New Agent Reverses Disease Process in Hypereosinophilic Syndrome: Presented at AAAAI

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Title: New Agent Reverses Disease Process in Hypereosinophilic Syndrome: Presented at AAAAI
URL: http://www.pslgroup.com/dg/21E8EE.htm
Doctor's Guide
March 19, 2008

By Em Brown, BSN

PHILADELPHIA -- March 19, 2008 -- The investigational anti-interleukin-5 (anti-IL-5) monoclonal antibody mepolizumab causes eosinophil levels to decrease to near-normal levels in virtually all patients with hypereosinophilic syndrome, results of an international phase 3 study show.

The actual primary endpoint of the study was a reduction in prednisone use to less than 10 mg daily for 8 consecutive weeks, which was met in 84% of patients.

Those findings were presented here at the American Academy of Asthma, Allergy & Immunology (AAAAI) Annual Meeting by principal investigator Marc E. Rothenberg, MD, Director, Allergy and Immunology, Cincinnati Children's Hospital, Cincinnati, Ohio.

The results are also being published in The New England Journal of Medicine (Rothenberg ME, et al. doi:10.1056/NEJMoa070812. Accessed March 19, 2008).

This placebo-controlled trial evaluated the efficacy of intravenous mepolizumab in 85 patients between 18 and 85 years of age with blood eosinophil counts greater than 1,500 eosinophils/mL. Patients were negative for the FIP1L1-PDGFRA fusion gene.

At baseline, all patients were taking daily prednisone therapy in doses ranging from 20 to 60 mg.

The primary endpoint -- a daily prednisone requirement of 10 mg or less -- was reached by 84% of patients on mepolizumab compared with 43% of those on placebo, Dr. Rothenberg reported. There was no increase in clinical disease activity during the study.

A blood eosinophil count of less than 600 eosinophils/mL was reached by 95% of patients on active treatment compared with 45% of patients on placebo, Dr. Rothenberg said in his presentation on March 16.

Serious adverse events occurred in 7 patients on mepolizumab and 5 patients on placebo; none was considered by the investigators to be treatment related.

"Anti-IL-5 therapy gets right to the root of the hypereosinophilic disease by preventing eosinophil production and proliferation ... and prevents eosinophil maturation," said Michael E. Wechsler, MD, Assistant Professor of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, Massachusetts, who has an editorial accompanying Dr. Rothenberg's published study.

"Most of these patients require moderately high doses of prednisone to control their disease," Dr. Wechsler pointed out in an interview during the AAAAI meeting. With anti-IL-5 treatment, there is a significant reduction in need for chronic corticosteroid therapy and its often serious adverse effects.

"We need another trial to determine if mepolizumab can be used as first-line therapy [in hypereosinophilic syndrome] ... It would also be useful to study if anti-IL-5 therapy is effective in other eosinophilic syndromes, like asthma," Dr. Wechsler said.

Funding for this study was provided by GlaxoSmithKline and the National Institutes of Health.

[Presentation title: Anti-IL-5, Mechanism of Action and Clinical Effects for HES Treatment. Session: Anti-IL-5 Therapy Finally Takes Center Stage. Session 3302]

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