title: Effectiveness of abatacept for patients with Sjögren's syndrome associated with rheumatoid arthritis. An open label, multicenter, one-year, prospective study: ROSE (Rheumatoid Arthritis with Orencia Trial toward Sjögren's syndrome Endocrinopathy) trial.
abstract: OBJECTIVE
  To clarify the efficacy and safety of abatacept for secondary Sjögren's syndrome (SS) associated with rheumatoid arthritis (RA).
  
  
  METHODS
  The primary endpoint of this open-labeled, prospective, observational multicenter study for secondary SS with RA was the remission rate of Simplified Disease Activity Index (SDAI) at 52 weeks after initiation of abatacept. The secondary endpoints included Saxon's test and Schirmer's test. Adverse events and adherence rate during the study period were also analyzed.
  
  
  RESULTS
  Thirty-six patients (all females) were enrolled in this study. The mean SDAI decreased significantly from 20.6 ± 11.2 (±SD) at baseline to 10.0 ± 10.5 at 52 weeks (p < 0.05). Patients with SDAI remission increased from 0 (0 week) to 12 patients (33.3%) at 52 weeks. Saliva volume assessed by Saxon's test increased significantly from 2136 ± 1809 (0 week) to 2397 ± 1878 (24 weeks) mg/2 min (n = 34, p < 0.05). Saliva volume increased significantly from 2945 ± 2090 (0 week) to 3419 ± 2121 (24 weeks) mg/2 min in 11 patients with Greenspan grade 1 or 2 of labial salivary gland biopsy (p < 0.05), but no change was noted in 18 patients with Greenspan grade 3 or 4. Tear volume by Schirmer's test increased significantly from 4.2 ± 4.8 (0 week) to 6.4 ± 7.8 (24 weeks) mm/5 min (n = 30, p < 0.05). The adherence rate to abatacept was 80.6% (29/36) over the 52-week period. Twelve adverse events occurred in 10 of the 36 patients, and 7 of these events were infections.
  
  
  CONCLUSIONS
  Abatacept seems to be effective for both RA and SS related manifestations.
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Hiroto
authors.initials: H
authors.lastname: Tsuboi
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Isao
authors.initials: I
authors.lastname: Matsumoto
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Hagiwara
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Tomoya
authors.initials: T
authors.lastname: Hirota
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Takahashi
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ebe
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Yokosawa
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Mizuki
authors.initials: M
authors.lastname: Yagishita
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Hidenori
authors.initials: H
authors.lastname: Takahashi
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Izumi
authors.initials: I
authors.lastname: Kurata
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Ayako
authors.initials: A
authors.lastname: Ohyama
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Fumika
authors.initials: F
authors.lastname: Honda
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Asashima
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Haruka
authors.initials: H
authors.lastname: Miki
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Naoto
authors.initials: N
authors.lastname: Umeda
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Yuya
authors.initials: Y
authors.lastname: Kondo
authors.affiliation: b The First Department of Internal Medicine, School of Medicine , University of Occupational and Environmental Health , Kitakyushu , Fukuoka , Japan , and.
authors.forename: Shintaro
authors.initials: S
authors.lastname: Hirata
authors.affiliation: b The First Department of Internal Medicine, School of Medicine , University of Occupational and Environmental Health , Kitakyushu , Fukuoka , Japan , and.
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Saito
authors.affiliation: b The First Department of Internal Medicine, School of Medicine , University of Occupational and Environmental Health , Kitakyushu , Fukuoka , Japan , and.
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: c Unit of Translational Medicine, Department of Immunology and Rheumatology , Nagasaki University Graduate School of Biomedical Sciences , Nagasaki , Japan.
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Horai
authors.affiliation: c Unit of Translational Medicine, Department of Immunology and Rheumatology , Nagasaki University Graduate School of Biomedical Sciences , Nagasaki , Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Nakamura
authors.affiliation: c Unit of Translational Medicine, Department of Immunology and Rheumatology , Nagasaki University Graduate School of Biomedical Sciences , Nagasaki , Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Kawakami
authors.affiliation: a Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba-city , Ibaraki , Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Sumida
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 / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012859:Sjogren's Syndrome / Q000188:drug therapy* / Q000209:etiology
chemical_list: D018501:Antirheumatic Agents; D000069594:Abatacept
keywords: Abatacept; Rheumatoid arthritis; Sjögren’s syndrome