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奥马珠单抗的依从性:一项多中心“真实世界”研究。

Adherence to omalizumab: A multicenter "real-world" study.

作者信息

Campisi Raffaele, Crimi Claudia, Intravaia Rossella, Strano Simona, Noto Alberto, Foschino Maria Pia, Valenti Giuseppe, Viviano Vittorio, Pelaia Corrado, Ricciardi Luisa, Scichilone Nicola, Crimi Nunzio

机构信息

Respiratory Medicine Unit, A.O.U. "Policlinico-Vittorio Emanuele", Catania, Italy.

Respiratory Medicine Unit, A.O.U. "Policlinico-Vittorio Emanuele", Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.

出版信息

World Allergy Organ J. 2020 Feb 12;13(2):100103. doi: 10.1016/j.waojou.2020.100103. eCollection 2020 Feb.

Abstract

BACKGROUND

Adherence to medications is crucial in patients with severe asthma in light of the negative clinical impact and costs of non-adherence. Adherence to omalizumab has not been well studied in real-world settings. The aim of this study was to assess adherence to omalizumab and evaluate treatment effectiveness in relation to adherence.

METHODS

This was a retrospective, observational, and multicenter real-world study. Omalizumab dose, timing of administration, and duration of treatment (<2 years; 2-4 years; > 4 years) were analyzed. Adherence was evaluated by examining rates of expected and missing doses. Good adherence (<10% of doses missed) and poor adherence (>10% doses missed) were determined. For effectiveness in relation to adherence of omalizumab we considered asthma exacerbations, hospitalizations, asthma control test (ACT), and Forced Expiratory Volume in 1 s (FEV).

RESULTS

A total of 196 patients were evaluated, and 161 were suitable for data analyses. Good adherence was shown in 90.7% of patients and poor adherence in 9.3%. Considering adherence in relation to treatment duration: <2 years, 87.8% of patients were adherent (expected doses, 1186; missed doses, 53); 2-4 years, 85.9% were adherent (expected doses, 2985; missed doses, 127); >4 years, 100% were adherent (expected doses, 6120; missed doses, none). Indices of efficacy between pre- and post-treatment showed significant improvement (p < 0.001). The effectiveness indices between pre- and post-treatment, among adherent and non-adherent patients, ACT, and asthma exacerbations both showed significant differences (p = 0.043 and p = 0.049, respectively). Binomial logistic regression analysis showed that increasing age, better ACT score, and 14-day timing were significantly associated with increased adherence to therapy.

CONCLUSIONS

High adherence to omalizumab was demonstrated in a real-world setting, which was associated with better outcomes and control of asthma.

摘要

背景

鉴于不依从药物治疗对重度哮喘患者的临床负面影响及成本,坚持用药至关重要。在现实环境中,对奥马珠单抗的依从性尚未得到充分研究。本研究旨在评估对奥马珠单抗的依从性,并评估依从性与治疗效果的关系。

方法

这是一项回顾性、观察性多中心现实世界研究。分析了奥马珠单抗的剂量、给药时间和治疗持续时间(<2年;2-4年;>4年)。通过检查预期剂量和漏服剂量率来评估依从性。确定了良好依从性(漏服剂量<10%)和不良依从性(漏服剂量>10%)。对于奥马珠单抗依从性与治疗效果的关系,我们考虑了哮喘急性加重、住院、哮喘控制测试(ACT)和第1秒用力呼气量(FEV)。

结果

共评估了196例患者,其中161例适合进行数据分析。90.7%的患者表现出良好依从性,9.3%表现出不良依从性。考虑依从性与治疗持续时间的关系:<2年,患者依从率为87.8%(预期剂量1186剂,漏服剂量53剂);2-4年,依从率为85.9%(预期剂量2985剂,漏服剂量127剂);>4年,依从率为100%(预期剂量6120剂,无漏服剂量)。治疗前后的疗效指标显示出显著改善(p<0.001)。治疗前后、依从和不依从患者之间、ACT和哮喘急性加重的疗效指标均显示出显著差异(分别为p=0.043和p=0.049)。二项式逻辑回归分析表明,年龄增加、ACT评分更好和14天的给药时间与治疗依从性增加显著相关。

结论

在现实世界中证明了对奥马珠单抗的高依从性,这与更好地控制哮喘及改善预后相关。

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