Table 5Inclusion Criteria for the Systematic Review

Criteria Description
Population Patients aged 6 to < 12 years with severe asthma with a type 2 or eosinophilic phenotype or with OCS-dependent asthma.
Subgroups:
  • baseline eosinophil count
  • allergic vs. nonallergic asthma
  • OCS-dependent asthma at baseline (yes vs. no)
  • number of exacerbations in the past year
  • baseline ICS dose (medium vs. high)
  • atopic medical history (yes vs. no)
Intervention Dupilumab as add-on therapy.a Dosing is based on patients’ body weight (subcutaneous administration):
  • ≥ 15 kg to < 30 kg: 100 mg q.2.w. or 300 mg q.4.w.
  • ≥ 30 kg to < 60 kg: 200 mg q.2.w. or 300 mg q.4.w.
  • ≥ 60 kg: 200 mg q.2.w.
Comparator Maintenance therapy with ICSs in combination with long-acting beta agonists alone or leukotriene receptor antagonists in combination with ≥ 1 of the following:
  • Long-acting muscarinic antagonists
  • OCSs (chronic)
  • IL-5 inhibitors (e.g., mepolizumab)
  • IgE inhibitors (e.g., omalizumab)
Note: Rescue medications (SABAs or SAMAs) may be part of any regimen for asthma.
Outcomes Efficacy outcomes:
  • mortality
  • acute asthma exacerbations:
    • hospitalization due to acute exacerbation
    • ED visit due to acute exacerbation
    • primary care visit due to asthma exacerbation
    • acute OCS “burst”
  • asthma symptoms (e.g., ACQ)
  • reduction in use of OCSs
  • change in pulmonary function (e.g., PEF, FEV1)
  • reduction in dose of ICS
  • HRQoL
  • reduction in use of rescue medication
  • improvements in symptoms of atopic dermatitis and rhinosinusitis
Harms outcomes: AEs, SAEs, WDAEs

Notable harms: hypersensitivity reactions, helminth infections, conjunctivitis and keratitis, eosinophilic pneumonia, vasculitis consistent with eosinophilic granulomatosis with polyangiitis, injection site reactions

Study designs Published and unpublished phase III and IV RCTs.

ACQ = Asthma Control Questionnaire; AE = adverse event; ED = emergency department; FEV1 = forced expiratory volume in 1 second; HRQoL = health-related quality of life; ICS = inhaled corticosteroid; IgE = immunoglobulin E; IL = interleukin; OCS = oral corticosteroid; PEF = peak expiratory flow; q.2.w. = every 2 weeks; q.4.w. = every 4 weeks; RCT = randomized controlled trial; SABA = short-acting beta agonist; SAE = serious adverse event; SAMA = short-acting muscarinic antagonist; WDAE = withdrawal due to adverse event.

a

For children (6 years to 11 years) with asthma, no initial loading dose is recommended.5

From: Clinical Review

Cover of Dupilumab (Dupixent)
Dupilumab (Dupixent): CADTH Reimbursement Review: Therapeutic area: Asthma [Internet].
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