TY - JOUR T1 - Longterm Safety and Efficacy of Subcutaneous Abatacept in Patients with Rheumatoid Arthritis: 5-year Results from a Phase IIIb Trial JF - The Journal of Rheumatology JO - J Rheumatol DO - 10.3899/jrheum.170344 SP - jrheum.170344 AU - Mark C. Genovese AU - César Pacheco-Tena AU - Arturo Covarrubias AU - Gustavo Leon AU - Eduardo Mysler AU - Mauro Keiserman AU - Robert M. Valente AU - Peter Nash AU - J. Abraham Simon-Campos AU - Jane Box AU - Clarence W. Legerton III AU - Evgeny Nasonov AU - Patrick Durez AU - Ayanbola Elegbe AU - Robert Wong AU - Xiaohui Li AU - Subhashis Banerjee AU - Rieke Alten Y1 - 2018/04/15 UR - http://www.jrheum.org/content/early/2018/04/09/jrheum.170344.abstract N2 - Objective To assess 5-year safety, tolerability, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate (MTX)-refractory patients with rheumatoid arthritis (RA). Methods The Abatacept Comparison of sub[QU]cutaneous versus intravenous in Inadequate Responders to methotrexatE (ACQUIRE) phase IIIb, randomized, double-dummy, multinational trial compared efficacy and safety of SC and intravenous (IV) ABA in patients with RA. In the initial 6-month double-blind (DB) period, patients received IV or SC ABA, plus MTX, and in the subsequent open-label longterm extension (LTE) period, all patients received SC ABA (125 mg/wk). The final 5-year safety, tolerability, and efficacy analyses are reported. Results Of 1385 patients who completed the DB period, 1372 entered LTE and 945 (68.8%) completed ≥ 5 years of treatment. During LTE, 97 (7.1%) patients discontinued treatment because of an adverse event (AE). Incidence rate (IR; event/100 patient-yrs of exposure; based on LTE data, 95% CI) for AE of interest were the following: serious AE 7.73 (6.96–8.58), infection 38.60 (36.24–41.12), serious infection 1.68 (1.35–2.07), malignancies 1.09 (0.84–1.42), and autoimmune disorders 1.33 (1.05–1.69), and were stable over time. No association between immunogenicity and either worsening of ABA safety or loss of efficacy was noted. Efficacy in the LTE was consistent with the DB period and was maintained to the end of the study. Conclusion These 5-year data establish that SC ABA (125 mg/wk) has a consistent safety profile and durable efficacy for longterm treatment of patients with RA who had an inadequate response to MTX. ER -