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Safety of anti‐immunoglobulin E therapy with omalizumab in allergic patients at risk of geohelminth infection

Cruz, A. A., Lima, F., Sarinho, E., Ayre, G., Martin, C., Fox, H., Cooper, P. J.·2007·Clinical & Experimental Allergy
DOI 10.1111/j.1365-2222.2007.02650.xPMC PMC1859973
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Abstract

Summary: 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.

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Fig. 1 Flow chart for determining intestinal helminth infection status. Intestinal helminth infections were defined as new infections if helminth eggs were detected in a faeces sample following a previously negative sample, or there was an increase in infection intensity [eggs per gram (epg)] for the same species at least 4 weeks after appropriate anthelmintic treatment or an increase in infection intensity (epg) for the same parasite species compared with the previous sample. The start date of a new infection was defined as the date on which the positive sample was taken. The end of a helminth infection was defined as the date on which either (1) anthelmintic treatment was given to treat a specific helminth infection or (2) no eggs/larvae were detected and the investigator considered the infection resolved or (3) when anthelmintic treatment was administered at the end of the 52-week treatment period.
Fig. 1 Flow chart for determining intestinal helminth infection status. Intestinal helminth infections were defined as new infections if helminth eggs were detected in a faeces sample following a previously negative sample, or there was an increase in infection intensity [eggs per gram (epg)] for the same species at least 4 weeks after appropriate anthelmintic treatment or an increase in infection intensity (epg) for the same parasite species compared with the previous sample. The start date of a new infection was defined as the date on which the positive sample was taken. The end of a helminth infection was defined as the date on which either (1) anthelmintic treatment was given to treat a specific helminth infection or (2) no eggs/larvae were detected and the investigator considered the infection resolved or (3) when anthelmintic treatment was administered at the end of the 52-week treatment period.CC BY · PubMed Central
Fig. 2 Flow of subjects through the study.
Fig. 2 Flow of subjects through the study.CC BY · PubMed Central
Fig. 3 Kaplan–Meier plot of time to first detection of infection with intestinal helminth parasite during core and follow-up phases. These data include data for discontinued patients, so the number of patients infected in this analysis (36 vs. 29) differs slightly from the number of reported infections during the 52-week treatment period (34 vs. 28).
Fig. 3 Kaplan–Meier plot of time to first detection of infection with intestinal helminth parasite during core and follow-up phases. These data include data for discontinued patients, so the number of patients infected in this analysis (36 vs. 29) differs slightly from the number of reported infections during the 52-week treatment period (34 vs. 28).CC BY · PubMed Central

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Metadata

Authors
Cruz, A. A., Lima, F., Sarinho, E., Ayre, G., Martin, C., Fox, H., & Cooper, P. J.
Venue
Clinical & Experimental Allergy
Publisher
Wiley
Published
2007-01-23
Volume
37
Issue
2
Pages
197-207
ISSN
  • 0954-7894
  • 1365-2222
DOI
10.1111/j.1365-2222.2007.02650.x
PMC
PMC1859973
Cited by
111
References
0
Language
en
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)

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CoChat. (2026). Citation check: Safety of anti‐immunoglobulin E therapy with omalizumab in allergic patients at risk of geohelminth infection. https://app.cochat.ai/papers/10.1111/j.1365-2222.2007.02650.x
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Cruz, A. A., Lima, F., Sarinho, E., Ayre, G., Martin, C., Fox, H., & Cooper, P. J. (2007). Safety of anti‐immunoglobulin E therapy with omalizumab in allergic patients at risk of geohelminth infection. Clinical & Experimental Allergy. https://doi.org/10.1111/j.1365-2222.2007.02650.x