. 2021 Dec;17(4):210144. doi: 10.1183/20734735.0144-2021

Table 1.

Indications and dosing of asthma biologics

Drug	Asthma indication (EMA)	NICE guidance (UK)	Dosing (adults)	Additional licensed indications
Omalizumab (“Xolair”)	Add-on therapy in patients aged 6+ years with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV₁ <80%, this is not required if aged 6–11 years) as well as frequent symptoms and who have had multiple severe asthma exacerbations despite daily high-dose ICS, plus a LABA	Optimised standard therapy Confirmed severe persistent allergic IgE-mediated asthma ≥4 exacerbations in past year or continuous OCS	Based on weight and serum IgE (75–600 mg), 2–4 weekly Subcutaneous injection Auto-injector pre-filled syringe available (75 mg and 150 mg)	Chronic spontaneous urticaria CRwNP
Mepolizumab (“Nucala”)	Add-on treatment of patients with severe refractory eosinophilic asthma in adults, adolescents and children aged 6+ years	Followed optimised treatment plan (i.e. adherent), plus either: BE ≥300 cells·μL⁻¹ with ≥4 exacerbations in past year requiring OCS or continuous OCS equivalent to ≥5 mg·day⁻¹ for previous 6 months or BE ≥400 cells·μL⁻¹ with ≥3 exacerbations in past year requiring OCS or continuous OCS equivalent to ≥5 mg·day⁻¹ for previous 6 months Review at 12 months	100 mg every 4 weeks Subcutaneous injection Auto-injector pre-filled syringe available	EGPA (300 mg dose) CRwNP
Reslizumab (“Cinqair”)	Add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose ICS plus another medicinal product for maintenance treatment	Asthma inadequately controlled despite ICS plus one other drug and BE ≥400 cells·μL⁻¹ with ≥3 exacerbations in past year requiring OCS Review at 12 months	Weight-based dosing (3 mg·kg⁻¹) every 4 weeks Intravenous infusion	None
Benralizumab (“Fasenra”)	Add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose ICS plus LABA	ICS and LABA, followed optimised treatment plan (i.e. adherent), plus either: BE ≥300 cells·μL⁻¹ with ≥4 exacerbations in past year requiring OCS or continuous OCS equivalent to ≥5 mg·day⁻¹ for previous 6 months or BE ≥400 cells·μL⁻¹ with ≥3 exacerbations in past year requiring OCS or continuous OCS equivalent to ≥5 mg·day⁻¹ for previous 6 months Review at 12 months	30 mg every 4 weeks for 3 doses then 8-weekly (most infrequent of any biologic) Subcutaneous injection Pre-filled syringe, auto-injector available	None
Dupilumab (“Dupixent”)	Add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with OCS-dependent asthma	Not yet published, expected 2021	300 mg every 2 weeks Subcutaneous injection	Atopic dermatitis CRwNP
Tezepelumab (Amgen/AstraZeneca)	Not yet approved Phase 3 data as add-on treatment in severe asthma aged 12 years or older (though note small number adolescents enrolled) suggests efficacy in eosinophilic phenotype (high BE or F_ENO)	N/A	210 mg every 4 weeks Subcutaneous injection	None

BE: blood eosinophils; N/A: not available. Blood eosinophils of 100 cells·μL⁻¹ (units used in USA) are equivalent to blood eosinophils of 0.1×10⁹ L⁻¹ (units used in UK).