Michael M Chen1, Florence Roufosse2, Sa A Wang3, Srdan Verstovsek3, Sandy R Durrani4, Marc E Rothenberg4, Thanai Pongdee5, Joseph Butterfield5, Timothy Lax6, Michael E Wechsler7, Miguel L Stein8, Princess U Ogbogu9, Basil M Kahwash9, Sameer K Mathur10, Dagmar Simon11, Praveen Akuthota12, Nicole Holland13, Lauren Wetzler13, JeanAnne M Ware13, Canting Guo1, Michael P Fay13, Paneez Khoury13, Amy D Klion13, Bruce S Bochner14. 1. Division of Allergy and Immunology, Northwestern University, Chicago, Ill. 2. Department of Internal Medicine, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. 3. Department of Leukemia, MD Anderson Cancer Center, Houston, Texas. 4. Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio. 5. Division of Allergic Diseases, Mayo Clinic, Rochester, Minn. 6. Division of Allergy and Inflammation, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Mass. 7. Division of Pulmonary, Critical Care and Sleep, Department of Medicine, National Jewish Health, Denver, Colo. 8. Allergy and Clinical Immunology Unit, Edith Wolfson Medical Center, Tel Aviv University, Holon, Israel. 9. Division of Allergy and Immunology, Department of Otolaryngology, Ohio State University Wexner Medical Center, Columbus, Ohio. 10. Division of Allergy, Pulmonary and Critical Care, Department of Medicine, University of Wisconsin, Madison, Wis. 11. Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. 12. Division of Pulmonary, Critical Care & Sleep Medicine, Department of Medicine, University of California San Diego, La Jolla, CA. 13. Laboratory of Parasitic Diseases, National Institutes of Health, Bethesda, Md. 14. Division of Allergy and Immunology, Northwestern University, Chicago, Ill. Electronic address: bruce.bochner@northwestern.edu.
Abstract
BACKGROUND: Treatment of hypereosinophilic syndrome (HES) often requires the use of immunomodulators with substantial side effect profiles. The emergence of biologics offers an alternative treatment modality. OBJECTIVE: To examine real-world practice data to describe the safety and consequences of various biologics suspected to directly or indirectly affect eosinophilic inflammation for the treatment of HES. METHODS: Retrospective data from 13 centers were collected via an online Research Electronic Data Capture repository. Inclusion criteria included (1) peripheral eosinophil count of 1,500/mm3 or greater without a secondary cause; (2) clinical manifestations attributable to the eosinophilia; and (3) having received mepolizumab (anti-IL-5), benralizumab (afucosylated anti-IL-5 receptor α), omalizumab (anti-IgE), alemtuzumab (anti-CD52), dupilumab (anti-IL-4 receptor α), or reslizumab (anti-IL-5) outside a placebo-controlled clinical trial. RESULTS: Of the 151 courses of biologics prescribed for 121 patients with HES, 59% resulted in improved HES symptoms and 77% enabled tapering of other HES medications. Overall, 105 patients were receiving daily systemic glucocorticoids at the time of a biologic initiation and were able to reduce the glucocorticoid dose by a median reduction of 10 mg of daily prednisone equivalents. Biologics were generally safe and well-tolerated other than infusion reactions with alemtuzumab. Thirteen of 24 patients had clinical improvement after switching biologics and nine patients responded to increasing the dose of mepolizumab after a lack of response to a lower dose. CONCLUSIONS: Biologics may offer a safer treatment alternative to existing therapies for HES, although the optimal dosing and choice for each subtype of HES remain to be determined. Limitations of this study include its retrospective nature and intersite differences in data collection and availability of each biologic.
BACKGROUND: Treatment of hypereosinophilic syndrome (HES) often requires the use of immunomodulators with substantial side effect profiles. The emergence of biologics offers an alternative treatment modality. OBJECTIVE: To examine real-world practice data to describe the safety and consequences of various biologics suspected to directly or indirectly affect eosinophilic inflammation for the treatment of HES. METHODS: Retrospective data from 13 centers were collected via an online Research Electronic Data Capture repository. Inclusion criteria included (1) peripheral eosinophil count of 1,500/mm3 or greater without a secondary cause; (2) clinical manifestations attributable to the eosinophilia; and (3) having received mepolizumab (anti-IL-5), benralizumab (afucosylated anti-IL-5 receptor α), omalizumab (anti-IgE), alemtuzumab (anti-CD52), dupilumab (anti-IL-4 receptor α), or reslizumab (anti-IL-5) outside a placebo-controlled clinical trial. RESULTS: Of the 151 courses of biologics prescribed for 121 patients with HES, 59% resulted in improved HES symptoms and 77% enabled tapering of other HES medications. Overall, 105 patients were receiving daily systemic glucocorticoids at the time of a biologic initiation and were able to reduce the glucocorticoid dose by a median reduction of 10 mg of daily prednisone equivalents. Biologics were generally safe and well-tolerated other than infusion reactions with alemtuzumab. Thirteen of 24 patients had clinical improvement after switching biologics and nine patients responded to increasing the dose of mepolizumab after a lack of response to a lower dose. CONCLUSIONS: Biologics may offer a safer treatment alternative to existing therapies for HES, although the optimal dosing and choice for each subtype of HES remain to be determined. Limitations of this study include its retrospective nature and intersite differences in data collection and availability of each biologic.
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