PMID- 26340860
OWN - NLM
STAT- MEDLINE
DCOM- 20161005
LR  - 20181113
IS  - 1550-7416 (Electronic)
IS  - 1550-7416 (Linking)
VI  - 18
IP  - 1
DP  - 2016 Jan
TI  - Evaluation of IgE Antibodies to Omalizumab (Xolair(R)) and Their Potential 
      Correlation to Anaphylaxis.
PG  - 115-23
LID - 10.1208/s12248-015-9821-x [doi]
AB  - Omalizumab (Xolair(R)) is a recombinant humanized monoclonal antibody that 
      selectively binds to human immunoglobulin E (IgE). Omalizumab is used to treat 
      IgE-mediated diseases such as chronic idiopathic urticaria (CIU) and moderate to 
      severe allergic asthma. In pre-marketing clinical trials in patients with asthma, 
      anaphylaxis was reported in 3 of 3,507 (0.1%) patients. In post-marketing 
      spontaneous reports, the frequency of anaphylaxis attributed to omalizumab use 
      was estimated to be at least 0.2% of patients based on an estimated exposure of 
      about 57,300 patients from June 2003 through December 2006. To better understand 
      the risk of anaphylaxis in patients with allergic asthma receiving omalizumab, a 
      post-marketing pharmacosurveillance study was initiated in 2009. As part of this 
      study, an assay was developed to detect antibodies of IgE isotype to omalizumab. 
      Serum samples from patients in the study were evaluated using this assay. Our 
      results indicated that there was no observable correlation between either 
      anaphylaxis or skin test reactivity and the presence of antibodies of IgE isotype 
      to omalizumab. Here, we discuss the development of this assay as well as the 
      results of the immunogenicity assessment.
FAU - Baker, Dana L
AU  - Baker DL
AD  - Department of Assay Development and Technology, Genentech, Inc., 1 DNA Way, South 
      San Francisco, California, 94080, USA.
FAU - Nakamura, Gerald R
AU  - Nakamura GR
AD  - Department of Assay Development and Technology, Genentech, Inc., 1 DNA Way, South 
      San Francisco, California, 94080, USA.
FAU - Lowman, Henry B
AU  - Lowman HB
AD  - Department of Assay Development and Technology, Genentech, Inc., 1 DNA Way, South 
      San Francisco, California, 94080, USA.
FAU - Fischer, Saloumeh Kadkhodayan
AU  - Fischer SK
AD  - Department of Assay Development and Technology, Genentech, Inc., 1 DNA Way, South 
      San Francisco, California, 94080, USA. fischer.sally@gene.com.
LA  - eng
PT  - Journal Article
DEP - 20150904
PL  - United States
TA  - AAPS J
JT  - The AAPS journal
JID - 101223209
RN  - 0 (Anti-Allergic Agents)
RN  - 0 (Antibodies)
RN  - 2P471X1Z11 (Omalizumab)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
MH  - Adult
MH  - Anaphylaxis/*epidemiology/etiology
MH  - Anti-Allergic Agents/adverse effects/*immunology
MH  - Antibodies/*analysis/genetics
MH  - Asthma/drug therapy
MH  - Humans
MH  - Immunoglobulin E/*analysis/genetics
MH  - Omalizumab/adverse effects/*immunology
MH  - Product Surveillance, Postmarketing
MH  - Skin Tests
PMC - PMC4706281
OTO - NOTNLM
OT  - DIG-FcepsilonR1-IgG
OT  - IgE isotype
OT  - biotin-mutant omalizumab-AAA
OT  - omalizumab (Xolair(R))
OT  - omalizumab/total IgE molar ratio
EDAT- 2015/09/06 06:00
MHDA- 2016/10/07 06:00
PMCR- 2016/09/04
CRDT- 2015/09/06 06:00
PHST- 2015/07/13 00:00 [received]
PHST- 2015/08/18 00:00 [accepted]
PHST- 2015/09/06 06:00 [entrez]
PHST- 2015/09/06 06:00 [pubmed]
PHST- 2016/10/07 06:00 [medline]
PHST- 2016/09/04 00:00 [pmc-release]
AID - 10.1208/s12248-015-9821-x [pii]
AID - 9821 [pii]
AID - 10.1208/s12248-015-9821-x [doi]
PST - ppublish
SO  - AAPS J. 2016 Jan;18(1):115-23. doi: 10.1208/s12248-015-9821-x. Epub 2015 Sep 4.