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More than a decade follow-up in patients with severe or difficult-to-treat asthma: The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) II - 04/05/18

Doi : 10.1016/j.jaci.2017.07.014 
Bradley E. Chipps, MD a, , Tmirah Haselkorn, PhD b, Brandee Paknis, PharmD c, Benjamin Ortiz, MD c, Eugene R. Bleecker, MD d, Farid Kianifard, PhD c, Aimee J. Foreman, MA e, Stanley J. Szefler, MD f, Robert S. Zeiger, MD, PhD g
for the

Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens Study Group

a Capital Allergy and Respiratory Disease Center, Sacramento, Calif 
b EpiMetrix, Los Altos, Calif 
c Novartis Pharmaceuticals Corporation, East Hanover, NJ 
d Center for Genomics & Personalized Medicine, Section of Pulmonary & Critical Care Medicine, Wake Forest University, Winston-Salem, NC 
e ICON, San Francisco, Calif 
f The Breathing Institute and Pulmonary Medicine Section, Children's Hospital, Colorado, Aurora, Colo 
g Department of Allergy, Kaiser Permanente Southern California, San Diego, Calif 

Corresponding author: Bradley E. Chipps, MD, Capital Allergy and Respiratory Disease Center, 5609 J St, Suite C, Sacramento, CA 95819.Capital Allergy and Respiratory Disease Center5609 J St, Suite CSacramentoCA95819

Abstract

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/μL (SD, 144/μL). 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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Key words : Asthma, severe, difficult-to-treat, control, long-term, observational study, follow-up, the Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens, exacerbations

Abbreviations used : AAAQ, ATAQ, ATS, ED, Feno, FVC, GERD, MiniAQLQ, NHLBI, PRO, TENOR, WPAI-Asthma


Plan


 The TENOR II study was sponsored by Genentech and Novartis Pharmaceuticals. Novartis Pharmaceuticals also provided writing support for the preparation of this article.
 Disclosure of potential conflict of interest: B. E. Chipps' institution received consulting fees from Genentech and Novartis for this work and consultancy fees and payment for lectures from AstraZeneca, Boehringer Ingelheim and Meda for other works. T. Haselkorn's institution received consulting fees from Genentech, Inc and Novartis Pharmaceuticals Corporation during this study. F. Kianifard, B. Ortiz, and B. Paknis are employed by and have stock options with Novartis Pharmaceuticals. E. R. Bleecker's institution received a grant from the National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute for this work and has personally received consultancy fees from AstraZeneca, MedImmune, Boehringer Ingelheim, Pfizer, GlaxoSmithKline, Forest, Novartis, Regeneron, and Sanofi. A. J. Foreman's institution received fee for analytic services from Novartis Pharmaceuticals for this work. S. J. Szefler received consulting fees from Genentech and Novartis and travel expenses from Novartis during this study; his institution has received consultancy fees from Roche, AstraZeneca, Aerocrine, Daiichi Sankyo, Boehringer-Ingelheim and has received grants from GlaxoSmithKline for other works; and he has personally received consultancy fees from Merck for other works. R. S. Zeiger has been paid consultant fees from Genentech for this work; his institution has received grants from Aerocrine, AstraZeneca, Genentech, MedImmune, and Merck for other works; and he has personally received consultant fees from AstraZeneca, Novartis, TEVA, and GlaxoSmithKline for other works.


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Vol 141 - N° 5

P. 1590 - mai 2018 Retour au numéro
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