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Title: Etanercept May Be Effective For Chronic, Severe Asthma: Presented at CHEST

"Etanercept May Be Effective For Chronic, Severe Asthma: Presented at CHEST"

By Peggy Peck Special to DG News SAN DIEGO, CA -- November 7, 2002 -- Etanercept, an arthritis drug, is effective in improving lung function and bronchial hyperresponsiveness in patients with chronic severe asthma, while reducing the requirement for rescue medications, according to results of a small, open label study. Suresh K Babu, MD, of the department of Respiratory Cell and Molecular Biology, Southampton General Hospital, Southampton, England, said patients were able to completely withdraw from nebulized salbutamol after 12-weeks of etanercept treatment. Dr. Babu said he theorized that etanercept would inhibit tumor necrosis factor alpha. TNF- [a is a pleiotropic cytokine and is ubiquitous in the development of an inflammatory response. It increases the trans-epithelial migration of neutrophils, promotes chemotaxis of eosinophils/monocytes, activates T-cell, and has growth promoting effects on fibroblasts in asthma. Etanercept is a recombinant fusion protein consisting of the soluble TNF- a receptor (p75) linked to the Fc portion of human IgG ₁.

Ten patients, aged 18 to 65 years, with chronic severe asthma on regular oral corticosteroids, high dose inhaled steroids, long acting beta-2 agonist and/or theophylline were enrolled. They had an FEV1 of at least 50 percent and demonstrated a reversibility of at least 9 percent with inhaled salbutamol.

The patients underwent baseline lung function measurements, methacholine challenge and completed an asthma control questionnaire before and after the study. Diary cards were issued to monitor changes in peak flows, symptom scores and use of rescue medications. The study involved administration of 25mg of etanercept twice weekly for 12 weeks.

The patients showed improvements in their lung function after 12 weeks of administration of Etanercept. The FEV₁/FVC ratio did not show significant change after treatment (74.7 ą 12.7 versus 77.2 ą 10.4 [p=0.306]).

FEV₁ (Lt) pre-treatment was 2.33 and post-treatment it was 2.71 (P=0.43) while FVC pre-treatment was 3.13 and post treatment was 3.2(P=0.080). The morning PEFR (Lt/min) was 320 pre-treatment and 395 post-treatment (P=0.043). Evening PEFR (Lt/min) was 357 before treatment compared to 391 after 12 weeks of treatment (P=0.225).

Asthma control score pre-treatment was 19 before treatment and 4 after treatment (P=0.043) while methacholine response was 233.4 before treatment and 6.34 after treatment (P=0.043).

The most significant aspect was the reduction in the use of rescue medications. All these patients were able to completely withdraw from the use of their nebulized salbutamol. The most common side-effects seen were skin rashes and respiratory tract infections.

The study was funded by Wyeth and Immunex Corporation.

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