Given the role of type 2 inflammation in the defence against parasites, an increased risk of parasitic infections (particularly helminths) due to the use of biological therapies targeting type 2 inflammation has raised a safety concern in severe asthma.

To address this question, we performed disproportionality analyses using Vigibase®, the WHO pharmacovigilance database, to assess whether biological therapies would be associated with an increased risk of reporting parasitic infections between January 1, 2006 and May 18, 2022. A control group defined as reports associated with current approved inhaled therapies and the key word ?asthma? was included.

We identified 90,704 patients with adverse events associated with omalizumab (n=18,352), mepolizumab (n=6731), benralizumab (n=3923), dupilumab (n=42,482) or the control group (n=19,349). A parasitic infection was noted in 4 (0.021%) controls, 11 (0.06%) patients with omalizumab, 5 (0.07%) with mepolizumab, 9 (0.23%) with benralizumab and 15 (0.035%) with dupilumab. Parasitic infections were significantly more reported with benralizumab compared with the control group (adjusted RORs 9.49 [95%IC 3.08-35.07]), omalizumab (adjusted RORs 3.99 [95%IC 1.55-10.19]) or dupilumab (adjusted RORs 5.79 [95%IC 2.39-13.31]; respectively). Similar results were found for helminthiases apart from a significant increase in reporting helminthiases with benralizumab compared with mepolizumab (adjusted RORs 11.39 [95%IC 2.02-213.00)].

In conclusion, this analysis from a world pharmacovigilance database found a higher rate of reported parasitic infections, particularly helminthiases, with benralizumab compared to controls or other biological therapies.