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- 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
- Authors
Hiroto Tsuboi; Isao Matsumoto; Shinya Hagiwara; Tomoya Hirota; Hiroyuki Takahashi; Hiroshi Ebe; Masahiro Yokosawa; Mizuki Yagishita; Hidenori Takahashi; Izumi Kurata; Ayako Ohyama; Fumika Honda; Hiromitsu Asashima; Haruka Miki; Naoto Umeda; Yuya Kondo; Shintaro Hirata; Kazuyoshi Saito; Yoshiya Tanaka; Yoshiro Horai
- 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 (p50.05). 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, p50.05). 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 (p50.05), 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, p50.05). 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. Conclusion: Abatacept seems to be effective for both RA and SS related manifestations.
- Subjects
ABATACEPT; DRUG efficacy; SJOGREN'S syndrome; RHEUMATOID arthritis; MEDICATION safety
- Publication
Modern Rheumatology, 2016, Vol 26, Issue 6, p891
- ISSN
1439-7595
- Publication type
Article
- DOI
10.3109/14397595.2016.1158773