Menzella Francesco, Fontana Matteo, Contoli Marco, Ruggiero Patrizia, Galeone Carla, Capobelli Silvia, Simonazzi Anna, Catellani Chiara, Scelfo Chiara, Castagnetti Claudia, Livrieri Francesco, Facciolongo Nicola
Pulmonology Unit, Arcispedale Santa Maria Nuova, Azienda USL - IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Respiratory Section, Department of Translational Medicine, University of Ferrara, Ferrara, Italy.
J Asthma Allergy. 2022 Apr 21;15:505-515. doi: 10.2147/JAA.S363398. eCollection 2022.
Treatment of severe asthma has made great strides thanks to rapid progress in understanding immune response and inflammatory pathways. This led to the advent of the first biologic for severe allergic asthma (SAA), omalizumab. Although the long-term efficacy and safety of omalizumab has been confirmed, increasingly longer follow-up data can further reinforce this evidence and potentially provide new ones, for example on any loss of efficacy or the appearance of unexpected side effects. This study reports omalizumab treatment-related outcomes after 16 years of follow-up.
In this real-life retrospective study, an extension of a previous 9-year follow-up study on patients initially recruited in a clinical trial, we enrolled 8 adult patients with SAA followed-up from November 2005 to December 2021. Study subjects were selected based on omalizumab eligibility criteria.
Exacerbation rate significantly decreased from 3.6 ± 2.1 events in year before index date to 0.1 ± 0.4 after 32 weeks of treatment (p < 0.0001). Mean annual number of mild-to-moderate exacerbations at 16 years was 0.88 compared with 1.8 in the year before the index date and 1.1 at 32 weeks. No hospitalizations were documented during the 16-year follow-up compared to 0.3 hospitalizations/patient in the year before the index date. Respiratory function also progressively and significantly improved. Regarding patient-reported outcomes (PROs), The AQLQ and ACT significantly improved from baseline throughout the follow-up, particularly up to 9 years of follow-up. During the study, an overall reduction in doses of asthma medications was observed, with a significant OCS-sparing effect.
Our study, the longest clinical follow-up on patients treated with anti-IgE, confirms and amplifies the results of the studies carried out so far, as they are maintained over a very long interval of time without drops in efficacy without any type of side effect.
由于在理解免疫反应和炎症途径方面取得了快速进展，重度哮喘的治疗取得了巨大进步。这导致了首个用于重度过敏性哮喘（SAA）的生物制剂奥马珠单抗的出现。尽管奥马珠单抗的长期疗效和安全性已得到证实，但越来越长的随访数据可以进一步强化这一证据，并有可能提供新的证据，例如关于疗效丧失或意外副作用的出现。本研究报告了16年随访后奥马珠单抗治疗相关的结果。
在这项真实世界的回顾性研究中，作为之前对最初在一项临床试验中招募的患者进行的9年随访研究的扩展，我们纳入了8例成年SAA患者，随访时间为2005年11月至2021年12月。研究对象根据奥马珠单抗的入选标准进行选择。
发作率从索引日期前一年的3.6±2.1次显著降至治疗32周后的0.1±0.4次（p<0.0001）。16年时轻度至中度发作的年均次数为0.88次，而索引日期前一年为1.8次，32周时为1.1次。与索引日期前一年每位患者0.3次住院相比，16年随访期间无住院记录。呼吸功能也逐渐且显著改善。关于患者报告的结局（PROs），在整个随访期间，AQLQ和ACT从基线显著改善，尤其是在长达9年的随访期间。在研究期间，观察到哮喘药物剂量总体减少，具有显著的口服糖皮质激素节省效应。
我们的研究是对接受抗IgE治疗患者最长的临床随访，证实并扩展了迄今为止开展的研究结果，因为这些结果在很长一段时间内得以维持，没有疗效下降，也没有任何类型的副作用。
