Reslizumab in children and adolescents with eosinophilic esophagitis: Results of a double-blind, randomized, placebo-controlled trial - 03/02/12
, Marc E. Rothenberg, MD, PhD c, Margaret H. Collins, MD d, Glenn T. Furuta, MD e, Jonathan E. Markowitz, MD f, George Fuchs, MD g, Molly A. O’Gorman, MD h, Juan Pablo Abonia, MD c, James Young, MS i, Timothy Henkel, MD, PhD j, H. Jeffrey Wilkins, MD j, Chris A. Liacouras, MD b
Corresponding author: Jonathan M. Spergel, MD, PhD, Children’s Hospital of Philadelphia, 3550 Market St, Philadelphia, PA 19104.Abstract |
Background |
Eosinophilic esophagitis is a chronic allergic disease with insufficient treatment options. Results from animal studies suggest that IL-5 induces eosinophil trafficking in the esophagus.
Objective |
We sought to evaluate the effect of reslizumab, a neutralizing antibody against IL-5, in children and adolescents with eosinophilic esophagitis.
Methods |
Patients with symptom severity scores of moderate or worse and an esophageal biopsy specimen with 24 or more intraepithelial eosinophils per high-power field were randomly assigned to receive infusions of 1, 2, or 3 mg/kg reslizumab or placebo at weeks 0, 4, 8, and 12. The coprimary efficacy measures were changes in peak esophageal eosinophil count and the physician’s global assessment score at week 15 (end of therapy).
Results |
Two-hundred twenty-six patients received study medication. Median reductions from baseline to the end of therapy in peak esophageal eosinophil counts were 59%, 67%, 64%, and 24% in the 1, 2, and 3 mg/kg reslizumab (all P < .001) and placebo groups, respectively. All treatment groups, including the placebo group, showed improvements in physician’s global assessment scores; the differences between the reslizumab and placebo groups were not statistically significant. The most common adverse events in the reslizumab groups were headache, cough, nasal congestion, and upper respiratory tract infection. One patient in each reslizumab group and 2 in the placebo group had serious adverse events; none were considered related to the study medication.
Conclusion |
Reslizumab significantly reduced intraepithelial esophageal eosinophil counts in children and adolescents with eosinophilic esophagitis. However, improvements in symptoms were observed in all treatment groups and were not associated with changes in esophageal eosinophil counts.
Le texte complet de cet article est disponible en PDF.Key words : Eosinophilic esophagitis, reslizumab, eosinophil, IL-5
Abbreviations used : ANCOVA, CHQ, GERD, hpf
Plan
| Sponsored by Ception Therapeutics, Inc, which has since been acquired by Cephalon, Inc. |
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| Disclosure of potential conflict of interest: J. M. Spergel is a consultant for DBV; has received research support from the Department of Defense (DOD), Cephalon, and the National Institutes of Health (NIH); is a member of the American Academy of Allergy, Asthma & Immunology; and is on the American Partnership for Eosinophilic Disorders (APFED) Medical Advisory Board. M. E. Rothenberg has equity interest in reslizumab through Cephalon; is consultant and chief scientific officer of Immune Pharmaceuticals; has received research support from the NIH, the Food Allergy & Anaphylaxis Network, and the DOD; is on the APFED Medical Advisory Board; and is on the International Eosinophil Society Executive Council. M. H. Collins is a central review pathologist for Cephalon, GlaxoSmithKline, and Meritage Pharma; is a consultant for Sunovion; and is president of the APFED Medical Advisory Board. G. T. Furuta is a consultant for Nutricia and Meritage and has received research support from the NIH, AstraZeneca, and the Thrasher Foundation. G. Fuchs III has received research support from Shire and Cephalon. J. P. Abonia has received research support from the NIH, Ception Therapeutics, and the Children’s Digestive Health and Nutrition Foundation. T. Henkel is a consultant for Cephalon and a shareholder in Ception Therapeutics. C. A. Liacouras is a speaker for Nutricia and is on the American Partnership for Eosinophilic Disorders Physician Board. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 129 - N° 2
P. 456 - février 2012 Retour au numéro
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