Damiański Piotr, Podolska Dorota, Kuna Piotr, Kupczyk Maciej
Clinical Department of Internal Medicine, Asthma and Allergy, Medical University of Lodz, Lodz, Poland.
Center for Allergy Research, Karolinska Institutet, Stockholm, Sweden.
Postepy Dermatol Alergol. 2023 Feb;40(1):93-101. doi: 10.5114/ada.2022.124722. Epub 2023 Feb 27.
Despite the proven efficacy of biologics in the treatment of severe asthma, still a limited number of patients are included in the Polish therapeutic programme.
To identify major limitations in the qualification paths and predominant reasons leading to exclusion from available biologic treatments. The clinical profiles of patients referred for biologics were also examined.
Data on demographic characteristics, clinical profile, biomarkers, and medical history from one visit of patients that had been referred for qualification for biologics in 2018/2019 to the Barlicki Hospital (Poland) were collected. A comparison between eligible and ineligible patients was made.
Within 2 years, only 116 patients had been referred to the biologic therapy of whom 93 (80%) had been suitable for the biologic programme. Criteria for the omalizumab programme included major limitations such as: frequent use of oral corticosteroids in the past, and serum total-IgE 30-1000 IU/ml, and for mepolizumab were blood eosinophil count (EOScount) > 350/μl and spirometric criterion. Ineligible patients had a significantly lower EOScount and better lung function than eligible individuals despite no significant differences in the number of exacerbations or quality of life between groups. A high percentage of ineligible patients had been referred to re-verify the diagnosis of severe asthma.
Potential limitations for biologic therapy include restrictive criteria limiting the group of patients to the most severe cases and referring patients with difficult-to-treat asthma without a differential diagnosis. Low awareness and knowledge among physicians who often are not familiar with qualification criteria require extensive education.
尽管生物制剂在治疗重度哮喘方面已证实具有疗效，但波兰治疗方案纳入的患者数量仍然有限。
确定资格认定途径中的主要限制因素以及导致患者被排除在可用生物制剂治疗之外的主要原因。同时还对转介接受生物制剂治疗的患者的临床特征进行了研究。
收集了2018/2019年转诊至波兰巴利茨基医院接受生物制剂资格认定的患者一次就诊时的人口统计学特征、临床特征、生物标志物和病史数据。对符合条件和不符合条件的患者进行了比较。
在2年时间里，只有116名患者被转介接受生物制剂治疗，其中93名（80%）适合生物制剂治疗方案。奥马珠单抗治疗方案的标准包括一些主要限制因素，如：过去频繁使用口服糖皮质激素、血清总IgE为30 - 1000 IU/ml，而美泊利珠单抗的标准是血液嗜酸性粒细胞计数（EOS计数）> 350/μl和肺功能测定标准。不符合条件的患者的EOS计数显著低于符合条件的患者，肺功能也更好，尽管两组之间在急性加重次数或生活质量方面没有显著差异。有很大比例的不符合条件的患者被转介重新核实重度哮喘的诊断。
生物制剂治疗的潜在限制包括严格的标准，将患者群体限制在最严重的病例，以及转诊难治疗的哮喘患者但未进行鉴别诊断。医生的认识和知识水平较低，他们往往不熟悉资格认定标准，这需要广泛的教育。
