title: Efficacy and safety of abatacept for patients with Sjögren's syndrome associated with rheumatoid arthritis: rheumatoid arthritis with orencia trial toward Sjögren's syndrome Endocrinopathy (ROSE) trial-an open-label, one-year, prospective study-Interim analysis of 32 patients for 24 weeks.
abstract: Abstract Objective. To assess the efficacy and safety of abatacept for secondary Sjögren's syndrome (SS) associated with rheumatoid arthritis (RA). Methods. The primary endpoint of this 1-year, open-labeled, prospective, observational multicenter study of RA-associated secondary SS was the rate of SDAI remission at 52 weeks after initiation of abatacept therapy. The secondary endpoints included that of Saxson's test and Schirmer's test. Adverse events during the study period were also analyzed. Results. Thirty-two patients (all females) were enrolled in this study. Interim analysis at 24 weeks included assessment of efficacy (n = 31) and safety (n = 32). The mean SDAI decreased from 19.8 ± 11.0 (± SD) at baseline to 9.9 ± 9.9 at 24 weeks (P < 0.05). Patients with clinical remission, as assessed by SDAI, increased from 0 patient (0 week) to 8 patients (25.8%) at 24 weeks. Saliva volume (assessed by Saxson's test) increased slightly from 2232 ± 1908 (0 week) to 2424 ± 2004 (24 weeks) mg/2 min (n = 29). In 11 patients with Greenspan grading 1/2 of labial salivary glands biopsy, saliva volume increased from 2945 ± 2090 (0 week) to 3419 ± 2121 (24 weeks) mg/2 min (P < 0.05). Schirmer's test for tear volume showed increase from 3.6 ± 4.6 (0 week) to 5.5 ± 7.1 (24 weeks) mm/5 min (n = 25; P < 0.05). Five adverse events occurred in five of 32 patients (15.6%), and three of these events were infections. Conclusion. Abatacept seems to be effective for both RA and RA-related secondary SS.
authors.affiliation: Department of Internal Medicine, Faculty of Medicine, University of Tsukuba , Tsukuba, Ibaraki Prefecture , Japan.
authors.forename: Hiroto
authors.initials: H
authors.lastname: Tsuboi
authors.forename: Isao
authors.initials: I
authors.lastname: Matsumoto
authors.forename: Shinya
authors.initials: S
authors.lastname: Hagiwara
authors.forename: Tomoya
authors.initials: T
authors.lastname: Hirota
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Takahashi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ebe
authors.forename: Masahiro
authors.initials: M
authors.lastname: Yokosawa
authors.forename: Chihiro
authors.initials: C
authors.lastname: Hagiya
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Asashima
authors.forename: Chinatsu
authors.initials: C
authors.lastname: Takai
authors.forename: Haruka
authors.initials: H
authors.lastname: Miki
authors.forename: Naoto
authors.initials: N
authors.lastname: Umeda
authors.forename: Yuya
authors.initials: Y
authors.lastname: Kondo
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ogishima
authors.forename: Takeshi
authors.initials: T
authors.lastname: Suzuki
authors.forename: Shintaro
authors.initials: S
authors.lastname: Hirata
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Saito
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Horai
authors.forename: Hideki
authors.initials: H
authors.lastname: Nakamura
authors.forename: Atsushi
authors.initials: A
authors.lastname: Kawakami
authors.forename: Takayuki
authors.initials: T
authors.lastname: Sumida
mesh_terms: D000069594:Abatacept / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000150:complications*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012859:Sjogren's Syndrome / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D000069594:Abatacept
keywords: Abatacept; Rheumatoid arthritis; Sjögren's syndrome