A Randomized, Multicenter Study Evaluating Xolair® Persistency Of Response After Long-Term Therapy (XPORT)

Publication date: Available online 5 November 2016
Source:Journal of Allergy and Clinical Immunology
Author(s): Dennis Ledford, William Busse, Benjamin Trzaskoma, Theodore A. Omachi, Karin Rosén, Bradley E. Chipps, Allan T. Luskin, Paul G. Solari
BackgroundFew data are available to assist clinicians with decisions regarding long-term use of asthma therapies, including omalizumab.ObjectiveTo evaluate the benefit and persistency of response in subjects continuing or withdrawing from long-term omalizumab treatment.MethodsEvaluating the Xolair® Persistency Of Response After Long-Term Therapy (XPORT) was a randomized, double-blind, placebo-controlled withdrawal study that included subjects with moderate-to-severe persistent asthma receiving long-term omalizumab. Subjects were randomized using a hierarchical dynamic randomization scheme, to continue their same dose of omalizumab or withdraw to placebo and were then followed every 4 weeks for 1 year. Primary outcome: any protocol-defined severe asthma exacerbation. Secondary outcome: time to first protocol-defined severe asthma exacerbation. Exploratory outcomes included changes in Asthma Control Questionnaire (ACQ) and Asthma Control Test (ACT) scores.ResultsSignificantly more subjects in the omalizumab group (67%) had no protocol-defined exacerbation than in the placebo group (47.7%); absolute difference of 19.3% (95% CI: 5.0%, 33.6%) represents a 40.1% relative difference. Time to first protocol-defined exacerbation analysis revealed a significantly different between-group exacerbation pattern that was consistent with the primary analysis. Subjects continuing omalizumab had significantly better asthma control (mean [SD] change from baseline to Week 52: ACT, –1.16 [4.14] vs placebo, –2.88 [5.38]; P = .0188 and ACQ, 0.22 [0.66] vs placebo, 0.63 [1.13]); P = .0039. Discontinuation of omalizumab was associated with an increase in free IgE and an increase in basophil expression of the high-affinity IgE receptor. No safety concerns were noted.ConclusionContinuation of omalizumab following long-term treatment results in continued benefit as evidenced by improved symptom control and reduced exacerbation risk.

Teaser

Continuation of omalizumab after long-term use results in improved symptom control and a reduced exacerbation risk. Use of biomarkers (FeNO and peripheral blood eosinophil counts) may further inform omalizumab treatment decisions.


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