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: Hiroto Tsuboi, Isao Matsumoto, Shinya Hagiwara, Tomoya Hirota, Hiroyuki Takahashi, Hiroshi Ebe, Masahiro Yokosawa, Chihiro Hagiya, Hiromitsu Asashima, Chinatsu Takai, Haruka Miki, Naoto Umeda, Yuya Kondo, Hiroshi Ogishima, Takeshi Suzuki, Shintaro Hirata, Kazuyoshi Saito, Yoshiya Tanaka, Yoshiro Horai, Hideki Nakamura, Atsushi Kawakami, Takayuki Sumida
• Journal: Modern rheumatology (Mod Rheumatol) Vol. 25 Issue 2 Pg. 187-93 (Mar 2015) ISSN: 1439-7609 [Electronic] England
• PMID: 25211401 (Publication Type: Journal Article, Observational Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antirheumatic Agents
• Abatacept

Topics

• Abatacept (adverse effects, therapeutic use)
• Adult
• Antirheumatic Agents (adverse effects, therapeutic use)
• Arthritis, Rheumatoid (complications)
• Female
• Humans
• Male
• Middle Aged
• Prospective Studies
• Sjogren's Syndrome (drug therapy, etiology)
• Treatment Outcome