Original Articles: Asthma Lower Airway DiseasesBaseline characteristics of patients enrolled in EXCELS: a cohort study
Section snippets
INTRODUCTION
Asthma causes disability in an estimated 7% to 8% of the world population.1, 2, 3, 4 For patients with moderate-to-severe persistent asthma, a large percentage have ongoing and poorly controlled disease that remains inadequately managed even with the use of systemic corticosteroids.2, 5, 6, 7, 8 Omalizumab (Xolair; Genentech Inc, South San Francisco, California) is a recombinant, humanized monoclonal antibody that selectively binds to human IgE.9, 10 Omalizumab is approved by the Food and Drug
Study Design
EXCELS is an ongoing, multicenter, prospective, observational cohort study. Patients were enrolled by asthma specialists in a variety of US-based practice settings, including managed care organizations, community practices, and academic centers. There was no protocol-mandated treatment assignment, and physicians and patients use their own discretion in determining a patient’s asthma treatment regimen, including omalizumab. The EXCELS protocol was approved by a local or central institutional
Baseline Demographics
A total of 7,951 participants were enrolled in the study. Cohort membership was uncertain for a small number (n = 24) of patients either because of incomplete baseline information or because the patient had previous exposure to omalizumab but was not receiving treatment at the time of enrollment. However, for completeness their data are included in the description of all enrolled patients but not in any other summaries or comparisons.
Baseline demographics for the omalizumab patients (n =
DISCUSSION
EXCELS represents a unique opportunity to define the long-term clinical safety and effectiveness profile of omalizumab in patients with moderate-to-severe persistent asthma. We present the EXCELS methods and describe the baseline demographic and clinical characteristics of the omalizumab and nonomalizumab cohorts with an additional focus on patients newly prescribed omalizumab at the time of enrollment. Although the study was initiated as an FDA postmarketing study to prospectively evaluate the
ACKNOWLEDGMENTS
Writing assistance was provided by Genentech.
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Cited by (46)
Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO
2017, Annals of Allergy, Asthma and ImmunologyA randomized multicenter study evaluating Xolair persistence of response after long-term therapy
2017, Journal of Allergy and Clinical ImmunologyCitation Excerpt :The majority of subjects in this study were recruited from a previously completed long-term, observational, epidemiologic study (Epidemiologic Study of Xolair [omalizumab]: Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate-to-Severe Asthma [EXCELS]; ClinicalTrials.gov identifier: NCT00252135). EXCELS included subjects 12 years of age or older with moderate-to-severe asthma with a history of a positive skin test response or in vitro reactivity to a perennial aeroallergen.14 Subjects from EXCELS must have completed EXCELS and not discontinued omalizumab since completion of EXCELS.
Cardiovascular and cerebrovascular events among patients receiving omalizumab: Results from EXCELS, a prospective cohort study in moderate to severe asthma
2017, Journal of Allergy and Clinical ImmunologySimilar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy
2015, Journal of Allergy and Clinical Immunology: In PracticeOmalizumab adherence in an observational study of patients with moderate to severe allergic asthma
2015, Annals of Allergy, Asthma and ImmunologyCitation Excerpt :Approximately 1 in 4 patients had consistent omalizumab treatment, defined as uninterrupted treatment without a gap of at least 28 days in omalizumab use, over 1 year, and this was associated with significant decreases in uncontrolled asthma events and asthma-related health care use; however, owing to the retrospective nature of the study, conclusions with regard to the causality of this association are limited.8 The primary objective of the present analysis was to evaluate adherence in patients newly treated with omalizumab and followed prospectively in the Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate to Severe Asthma (EXCELS) multicenter, observational study.9 Secondary objectives were: (1) to assess associations between demographic and clinical characteristics and adherence; and (2) to evaluate the relation between adherence and asthma control.
Incidence of malignancy in patients with moderate-to-severe asthma treated with or without omalizumab
2014, Journal of Allergy and Clinical Immunology
Disclosures: Authors have nothing to disclose.
Financial Support: EXCELS is sponsored by Genentech Inc and Novartis Pharmaceuticals Corp.
Clinical Trial Registration:clinicaltrials.gov identifier: NCT00252135.