PMID- 17339107
OWN - NLM
STAT- MEDLINE
DCOM- 20070911
LR  - 20220408
IS  - 0954-6111 (Print)
IS  - 0954-6111 (Linking)
VI  - 101
IP  - 7
DP  - 2007 Jul
TI  - Predicting and evaluating response to omalizumab in patients with severe allergic 
      asthma.
PG  - 1483-92
AB  - BACKGROUND: Omalizumab is a monoclonal antibody indicated for treatment of severe 
      persistent allergic asthma inadequately controlled despite optimal controller 
      therapy. We investigated whether patient selection could be targeted further. 
      METHODS: Data from seven randomized controlled omalizumab trials were analyzed to 
      investigate whether pre-treatment patient baseline clinical characteristics could 
      be identified that were predictive of a superior response to omalizumab. We also 
      studied whether patients who respond to omalizumab following a course of 
      treatment could be reliably identified. Univariate/multivariate analyses of 
      INNOVATE data were performed to identify predictive baseline measures and further 
      investigated in efficacy analyses of pooled data from seven studies. The best 
      method of identifying responders to omalizumab following treatment was determined 
      by assessing the ability of various clinical response criteria to identify 
      responders and discriminate patient exacerbation and other outcomes. RESULTS: 
      Baseline total immunoglobulin E (IgE) was the only predictor of efficacy in 
      INNOVATE. However, pooled analysis showed treatment benefits irrespective of IgE 
      levels. In omalizumab-treated patients, physician's overall assessment following 
      a course of treatment identified 61% as responders and best discriminated 
      treatment outcomes. CONCLUSION: Baseline characteristics do not reliably predict 
      benefit with omalizumab. Physician's overall assessment after 16 weeks of 
      treatment is the most meaningful measure of response to therapy.
FAU - Bousquet, J
AU  - Bousquet J
AD  - Service de Pneumologie, Hopital Arnaud de Villeneuve, 371 Avenue du Doyen G 
      Giraud, Montpellier 34295, France. jean.bousquet@wanadoo.fr
FAU - Rabe, K
AU  - Rabe K
FAU - Humbert, M
AU  - Humbert M
FAU - Chung, K F
AU  - Chung KF
FAU - Berger, W
AU  - Berger W
FAU - Fox, H
AU  - Fox H
FAU - Ayre, G
AU  - Ayre G
FAU - Chen, H
AU  - Chen H
FAU - Thomas, K
AU  - Thomas K
FAU - Blogg, M
AU  - Blogg M
FAU - Holgate, S
AU  - Holgate S
LA  - eng
GR  - G0800766/MRC_/Medical Research Council/United Kingdom
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20070306
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Antibodies, Anti-Idiotypic)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 2P471X1Z11 (Omalizumab)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
CIN - Expert Rev Clin Immunol. 2007 Jul;3(4):463-7. PMID: 20477152
MH  - Anti-Asthmatic Agents/*therapeutic use
MH  - Antibodies, Anti-Idiotypic
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Asthma/*drug therapy/immunology/physiopathology
MH  - Forced Expiratory Volume
MH  - Health Status Indicators
MH  - Humans
MH  - Immunoglobulin E/blood
MH  - Omalizumab
MH  - Patient Selection
MH  - Prognosis
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
EDAT- 2007/03/07 09:00
MHDA- 2007/09/12 09:00
CRDT- 2007/03/07 09:00
PHST- 2006/12/21 00:00 [received]
PHST- 2007/01/09 00:00 [accepted]
PHST- 2007/03/07 09:00 [pubmed]
PHST- 2007/09/12 09:00 [medline]
PHST- 2007/03/07 09:00 [entrez]
AID - S0954-6111(07)00038-8 [pii]
AID - 10.1016/j.rmed.2007.01.011 [doi]
PST - ppublish
SO  - Respir Med. 2007 Jul;101(7):1483-92. doi: 10.1016/j.rmed.2007.01.011. Epub 2007 
      Mar 6.