Geng Bob, Dixon Anne E, Ko Jinnie, Janampally Pranathi, Haselkorn Tmirah, Holweg Cecile T J, Casale Thomas B, Jarjour Nizar
The University of California San Diego School of Medicine, San Diego, California.
University of Vermont Medical Center, Burlington, Vermont.
Ann Allergy Asthma Immunol. 2022 May;128(5):553-560. doi: 10.1016/j.anai.2022.01.025. Epub 2022 Jan 31.
Effectiveness of asthma treatment, including biologics, may be different in patients with higher body mass index (BMI).
To evaluate response to omalizumab (dosed by serum immunoglobulin E level and weight) by BMI category.
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.
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]).
Omalizumab provides benefit to patients with moderate-to-severe allergic asthma, regardless of BMI.
Studies 008/009 were conducted before clinical trial registration was required, and therefore clinical trial registration numbers are not available.
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。
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。
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。
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。
无论BMI如何，奥马珠单抗对中重度过敏性哮喘患者均有益。
008/009研究在需要进行临床试验注册之前开展，因此没有临床试验注册号。
