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

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.

Keywords:

• Sjögren's syndrome
• Rheumatoid arthritis
• Abatacept

Authors’ contributions

All authors contributed to the study design, data collection and participated in the writing of the manuscript and all agree to accept equal responsibility for the accuracy of the contents of this paper.

Acknowledgments

We thank Dr. F. G. Issa for the critical reading of the manuscript. This work was supported by Health and Labour Sciences Research Grants for research on intractable diseases (The Research Team for Autoimmune Diseases) from the Ministry of Health, Labour and Welfare of Japan.

Conflict of interest

This study was supported in part by Bristol-Myers Squibb (BMS); H.T. received lecture fees and/or honoraria from BMS; Y.T. received consulting fees, speaking fees, and/or honoraria from Abbvie, Chugai, Astellas, Takeda, Santen, Mitsubishi-Tanabe, Pfizer, Janssen, Eisai, Daiichi- Sankyo, UCB, GlaxoSmithKline, BMS, and received research grants from Mitsubishi-Tanabe, Chugai, MSD, Astellas, Novartis.

I.M., Y.H., H.N., A.K., and T.S. received research grants, lecture fees and/or honoraria from BMS.