Bleecker Eugene, Blaiss Michael, Jacob-Nara Juby, Huynh Lynn, Duh Mei Sheng, Guo Tracy, Ye Mingchen, Stanford Richard H, Wang Zhixiao, Soler Xavier, Nag Arpita, Nair Radhika, Borsos Kinga
Mayo Clinic, Scottsdale, Ariz.
Medical College of Georgia at Augusta University, Augusta, Ga.
J Allergy Clin Immunol. 2024 Dec;154(6):1500-1510. doi: 10.1016/j.jaci.2024.07.029. Epub 2024 Aug 24.
In the United States, dupilumab is approved for moderate-to-severe eosinophilic or oral corticosteroid-dependent asthma, and omalizumab is approved for managing moderate-to-severe allergic asthma uncontrolled by inhaled corticosteroids. However, limited comparative effectiveness data exist for these biologics due to differing patient characteristics and treatment histories.
This study assessed the real-world effectiveness of dupilumab and omalizumab for asthma in patients in the United States.
In this retrospective observational study, TriNetX Dataworks electronic medical record data were used to identify patients with asthma age ≥12 years who initiated (index) dupilumab or omalizumab between November 2018 and September 2020 and who had at least 12 months of pre- and post-index clinical information. Inverse probability of treatment weighting was applied to balance potential confounding in treatment groups. Asthma exacerbation rates and systemic corticosteroid (SCS) prescriptions were compared using a doubly robust negative binomial regression model, adjusting for baseline exacerbation/SCS rates and patient characteristics with ≥10% standardized differences after inverse probability of treatment weighting.
All inclusion and exclusion criteria were met by 2138 dupilumab patients and 1313 omalizumab patients. After weighting, the majority of baseline characteristics were balanced (standard difference <10%) between the 2 groups. Dupilumab was associated with a 44% lower asthma exacerbation rate (P < .0001) versus omalizumab. Additionally, dupilumab treatment significantly (P < .05) reduced SCS prescriptions by 28% during the follow-up period compared with omalizumab treatment.
The US ADVANTAGE real-world study demonstrated a significant reduction in severe asthma exacerbations and SCS prescriptions for patients prescribed dupilumab compared with patients prescribed omalizumab during 12 months of follow-up.
在美国,度普利尤单抗被批准用于治疗中度至重度嗜酸性粒细胞性或口服糖皮质激素依赖型哮喘,奥马珠单抗被批准用于治疗吸入性糖皮质激素无法控制的中度至重度过敏性哮喘。然而,由于患者特征和治疗史不同,这些生物制剂的比较有效性数据有限。
本研究评估了度普利尤单抗和奥马珠单抗在美国哮喘患者中的真实世界有效性。
在这项回顾性观察研究中,使用TriNetX Dataworks电子病历数据来识别年龄≥12岁、在2018年11月至2020年9月期间开始(索引)使用度普利尤单抗或奥马珠单抗且有至少12个月索引前和索引后临床信息的哮喘患者。应用治疗权重的逆概率来平衡治疗组中的潜在混杂因素。使用双稳健负二项回归模型比较哮喘加重率和全身糖皮质激素(SCS)处方,并在治疗权重的逆概率后,对基线加重/SCS率和标准化差异≥10%的患者特征进行调整。
2138名度普利尤单抗患者和1313名奥马珠单抗患者符合所有纳入和排除标准。加权后,两组之间的大多数基线特征达到平衡(标准差<10%)。与奥马珠单抗相比,度普利尤单抗使哮喘加重率降低了44%(P <.0001)。此外,与奥马珠单抗治疗相比,度普利尤单抗治疗在随访期间使SCS处方显著(P <.05)减少了28%。
美国ADVANTAGE真实世界研究表明,在12个月的随访期间,与使用奥马珠单抗的患者相比,使用度普利尤单抗的患者严重哮喘加重和SCS处方显著减少。