Response to omalizumab using patient enrichment criteria from trials of novel biologics in asthma

Browse  Early View Articles 
Online Version of Record published before inclusion in an issue

T. B. Casale, B. E. Chipps, K. Rosén, B. Trzaskoma, T. Haselkorn, T. A. Omachi, S. Greenberg, N. A. Hanania

Abstract

Background

Recent efficacy studies of asthma biologics have included highly enriched patient populations. Using a similar approach, we examined factors that predict response to omalizumab to facilitate selection of patients most likely to derive the greatest clinical benefit from therapy.

Methods

Data from two phase III clinical trials of omalizumab in patients with allergic asthma were examined. Differences in rates of asthma exacerbations between omalizumab and placebo groups during the 16-week inhaled corticosteroid (ICS) dose-stable phase were evaluated with respect to baseline blood eosinophil counts (eosinophils <300/μL [low] vs ≥300/μL [high]) and baseline markers of asthma severity (emergency asthma treatment in prior year, asthma hospitalization in prior year, forced expiratory volume in 1 second [FEV1; FEV1 <65% vs ≥65% predicted], inhaled beclomethasone dipropionate dose [<600 vs ≥600 μg/day], and long-acting beta-agonist [LABA] use [yes/no]).

Results

Adults/adolescents (N = 1071) were randomized to receive either omalizumab (n = 542) or placebo (n = 529). In the 16-week ICS dose-stable phase, rates of exacerbations requiring ≥3 days of systemic corticosteroid treatment were 0.066 and 0.147 with omalizumab and placebo, respectively, representing a relative rate reduction in omalizumab-treated patients of 55% (95% CI, 32%-70%; P = .002). For patients with eosinophils ≥300/μL or with more severe asthma, this rate reduction was significantly more pronounced.

Conclusion

In patients with allergic asthma, baseline blood eosinophil levels and/or clinical markers of asthma severity predict response to omalizumab.


PDF

 

 

(You must be logged in to add and reply comments)

Interasma on Twitter

Interasma Top story: Sarah B D on Twitter: "@picardonhealth I got the flu shot because I’… https://t.co/PKYRRO1cxM, see more https://t.co/CpGiFuOOYd
49mreplyretweetfavorite
Interasma Top story: Rae Brager on Twitter: "@DrAnneEllis Also decrease REM sleep and the… https://t.co/fy2uqXrC3v, see more https://t.co/CpGiFuOOYd
3hreplyretweetfavorite
Interasma Top story: Dr. Ellis on Twitter: "Rupatadine also low/moderate potential for in… https://t.co/RZVJTybrxF, see more https://t.co/CpGiFuOOYd
11hreplyretweetfavorite
Interasma Top story: Dr. Winder Gill on Twitter: "I'd like to do a poll of how many medic… https://t.co/DCyPZUyIAr, see more https://t.co/CpGiFuOOYd
13hreplyretweetfavorite
Interasma Top story: Salt raises blood pressure, but our gut bacteria can stop it https://t.co/4l5nkVGpC6, see more https://t.co/CpGiFuOOYd
14hreplyretweetfavorite

Editor: Juan C. Ivancevich, MD

Copyright © Interasma 2003-2017  •  Terms of Use  •  Privacy Policy  •  Contact Us  •  Sitemap

Powered by FREI SA

InterAsma