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
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.
World Allergy Organ J. 2020 Feb 12;13(2):100103. doi: 10.1016/j.waojou.2020.100103. eCollection 2020 Feb.
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.
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).
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.
High adherence to omalizumab was demonstrated in a real-world setting, which was associated with better outcomes and control of asthma.
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。
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)。
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。
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。