体重指数对中重度过敏性哮喘成人患者奥马珠单抗治疗反应的影响。

Impact of body mass index on omalizumab response in adults with moderate-to-severe allergic asthma.

作者信息

Geng Bob, Dixon Anne E, Ko Jinnie, Janampally Pranathi, Haselkorn Tmirah, Holweg Cecile T J, Casale Thomas B, Jarjour Nizar

机构信息

The University of California San Diego School of Medicine, San Diego, California.

University of Vermont Medical Center, Burlington, Vermont.

出版信息

Ann Allergy Asthma Immunol. 2022 May;128(5):553-560. doi: 10.1016/j.anai.2022.01.025. Epub 2022 Jan 31.

DOI:10.1016/j.anai.2022.01.025

PMID:35101644

Abstract

BACKGROUND

Effectiveness of asthma treatment, including biologics, may be different in patients with higher body mass index (BMI).

OBJECTIVE

To evaluate response to omalizumab (dosed by serum immunoglobulin E level and weight) by BMI category.

METHODS

Pooled data from 2 randomized, double-blind, placebo-controlled studies of adults with moderate-to-severe allergic asthma were analyzed by BMI category (<25 kg/m [normal or underweight], n = 397; 25 to <30 kg/m [overweight], n = 330; ≥ 30 kg/m [obese], n = 268). Placebo-adjusted exacerbation rate reductions were evaluated by Poisson regression modeling. Changes from baseline in forced expiratory volume in 1 second, beclomethasone dipropionate (BDP) dose, Total Asthma Symptom Score, and Asthma Quality of Life Questionnaire were evaluated by analysis of covariance.

RESULTS

Greater placebo-adjusted exacerbation rate reductions (95% confidence interval) were observed with increasing BMI (normal or underweight, -37.4% [-69.0% to 26.8%]; overweight, -52.7% [-78.4% to 3.7%]; obese, -71.9% [-86.9% to -39.5%]). There were no differences in forced expiratory volume in 1 second improvement between BMI categories at week 16 (normal or underweight, 76.2 [5.3-147.1] mL; overweight, 98.1 [13.9-182.4] mL; obese, 69.1 [-18.9 to 157.2] mL). No differences in BDP dose reduction (µg) were noted between BMI categories (normal or underweight, 23.0 [15.7-30.3]; overweight, 22.5 [13.5-31.5]; obese, 16.6 [5.8-27.3]). Fewer patients in the higher BMI categories eliminated BDP use. There were trends for smaller improvements with higher BMI in Total Asthma Symptom Score (normal/underweight, -0.52 [-0.82 to -0.22]; overweight, -0.50 [-0.80 to -0.20]; obese, -0.39 [-0.77 to 0.00]) and Asthma Quality of Life Questionnaire (normal or underweight, 0.34 [0.16-0.52]; overweight, 0.34 [0.13-0.55]; obese, 0.15 [-0.08 to 0.39]).

CONCLUSION

Omalizumab provides benefit to patients with moderate-to-severe allergic asthma, regardless of BMI.

TRIAL REGISTRATION

Studies 008/009 were conducted before clinical trial registration was required, and therefore clinical trial registration numbers are not available.

摘要

背景

包括生物制剂在内的哮喘治疗效果在体重指数（BMI）较高的患者中可能有所不同。

目的

按BMI类别评估奥马珠单抗（根据血清免疫球蛋白E水平和体重给药）的反应。

方法

对两项针对成人中重度过敏性哮喘的随机、双盲、安慰剂对照研究的汇总数据按BMI类别进行分析（<25 kg/m²[正常或体重过轻]，n = 397；25至<30 kg/m²[超重]，n = 330；≥30 kg/m²[肥胖]，n = 268）。通过泊松回归模型评估安慰剂调整后的加重率降低情况。通过协方差分析评估一秒用力呼气量、二丙酸倍氯米松（BDP）剂量、总哮喘症状评分和哮喘生活质量问卷相对于基线的变化。

结果

随着BMI增加，观察到更大的安慰剂调整后的加重率降低（95%置信区间）（正常或体重过轻，-37.4%[-69.0%至26.8%]；超重，-52.7%[-78.4%至3.7%]；肥胖，-71.9%[-86.9%至-39.5%]）。在第16周时，各BMI类别之间一秒用力呼气量改善情况无差异（正常或体重过轻，76.2[5.3 - 147.1]mL；超重，98.1[13.9 - 182.4]mL；肥胖，69.1[-18.9至157.2]mL）。各BMI类别之间BDP剂量减少量（μg）无差异（正常或体重过轻，23.0[15.7 - 30.3]；超重，22.5[13.5 - 31.5]；肥胖，16.6[5.8 - 27.3]）。较高BMI类别的患者中停用BDP的人数较少。在总哮喘症状评分（正常/体重过轻，-0.52[-0.82至-0.22]；超重，-0.50[-0.80至-0.20]；肥胖，-0.39[-0.77至0.00]）和哮喘生活质量问卷（正常或体重过轻，0.34[0.16 - 0.52]；超重，0.34[0.13 - 0.55]；肥胖，0.15[-0.08至0.39]）方面，BMI越高改善趋势越小。