Table 1.

Monoclonal antibodies in the pediatric population with severe asthma.

Name	Target	Mechanism of Action	Authorized (Age)		Indication	Dosage S.Q.	Comorbidities Treatable	Predictors Response	Clinical Outcomes					Adverse Effects
			FDA	EMA					E	C	P.F.	QoL	OCS
OMALIZUMAB	IgE	Circulating IgE binding preventing receptor binding FcεR.I. in mast cells, basophils, and dendritic plasmacytoid cells; FcεRII in dendritic plasmacytoid cells and Eos. Reduction of free IgE and downregulation of receptor expression.	≥6	≥6	Uncontrolled allergic SA with sensitization to perennial pneumoallergens and in range according to weight and IgE.	By weight and total IgE: FDA: 75–375 mg IgE (KU/L): 6–11 y: 30–1300 mg. : 30–700 mg. EMA: 75–600 mg IgE (KU/L): ≥6 y: 30–1300 mg/2–4 w. Prefilled syringe. Home administration.	Idiopathic chronic urticaria. Nasal polyposis.	Eos ≥ 260/μL FeNO > 20 ppb	↓	↑	=↑	↑	↓	Local reaction. Headache. Fever (6–12 years). Anaphylaxis (very rare).
MEPOLIZUMAB	IL-5	Circulating IL-5 binding prevents binding to the α-receptor. Eos reduction.	≥6	≥6	SA uncontrolled and Eos ≥ 150/μL or ≥300/μL in the last year.	6–11 y: 40 mg. ≥12 y: 100 mg/4 w. Prefilled syringe or autoinjector (pen). Home administration.	Nasal polyposis. EGPA. HES.	↑ Eos ↑ E Nasal polyposis OCS	↓	↑	↑	↑	↓	Local reaction. Headache. Nasal congestion. Anaphylaxis (very rare).
BENRALIZUMAB	IL-5Rα	Binding to IL-5Rα Rapid apoptosis of Eos by cytotoxicity mechanism.	≥12	No	SA uncontrolled and Eos ≥ 150/μL or ≥300/μL in the last year.	30 mg/8 w (first 3 doses every four w). Prefilled syringe or autoinjector (pen). Home administration.		↑ Eos ↑ E Nasal polyposis OCS ↓ PF	↓	↑	↑	↑	↓	Local reaction. Headache. Pharyngitis. Anaphylaxis (very rare).
DUPILUMAB	IL-4Rα	Binding to IL-4Rα blocking IL-4/IL-13 signaling. T2 inflammatory pathway downregulation. Prevent Eos extravasation to tissues.	≥6	≥12	SA uncontrolled and Eos ≥ 150/μL and ≤1500/μL and/or FeNO ≥ 25 ppb and/or need for OCS.	FDA: 6–11 y ≤ 30 kg:100 mg/2 w or 300 mg/4 w. 6–11 y > 30 kg: 200 mg/2 w or 300 mg/4 w. FDA and EMA ≥ 12 y: 200 mg/2 w (first dose 400 mg). Prefilled syringe or autoinjector (pen). Home administration.	AD. Nasal polyposis. EEo.	↑ Eos ↑ FeNO	↓	↑	↑	↑	↓	Local reaction. Transient elevation of eosinophilia. EGPA (very rare). Anaphylaxis (very rare).
TEZEPELUMAB	TSLP	Binding to circulating TSLP prevents receptor binding. Acts at high levels of the inflammatory cascade.	≥12	≥12	SA T2 or non-T2 with exacerbations.	210 mg/4 w. Prefilled syringe or autoinjector (pen).		↑ Eos ↑ FeNO T2 low	↓	↑	↑	↑	=	Local reaction. Pharyngitis. Arthralgias. Lumbar pain. Nasal congestion. Anaphylaxis (very rare).

IL-5Rα receptor α-subunit, IL-4Rα: IL-4 receptor α-subunit, SA: severe asthma, S.Q: subcutaneous, FDA: Food and Drug Administration, EMA: European Medicines Agency, EGPA: eosinophilic granulomatosis with polyangiitis, HES: hypereosinophilic syndrome, AD: atopic dermatitis, EEo: eosinophilic esophagitis, FeNO: fractional exhaled nitric oxide, ppb: parts per billion, Eos: peripheral blood eosinophils, OCS: oral corticosteroids, PF: pulmonary function, E: exacerbations, C: control, QoL: quality of life, w: week, y: year.