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

Abstract

BackgroundEffectiveness of asthma treatment, including biologics, may be different in patients with higher body mass index (BMI). ObjectiveTo evaluate response to omalizumab (dosed by serum immunoglobulin E level and weight) by BMI category. MethodsPooled data from 2 randomized, double-blind, placebo-controlled studies of adults with moderate-to-severe allergic asthma were analyzed by BMI category (<25 kg/m2 [normal or underweight], n = 397; 25 to <30 kg/m2 [overweight], n = 330; ≥ 30 kg/m2 [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. ResultsGreater 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]). ConclusionOmalizumab provides benefit to patients with moderate-to-severe allergic asthma, regardless of BMI. Trial RegistrationStudies 008/009 were conducted before clinical trial registration was required, and therefore clinical trial registration numbers are not available.