Treating severe Ig-E mediated allergic adult asthmatics with Omalizumab outside the dosing table

Abstract

INTRODUCTION: According to the summary of product characteristics of omalizumab, patients whose weight and/or total IgE falls outside the dosing table are not eligible to receive omalizumab. In view of the absence of alternative biological agents for asthma in Malta at time of data collection, it was decided that such patients would receive the maximum recommended dose of 600mg every 2 weeks.

METHODS: The aim of this study was to assess the safety, efficacy and tolerability of adult patients receiving omalizumab for asthma who did not fall within the dosing table and compare these factors to patients within the dosing table. All adult patients receiving omalizumab for more than one year were recruited. Data collection included demographic data, baseline weight, IgE levels, side-effects reported, number of exacerbations, hospitalizations and corticosteroids needed.

RESULTS: Our cohort included 71 patients (mean age 48.8 ± 13.3, 45% males). When comparing patients who received omalizumab according to the recommended dosing chart (n=56) versus those who did not (n=15), there was no statistical significance for treatment discontinuation (p=0.79). Mean baseline IgE was higher in the outside of dosing category (p=0.001). Mean total number of exacerbations since treatment initiation was significantly less for the outside of dosing category (p=0.01) as was the mean total number of systemic corticosteroid courses (p=0.02). There was no statistical significance in hospitalization rate (p=0.09).

CONCLUSIONS: Our results reaffirm our decision to treat severe IgE-mediated asthmatic patients with an IgE level and/or weight outside the dosing chart with the maximum recommended dose with good clinical outcomes and good safety and tolerability profiles.