Nygaard Leo, Henriksen Daniel Pilsgaard, Madsen Hanne, Davidsen Jesper Rømhild
Department of Respiratory Medicine, Odense University Hospital, Odense C, Denmark.
Research Unit of Respiratory Medicine, Clinical Institute, University of Southern Denmark, Odense C, Denmark.
Eur Clin Respir J. 2017 Aug 7;4(1):1359477. doi: 10.1080/20018525.2017.1359477. eCollection 2017.
: Omalizumab improves asthma control in patients with uncontrolled severe allergic asthma; however, appropriate patient selection is crucial. Information in this field is sparse. : We aimed to estimate whether potential omalizumab candidates were appropriately selected according to guidelines, and the clinical effect of omalizumab treatment over time. : We performed a retrospective observational study on adult patients with asthma treated with omalizumab during 2006-2015 at the Department of Respiratory Medicine at Odense University Hospital (OUH), Denmark. Data were obtained from the Electronic Patient Journal of OUH and Odense Pharmaco-Epidemiological Database. Guideline criteria for omalizumab treatment were used to evaluate the appropriateness of omalizumab candidate selection, and the Asthma Control Test (ACT) to assess the clinical effects of omalizumab at weeks 16 and 52 from treatment initiation. : During the observation period, 24 patients received omalizumab, but only 10 patients (42%) fulfilled criteria recommended by international guidelines. The main reasons for not fulfilling the criteria were inadequately reduced lung function, insufficient number of exacerbations, and asthma standard therapy below Global Initiative for Asthma (GINA) step 4-5. Seventeen and 11 patients completed treatment at weeks 16 and 52, with a statistically significant increase in ACT score of 5.1 points [95% confidence interval (CI) 3.1-7.2, = 0.0001] and 7.7 points (95% CI 4.3-11.1, = 0.0005), respectively. : Only 42% of the omalizumab-treated patients were appropriately selected according to current guidelines. Still, as omalizumab showed significant improvement in asthma control over time, it is important to keep this drug in mind as an add-on to asthma therapy in well-selected patients.
奥马珠单抗可改善重度过敏性哮喘控制不佳患者的哮喘控制情况;然而,合适的患者选择至关重要。该领域的信息较为匮乏。我们旨在评估潜在的奥马珠单抗候选患者是否根据指南进行了恰当选择,以及奥马珠单抗治疗随时间的临床效果。我们对2006年至2015年期间在丹麦欧登塞大学医院(OUH)呼吸内科接受奥马珠单抗治疗的成年哮喘患者进行了一项回顾性观察研究。数据来自OUH的电子患者日志和欧登塞药物流行病学数据库。使用奥马珠单抗治疗的指南标准来评估奥马珠单抗候选患者选择的恰当性,并使用哮喘控制测试(ACT)来评估从治疗开始第16周和第52周时奥马珠单抗的临床效果。在观察期内,24例患者接受了奥马珠单抗治疗,但只有10例患者(42%)符合国际指南推荐的标准。未达标准的主要原因是肺功能下降不充分、加重发作次数不足以及哮喘标准治疗低于全球哮喘防治创议(GINA)第4 - 5级。17例和11例患者分别在第16周和第52周完成治疗,ACT评分分别有统计学显著提高,提高了5.1分[95%置信区间(CI)3.1 - 7.2,P = 0.0001]和7.7分(95%CI 4.3 - 11.1,P = 0.0005)。根据当前指南,接受奥马珠单抗治疗的患者中只有42%被恰当选择。尽管如此,由于奥马珠单抗随时间推移在哮喘控制方面显示出显著改善,对于精心挑选的患者,将这种药物作为哮喘治疗的附加药物予以考虑是很重要的。