Journal
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
Volume 141, Issue 5, Pages 1590-+Publisher
MOSBY-ELSEVIER
DOI: 10.1016/j.jaci.2017.07.014
Keywords
Asthma; severe; difficult-to-treat; control; long-term; observational study; follow-up; the Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens; exacerbations
Categories
Funding
- Genentech
- Novartis
- AstraZeneca
- Boehringer Ingelheim
- Meda
- Genentech, Inc
- Novartis Pharmaceuticals
- National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute
- MedImmune
- Pfizer
- GlaxoSmithKline
- Forest
- Regeneron
- Sanofi
- Roche
- Aerocrine
- Daiichi Sankyo
- Boehringer-Ingelheim
- Merck
- TEVA
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Background: The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR I) study demonstrated high morbidity in patients with severe or difficult-to-treat asthma despite standard-of-care treatment. Objective: We sought to determine the long-term natural history of disease and outcomes in patients in TENOR I after more than a decade. Methods: TENOR I was a multicenter observational study (2001-2004) of 4756 patients with severe or difficult-to-treat asthma. TENOR II was a follow-up study of TENOR I patients using a single cross-sectional visit in 2013/2014. Overall, the sites participating in TENOR II originally enrolled 1230 patients in TENOR I. Clinical and patient-reported outcomes were assessed, including very poorly controlled asthma based on National Heart, Lung, and Blood Institute guidelines. Results: A total of 341 (27.7%) patients were enrolled in TENOR II and were representative of the TENOR I cohort. The most frequent comorbidities were rhinitis (84.0%), sinusitis (47.8%), and gastroesophageal reflux disease (46.3%). Mean percent predicted prebronchodilator and postbronchodilator FEV1 were 72.7% (SD, 21.4%) and 78.2% (SD, 20.7%), respectively. A total of 231 (72.9%) of 317 patients had positive test responses to 1 or more allergen-specific IgEs. The mean blood eosinophil count was 200/mL (SD, 144/mL). Eighty-eight (25.8%) patients experienced an asthma exacerbation in the prior 3 months requiring hospital attention, oral corticosteroids, or both. More than half (197/339 [58.1%]) had very poorly controlled asthma. Medication use suggested undertreatment. Conclusion: TENOR II provides longitudinal data to characterize disease progression, heterogeneity, and severity in patients with severe or difficult-to-treat asthma. Findings show continued morbidity, including a high degree of comorbid conditions, allergic sensitization, exacerbations, and very poorly controlled asthma, including reduced lung function.
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