The eXpeRience registry: The ‘real-world’ effectiveness of omalizumab in allergic asthma

Abstract

Omalizumab has demonstrated therapeutic benefits in controlled clinical trials. Evaluation of outcomes in real-world clinical practice is needed to provide a complete understanding of the benefits of omalizumab treatment. eXpeRience was a 2-year, international, single-arm, open-label, observational registry that evaluated real-world effectiveness, safety and use of omalizumab therapy in 943 patients with uncontrolled persistent allergic asthma. Effectiveness variables (physician's Global Evaluation of Treatment Effectiveness [GETE], and change from baseline in exacerbation rate, symptoms, rescue medication use, and oral corticosteroid [OCS] use) were evaluated at pre-specified time-points. Safety data were also recorded. By physician's GETE, 69.9% of patients were responders to omalizumab after 16 (±1) weeks. The proportion of patients with no clinically significant exacerbations increased from 6.8% during the 12-month pre-treatment period to 54.1% and 67.3% at Months 12 and 24, respectively. Symptoms and rescue medication use at Month 24 were reduced by >50% from baseline. Maintenance OCS use was lower at Month 24 (14.2%) compared with Month 12 (16.1%) and baseline (28.6%). Overall, omalizumab had an acceptable safety profile. The results from eXpeRience indicate that omalizumab was associated with improvements in outcomes in patients with uncontrolled persistent allergic asthma; these improvements were consistent with the results of clinical trials.

Real-world effectiveness and safety of omalizumab in patients with uncontrolled severe allergic asthma from the Czech Republic

“…Supporting the results from clinical studies, real-world studies conducted in various European countries also reported improvement in asthma control and quality of life of patients after treatment with omalizumab [9][10][11][12]. To strengthen the evidence for omalizumab, a 2-year, global, post-marketing observational registry (eXpeRience) was conducted [13,14].…”

“…Patients were followed up for 2 years after initiation of omalizumab treatment and data were collected for analysis at week 16 ±1 week, and months 8, 12, 18, and 24. Data reported in this analysis include patient response to therapy (as determined by physician's global evaluation of treatment effectiveness (GETE)), lung function (FEV 1 % predicted and peak expiratory flow (PEF)), clinical symptoms (day-and night-time symptoms), use of rescue medication, use of oral and inhaled corticosteroids, number of clinically significant and severe asthma exacerbations, Asthma Control Test (ACT), patients' health-related quality of life (mini-Asthma Quality of Life Questionnaire (mini-AQLQ)), medical healthcare resource use (hospitalisations, emergency room (ER) visits or unscheduled doctor visits or interventions), number of missed days of work/school, serious adverse events (SAEs) and deaths [13,16,17].…”

A Pharmaco-Economic Analyzis of Treating Severe Uncontrolled Child Asthma with Omalizumab — Actual Russian Clinical Practice Data

“…(возраст 6-17 лет, n = 97) [данные не опу-бликованы]; результатов РКИ IA-05EUP (европейская популяция детей в возрасте 6-11 лет, группа омализу-маба -n = 421, группа плацебо -n = 192) [8]; резуль-татов проспективного наблюдательного исследования eXpeRience [12]. Следует отметить, что РКИ IA-05EUP на данный момент является единственным, в котором исследовался эффект омализумаба исключительно в дет-ской популяции [8].…”

“…Марковские переходы стандартной терапии с добав-лением омализумаба экстраполированы путем примене-ния к марковским переходам для стандартной терапии известных клинических эффектов омализумаба, описан-ных выше [8,12,13].…”

“…Нами были использованы результаты из двухлетнего международного наблюдательного реги-стра eXpeRience (пациенты 12-85 лет), в котором тера-пия омализумабом через 48 нед позволяла достигнуть полного контроля над БА у 38,4% пациентов и частично-го -у 46,6%. Данные состояния оставались стабильными и через 96 нед -41,1 и 46,0% соответственно [12].…”