Magazine article Drug Topics

New Treatment in Pipeline May Alter Asthma Therapy

Magazine article Drug Topics

New Treatment in Pipeline May Alter Asthma Therapy

Article excerpt

The 17 million Americans suffering from asthma may soon have a better deal. Clinical trial results from two novel therapies that could change the treatment of allergic asthma stole the spotlight at the annual meeting in San Diego of the American Academy of Allergy, Asthma, and Immunology (AAAAI). Both treatments directly or indirectly target IgE, which causes the release of inflammatory agents such as histamine, prostaglandins, and leukotrienes. Those agents are the source of the patient's symptoms.

The new therapy nearest to the clinic is the humanized anti-IgE monoclonal antibody rhuMAb-E25 (olizumab, Genentech, developed in cooperation with Novartis and Tanox). A New Drug Application is expected to be filed by midyear.

Phase III data presented by William Busse, M.D., of the University of Wisconsin, who is also the AAAAI president-elect, indicated that the drug was both safe and effective in children as well as adults. It reduces the need for inhaled rescue medications for exacerbations of asthma, as well as the need for corticosteroids, he said.

In one trial, 525 adults who were symptomatic despite taking inhaled corticosteroids were randomized to rhuMAb-25, given subcutaneously, or to placebo over 16 weeks. This was followed by a 12-week period in which the dose of steroids was gradually reduced in both groups. Busse reported that during the stable treatment period, 39 patients (14.6% of 268 patients) on the anti-IgE monoclonal antibody had exacerbations of their asthma, compared with 60 (23.3% of 257 patients) on placebo. During the corticosteroid-reduction period, 57 of the 268 on olizumab (21.3%) had asthma exacerbations, compared with 83 of 257 (32.3%) of the placebo group.

Adverse events were seen in six patients in both groups, but none were judged to be drug related. The one case of anaphylaxis was seen in a patient with known sensitivity to quinolones after being treated with that antibiotic.

In the second phase III study, in 334 children aged six to 12, no adverse events were reported to be drug related in either the placebo or drug arm of the study. Safety data from a five-month follow-- up of this group is pending, Busse said.

In a different approach, Jonathan Corren, M.D., of the University of California Los Angeles, medical director of the Allergy Research Foundation, reported that interleukin or Il 4-R (Nuvance, Immunex) significantly improved the FEV^sub 1^, an important measure of lung function as well as asthma symptoms. It also reduced the need for beta agonist rescue medication and decreased inflammation, which was measured by nitric oxide production, when given as a single dose. …

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