title: Comparison of efficacy and safety of tacrolimus and methotrexate in combination with abatacept in patients with rheumatoid arthritis; a retrospective observational study in the TBC Registry.
abstract: OBJECTIVE
  Tacrolimus (TAC) and abatacept (ABT) inhibit T-cells via different mechanisms and, in combination, may be effective against rheumatoid arthritis. However, they may also disrupt normal immune functions. We compared the efficacy and safety of ABT administered to patients in combination with TAC, methotrexate (MTX), or other drugs.
  
  
  METHODS
  This was a retrospective multicenter study conducted to compare the efficacy and safety of ABT in 211 patients: the drug was administered together with TAC (ABT+ TAC group; 22 patients), MTX (ABT+ MTX group; 102 patients), or patients treated without concomitant MTX or TAC (ABT mono group; 87 patients). The disease activity, treatment continuation rate, and reason for discontinuation of treatment were investigated.
  
  
  RESULTS
  The retention rate at Week 24 was similar in the three groups. There were no cases of discontinuation related to the appearance of adverse events in the ABT+ TAC group. At Week 24, according to the European League Against Rheumatism response criteria, the "good" response rates were 33.3%, 13.4%, and 13.4% in the ABT+ TAC, ABT+ MTX, and ABT mono groups, respectively. Statistically significant decreases in various disease activity scores/indices were observed in all the groups as early as Week 4.
  
  
  CONCLUSIONS
  Although the sample size was small, the results of this retrospective study suggest that the ABT+ TAC combination therapy has at least comparable safety and efficacy to those of the ABT+ MTX combination, and that it can thus be a useful option for patients who cannot take MTX.
authors.affiliation: a Department of Orthopedic Surgery , Konan Kosei Hospital , Aichi , Japan.
authors.forename: Takayoshi
authors.initials: T
authors.lastname: Fujibayashi
authors.affiliation: b Department of Orthopedic Surgery , Nagoya University Graduate School of Medicine , Nagoya, Aichi , Japan.
authors.forename: Nobunori
authors.initials: N
authors.lastname: Takahashi
authors.affiliation: c Department of Orthopedic Surgery and Rheumatology , Nagoya Medical Center , Nagoya , Japan.
authors.forename: Daihei
authors.initials: D
authors.lastname: Kida
authors.affiliation: c Department of Orthopedic Surgery and Rheumatology , Nagoya Medical Center , Nagoya , Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Kaneko
authors.affiliation: d Department of Rheumatology , Toyohashi Municipal Hospital , Toyohashi , Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Hirano
authors.affiliation: e Department of Orthopedic Surgery , Kariya-Toyota General Hospital , Kariya , Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Fukaya
authors.affiliation: f Department of Rheumatology , JCHO Tokyo Shinjuku Medical Center , Tokyo , Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Yabe
authors.affiliation: g Department of Orthopedic Surgery , Anjo Kosei Hospital , Anjo , Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Oguchi
authors.affiliation: h Department of Orthopedic Surgery , Shizuoka Kosei Hospital , Shizuoka , Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Tsuboi
authors.affiliation: i Department of Orthopedic Surgery , Ichinomiya Municipal Hospital , Ichinomiya , Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Miyake
authors.affiliation: b Department of Orthopedic Surgery , Nagoya University Graduate School of Medicine , Nagoya, Aichi , Japan.
authors.forename: Toki
authors.initials: T
authors.lastname: Takemoto
authors.affiliation: a Department of Orthopedic Surgery , Konan Kosei Hospital , Aichi , Japan.
authors.forename: Masashi
authors.initials: M
authors.lastname: Kawasaki
authors.affiliation: b Department of Orthopedic Surgery , Nagoya University Graduate School of Medicine , Nagoya, Aichi , Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishiguro
authors.affiliation: b Department of Orthopedic Surgery , Nagoya University Graduate School of Medicine , Nagoya, Aichi , Japan.
authors.forename: Toshihisa
authors.initials: T
authors.lastname: Kojima
mesh_terms: D000069594:Abatacept / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D012042:Registries; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000069594:Abatacept; D016559:Tacrolimus; D008727:Methotrexate
keywords: Abatacept; Clinical response; Methotrexate; Rheumatoid arthritis; Tacrolimus