Baseline characteristics of patients enrolled in EXCELS: a cohort study.
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.


OBJECTIVE
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.
Massachusetts General Hospital, Division of Rheumatology, Allergy and Immunology, Boston, Massachusetts, USA. aalong@partners.org
Aidan A
AA
Long
James E
JE
Fish
Abdelkader
A
Rahmaoui
Mary K
MK
Miller
Mary S
MS
Bradley
Hassan N
HN
Taki
Anthony N
AN
Demeo
Stephen A
SA
Tilles
Stanley J
SJ
Szefler
D000293:Adolescent; D000328:Adult; D000368:Aged; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D002648:Child; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration
D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab