Riccardi Elisa, Guida Giuseppe, Garino Sonia, Bertolini Francesca, Carriero Vitina, Brusamento Mattia, Pizzimenti Stefano, Giannoccaro Fabiana, Falzone Erica, Arrigo Elisa, Levra Stefano, Ricciardolo Fabio Luigi Massimo
Regional Hospital Parini, Pulmonology Unit, Aosta, 11100 Aosta, Italy.
Department of Clinical and Biological Sciences, University of Turin, Orbassano, 10043 Turin, Italy.
J Clin Med. 2024 Aug 13;13(16):4750. doi: 10.3390/jcm13164750.
: Indirect comparison among biologics in severe asthma (SA) is a challenging but desirable goal for clinicians in real life. The aim of the study is to define characteristics of a biologic-treated T2-driven-SA population and to evaluate the effectiveness of biologic treatments in a real-world setting by variation in intra/inter-biologic parameters in an up to 4-year follow-up. : Demographic, clinical, functional, and biological characteristics were evaluated retrospectively in 104 patients recruited until July 2022 at baseline (T0) and over a maximum of 4 years (T4) of biologic therapy (omalizumab/OmaG = 41, from T0 to T4, mepolizumab/MepoG = 26, from T0 to T4, benralizumab/BenraG = 18, from T0 to T2, and dupilumab/DupiG = 19, from T0 to T1). Variations of parameters using means of paired Delta were assessed. : At baseline, patients had high prevalence of T2-driven comorbidities, low asthma control test (ACT mean 17.65 ± 4.41), impaired pulmonary function (FEV 65 ± 18 %pred), frequent exacerbations/year (AEs 3.5 ± 3), and OCS dependence (60%). DupiG had lower T2 biomarkers/comorbidities and AEs, and worse FEV (57 ± 19 %pred) compared to other biologics ( < 0.05). All biologics improved ACT, FEV%, FVC%, AEs rate, and OCS use. FEV% improved in MepoG and BenraG over the minimal clinically important difference and was sustained over 4 years in OmaG and MepoG. A significant RV reduction in OmaG (T4) and DupiG (T1), and BenraG normalization (T2) of airflow limitation were found. We observed through inter-biologic parameters pair delta variation comparison a significant nocturnal awakenings reduction in BenraG vs. OmaG/MepoG, and neutrophils reduction in BenraG/DupiG vs. OmaG. : Indirect comparison among biologics unveils clinical and functional improvements that may mark a different effectiveness. These results may highlight the preference of a single biologic compared to another with regard to specific treatable traits.
对于临床医生而言，在重度哮喘（SA）中对生物制剂进行间接比较是一项具有挑战性但在现实生活中值得追求的目标。本研究的目的是确定接受生物制剂治疗的T2驱动型SA患者群体的特征，并通过在长达4年的随访中生物制剂内/生物制剂间参数的变化，评估生物制剂在现实环境中的治疗效果。：对2022年7月前招募的104例患者的人口统计学、临床、功能和生物学特征进行回顾性评估，这些患者在基线（T0）以及接受生物制剂治疗（奥马珠单抗/OmaG = 41例，从T0至T4；美泊利单抗/MepoG = 26例，从T0至T4；贝那利珠单抗/BenraG = 18例，从T0至T2；度普利尤单抗/DupiG = 19例，从T0至T1）的最长4年期间（T4）进行评估。使用配对差值均值评估参数变化。：在基线时，患者T2驱动的合并症患病率高，哮喘控制测试分数低（ACT均值为17.65±4.41），肺功能受损（FEV为65±18%预计值），每年频繁发作（加重次数/AEs为3.5±3次），且依赖口服糖皮质激素（OCS，60%）。与其他生物制剂相比，DupiG的T2生物标志物/合并症和加重次数较低，而FEV更差（57±19%预计值）（P<0.05）。所有生物制剂均改善了ACT、FEV%、FVC%、加重次数发生率和OCS使用情况。MepoG和BenraG的FEV%改善超过了最小临床重要差异，且在OmaG和MepoG中持续了4年。发现OmaG（T4）和DupiG（T1）的残气量显著降低，以及BenraG（T2）的气流受限情况恢复正常。通过生物制剂间参数配对差值变化比较，我们观察到BenraG与OmaG/MepoG相比夜间觉醒次数显著减少，以及BenraG/DupiG与OmaG相比中性粒细胞减少。：生物制剂之间的间接比较揭示了可能标志着不同疗效的临床和功能改善。这些结果可能突出了在特定可治疗特征方面，一种生物制剂相对于另一种生物制剂的优势。
