PMID- 22948442
OWN - NLM
STAT- MEDLINE
DCOM- 20130220
LR  - 20151119
IS  - 1423-0097 (Electronic)
IS  - 1018-2438 (Linking)
VI  - 160
IP  - 1
DP  - 2013
TI  - Omalizumab protects against allergen- induced bronchoconstriction in allergic 
      (immunoglobulin E-mediated) asthma.
PG  - 102-10
LID - 10.1159/000339243 [doi]
AB  - BACKGROUND: Omalizumab has been shown to suppress responses to inhaled allergens 
      in allergic asthma patients with pretreatment immunoglobulin E (IgE) </=700 IU/ml. 
      To extend current dosing tables, we evaluated the potential of high omalizumab 
      doses to block allergen-induced bronchoconstriction in patients with higher IgE 
      levels. METHODS: Asthmatic adults (18-65 years; body weight 40-150 kg) were 
      divided into groups according to screening IgE (group 1: 30-300 IU/ml; group 2: 
      700-2,000 IU/ml) and randomized 2:1 to omalizumab/placebo every 2 or 4 weeks for 
      12-14 weeks. Allergen bronchoprovocation (ABP) testing was performed before 
      treatment and at weeks 8 and 16. The primary efficacy endpoint, the early-phase 
      allergic response (EAR), was defined as the maximum percentage drop in forced 
      expiratory volume in 1 s during the first 30 min after ABP. Serum free IgE was 
      determined as a pharmacodynamic endpoint, and the exhaled fractional 
      concentration of nitric oxide (FE(NO)) was an exploratory endpoint. RESULTS: 
      Fifty patients were included in the study. Omalizumab improved EAR; at week 8, 
      EAR was 23.1% for placebo, 9.3% in group 1 (p = 0.018 versus placebo) and 5.6% in 
      group 2 (p < 0.001). At week 16, EAR was 20%, 11.8% (p = 0.087) and 5.1% (p < 
      0.001), respectively. Free IgE decreased in groups 1 and 2 and remained <50 ng/ml 
      in all patients during weeks 6-16. Omalizumab completely suppressed FE(NO) 
      increases after ABP in both groups. CONCLUSIONS: Omalizumab blocked early 
      asthmatic responses over a broad range of IgE/body weight combinations. Extending 
      the dosing tables enables omalizumab to benefit a wider range of patients.
CI  - Copyright (c) 2012 S. Karger AG, Basel.
FAU - Zielen, Stefan
AU  - Zielen S
AD  - Department of Pediatric Allergy, Pneumology and Cystic Fibrosis, University 
      Children's Hospital, J.W. Goethe University, Frankfurt, Germany. 
      Stefan.Zielen@kgu.de
FAU - Lieb, Adrian
AU  - Lieb A
FAU - De La Motte, Stephan
AU  - De La Motte S
FAU - Wagner, Frank
AU  - Wagner F
FAU - de Monchy, Jan
AU  - de Monchy J
FAU - Fuhr, Rainard
AU  - Fuhr R
FAU - Munzu, Clara
AU  - Munzu C
FAU - Koehne-Voss, Stephan
AU  - Koehne-Voss S
FAU - Riviere, Gilles-Jacques
AU  - Riviere GJ
FAU - Kaiser, Guenther
AU  - Kaiser G
FAU - Erpenbeck, Veit J
AU  - Erpenbeck VJ
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120828
PL  - Switzerland
TA  - Int Arch Allergy Immunol
JT  - International archives of allergy and immunology
JID - 9211652
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Antibodies, Anti-Idiotypic)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 2P471X1Z11 (Omalizumab)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Asthmatic Agents/administration & dosage/*therapeutic use
MH  - Antibodies, Anti-Idiotypic/administration & dosage/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/*therapeutic use
MH  - Asthma/*drug therapy/physiopathology/prevention & control
MH  - Bronchial Provocation Tests
MH  - Bronchoconstriction/drug effects
MH  - Double-Blind Method
MH  - Female
MH  - Forced Expiratory Volume/drug effects
MH  - Humans
MH  - Immunoglobulin E/blood/immunology
MH  - Male
MH  - Middle Aged
MH  - Omalizumab
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2012/09/06 06:00
MHDA- 2013/02/21 06:00
CRDT- 2012/09/06 06:00
PHST- 2011/10/09 00:00 [received]
PHST- 2012/05/02 00:00 [accepted]
PHST- 2012/09/06 06:00 [entrez]
PHST- 2012/09/06 06:00 [pubmed]
PHST- 2013/02/21 06:00 [medline]
AID - 000339243 [pii]
AID - 10.1159/000339243 [doi]
PST - ppublish
SO  - Int Arch Allergy Immunol. 2013;160(1):102-10. doi: 10.1159/000339243. Epub 2012 
      Aug 28.