Solidoro Paolo, Nicola Stefania, Ridolfi Irene, Canonica Giorgio Walter, Blasi Francesco, Paggiaro Pierluigi, Heffler Enrico, Bagnasco Diego, Patrucco Filippo, Ribolla Fulvia, Bucca Caterina, Rolla Giovanni, Albera Carlo, Brussino Luisa
S.C. Pneumologia U, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza, Corso Bramante, 88, 10126 Turin, Italy.
Department of Medical Sciences, University of Turin, Corso Achille Mario Dogliotti, 14, 10126 Turin, Italy.
Biomedicines. 2022 Jan 18;10(2):200. doi: 10.3390/biomedicines10020200.
Biologic drugs have dramatically improved severe eosinophilic asthma (SEA) outcomes. Our aim was to evaluate the long-term efficacy of biological therapy in SEA in a real-life setting and to identify the predictors for switching to another biological drug in patients with poor asthma control. The outcomes for efficacy were decreased annual exacerbations (AE) and improved asthma control test (ACT).
In 90 SEA patients being treated with a biological drug, clinical examination, ACT, blood eosinophils count and spirometry were assessed before (T0) and after 6 (T1), 12 (T2), 24 (T3) and 36 (T4) months from the start of biological therapy. Patients were considered responders (R) or non-responders (NR) to biologics depending on whether or not they had less than two AE and a 20% increase in the ACT after 12 months of treatment.
75% of the patients were R, 25% NR. In R patients, biological therapy add-on was followed by significant improvement in AE and ACT throughout the whole follow-up period. The percentage of patients on oral corticosteroids (OCS) dropped from 40% to 12%. By contrast, the NR patients were shifted to another biological drug after 12 months of therapy, as they still had high AE and nearly unchanged ACT; 40% of them still needed OCS treatment. The predictors of switching to another biological drug were three or more AE, ACT below 17, nasal polyposis and former smoking ( < 0.05). In NR, the shift to another biological drug was followed by a significant decrease in AE and an increase in the ACT.
This real-life study confirms the long-term efficacy of biologics in most SEA patients and indicates that even in non-responders to a first biological drug, it is worth trying a second one. It is hoped that the availability of additional biologics with different targets will help improve the personalization of SEA therapy.
生物药物显著改善了重度嗜酸性粒细胞性哮喘（SEA）的治疗效果。我们的目的是评估在现实临床环境中生物疗法对SEA的长期疗效，并确定哮喘控制不佳的患者改用另一种生物药物的预测因素。疗效指标为年度发作次数（AE）减少和哮喘控制测试（ACT）改善。
对90例接受生物药物治疗的SEA患者，在生物治疗开始前（T0）以及开始治疗6个月（T1）、12个月（T2）、24个月（T3）和36个月（T4）后进行临床检查、ACT、血液嗜酸性粒细胞计数和肺功能测定。根据治疗12个月后AE是否少于2次以及ACT是否提高20%，将患者分为生物药物治疗反应者（R）或无反应者（NR）。
75%的患者为R，25%为NR。在R组患者中，在整个随访期间，附加生物疗法后AE和ACT均有显著改善。口服糖皮质激素（OCS）治疗的患者比例从40%降至12%。相比之下，NR组患者在治疗12个月后改用另一种生物药物，因为他们的AE仍然很高且ACT几乎没有变化；其中40%的患者仍需要OCS治疗。改用另一种生物药物的预测因素为AE达3次或更多、ACT低于17、鼻息肉病和既往吸烟（P<0.05）。在NR组中，改用另一种生物药物后AE显著减少，ACT增加。
这项现实临床研究证实了生物药物对大多数SEA患者的长期疗效，并表明即使对第一种生物药物无反应的患者，尝试第二种生物药物也是值得的。希望有更多具有不同靶点的生物药物可供使用，这将有助于改善SEA治疗的个性化。
