EFFECTS OF OMALIZUMAB ON MARKERS OF TYPE 2 INFLAMMATION: RESULTS FROM THE EXTRA STUDY

Abstract

Introduction Targeting type 2 (T2) inflammation in moderate-to-severe asthma with omalizumab improves asthma control and reduces exacerbations. Whether omalizumab impacts T2 inflammatory biomarkers has not been fully elucidated. We examined the impact of omalizumab on T2 inflammatory biomarkers. Methods Post-hoc analyses of moderate-to-severe, uncontrolled allergic asthmatics (12-75 years) from the prospective, randomized, placebo-controlled trial of omalizumab, EXTRA were conducted. Changes from baseline in fractional exhaled nitric oxide (FeNO), blood eosinophils (EOS) and serum interleukin-13 (IL-13) with omalizumab versus placebo were evaluated. FeNO was measured at Weeks 4, 8, 16, 32, and 48, EOS at Weeks 16, 32 and 48, and IL-13 at Week 16. FeNO was further analyzed using dichotomized baseline subgroups with cutoff points at 25ppb or 50ppb. Results Compared with placebo, omalizumab-treated patients had larger decreases in all T2 biomarkers throughout treatment. At Week 48, median [IQR]% changes of -13.1 [-43.9, 26.6]% versus 0 [-28.9, 40]% and -11.1 [-48.5, 36.2]% versus 0.0 [-36.0, 40.0]% were observed in the omalizumab and placebo-treated groups for EOS and FeNO, respectively. FeNO reductions were observed by Week 4 and were greater in omalizumab-treated patients with higher baseline FeNO (-60.2 [-71.6, -26.8]% versus -4.6 [-34.2, 42.3]% in ≥50 versus Conclusions Omalizumab treatment reduced T2 inflammatory biomarkers. Reductions were more pronounced in patients with higher baseline levels. These findings highlight the anti-inflammatory effects of omalizumab. FeNO percent change upon omalizumab treatment by baseline levels.