Biologics for Asthma

The chart below provides a comparison of biologics for severe asthma. These products are for administration in a healthcare setting due to the possibility of serious allergic reactions. Because hypersensitivity reactions (including anaphylaxis) may have a delayed onset, consider providing an epinephrine autoinjector for these patients.3,5 Biologics reduce exacerbation rate by about 50%.1 Benralizumab and mepolizumab have the best evidence for a steroid-sparing effect. Omalizumab has the best evidence for improving asthma symptoms and quality of life. Omalizumab is for allergic asthma, and the other biologics are for eosinophilic asthma. Some patients have both.4 In overlapping cases, the biologic may be chosen based on which condition is of more concern.4 Although these products target the immune system, their use does not contraindicate vaccination with live or inactivated vaccines that are clinically appropriate in this patient population. Dupilumab (Dupixent), a biologic approved for atopic dermatitis, is under investigation for asthma. Its labeling advises against concomitant use of live vaccines6,7 due to lack of information.7 Information in chart is based on U.S. product labeling unless otherwise denoted. Information from Canadian labeling is included where it differs significantly from U.S. product information.

Abbreviations: N/A = not available; SQ = subcutaneous

Drug

Asthma Indication

Dosing for Asthma

Costa

Commentsb

Interleulkin-5 antagonist, alpha-directed cytolytic monoclonal antibody (IgG1 kappa)

Benralizumab (Fasenra)

Severe eosinophilic asthma,c ≥12 yrs of age (Canada: ≥18 yrs of age)

30 mg SQ q 4 wks x 3 doses, then every 8 weeks.

30 mg/1 mL syringe

U.S.: $4,752.11

Canada: $4,187.07

Common side effects: headache 8%, pharyngitis 5%.

Most convenient schedule after first three doses.1

Must be refrigerated.


Mepolizumab (Nucala)

Severe eosinophilic asthma,c ≥12 yrs of age (Canada: 18 yrs and older)

(U.S.: also indicated for eosinophilic granulomatosis with polyangitis.)

100 mg SQ q 4 weeks

100 mg vial

U.S.: $2,868.67

Canada: $2,093.54


Common side effects: headache ~20%, injection site reaction 8%, back pain ~5%, fatigue 5%.

Interleukin-5 antagonist, monoclonal antibody (IgG4 kappa)

Reslizumab (Cinqair)

Severe eosinophilic asthma,c ≥18 yrs of age

3 mg/kg IV infusion over 20 to 50 min. q 4 wks

100 mg/10 mL vial

U.S.: $878

Canada: N/A


Common side effects: oropharyngeal pain 2%.

Anaphylaxis occurs in ~0.2% of patients.

Must be refrigerated.

Anti-IgE antibody

Omalizumab (Xolair)

Moderate to severe asthma in patients ≥6 yrs of age with a positive skin test or in vitro reactivity to a perennial aeroallergen

(Also indicated for chronic idiopathic urticaria in patients ≥12 yrs of age who fail antihistamines.)


75 to 375 mg SQ q 2 to 4 wks. Dose based on age, weight, and serum total IgE level (consult labeling).

150 mg vial

U.S.: $1,084.66

Canada: N/A

Common side effects: arthralgia 8%, pain 7%.

Anaphylaxis occurs in 0.2% of patients.

NNT = 13 kids for 16 weeks to prevent one exacerbation.2

NNT = 9 adults for 24 weeks to prevent one exacerbation.8

Must be refrigerated.

U.S. product labeling used in creation of this chart: Fasenra (November 2017), Nucala (December 2017), Xolair (June 2016), Cinqair (June 2016). Canada: Fansenra (February 2018), Nucala (August 2016),

  1. U.S. cost is wholesale acquisition cost. Medication pricing by Elsevier, accessed March 2018. Canadian cost is wholesale. Cost is for generic, if available, of dose specified.
  2. Keep in mind that adverse reaction rates of one drug cannot be directly compared to another drug and may not reflect the rates observed in clinical practice.
  3. There are some differences in the IL-5 inhibitors based on the eosinophil count required in clinical trials, but no comparative studies have been done. An exploratory analysis suggests that a baseline blood eosinophil count of ≥150 cells/mcL is a potential predictor of Nucala (mepolizumab) treatment benefit. A blood eosinophil count of at least 400 cells/mcL was required in the reslizumab (Cinqair) studies and 150 cells/mcL for the benralizumab (Fasenra) studies.

Project Leader in preparation of this clinical resource (340610): Melanie Cupp, Pharm.D., BCPS

References

  1. Saco TV, Pepper A, Casale TB. Use of biologics in allergic diseases: what to choose and when. Ann Allergy Asthma Immunol 2018;120:357-66.
  2. Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics 2001;108:e36.
  3. American Academy of Allergy Asthma & Immunology. Omalizumab administration recommendations. February 22, 2018. http://www.aaaai.org/ask-the-expert/omalizumabss. (Accessed April 12, 2018).
  4. Asthma Canada. Biologics. https://asthma.ca/get-help/asthma-3/treatment/biologics/. (Accessed April 12, 2018).
  5. Benralizumab (Fasenra) for severe eosinophilic asthma. JAMA 2018;319:1501-2.
  6. Product information for Dupixent. Sanofi-Aventis U.S. Bridgewater, NJ 08807. April 2018.
  7. Product monograph for Dupixent. Sanofi-Aventis Canada. Laval, QC H7V 0A3. November 2017.
  8. Lanier BQ, Corren J, Lumry W, et al. Omalizumab is effective in the long-term control of severe allergic asthma. Ann Allergy Asthma Immunol 2003;91:154-9.

Cite this document as follows: Clinical Resource, Biologics for Asthma. Pharmacist’s Letter/Prescriber’s Letter. June 2018.

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