To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ERS: Two Studies Favor Xolair (Omalizumab) Over Beclomethasone For Asthma Attack Prevention URL: http://www.pslgroup.com/dg/2076CA.htm Doctor's Guide September 28, 2001
By Cameron Johnston Special to DG News
BERLIN, GERMANY -- September 28, 2001 --Omalizumab (Xolair rhuMAb-E25), has been proven in early clinical trials to have a marked effect in preventing asthmatic attacks.
In an industry-sponsored press meeting at the annual meeting of the European Respiratory Society, held there this week, Dr. Sally Wenzel, a professor of medicine and co-director of clinical research at the National Jewish Medical and Research Center, in Denver, USA said this is the first drug to demonstrate in practice, what academics have anticipated would happen at the theoretical level.
Omalizumab, the first anti-immunoglobulin E (IgE) agent to be developed. It acts by binding to IgE receptors in mast cells. This then blocks free-floating or serum IgE from attaching to the mast cells, and prevents those cells from degranulating and releasing histamine into the bronchial system. IgE is present in all individuals in small concentrations (<30 IU/mL).
In two studies, already published (Soler, et al. Euro Resp J 2001;18:254-61) and (Busse, et al. J All Clin Immunol vol 108, No 2) symptomatic subjects who were not well manage with inhaled corticosteroids went through a run-in phase with beclomethasone and then were randomized to receive either subcutaneous omalizumab (450-740 mg divided into two doses), or a placebo.
The design of the trials was such that the subjects would receive the study drug for a stable 16-week period during which time they were expected to continue using their usual medication, followed by a 12-week period in which they would reduce their usual medication to the lowest tolerable dose. Once this lowest dose was achieved, they were expected to maintain that level, if possible, for a further four weeks.
Over the 28-week core period, Dr. Wenzel said there were significantly fewer hospitalizations due to acute exacerbations in the omalizumab group compared with the placebo group. The same pattern was seen after 52 weeks of follow up.
In the first study, which involved 274 patients on omalizumab, 79 percent were able to reduce their beclomethasone consumption by at least 50 percent (compared with 55 percent in the placebo group). Furthermore, 43 percent of those in the omalizumab group were able to stop taking beclomethasone completely.
In the second study, subjects were able to reduce their steroid use by 75 and 55 percent (omalizumab and beclothesone, respectively).
A third analysis of data from these two phase III studies, as well as from other research, showed that in 254 patients with severe asthma (i.e., who had been intubated, or admitted to hospital, or had had one emergency room visit in the past 12 months) the mean number of exacerbations was reduced by 55 percent compared with placebo.
According to Dr. Wenzel, investigators' evaluation placed the treatment results at excellent or good in 70 percent of the cases.
While the drug won't be available for some time, Dr. Wenzel said the issue of taking a subcutaneous medication will eventually be accepted 'just like insulin is with diabetics."
Cost, on the other hand, might be a more significant issue. Doctors and representatives speaking for Novartis and its subsidiary, Genetech, which developed omalizumab, would not put a price on it, but compared it to drugs like Enbrel (etanercept), which is used to treat rheumatoid arthritis, and which sells for approximately $9000 US per year. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.