Safety of Omalizumab in Allergic Patients at Risk of Helminth Infection
Author Information
Author(s): Cruz A A, Lima F, Sarinho E, Ayre G, Martin C, Fox H, Cooper P J
Primary Institution: ProAR, Faculdade de Medicina da Bahia-UFBA, Instituto de Investigação em Imunologia (iii) CNPq, Salvador, BA, Brazil
Hypothesis
Is omalizumab therapy safe for allergic patients at high risk of intestinal helminth infection?
Conclusion
Omalizumab therapy appeared to be safe and well tolerated, but may be associated with a modest increase in the incidence of geohelminth infection.
Supporting Evidence
- 50% of omalizumab subjects experienced at least one intestinal geohelminth infection compared to 41% of placebo subjects.
- The odds ratio for infection in the omalizumab group was 1.47, indicating a potential increased risk.
- Omalizumab therapy was well tolerated with no significant increase in morbidity from helminth infections.
- Time to first infection was similar between treatment groups.
Takeaway
This study looked at whether a medicine called omalizumab is safe for people with allergies who might get infections from worms. It found that while the medicine is mostly safe, it might slightly increase the chance of getting these worm infections.
Methodology
A randomized, double-blind, placebo-controlled trial was conducted in 137 subjects aged 12–30 years at high risk of geohelminth infection, receiving either omalizumab or placebo for 52 weeks.
Potential Biases
There were non-statistically significant baseline imbalances between the treatment groups.
Limitations
The study had a relatively small sample size, limiting the power to detect small increases in infection risk.
Participant Demographics
Participants were aged 12–30 years, with a diagnosis of allergic asthma and/or perennial allergic rhinitis.
Statistical Information
P-Value
0.035
Confidence Interval
0.94–5.15
Statistical Significance
p=0.035
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website