INSERM U 600, UMR 6212, Université de la Méditerranée., Marseille, France.
Université de la Réunion, St Denis, France.
Allergy. 2017 Dec;72(12):1953-1961. doi: 10.1111/all.13202. Epub 2017 Jun 14.
Omalizumab, an anti-IgE antibody, is used to treat patients with severe allergic asthma. The evolution of lung function parameters over time and the difference between omalizumab responder and nonresponder patients remain inconclusive. The objective of this real-life study was to compare the changes in forced expiratory volume in 1 second (FEV1) of omalizumab responders and nonresponders at 6 months.
A multicenter analysis was performed in 10 secondary and tertiary institutions. Lung function parameters (forced vital capacity (FVC), pre- and postbronchodilator FEV1, residual volume (RV), and total lung capacity (TLC) were determined at baseline and at 6 months. Omalizumab response was assessed at the 6-month visit. In the omalizumab responder patients, lung function parameters were also obtained at 12, 18, and 24 months.
Mean prebronchodilator FEV1 showed improvement in responders at 6 months, while a decrease was observed in nonresponders (+0.2±0.4 L and -0.1±0.4 L, respectively, P<.01). After an improvement at 6 months, pre- and postbronchodilator FEV1 remained stable at 12, 18, and 24 months. The FEV1/FVC remained unchanged over time, but the proportion of patients with an FEV1/FVC ratio <0.7 decreased at 6, 12, 18, and 24 months (55.2%, 54.0%, 54.0%, and 44.8%, respectively, P<.05). Mean RV values decreased at 6 months but increased at 12 months and 24 months (P<.05). Residual volume/total lung capacity (RV/TLC) ratio decreased at 6 months and remained unchanged at 24 months.
After omalizumab initiation, FEV1 improved at 6 months in responder patients and then remained stable for 2 years. RV and RV/TLC improved at 6 months.
奥马珠单抗是一种抗 IgE 抗体,用于治疗严重过敏性哮喘患者。关于肺功能参数随时间的变化以及奥马珠单抗应答者和无应答者之间的差异,目前尚无定论。本真实世界研究的目的是比较奥马珠单抗应答者和无应答者在 6 个月时的 1 秒用力呼气量(FEV1)变化。
在 10 家二级和三级医疗机构进行了多中心分析。在基线和 6 个月时测定肺功能参数(用力肺活量(FVC)、支气管扩张剂前后 FEV1、残气量(RV)和肺总量(TLC)。在 6 个月时评估奥马珠单抗的应答情况。在奥马珠单抗应答者中,还在 12、18 和 24 个月时获得了肺功能参数。
在 6 个月时,应答者的支气管扩张剂前 FEV1 显示出改善,而无应答者的 FEV1 则下降(分别为+0.2±0.4 L 和-0.1±0.4 L,P<.01)。在 6 个月时改善后,支气管扩张剂前和后 FEV1 在 12、18 和 24 个月时保持稳定。FEV1/FVC 随时间保持不变,但在 6、12、18 和 24 个月时,FEV1/FVC 比值<0.7 的患者比例降低(分别为 55.2%、54.0%、54.0%和 44.8%,P<.05)。RV 值在 6 个月时降低,但在 12 个月和 24 个月时升高(P<.05)。残气量/肺总量(RV/TLC)比值在 6 个月时降低,在 24 个月时保持不变。
奥马珠单抗起始后,应答者在 6 个月时 FEV1 改善,随后 2 年内保持稳定。RV 和 RV/TLC 在 6 个月时改善。