Abatacept ameliorates both glandular and extraglandular involvements in patients with Sjogren’s syndrome associated with rheumatoid arthritis: Findings from an open-label, multicentre, 1-year, prospective study: The ROSE (Rheumatoid Arthritis with Orencia
Abatacept ameliorates both glandular and extraglandular involvements in patients with Sjogren’s syndrome associated with rheumatoid arthritis: Findings from an open-label, multicentre, 1-year, prospective study: The ROSE (Rheumatoid Arthritis with Orencia
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阿巴西普可改善与类风湿性关节炎相关的干燥综合征患者的腺体和腺外受累：一项开放标签、多中心、为期 1 年的前瞻性研究的结果：ROSE（类风湿性关节炎与 Orencia）
DOI：
10.1093/mr/roac011
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发表时间：
2022
影响因子：
2.2
通讯作者：
Ogasawara M
中科院分区：
文献类型：
--
作者：
Tsuboi H;Toko H;Honda F;Abe S;Takahashi H;Yagishita M;Hagiwara S;Ohyama A;Kondo Y;Nakano K;Tanaka Y;Shimizu T;Nakamura H;Kawakami A;Fujieda Y;Atsumi T;Suzuki Y;Kawano M;Nishina N;Kaneko Y;Takeuchi T;Kobayashi H;Takei M;Ogasawara M
目的探讨静脉注射阿巴西普（abatacept）治疗类风湿性关节炎（RA）相关的干燥综合征（SS）腺体及腺体外受累的有效性和安全性。主要终点是52周时通过SDAI测量的缓解率。次要终点包括Saxon检验、Schirmer检验、ESSDAI和ESSPRI的变化。结果68例患者（ROSE组36例，ROSE II组32例，均为女性）接受了ROSE治疗。SDAI从基线时的23.6 ± 13.2显著降低至52周时的9.9 ± 9.5。SDAI缓解的患者从0（0周）增加至52周时的19例患者（27.9%）。唾液量在24周时显著增加。泪液量在52周时显著增加。ESSDAI和ESSPRI在12周时均显著降低，并且这些反应维持至52周。在52周期间，阿巴西普的依从率为83.8%。22例不良事件发生在15 patients.ConclusionAbatacept改善了腺体和腺体外的参与，以及系统性疾病活动和患者报告的结果的基础上的复合措施，在SS与RA。
ObjectiveTo clarify the efficacy and safety of intravenous abatacept for glandular and extraglandular involvements in Sjögren’s syndrome (SS) associated with rheumatoid arthritis (RA).Materials and methodsWe performed an open-label, prospective, 1-year, observational multicenter study (ROSE and ROSE II trials). The primary endpoint was the remission rate as measured by SDAI at 52 weeks. The secondary endpoints included the changes in the Saxon’s test, Schirmer’s test, ESSDAI and ESSPRI. Adverse events and adherence rates were also analyzed.Results68 patients (36 in ROSE and 32 in ROSE II, all women) were enrolled. SDAI decreased significantly from 23.6 ± 13.2 at baseline to 9.9 ± 9.5 at 52 weeks. Patients with SDAI remission increased from 0 (0 weeks) to 19 patients (27.9%) at 52 weeks. Saliva volume increased significantly at 24 weeks. Tear volume increased significantly at 52 weeks. Both ESSDAI and ESSPRI were significantly decreased at 12 weeks, and these responses were maintained up to 52 weeks. The rate of adherence to abatacept over the 52-week period was 83.8%. Twenty-two adverse events occurred in 15 patients.ConclusionAbatacept ameliorated both glandular and extraglandular involvements, as well as the systemic disease activities and patient-reported outcomes based on composite measures, in SS associated with RA.