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Patients with Severe Allergic Asthma Get Continued Benefits After 3 Years of Treatment With Omalizumab: Presented at AAAAI

By Paula Moyer

MIAMI BEACH, F.L. -- March 6, 2005 -- Patients with severe allergic asthma get continued benefit from omalizumab (Xolair) for up to 3 years after beginning treatment, according to investigators who presented their findings here at the 62^nd annual meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI).

Omalizumab is a monoclonal antibody that targets immunoglobulin E (IgE), a critical component in allergic disease.

The findings, presented on March 4^th, are based on up to 3 years of follow-up. Patients had participated in a 96-week open-label extension study; some of those patients continued in a second extension study and were followed for an additional 52 weeks.

Among the 341 patients with severe allergic asthma who received omalizumab or placebo in the 32-week core study, 222 continued in the initial 96-week extension, and of those, 178 continued in the second extension that constituted the current research.

The investigators conducted the study because they had seen improvements and good tolerance in the two previous studies, and they wanted to see if the results could be sustained.

Principal investigator Jacque Hebert, MD, Researcher, Centre de Référence en Agriculture et Agroalimentaire du Québec, Quebec City, Quebec, Canada, reported on long-term control and safety data in an additional 52-week open-label extension study.

"The improvements seen in Extension 1 were maintained in Extension 2," Dr. Hebert said during his presentation. "Decreases in inhaled corticosteroids were sustained and excellent or good asthma control continued."

Dr. Hebert and colleagues measured the efficacy of omalizumab by spirometry; they rated asthma control as excellent, good, limited, or poor. Patient use of inhaled corticosteroids and adverse events were also tracked.

Average forced expiratory volume in 1 second (FEV₁) was similar between the start of the first extension, at 2.24 L, and at the end of the second extension, at 2.26 L.

At the beginning of the first extension 67% of patients had excellent or good asthma control. By the end of the second extension, 77% had this level of control. Among the 96 patients who received the same inhaled corticosteroids throughout the extensions, with no oral corticosteroids, the mean dose of inhaled corticosteroids decreased an average of 20% between the start of the first extension and the end of the second extension.

The overall incidence of adverse events was similar in the omalizumab and placebo groups during the core study, approximately 80% in both groups, and consisted of nasophyringitis, respiratory tract infections, back pain, sinusitis, and headache.

During the first extension, 88% of patients experienced adverse events, and during the second extension, 75% experienced at least one adverse event. These were typically mild to moderate, primarily respiratory symptoms ranging from wheezing to nasopharyngitis. No patients died during the study.

"These findings extend the results of previous long-term studies of omalizumab in patients with severe persistent asthma," Dr. Hebert said.

Xolair is manufactured by Genentech and Novartis; the study was funded by Novartis.


[Presentation title: Omalizumab, an Anti-IgE Monoclonal Antibody, Demonstrates Long-Term Asthma Control, Safety and Tolerability in Patients With Severe Allergic Asthma. Abstract 35]

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