IMPROVEMENTS IN SELECT PATIENT-REPORTED OUTCOMES ARE SIMILAR ACROSS DIFFERENT OMALIZUMAB DOSING REGIMENS

Abstract

<h3>Introduction</h3> For patients with asthma, the dose/frequency of omalizumab is determined by bodyweight and pretreatment IgE levels. Since patients who fall outside the dosing table are treated with omalizumab, we assessed patient-reported outcomes (Asthma Control Test [ACT], Global Evaluation of Treatment Effectiveness [GETE], Work Productivity and Activity Impairment [WPAI-Asthma]) stratified by where they fell on the omalizumab dosing table. <h3>Methods</h3> This post hoc analysis examined data from the open-label, 48-week, PROSPERO study (NCT01922037; N=801, ≥12 years with asthma initiated on omalizumab by physician-assessment). For this analysis, subgroups are those who (i) fall within the recommended dosing table (n=506), (ii) fall into the section of the approved dosing table where not enough clinical data was available to make dose recommendations (defined as ‘insufficient data to recommend a dose'; n=72), or (iii) fall outside the dosing table (not in (i) or (ii) and with IgE <30 or >700IU/mL and/or weighing <30 or >150kg; n=209). <h3>Results</h3> Patient characteristics were similar between groups, with the expected exception of total IgE. Improvement in ACT was similar for all groups (mean±SD CFB Month 12: (i) 4.3±5.3, (ii) 5.5±4.9, (iii) 4.5±4.9). At Month 12, GETE was rated by most patients as good/excellent ((i) 76.4% (ii) 82.1% (iii) 75.3%). Improvement in WPAI % activity impairment was similar for all groups (mean±SD CFB Month 12 (i) -20.4±33.0 (ii) -26.1±34.6) (iii) -20.1±30.6). Overall safety in Casale JACI:IP 2019;7(1):156-64. <h3>Conclusions</h3> Select patient-reported outcomes improved regardless of whether patients fell inside or outside the omalizumab dosing table for asthma.