Management of Uncontrolled Asthma: A Framework for Novel and Legacy Biologic Treatments

Figures & data

Table 1 Available Asthma Biologic Therapies

Asthma Biologic Therapy	FDA Approval	Mechanism of Action	Asthma Exacerbation	Lung Function	Corticosteroid Weaning	SQ and IV
Omalizumab	2003	Anti-IgE; binds to IgE	Reduces by ~25%	Minimal or equivocal improvement	Decreases use of ICS	Subcutaneous Every 2–4 weeks
Mepolizumab	2015	Anti–IL-5; binds to IL-5 ligand	Reduces by ~50%	Nominal improvement	Decreases total use of OCS and has been shown to facilitate complete weaning from chronic OCS (14%)	Subcutaneous every 4 weeks
Reslizumab	2016	Anti–IL-5; binds to IL-5 ligand	Reduces by ~50–60%	Improved	Has not been specifically evaluated for this indication	Intravenous every 4 weeks
Benralizumab	2017	Anti–IL-5; binds to IL-5 receptor α	Reduces by ~25–60%	Improved	Decreases total use of OCS and has been shown to facilitate complete weaning from chronic OCS (50%)	Subcutaneous every 4 weeks for 3 doses then every 8 weeks
Dupilumab	2018	Anti–IL-4R; binds to IL-4 receptor α	Reduces by ~50–70%	Improved	Decreases total use of OCS and has been shown to facilitate complete weaning from chronic OCS (50%)	Subcutaneous every 2 weeks
Tezepelumab^Citation40,Citation42,Citation48	2021	Anti-TSLP; binds to TSLP ligand	Reduces by ~50 – 70%	Improved	Did not demonstrate a statistically significant reduction in maintenance OCS dose compared with placebo.	Subcutaneous every 4 weeks

Notes: Data from McGregor MC, Krings JG, Nair P, Castro M. Role of Biologics in Asthma. Am J Respir Crit Care Med. 2019;199(4):433–445.³²

Abbreviations: IgE, immunoglobulin; IL, interleukin; ICS, inhaled corticosteroids; TSLP, thymic stromal lymphopoietin; OCS, oral corticosteroids; SQ, subcutaneous; IV, intravenous; FDA, Federal Drug Administration.

Table 2 Critical Biologic Administration Information

Asthma Biologic Therapy	Type of Injector	Region for Injection	Room Temperature-Time Recommendations	Biologic Expiration after Being at Room Temperature	Home Storage
Omalizumab^Citation43	Prefilled Syringe	Front and middle of the thighs and the stomach area (abdomen). The outer area of the upper arms may also be used if a caregiver is giving the injection.	Set aside the carton for at least 15 to 30 minutes so the prefilled syringe can warm up on its own to room temperature.	The total combined time out of the refrigerator may not exceed 2 days. If the prefilled syringe is exposed to temperatures above 77 °F (25 °C), do not use it and throw it away in a sharps disposal container.	Store in the refrigerator between 36°F and 46°F (2°C to 8°C).
Mepolizumab^Citation44	Autoinjector and Prefilled Syringe	Front and middle of the thighs and the stomach area (abdomen). The outer area of the upper arms may also be used if a caregiver is giving the injection.	Wait 30 minutes (and no more than 8 hours) before use.	If necessary, an unopened carton can be stored outside the refrigerator at up to 86°F (30°C) for up to 7 days.	Store in the refrigerator between 36°F to 46°F (2°C to 8°C).
Reslizumab^Citation45	Not available for home administration	Intravenous, is given in a clinic or infusion center	N/a	N/a	N/a
Benralizumab^Citation46	Autoinjector and Prefilled Syringe	Front and middle of the thighs and the stomach area (abdomen). The outer area of the upper arms may also be used if a caregiver is giving the injection.	Warm-up at room temperature between 68°F to 77°F (20°C to 25°C) for about 30 minutes before giving the injection	May be kept at room temperature between 68°F to 77°F (20°C to 25°C) for a maximum of 14 days.	Store in the refrigerator between 36°F to 46°F (2°C to 8°C).
Dupilumab^Citation47	Autoinjector and Prefilled Syringe	Front and middle of the thighs and the stomach area (abdomen). The outer area of the upper arms may also be used if a caregiver is giving the injection.	Let it naturally warm to room temperature for at least 45 minutes.	It may be stored at room temperature up to 77°F (25°C) up to 14 days.	Store in the refrigerator between 36°F to 46°F (2°C to 8°C)
Tezepelumab^Citation48	Prefilled Syringe	Front and middle of the thighs and the stomach area (abdomen). The outer area of the upper arms may also be used if a caregiver is giving the injection.	Allow it to reach room temperature. This generally takes 60 minutes.	May be kept at room temperature between 68°F to 77°F (20°C to 25°C) for a maximum of 30 days	Store in the refrigerator between 36°F to 46°F (2°C to 8°C).

Abbreviations: F, Fahrenheit; C, celsisus.

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DUPIXENT® (dupilumab) - HIGHLIGHTS OF PRESCRIBING INFORMATION. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761055s014lbl.pdf. Accessed June 27, 2022.

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NUCALA (mepolizumab) - HIGHLIGHTS OF PRESCRIBING INFORMATION. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl.pdf. Accessed June 27, 2022.

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XOLAIR® (omalizumab) - HIGHLIGHTS OF PRESCRIBING INFORMATION. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf. Accessed June 27, 2022.

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CINQAIR® (reslizumab) - HIGHLIGHTS OF PRESCRIBING INFORMATION. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761033lbl.pdf. Accessed June 27, 2022.

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Fasenra (benralizumab) - HIGHLIGHTS OF PRESCRIBING INFORMATION. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761070Orig1s000TOC.cfm. Accessed June 27, 2022.

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