@article {WESTHOVENS736, author = {RENE WESTHOVENS and JOEL M. KREMER and LARRY W. MORELAND and PAUL EMERY and ANTHONY S. RUSSELL and TRACY LI and RICHARD ARANDA and JEAN-CLAUDE BECKER and KEQIN QI and MAXIME DOUGADOS}, title = {Safety and Efficacy of the Selective Costimulation Modulator Abatacept in Patients with Rheumatoid Arthritis Receiving Background Methotrexate: A 5-year Extended Phase IIB Study}, volume = {36}, number = {4}, pages = {736--742}, year = {2009}, doi = {10.3899/jrheum.080813}, publisher = {The Journal of Rheumatology}, abstract = {Objective. To evaluate the safety and efficacy of abatacept plus methotrexate (MTX) over 5 years in patients with rheumatoid arthritis. Methods. Patients were randomized to abatacept 10 or 2 mg/kg or placebo, plus MTX. Patients completing the 1-year, double-blind period entered the longterm extension, where all patients received a fixed dose of abatacept ~10 mg/kg. We describe safety analyses for all patients who received at least 1 dose of abatacept and efficacy analyses for the original ~10 mg/kg abatacept-treated group, over 5 years. Results. Of the 235 abatacept- or placebo-treated patients completing the double-blind period, 219 entered the longterm extension; 130 (59.4\%) were continuing at Year 5. No unexpected safety events were observed during the longterm extension compared with the double-blind period. Incidence rates of adverse events (AE) and serious AE were 489.7 and 20.0/100 patient-years in Year 1 versus 374.9 and 18.9/100 patient-years in the cumulative period, respectively. Using exploratory analyses, improvements observed at Year 1 in the 10 mg/kg group were maintained at Year 5, as assessed by ACR responses (ACR20 = 77.1\% vs 82.7\%; ACR50 = 53.0\% vs 65.4\%; ACR70 = 28.9\% vs 40.4\% at Years 1 and 5, respectively) and disease activity (Low Disease Activity State = 48.2\% vs 58.5\%; Disease Activity Score-28-defined remission = 25.3\% vs 45.3\% at Years 1 and 5, respectively). Conclusion. Abatacept maintained the efficacy observed at Year 1 over 5 years of treatment, and demonstrated consistent safety and tolerability. These data, along with relatively high retention rates, support the longterm clinical benefit provided by selective T cell costimulation modulation. Clinical trial registry: ClinicalTrials.gov; clinical trial registration number: NCT00254293.}, issn = {0315-162X}, URL = {https://www.jrheum.org/content/36/4/736}, eprint = {https://www.jrheum.org/content/36/4/736.full.pdf}, journal = {The Journal of Rheumatology} }