Hansen Susanne, Baastrup Søndergaard Marianne, von Bülow Anna, Bjerrum Anne-Sofie, Schmid Johannes, Rasmussen Linda M, Johnsen Claus R, Ingebrigtsen Truls, Håkansson Kjell Erik Julius, Johansson Sofie Lock, Bisgaard Maria, Assing Karin Dahl, Hilberg Ole, Ulrik Charlotte, Porsbjerg Celeste
Respiratory Research Unit, Department of Respiratory Medicine and Infectious Diseases, Bispebjerg & Frederiksberg Hospital, Copenhagen, Denmark; Center for Clinical Research and Prevention, Bispebjerg & Frederiksberg Hospital, Copenhagen, Denmark.
Respiratory Research Unit, Department of Respiratory Medicine and Infectious Diseases, Bispebjerg & Frederiksberg Hospital, Copenhagen, Denmark.
Chest. 2024 Feb;165(2):253-266. doi: 10.1016/j.chest.2023.10.046. Epub 2023 Nov 3.
BACKGROUND: The development of novel targeted biologic therapies for severe asthma has provided an opportunity to consider remission as a new treatment goal. RESEARCH QUESTION: How many patients with severe asthma treated with biologic therapy achieve clinical remission, and what predicts response to treatment? STUDY DESIGN AND METHODS: The Danish Severe Asthma Register is a nationwide cohort including all adult patients receiving biologic therapy for severe asthma in Denmark. This observational cohort study defined "clinical response" to treatment following 12 months as a ≥ 50% reduction in exacerbations and/or a ≥ 50% reduction in maintenance oral corticosteroid dose, if required. "Clinical remission" was defined by cessation of exacerbations and maintenance oral corticosteroids, as well as a normalization of lung function (FEV > 80%) and a six-question Asthma Control Questionnaire score ≤ 1.5 following 12 months of treatment. RESULTS: Following 12 months of treatment, 104 (21%) of 501 biologic-naive patients had no response to treatment, and 397 (79%) had a clinical response. Among the latter, 97 (24%) fulfilled the study criteria of clinical remission, corresponding to 19% of the entire population. Remission was predicted by shorter duration of disease and lower BMI in the entire population of patients treated with biologic therapy. INTERPRETATION: Clinical response was achieved in most adult patients initiating biologic therapy, and clinical remission was observed in 19% of the patients following 12 months of treatment. Further studies are required to assess the long-term outcome of achieving clinical remission with biologic therapy.
背景:新型靶向生物疗法用于重度哮喘的研发为将病情缓解作为新的治疗目标提供了契机。 研究问题:接受生物疗法治疗的重度哮喘患者中有多少实现了临床缓解,以及哪些因素可预测治疗反应? 研究设计与方法:丹麦重度哮喘登记处是一个全国性队列,纳入了丹麦所有接受生物疗法治疗重度哮喘的成年患者。这项观察性队列研究将治疗12个月后的“临床反应”定义为病情加重次数减少≥50%和/或(如有需要)维持口服糖皮质激素剂量减少≥50%。“临床缓解”的定义为病情加重停止、不再使用维持口服糖皮质激素,以及治疗12个月后肺功能正常(第一秒用力呼气容积>80%)且哮喘控制问卷六题评分≤1.5。 结果:治疗12个月后,501例初治生物制剂的患者中有104例(21%)对治疗无反应,397例(79%)有临床反应。在后者中,97例(24%)达到临床缓解的研究标准,相当于全体患者的19%。在接受生物疗法治疗的全体患者中,疾病持续时间较短和体重指数较低可预测缓解情况。 解读:大多数开始接受生物疗法的成年患者实现了临床反应,治疗12个月后19%的患者实现了临床缓解。需要进一步研究来评估生物疗法实现临床缓解的长期结果。
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