PMID- 23816920 OWN - NLM STAT- MEDLINE DCOM- 20131112 LR - 20220325 IS - 1423-0097 (Electronic) IS - 1018-2438 (Print) IS - 1018-2438 (Linking) VI - 162 IP - 1 DP - 2013 TI - Immunologic effects of omalizumab in children with severe refractory atopic dermatitis: a randomized, placebo-controlled clinical trial. PG - 89-93 LID - 10.1159/000350486 [doi] AB - 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 trials.gov 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. CI - Copyright (c) 2013 S. Karger AG, Basel. FAU - Iyengar, Shuba Rajashri AU - Iyengar SR AD - Division of Pediatric Allergy, Massachusetts General Hospital, Boston, Mass., USA. FAU - Hoyte, Elizabeth G AU - Hoyte EG FAU - Loza, Angelica AU - Loza A FAU - Bonaccorso, Salvatore AU - Bonaccorso S FAU - Chiang, David AU - Chiang D FAU - Umetsu, Dale T AU - Umetsu DT FAU - Nadeau, Kari Christine AU - Nadeau KC LA - eng SI - ClinicalTrials.gov/NCT01678092 GR - R21 AI095838/AI/NIAID NIH HHS/United States GR - U01 AI147462/AI/NIAID NIH HHS/United States PT - Clinical Trial PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20130627 PL - Switzerland TA - Int Arch Allergy Immunol JT - International archives of allergy and immunology JID - 9211652 RN - 0 (Anti-Allergic Agents) RN - 0 (Antibodies, Anti-Idiotypic) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Cytokines) RN - 0 (anti-IgE antibodies) RN - 2P471X1Z11 (Omalizumab) RN - 37341-29-0 (Immunoglobulin E) SB - IM MH - Adolescent MH - Anti-Allergic Agents/*therapeutic use MH - Antibodies, Anti-Idiotypic/*therapeutic use MH - Antibodies, Monoclonal, Humanized/*therapeutic use MH - Child MH - Child, Preschool MH - Cytokines/blood MH - Dermatitis, Atopic/*drug therapy/immunology MH - Double-Blind Method MH - Humans MH - Immunoglobulin E/blood MH - Omalizumab MH - Severity of Illness Index MH - Treatment Outcome MH - Young Adult PMC - PMC4161454 MID - NIHMS606204 EDAT- 2013/07/03 06:00 MHDA- 2013/11/13 06:00 PMCR- 2014/09/11 CRDT- 2013/07/03 06:00 PHST- 2012/11/19 00:00 [received] PHST- 2013/03/01 00:00 [accepted] PHST- 2013/07/03 06:00 [entrez] PHST- 2013/07/03 06:00 [pubmed] PHST- 2013/11/13 06:00 [medline] PHST- 2014/09/11 00:00 [pmc-release] AID - 000350486 [pii] AID - 10.1159/000350486 [doi] PST - ppublish SO - Int Arch Allergy Immunol. 2013;162(1):89-93. doi: 10.1159/000350486. Epub 2013 Jun 27.