 3.650
Authors: Rene Westhovens; Manuel Robles; Antonio Carlos Ximenes; Jurgen Wollenhaupt; Patrick Durez; Juan Gomez-Reino; Walter Grassi; Boulos Haraoui; William Shergy; Sung-Hwan Park; Harry Genant; Charles Peterfy; Jean-Claude Becker; Bindu Murthy Journal: Ann Rheum Dis Date: 2014-12-30 Impact factor: 19.103
Authors: D S Courvoisier; D Alpizar-Rodriguez; J E Gottenberg; M V Hernandez; F Iannone; E Lie; M J Santos; K Pavelka; C Turesson; X Mariette; D Choquette; M L Hetland; A Finckh Journal: EBioMedicine Date: 2016-08-18 Impact factor: 8.143