Use of Omalizumab in the Treatment of Food Allergy and Anaphylaxis - A Multicenter Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Number of Patients by Response to Treatment
研究概览
简要总结
This was a retrospective, multi-center observational study conducted across four allergy departments in Europe (Berlin, Leipzig, Barcelona, and Basel). The study included patients with immunoglobulin E (IgE)-mediated food allergy who were treated with omalizumab, either as monotherapy or in combination with oral immunotherapy (OIT) between 2002-2022.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •None identified.
结局指标
主要结局
Number of Patients by Response to Treatment
时间窗: Months 3, 6, 12, and 24
Patients were classified as treatment responders if an oral food challenge was negative, or a decrease in severity of food allergy during an oral food challenge was determined and no anaphylactic reactions occurred during treatment. Non-responders were those who experienced repetitive food anaphylactic reactions during treatment. Partial treatment responders were patients who experienced less than 1 food anaphylactic reaction despite undergoing treatment.
次要结局
- Frequency of Accidental Reactions(Up to approximately 7 years)
- Change From Baseline in Allergen Threshold Levels(From Baseline up to approximately 7 years)
- Change From Baseline in Severity of Anaphylactic Reactions(From Baseline up to approximately 7 years)
- Health-related Quality of Life (HRQoL) Based on Patient Reported Data as Measured by the EuroQol-5 Dimensions (EQ-5D) Questionnaire(Months 3, 6, 12, and 24)
- HRQoL Based on Patient Reported Data as Measured by the Food Allergy Quality of Life Questionnaire (FAQLQ)(Months 3, 6, 12, and 24)