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Omalizumab, Inhaled Corticosteroid Combo Decreases Asthma Inflammation: Presented at ACAAI

By Carole Bullock

DALLAS, TX -- November 13, 2007 -- The addition of omalizumab (OMA) to inhaled corticosteroids (ICS) in patients with persistent moderate-to-severe asthma reduced the amount of peripheral blood eosinophils, signalling a decrease in inflammation, researchers reported here at the American College of Allergy, Asthma and Immunology (ACAAI) annual scientific meeting.

The "addition of OMA to patients with moderate-severe persistent allergic asthma inadequately controlled by ICS significantly decreased eosinophils," Marc Massanari, PhD, Head of Medical Affairs, Novartis Pharmaceuticals, East Hanover, New Jersey, United States, reported in a poster presentation on November 11.

Although OMA is effective in improving symptoms in such patients, the researchers wanted to examine its biochemical actions. "We recognize that asthma is a chronic inflammatory disease, and so we looked at a subgroup of patients already taking corticosteroids so see if the improvement translates into an effect on the eosinophils," said Dr. Massanari.

"OMA's unique mechanism of binding circulating IgE leads to a marked reduction in high-affinity IgE receptor density on basophils and mast cells," the authors wrote. "These effects have been shown to reduce mast cell degranulation and release of inflammatory mediators to decrease eosinophil chemotaxis."

In a previous study, researchers demonstrated that OMA decreased eosinophils in the sputum and airway tissue of patients with mild asthma who were not receiving ICS.

The new study explores the effect of OMA on peripheral blood (PB) eosinophils, a marker of inflammation, in a pooled analysis of clinical trial data where OMA was added to ICS in patients with persistent moderate-to-severe allergic asthma.

OMA or placebo (PBO) was administered for 28 to 32 weeks in 5 randomised double-blind PBO-controlled phase 3 trials. All patients were persistently symptomatic despite use of concurrent moderate-to-high dose ICS. "Trial designs were similar allowing for pooling of data," Dr. Massanari noted.

The change from baseline in PB eosinophils was analysed using analysis of covariance in 2,236 patients (1,136 OMA, 1,100 PBO, who the "intent-to-treat population" in the pooled analysis.

Mean baseline PB eosinophils were similar between groups (0.32 x109 OMA and 0.33 x 109 PBO), as was the ICS dose (1,406 ug beclomethasone equivalent per day and baseline serum mean IgE was 211 IU/ml.).

Compared to treatment with PBO, OMA was associated with a significant decrease in PB eosinophils (95% confidence interval [CI], -0.068, -0.034; P <.0001).

"The study shows that this add-on therapy (OMA) is treating the underlying aetiology -- the inflammation," said Dr. Massanari.


[Presentation title: Addition of Omalizumab to Inhaled Corticosteroids in Patients With Persistent Moderate-Severe Asthma Is Associated With a Decrease in Peripheral Blood Eosinophils. Abstract P225]

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