PMID- 17250692
OWN - NLM
STAT- MEDLINE
DCOM- 20070813
LR  - 20220409
IS  - 0954-7894 (Print)
IS  - 1365-2222 (Electronic)
IS  - 0954-7894 (Linking)
VI  - 37
IP  - 2
DP  - 2007 Feb
TI  - Safety of anti-immunoglobulin E therapy with omalizumab in allergic patients at 
      risk of geohelminth infection.
PG  - 197-207
AB  - BACKGROUND: Although the role of immunoglobulin E (IgE) in immunity against 
      helminth parasites is unclear, there is concern that therapeutic antibodies that 
      neutralize IgE (anti-IgE) may be unsafe in subjects at risk of helminth 
      infection. OBJECTIVE: We conducted an exploratory study to investigate the safety 
      of omalizumab (anti-IgE) in subjects with allergic asthma and/or perennial 
      allergic rhinitis at high risk of intestinal helminth infection. The primary 
      safety outcome was risk of infections with intestinal helminths during anti-IgE 
      therapy. METHODS: A randomized, double-blind, placebo-controlled trial was 
      conducted in 137 subjects (12-30 years) at high risk of geohelminth infection. 
      All subjects received pre-study anthelmintic treatment, followed by 52 weeks' 
      treatment with omalizumab or placebo. RESULTS: Of the omalizumab subjects 50% 
      (34/68) experienced at least one intestinal geohelminth infection compared with 
      41% (28/69) of placebo subjects [odds ratio (OR) 1.47, 95% confidence interval 
      (CI) 0.74-2.95, one-sided P=0.14; OR (adjusted for study visit, baseline 
      infection status, gender and age) 2.2 (0.94-5.15); one-sided P=0.035], providing 
      some evidence for a potential increased incidence of geohelminth infection in 
      subjects receiving omalizumab. Omalizumab therapy was well tolerated, and did not 
      appear to be associated with increased morbidity attributable to intestinal 
      helminths as assessed by clinical and laboratory adverse events, maximal helminth 
      infection intensities and additional anthelmintic requirements. Time to first 
      infection (OR 1.30, 95% CI 0.79-2.15, one-sided P=0.15) was similar between 
      treatment groups. Infection severity and response to anthelmintics appeared to be 
      unaffected by omalizumab therapy. CONCLUSIONS: In this exploratory study of 
      allergic subjects at high risk of helminth infections, omalizumab therapy 
      appeared to be safe and well tolerated, but may be associated with a modest 
      increase in the incidence of geohelminth infection.
FAU - Cruz, A A
AU  - Cruz AA
AD  - ProAR, Faculdade de Medicina da Bahia-UFBA, Instituto de Investigacao em 
      Imunologia (iii), CNPq, Salvador, BA, Brazil. cruz.aa@terra.com.br
FAU - Lima, F
AU  - Lima F
FAU - Sarinho, E
AU  - Sarinho E
FAU - Ayre, G
AU  - Ayre G
FAU - Martin, C
AU  - Martin C
FAU - Fox, H
AU  - Fox H
FAU - Cooper, P J
AU  - Cooper PJ
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Clin Exp Allergy
JT  - Clinical and experimental allergy : journal of the British Society for Allergy 
      and Clinical Immunology
JID - 8906443
RN  - 0 (Anti-Allergic Agents)
RN  - 0 (Antibodies, Anti-Idiotypic)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunologic Factors)
RN  - 2P471X1Z11 (Omalizumab)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - *Anti-Allergic Agents/therapeutic use
MH  - Antibodies, Anti-Idiotypic
MH  - *Antibodies, Monoclonal/therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Asthma/*drug therapy
MH  - Child
MH  - Contraindications
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Helminthiasis/*complications
MH  - Humans
MH  - Immunoglobulin E/*therapeutic use
MH  - Immunologic Factors/*therapeutic use
MH  - Male
MH  - Omalizumab
MH  - Rhinitis, Allergic, Perennial/*drug therapy
MH  - Risk Factors
PMC - PMC1859973
EDAT- 2007/01/26 09:00
MHDA- 2007/08/19 09:00
PMCR- 2006/03/27
CRDT- 2007/01/26 09:00
PHST- 2007/01/26 09:00 [pubmed]
PHST- 2007/08/19 09:00 [medline]
PHST- 2007/01/26 09:00 [entrez]
PHST- 2006/03/27 00:00 [pmc-release]
AID - CEA2650 [pii]
AID - 10.1111/j.1365-2222.2007.02650.x [doi]
PST - ppublish
SO  - Clin Exp Allergy. 2007 Feb;37(2):197-207. doi: 10.1111/j.1365-2222.2007.02650.x.