Department of Medicine V, University Hospital, LMU Munich, Munich, Germany; Comprehensive Pneumology Center Munich (CPC-M), Member of the German Center for Lung Research (DZL), Munich, Germany.
Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany.
J Allergy Clin Immunol Pract. 2023 Sep;11(9):2701-2712.e2. doi: 10.1016/j.jaip.2023.05.047. Epub 2023 Jun 8.
Recently, criteria for evaluation of response to biologics have been proposed and the concept of clinical remission has gained attention as a possible goal even in severe asthma.
To analyze the response and remission in the German Asthma Net severe asthma registry cohort.
We included adults not using a biologic at baseline (V0) and compared patients treated between V0 and 1-year visit (V1) without using a biologic (group A) to patients starting with a biologic after V0 and continuing it up to V1 (group B). We applied the Biologics Asthma Response Score to quantify composite response in good, intermediate, or insufficient. We defined clinical remission (R) as absence of significant symptoms (Asthma Control Test score ≥ 20 at V1) in the absence of exacerbations and oral corticosteroid therapy.
Group A included 233 and group B 210 patients, the latter receiving omalizumab (n = 33), mepolizumab (n = 40), benralizumab (n = 81), reslizumab (n = 1), or dupilumab (n = 56). At baseline, group B had less often an allergic phenotype (35.2% vs 41.6%), lower Asthma Control Test score (median, 12 vs 14), more exacerbations in the past year (median, 3 vs 2), and more often high-dose inhaled corticosteroid treatment (71.4% vs 51.5%) than group A. After 1 year of treatment, rates of response (good: 61.4% vs 34.8%; intermediate: 26.7% vs 42.9%; insufficient: 11.9% vs. 22.3%) and/or clinical remission (37.6% vs 17.2%) were higher in group B than in group A.
Despite more severe asthma at baseline, patients treated with biologics had a markedly higher probability of achieving good clinical response and/or remission than patients treated without biologics.
最近，提出了评估生物制剂疗效的标准，并且临床缓解作为严重哮喘的可能目标也受到了关注。
分析德国哮喘网络严重哮喘登记研究队列中的反应和缓解情况。
我们纳入了基线时未使用生物制剂的成年人，并比较了在基线时（V0）和 1 年随访时（V1）未使用生物制剂治疗的患者（组 A）与在 V0 后开始使用生物制剂并持续使用至 V1 的患者（组 B）。我们应用生物制剂哮喘反应评分来量化良好、中等或不佳的综合反应。我们定义临床缓解（R）为在无加重和口服皮质类固醇治疗的情况下，哮喘控制测试评分≥20（V1 时）无明显症状。
组 A 包括 233 例患者，组 B 包括 210 例患者，其中奥马珠单抗（n=33）、美泊利单抗（n=40）、贝那利珠单抗（n=81）、瑞利珠单抗（n=1）和度普利尤单抗（n=56）。基线时，组 B 的过敏表型较少（35.2% vs. 41.6%），哮喘控制测试评分较低（中位数 12 分 vs. 14 分），过去一年中加重的次数更多（中位数 3 次 vs. 2 次），并且更高比例的患者接受高剂量吸入皮质类固醇治疗（71.4% vs. 51.5%）。治疗 1 年后，组 B 的反应率（良好：61.4% vs. 34.8%；中等：26.7% vs. 42.9%；不佳：11.9% vs. 22.3%）和/或临床缓解率（37.6% vs. 17.2%）均高于组 A。
尽管基线时哮喘更为严重，但接受生物制剂治疗的患者与未接受生物制剂治疗的患者相比，达到良好临床反应和/或缓解的可能性显著更高。
