Molimard M, Mala L, Bourdeix I, Le Gros V
INSERM, Unité 657, IFR 99, Université de Bordeaux, Département de Pharmacologie, CHU de Bordeaux, 33076 Bordeaux Cedex, France.
Novartis Pharma S.A.S., 2-4 rue Lionel Terray, 92506 Rueil Malmaison Cedex, France.
Respir Med. 2014 Apr;108(4):571-6. doi: 10.1016/j.rmed.2014.02.003. Epub 2014 Feb 12.
Severe persistent asthma represents a major and costly public health issue. There is evidence that long-term treatment with omalizumab might have disease-modifying activity but data on the consequences of discontinuing treatment after a positive response are limited. The purpose of this study was to investigate-in real-life prescribing conditions-what happens when omalizumab is discontinued in patients with severe, persistent allergic asthma who have responded well to omalizumab treatment.
An observational, descriptive, cross-sectional, retrospective study to establish the time to loss of asthma control after the discontinuation of courses of omalizumab treatment of varying duration.
24 lung specialists reviewed data from 61 responder patients who had discontinued omalizumab after a mean duration of 22.7 ± 13.1 [range: 2.5; 59.5] months of treatment. Loss of asthma control was documented in 34 patients (55.7%) with a median interval between discontinuation and loss of control of 13.0 months (mean 20.4 ± 2.6 [95% CI: 8.3-28.1]). No correlation was detected between time to loss of control and duration of treatment, although control tended to be sustained for longer in patients whose response had been classified as "excellent" as opposed to "good" (median: 17.0 vs. 12.8 months; NS).
The discontinuation of omalizumab was not associated with any rebound effect or exacerbation of the disease, and control was sustained throughout the follow-up period of at least 6 months in nearly half of all patients, including all of those who had been treated for 3.5 years or more. After the reintroduction of omalizumab, 4 out of 20 patients did not respond again.
重度持续性哮喘是一个重大且代价高昂的公共卫生问题。有证据表明,长期使用奥马珠单抗治疗可能具有改善疾病的活性,但关于在出现阳性反应后停药的后果的数据有限。本研究的目的是在实际处方条件下,调查在对奥马珠单抗治疗反应良好的重度持续性过敏性哮喘患者中停用奥马珠单抗时会发生什么情况。
一项观察性、描述性、横断面、回顾性研究,以确定不同疗程的奥马珠单抗治疗停药后哮喘控制丧失的时间。
24位肺部专家回顾了61例反应者的数据,这些患者在平均治疗22.7±13.1[范围:2.5;59.5]个月后停用了奥马珠单抗。34例患者(55.7%)出现哮喘控制丧失,停药至控制丧失的中位间隔时间为13.0个月(平均20.4±2.6[95%CI:8.3-28.1])。未发现控制丧失时间与治疗持续时间之间存在相关性,尽管与“良好”反应的患者相比,反应被分类为“优秀”的患者的控制往往维持更长时间(中位值:17.0对12.8个月;无显著性差异)。
停用奥马珠单抗与疾病的任何反弹效应或加重均无关,并且在近一半的所有患者中,包括所有接受治疗3.5年或更长时间的患者,在至少6个月的随访期内控制得以维持。重新使用奥马珠单抗后,20例患者中有4例未再次出现反应。