家庭灰尘虫SCIT降低了喘风险,并显著改善了长期的鼻炎和喘控制-RWE的一项研究
Marek Jutel1,2, Ludger Klimek3, Hartmut Richter4
1ALL-MED Medical Research Institute, Wrocław, Poland.
Allergy
|March 2, 2024
概括
家庭灰尘 (HDM) 过敏原免疫疗法 (AIT) 在5 - 70岁的患者中显著减少过敏性鼻炎和喘进展. 这些真实数据显示了长期的益处,包括在15个月的皮下AIT (SCIT) 后降低了新发喘的风险.
科学领域:
- 免疫学 免疫学 免疫学
- 过敏学 过敏学
- 药物监督 药物监督 药物监督
背景情况:
- 德国的法规 (TAO) 影响了家用灰尘虫 (HDM) 和过敏原免疫疗法 (AIT) 市场.
- 德国批准了三种HDM皮下AIT (SCIT) 产品,可在2026年完成TAO后完成.
- 对HDM AIT有效性的长期临床试验数据有限.
研究的目的:
- 使用真实世界数据 (RWD) 评估特定本地HDMSCIT产品的长期有效性.
- 提供每种产品对AIT有效性的分析,与国际准则保持一致.
- 评估SCIT对过敏性鼻炎 (AR) 和喘进展和发病的影响.
主要方法:
- 使用纵向索赔数据库进行的回顾性观察性队列研究,涵盖了德国60%的法定医疗保健处方.
- 包括年龄在5-70岁的患者,他们接受了第一次SCIT处方 (2009-2013) 与仅接受症状AR药物的匹配对照组相比.
- 随访期长达6年,截至2017年2月,分析AR和喘药物处方以及喘发作.
主要成果:
- 2年后,SCIT组显示AR药物 (62.8%) 和喘药物 (42.4%) 的处方显著减少.
- 与非AIT组相比,SCIT组的新发喘风险降低了27.0% (p=0.0212).
- 在SCIT组中,喘发作延迟,预防效果观察到从治疗开始后15个月左右开始.
结论:
- 这种产品特定的RWD分析表明,在5 - 70岁的患者中,本地HDM SCIT的长期益处.
- SCIT有效地降低了AR和喘的进展,治疗后的效果持续长达6年.
- 观察到喘发作的风险显著降低,从SCIT15个月后开始.
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