Davies Drew, Lanario Joseph W, Hyland Michael E, Masoli Matthew
Department of Respiratory Medicine, Royal Devon and Exeter Hospital, University of Exeter, Exeter, UK.
Faculty of Health, University of Plymouth, Plymouth, UK.
J Asthma Allergy. 2025 May 8;18:743-752. doi: 10.2147/JAA.S490267. eCollection 2025.
Biologic therapy in asthma can be life-changing and affect health-related quality of life, but symptoms are rarely used in the assessment of response.
To examine the change in health-related quality of life and asthma control between starting a biologic and assessment of biologic response, assessing whether this change can provide early prediction of eventual clinical response at 12 months.
A service evaluation of severe asthmatics initiating a biologic at the Royal Devon NHS trust between 2019 and 22. Health-Related Quality of Life (Severe Asthma Questionnaire) and asthma control (Asthma Control Questionnaire-6) was captured at baseline, 8 weeks, 16 weeks and 12 months. Patients were classified as responder or non-responder using NICE Criteria for biologic response. Independent samples -tests were used to determine statistical difference in change from baseline patient reported outcome measure scores between responder and non-responders.
One hundred and eight initiations (103 patients) of biologic therapy were included. At 8 weeks and 16 weeks, responders had greater improvement in Severe Asthma Questionnaire & Severe Asthma Questionnaire Global compared to non-responders (p<0.05). Improvement in Asthma Control Questionnaire only achieved significance between all-responders and non-responders at 16 weeks (p<0.05).
This study provides evidence of the early and sustained improvement in health-related quality of life and symptoms after starting biologic therapy. The findings support the use of the Severe Asthma Questionnaire and the Asthma Control Questionnaire as per the Core Outcome Measures Sets for Severe Asthma (COMSA). We have shown that health-related quality of life and asthma control can assist earlier assessment of response and non-response to biologics.
哮喘的生物治疗可能会改变生活,并影响与健康相关的生活质量,但症状很少用于评估治疗反应。
研究开始使用生物制剂治疗至评估生物制剂反应期间与健康相关的生活质量和哮喘控制情况的变化,评估这种变化是否能为12个月时最终的临床反应提供早期预测。
对2019年至2022年期间在皇家德文郡国民保健服务信托基金开始使用生物制剂的重度哮喘患者进行服务评估。在基线、8周、16周和12个月时收集与健康相关的生活质量(严重哮喘问卷)和哮喘控制情况(哮喘控制问卷-6)。使用英国国家卫生与临床优化研究所(NICE)的生物制剂反应标准将患者分为反应者或无反应者。采用独立样本t检验来确定反应者和无反应者之间从基线开始患者报告的结局指标得分变化的统计学差异。
纳入了108例生物制剂治疗起始病例(103例患者)。在8周和16周时,与无反应者相比,反应者在严重哮喘问卷和严重哮喘问卷总体得分方面有更大改善(p<0.05)。哮喘控制问卷的改善仅在16周时在所有反应者和无反应者之间达到显著差异(p<0.05)。
本研究提供了证据,表明开始生物制剂治疗后与健康相关的生活质量和症状会早期且持续改善。这些发现支持根据重度哮喘核心结局指标集(COMSA)使用严重哮喘问卷和哮喘控制问卷。我们已经表明,与健康相关的生活质量和哮喘控制情况有助于更早地评估对生物制剂的反应和无反应情况。