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Omalizumab May Be Helpful in Refractory Asthma Patients

Laurie Barclay, MD

Sept. 15, 2003 — Omalizumab is effective in controlling asthma in
patients poorly controlled on high-dose inhaled steroids, according to
the results of an open-label study presented on Sept. 11 at the World
Allergy Organization Congress-XVIII ICACI in Vancouver, British
Columbia, Canada.

"This study indicates that IgE contributes to the control and severity
of asthma, since reducing the levels of free circulating IgE to very low
levels by using the blocking antibody to IgE, omalizumab, improved the
control of asthma in these patients with severe asthma," presenter Fan
Chung, MD, DSc, FRCP, from the National Heart and Lung Institute,
Imperial College, in London, U.K., told Medscape.

In this study involving 49 medical centers in five European countries,
312 patients, aged 12 to 73 years, with moderate to severe allergic
asthma, were randomized (2:1) to continue best standard care with or
without subcutaneous omalizumab, at least 0.016 mg/kg/IgE [IU/mL] per
four weeks for one year. At study entry, all patients were poorly
controlled on high-dose inhaled steroids, and 99% were GINA treatment
step 3/4.

The rate of asthma deterioration-related events, including a course of
oral steroids or antibiotics, missed school or work, an unscheduled
physician visit, or an emergency room visit or hospitalization, was 4.92
per patient-year for omalizumab and 9.76 per patient-year with best
standard care alone (P < .001).

Patients receiving omalizumab also had fewer asthma exacerbations (1.12
vs. 2.86 per patient-year; P < .001), with significant parallel
improvements in lung function and symptoms. This group also had less
absenteeism from school or work (P = .031) and a lower proportion of
patients with at least one unscheduled physician visit (P = .007).

"In terms of the management of severe or 'difficult-to-treat' or
'therapy-resistant' asthma, omalizumab will be a very useful additional
treatment for such patients, added to inhaled (and sometimes, oral)
corticosteroids and long-acting beta-agonists, which these patients are
usually established on," Dr. Chung said.

Novartis Pharmaceuticals designed and supported this study, and employs
three of its authors. Dr. Chung has participated in several clinical
studies on omalizumab, all supported by Novartis Pharmaceuticals, and he
has been on advisory boards for Novartis.

WAOC 2003: Abstract O-17-4. Presented Sept. 11, 2003.

Reviewed by Gary D. Vogin, MD

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