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 FENO) | 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).