阿巴西普可降低早期原发干燥综合征的疾病活动度
发表者：金银姬
日期：2015-02-27
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摘要：目的：评估阿巴西普在早期活动的原发性干燥综合征患者中的有效性及安全性。
方法：参与开放性研究的15名（女12名，男3名）干燥综合征患者符合修订的AECG分类标准，且未使用生物DMARDS药物。患者接受八次阿巴西普静脉注射，分别为第1天、第15天、第29天，此后每隔4周注射一次。随访时间为第4、12、24（治疗）、36及48周（停止治疗）。根据EULAR-ESSDAI及ESSPRI进行疾病活动度评估。
结果：阿巴西普治疗后ESSDAI、ESSPRI、RF及IgG水平明显下降，停止治疗后上述指标升高。治疗期间唾液腺及泪腺功能无明显改变。治疗期间健康相关生命质量（HR-QoL）显著改善，且未见严重不良反应及感染等副作用。
结论：该研究提示阿巴西普为有效、安全、耐受性良好的药物，且在早期pSS患者中可改善疾病活动度、实验室指标及HR-Qol。
附原文：Objective To assess the efficacy and safety of abatacept in patients with early and active primarySjögren’s syndrome ( pSS). Methods All 15 patients (12 women, three men) included in the open-label Active Sjögren Abatacept Pilot study met the revised American-European Consensus Group criteria for pSS and were biological diseasemodifying antirheumatic drug-naive. Patients were treated with eight intravenous abatacept infusions on days 1, 15 and 29 and every 4 weeks thereafter. Followup was conducted at 4, 12, 24 (on treatment), 36 and 48 weeks (off treatment). Disease activity was assessed with European League Against Rheumatism (EULAR) Sjögren’s Syndrome Disease Activity Index (ESSDAI) and EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI). Several other functional, laboratory and subjective variables were analysed. Generalised estimating equations were used to analyse parameters over time. Results ESSDAI, ESSPRI, rheumatoid factor and IgG levels decreased significantly during abatacept treatment and increased post-treatment. Salivary and lacrimal gland function did not change during treatment. Fatigue and health-related quality of life (HR-QoL) improved significantly during treatment. No serious side effects or infections were seen. Conclusions In this open-label study, abatacept treatment is effective, safe and well tolerated, and results in improved disease activity, laboratory parameters, fatigue and HR-QoL in patients with early and active pSS.
引自：Meiners PM, et al. Abatacept treatment reduces disease activity in early primary Sjögren’s syndrome (open-label proof of concept ASAP study).Ann Rheum Dis 2014;0:1–4. doi:10.1136/annrheumdis-2013-204653 （注：干燥综合症病人或亲属可加QQ群交流，群号： 118194945 ，本网站站长私人微信号： ssgzz88 ）
方法：参与开放性研究的15名（女12名，男3名）干燥综合征患者符合修订的AECG分类标准，且未使用生物DMARDS药物。患者接受八次阿巴西普静脉注射，分别为第1天、第15天、第29天，此后每隔4周注射一次。随访时间为第4、12、24（治疗）、36及48周（停止治疗）。根据EULAR-ESSDAI及ESSPRI进行疾病活动度评估。
结果：阿巴西普治疗后ESSDAI、ESSPRI、RF及IgG水平明显下降，停止治疗后上述指标升高。治疗期间唾液腺及泪腺功能无明显改变。治疗期间健康相关生命质量（HR-QoL）显著改善，且未见严重不良反应及感染等副作用。
结论：该研究提示阿巴西普为有效、安全、耐受性良好的药物，且在早期pSS患者中可改善疾病活动度、实验室指标及HR-Qol。
附原文：Objective To assess the efficacy and safety of abatacept in patients with early and active primarySjögren’s syndrome ( pSS). Methods All 15 patients (12 women, three men) included in the open-label Active Sjögren Abatacept Pilot study met the revised American-European Consensus Group criteria for pSS and were biological diseasemodifying antirheumatic drug-naive. Patients were treated with eight intravenous abatacept infusions on days 1, 15 and 29 and every 4 weeks thereafter. Followup was conducted at 4, 12, 24 (on treatment), 36 and 48 weeks (off treatment). Disease activity was assessed with European League Against Rheumatism (EULAR) Sjögren’s Syndrome Disease Activity Index (ESSDAI) and EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI). Several other functional, laboratory and subjective variables were analysed. Generalised estimating equations were used to analyse parameters over time. Results ESSDAI, ESSPRI, rheumatoid factor and IgG levels decreased significantly during abatacept treatment and increased post-treatment. Salivary and lacrimal gland function did not change during treatment. Fatigue and health-related quality of life (HR-QoL) improved significantly during treatment. No serious side effects or infections were seen. Conclusions In this open-label study, abatacept treatment is effective, safe and well tolerated, and results in improved disease activity, laboratory parameters, fatigue and HR-QoL in patients with early and active pSS.
引自：Meiners PM, et al. Abatacept treatment reduces disease activity in early primary Sjögren’s syndrome (open-label proof of concept ASAP study).Ann Rheum Dis 2014;0:1–4. doi:10.1136/annrheumdis-2013-204653 （注：干燥综合症病人或亲属可加QQ群交流，群号： 118194945 ，本网站站长私人微信号： ssgzz88 ）