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Vol. 162, No. 1, 2013
Issue release date: August 2013
Int Arch Allergy Immunol 2013;162:89-93

Immunologic Effects of Omalizumab in Children with Severe Refractory Atopic Dermatitis: A Randomized, Placebo-Controlled Clinical Trial

Iyengar S.R. · Hoyte E.G. · Loza A. · Bonaccorso S. · Chiang D. · Umetsu D.T. · Nadeau K.C.
aDivision of Pediatric Allergy, Massachusetts General Hospital and bDivision of Immunology, Children's Hospital Boston, Harvard Medical School, Boston, Mass., and cDivision of Pulmonary, Allergy and Critical Care, Stanford University School of Medicine, Palo Alto, Calif., USA

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Background: Severe refractory atopic dermatitis (AD) is a chronic, debilitating condition that is associated with elevated serum immunoglobulin E (IgE) levels. Thymic stromal lymphopoietin (TSLP), thymus and activation-regulated chemokine (TARC) and OX40 ligand (OX40L) are important immunologic factors involved in the pathogenesis of AD. Omalizumab, an anti-IgE antibody indicated for use in allergic asthma, is implicated in regulating allergen presentation by dendritic cells and the T cell response during the effector phases of allergic disease. We investigated if anti-IgE therapy modulates the allergen-specific responses mediated by the TSLP pathway in young patients with severe refractory AD. Methods: This was a randomized, double-blind, placebo-controlled study of 8 patients between the ages of 4 and 22 years (mean = 11.6 years) with severe refractory AD (clinical NCT01678092). Serum IgE ranged from 218 to 1,890 (mean = 1,068 IU/ml). Subjects received omalizumab (n = 4) or placebo (n = 4) every 2-4 weeks over 24 weeks using a regimen extrapolated from the package insert. TSLP, TARC, OX40L and other cytokines involved in AD were measured by using cytometric bead arrays. Results: All patients receiving omalizumab had strikingly decreased levels of TSLP, OX40L, TARC (involved in Th2 polarization) and interleukin (IL)-9 compared to placebo. In addition, there was a marked increase in IL-10, a tolerogenic cytokine, in the omalizumab-treated group. Patients on anti-IgE therapy had an improvement in clinical outcomes as measured by the SCORAD system; however, these effects were comparable to improvements in the control group. Conclusions: Anti-IgE therapy with omalizumab decreases levels of cytokines that are involved in Th2 polarization and allergic inflammation, including TSLP, TARC and OX40L.

 goto top of outline Author Contacts

Correspondence to: Dr. Shuba Rajashri Iyengar
Division of Pediatric Allergy and Immunology
Massachusetts General Hospital for Children
175 Cambridge Street, Suite 559a, Charles River Park South, Boston, MA 02114 (USA)

 goto top of outline Article Information

Received: November 19, 2012
Accepted after revision: March 1, 2013
Published online: June 27, 2013
Number of Print Pages : 5
Number of Figures : 0, Number of Tables : 1, Number of References : 23

 goto top of outline Publication Details

International Archives of Allergy and Immunology

Vol. 162, No. 1, Year 2013 (Cover Date: August 2013)

Journal Editor: Valenta R. (Vienna), Bohle B. (Vienna)
ISSN: 1018-2438 (Print), eISSN: 1423-0097 (Online)

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