Original Articles: Asthma Lower Airway Diseases
Baseline characteristics of patients enrolled in EXCELS: a cohort study

https://doi.org/10.1016/S1081-1206(10)60184-6Get rights and content

Background

The Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate-to-Severe Asthma (EXCELS) is a unique opportunity to evaluate the prospective, long-term clinical safety and effectiveness of the anti-IgE antibody omalizumab (Xolair) in real-world clinical practice.

Objectives

To describe the study design and study cohorts of EXCELS at baseline and to compare the characteristics of this population with other large asthma cohorts.

Methods

Patients with moderate-to-severe persistent asthma and a positive skin test result or in vitro reactivity to a perennial aeroallergen were eligible for EXCELS. Two cohorts of patients with asthma were enrolled: those treated with omalizumab and those not treated with omalizumab. We analyzed baseline demographic and clinical characteristics, including asthma history and control and allergy history.

Results

Large proportions of patients enrolled in EXCELS had historically severe and poorly or not well-controlled asthma at the time of enrollment, objective evidence of airway obstruction, a history of long-term oral corticosteroid use, and/or other allergic disorders. Minor differences were observed between the omalizumab and nonomalizumab cohorts. Our total patient cohort was generally similar to other large cohorts. In a subgroup analysis, patients who had received omalizumab within 7 days before enrollment had more severe asthma and greater degrees of impairment at baseline than nonomalizumab patients.

Conclusions

This study of baseline characteristics in EXCELS offers a unique opportunity to better understand the history of allergic patients with moderate-to-severe asthma in a real-world treatment setting. This analysis of EXCELS baseline data sets the foundation for long-term assessment of the safety and effectiveness of omalizumab.

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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      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.

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      2015, Annals of Allergy, Asthma and Immunology
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      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.

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    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.

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