Exploration of Asthma & Allergy

Table 3.

RCT of monoclonal antibodies for the treatment of EG/EGE

Monoclonal antibody	Target	Author	Design	Study population	Dose	Primary outcome
Benralizumab	IL5Rα	Kuang et al. [31]	Placebo-controlled, phase 2 RCT (primary focused on HES)	n 7 (adults)	30 mg subcutaneously given every 4 weeks, followed by open-label 30 mg subcutaneously given every 4 weeks for up to 48 weeks.	At week 12 reduction of at least 50% in the absolute eosinophil count
Omalizumab	IgE	Foroughi et al. [35]	Open-label clinical trial	n 9 (adolescents and adults)	Dosage depending on body weight and total IgE every 2 weeks for a total of 8 doses	Efficacy of anti-IgE therapy in EGIDs and investigate the role of IgE in disease pathogenesis
Lirentelimab (AK002)	Siglec-8	Dellon et al. [37]	Placebo-controlled, phase 2 RCT	n 65 (adults)	0.3–1.0 mg/kg, 0.3–3.0 mg/kg (4 i.v. doses every 4 weeks), or placebo	At week 12 change in peak gastric/duodenal eosinophil count

Monoclonal antibody

Target

Author

Design

Study population

Dose

Primary outcome

Benralizumab

IL5Rα

Kuang et al. [31]

Placebo-controlled, phase 2 RCT (primary focused on HES)

n 7 (adults)

30 mg subcutaneously given every 4 weeks, followed by open-label 30 mg subcutaneously given every 4 weeks for up to 48 weeks.

At week 12 reduction of at least 50% in the absolute eosinophil count

Omalizumab

IgE

Foroughi et al. [35]

Open-label clinical trial

n 9 (adolescents and adults)

Dosage depending on body weight and total IgE every 2 weeks for a total of 8 doses

Efficacy of anti-IgE therapy in EGIDs and investigate the role of IgE in disease pathogenesis

Lirentelimab (AK002)

Siglec-8

Dellon et al. [37]

Placebo-controlled, phase 2 RCT

n 65 (adults)

0.3–1.0 mg/kg, 0.3–3.0 mg/kg (4 i.v. doses every 4 weeks), or placebo

At week 12 change in peak gastric/duodenal eosinophil count

i.v.: intravenous