Mechanisms of AllergyAnti–interleukin-5 (mepolizumab) therapy for hypereosinophilic syndromes☆
Section snippets
Methods
After local institutional review board and FDA approval and informed consent was obtained, patients with HES involving peripheral blood and/or tissue eosinophilia (18 to 65 years old) were monitored (by complete blood counts and physical examination) at 2- to 4-week intervals for a period of 28 weeks. Patients were also evaluated by pulmonary function testing, electrocardiograms, and echocardiograms at weeks 0, 8, and 20. It is important to note that the entry criteria for this study permitted
Results
Patient 1 was a 48-year-old woman with a 10-year history of IHES with biopsy-proven involvement of the lungs, gastrointestinal tract, and skin (eosinophilic cellulitis). Her treatment had been primarily oral methylprednisolone and methotrexate with previous trials of hydroxyurea, interferon-α, and phototherapy. At the time of the study, her gastrointestinal symptoms were inactive and her main target organs were the skin and lungs. During the initial 8 weeks of the protocol, she had an
Discussion
In summary, we have shown that anti–IL-5 appears to be safe in 4 patients with diverse manifestations of HES. In addition, several disease parameters appear to be improved by anti–IL-5 therapy, including peripheral blood eosinophil counts in all patients, FEV1 measurements, a variety of clinical symptoms, QOL measurements, and tissue eosinophilia in 1 patient. However, since this study is an open-label, noncontrolled trial, definitive proof that anti–IL-5 is responsible for these improvements
Acknowledgments
We thank Dr A. Rosen for providing clinical care, members of the Data Safety Monitoring Board (Drs Leonard Bernstein, Charles Pierce, and Philip Walson and Alice Ostendorf, RN), and Carol Johnson and Andrea Lippelman for administrative assistance.
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Supported in part by the Burroughs Wellcome Fund and the NIH-supported Clinical Research Center and the Translational Research Office at Cincinnati Children's Hospital Medical Center.