Background: In Japan, biologic therapy was initiated for patients with severe asthma in 2009. In recent years, four biologics with different mechanisms of action have become available in the clinical setting. However, the efficacy of switching between biologics remains uncertain.
Methods: To elucidate the efficacy of switching between biologics, 97 patients were enrolled who had received any biologic therapy for severe asthma at Jikei University Hospital, Tokyo, Japan, from July 2009 to December 2020. We retrospectively examined the patient characteristics, biomarkers, pulmonary function test results, selected biologics, and efficacy.
Results: Thirty-one males and 66 females received any biologics. The mean age was 53.3 years at the initiation of biologic therapy. Initially, 33, 41, 15 and eight patients received omalizumab, mepolizumab, benralizumab, and dupilumab, respectively. Among three representative indicators for biologics administration, the peripheral blood eosinophil count, serum IgE levels and fractional exhaled nitric oxide, 64% of the patients had two indicators, and 28% had three indicators. Thirty-four patients (35%) switched from the initial biologic to another, and the reasons for switching included persistent asthmatic symptoms (n=22), schedule of hospital visits (n=5), and other reasons. Thus, the treatment was effective in 11 patients after switching. In addition, two patients received combination therapy with different biologics. Eighteen patients (19%) interrupted treatment for various reasons. Regardless of whether the biologic was the initial therapy, the overall efficacy of the four biologics was 60% based on the global evaluation of treatment effectiveness.
Conclusion: Switching between biologics can be a promising option for severe asthma patients in whom treatment with an initial biologic is ineffective.



中文翻译：

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日本严重哮喘患者更换生物制剂的有效性：单中心回顾性研究

背景：日本于 2009 年开始对严重哮喘患者进行生物治疗。近年来，四种具有不同作用机制的生物制剂已进入临床。然而，生物制剂之间转换的功效仍不确定。
方法：为了阐明生物制剂转换的疗效，纳入了 2009 年 7 月至 2020 年 12 月在日本东京慈惠大学医院接受过任何生物制剂治疗严重哮喘的 97 名患者。我们回顾性检查了患者特征、生物标志物、肺功能功能测试结果、所选生物制剂和功效。
结果： 31 名男性和 66 名女性接受了任何生物制剂。开始生物治疗时的平均年龄为 53.3 岁。最初，分别有 33、41、15 和 8 名患者接受了奥马利珠单抗、美泊利珠单抗、贝那利珠单抗和杜匹鲁单抗。在生物制剂给药的三个代表性指标中，外周血嗜酸性粒细胞计数、血清IgE水平和呼出一氧化氮分数，64%的患者有两个指标，28%的患者有三个指标。34 名患者 (35%) 从最初的生物制剂转换为另一种生物制剂，转换的原因包括持续性哮喘症状 (n=22)、医院就诊时间表 (n=5) 和其他原因。因此，转换后的治疗对 11 名患者有效。此外，两名患者接受了不同生物制剂的联合治疗。十八名患者（19%）因各种原因中断治疗。无论该生物制剂是否为初始治疗，根据治疗效果的总体评估，四种生物制剂的总体疗效均为 60%。
结论：对于初始生物制剂治疗无效的严重哮喘患者来说，生物制剂之间的转换可能是一个有前途的选择。