title: Long-term safety and efficacy of treatment with subcutaneous abatacept in Japanese patients with rheumatoid arthritis who are methotrexate inadequate responders.
abstract: OBJECTIVE
  To assess the long-term safety, immunogenicity, and efficacy of subcutaneous (SC) abatacept in combination with methotrexate (MTX) in Japanese patients with rheumatoid arthritis who were MTX inadequate responders, in a long-term extension (LTE) to a double-dummy, double-blind study (NCT01001832).
  
  
  METHODS
  Patients, who had previously received SC or intravenous (IV) abatacept with MTX (6-8 mg/week) for 24 weeks, received SC abatacept (125 mg/week) with MTX for an additional 52 weeks. Safety, immunogenicity, and efficacy were assessed.
  
  
  RESULTS
  The LTE included 112 patients. SC abatacept was generally well tolerated in the LTE, with no new safety signals. American College of Rheumatology 20, 50, and 70 response rates, disease activity score 28 (C-reactive protein) remission rates (< 2.6), and Health Assessment Questionnaire-Disability Index response rates (≥ 0.3 improvement from baseline) achieved at the end of the double-blind period were maintained over the LTE and were comparable in patients who received SC or IV abatacept in the double-blind period. Seropositivity for immunogenicity occurred in 4 (3.6%) patients. Self-injection of SC abatacept was well controlled and not associated with additional safety events.
  
  
  CONCLUSIONS
  SC abatacept had acceptable safety and was well tolerated and effective over the LTE (76 weeks in total), with low rates of immunogenicity in Japanese patients.
authors.affiliation: a Department of Rheumatology and Clinical Immunology , Saitama Medical Center, Saitama Medical University , Kawagoe-shi, Saitama , Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Amano
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Matsubara
authors.forename: Takaaki
authors.initials: T
authors.lastname: Tanaka
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Inoue
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Iwahashi
authors.forename: Toshihisa
authors.initials: T
authors.lastname: Kanamono
authors.forename: Teruaki
authors.initials: T
authors.lastname: Nakano
authors.forename: Shoichi
authors.initials: S
authors.lastname: Uchimura
authors.forename: Tomomaro
authors.initials: T
authors.lastname: Izumihara
authors.forename: Akira
authors.initials: A
authors.lastname: Yamazaki
authors.forename: Chetan S
authors.initials: CS
authors.lastname: Karyekar
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
mesh_terms: D000069594:Abatacept / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D002097:C-Reactive Protein / Q000378:metabolism; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D018796:Immunoconjugates / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D019233:Retreatment; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D018796:Immunoconjugates; D000069594:Abatacept; D002097:C-Reactive Protein; D008727:Methotrexate
keywords: Abatacept; Japan; Long-term; Rheumatoid arthritis; Subcutaneous injections