Validation of an anti-α-Gal IgE fluoroenzyme-immunoassay for the screening of patients at risk of severe anaphylaxis to cetuximab, BMC Cancer

Background The link between immediate hypersensitivity reactions (HSR) following the first cetuximab infusion and the IgE sensitization against anti-galactose-α-1,3-galactose (α-Gal) is now well-established. An automated Fluoroenzyme-Immunoassay (FEIA) is available and may facilitate the screening of patients with anti-α-Gal IgE before treatment. Methods This study aimed to evaluate its performances as compared to a previously validated anti-cetuximab IgE ELISA, using 185 samples from two previously studied cohorts. Results Despite 21.1% of discrepancies between the two techniques, FEIA discriminated better positive patients and similarly negative ones with a ≥ 0.525 kUA/L threshold. Sensitivity was 87.5% for both tests, specificity was better for FEIA (96.3% vs ELISA: 82.1%). FEIA had a higher positive likelihood ratio (23.9 vs ELISA: 4.89) and a similar negative likelihood ratio (0.13 vs ELISA: 0.15). In our population, the risk of severe HSR following a positive test was higher with FEIA (56.7% vs ELISA: 19.6%) and similar following a negative test (0.7% vs ELISA: 0.8%). Conclusion Although the predictive value of the IgE screening before cetuximab infusion remains discussed, this automated commercial test can identify high-risk patients and is suitable for routine use in laboratories. It could help avoiding cetuximab-induced HSR by a systematic anti-α-Gal IgE screening before treatment.

IgE and mast cells in allergic disease

Prevalence of anti-cetuximab IgE. IgE levels were measured in serum

Alpha-Gal-containing biologics and anaphylaxis - ScienceDirect

BMC Cancer 1/2023

Full article: Current and Future Strategies for the Diagnosis and Treatment of the Alpha-Gal Syndrome (AGS)

Frontiers Allergen-Specific IgA Antibodies Block IgE-Mediated Activation of Mast Cells and Basophils

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Description of the study population. HSR: Hypersensitivity reaction.

Anti-IgE as a mast cell–stabilizing therapeutic agent - ScienceDirect

Validation of an anti-α-Gal IgE fluoroenzyme-immunoassay for the screening of patients at risk of severe anaphylaxis to cetuximab, BMC Cancer

Risk of bias and applicability concerns summary.

The basophil activation test differentiates between patients with alpha-gal syndrome and asymptomatic alpha-gal sensitization - ScienceDirect