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Ustekinumab (Stelara) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2017 Apr.

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Ustekinumab (Stelara) [Internet].

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Table 4Key Characteristics of Ustekinumab, Vedolizumab, Infliximab, and Adalimumab

UstekinumabVedolizumabInfliximabAdalimumab
MechanismIL-12 and IL-23 inhibitorIntegrin inhibitorTNF alpha antagonist
IndicationsaAdult CD
Adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, loss of response to, or intolerance to either conventional therapy (CS or immunomodulators) or one or more TNF antagonist, or who were CS dependent
Adult CD
Adult patients with moderately to severely active CD who have had an inadequate response with, loss of response to, or intolerance to immunomodulators or a TNF antagonist; or who have had an inadequate response to, intolerance to, or demonstrated dependence on CS
Adult CD
Reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing and reduction of CS use in adults with moderately to severely active CD who have had an inadequate response with a CS and/or aminosalicylate
Pediatric CD
Reduction of signs and symptoms and induction and maintenance of clinical remission in pediatrics with moderately to severely active CD who have had an inadequate response with conventional therapy
Fistulizing CD
Adults with fistulizing CD who have not responded despite conventional treatment
Adult CD
  • Reduction of signs and symptoms and induction and maintenance of clinical remission in adults with moderately to severely active CD who have had an inadequate response with conventional therapy
  • Reduction of signs and symptoms and induction of clinical remission in adults with moderately to severely active CD who have loss of response to or intolerance to infliximab
Pediatric CD
Reduction of signs and symptoms and induction and maintenance of clinical remission in severely active CD and/or who have had an inadequate response with or intolerance to conventional therapy and/or a TNF antagonist
AdministrationIV (induction) and SC (maintenance)IVSC
Recommended Dose
  • Induction: tiered weight-based dose approximating 6 mg/kg IV at week 0
  • Maintenance: 90 mg SC at week 8 and q.8.w. thereafter
  • Alternative maintenance: 90 mg SC at week 12 and q.12.w. thereafter; may switch to q.8.w. for inadequate response
Adults (moderate-to-severe CD)
  • Induction: 300 mg at weeks 0, 2, and 6
  • Maintenance: 300 mg q.8.w. starting at week 6
Adults (moderate-to-severe CD)
  • Induction: 5 mg/kg at weeks 0, 2, and 6
  • Maintenance: 5 mg/kg q.8.w.; 10 mg/kg for incomplete responders
Adults (fistulizing CD)
  • Induction: 5 mg/kg at weeks 0, 2, and 6
  • Maintenance: 5 mg/kg q.8.w. or 10 mg/kg q.8.w. for those with relapse following an initial response
Pediatrics (moderate-to-severe CD)
  • Induction: 5 mg/kg at weeks 0, 2, and 6
  • Maintenance: 5 mg/kg q.8.w.
Adult CD
  • Induction: 160 mg at week 0, 80 mg at week 2
  • Maintenance: 40 mg q.2.w. beginning at week 4; dose escalation for patients with a disease flare or nonresponse
Pediatrics CD
  • Induction: 160 mg at week 0, 80 mg at week 2
  • Maintenance: 20 mg q.2.w. beginning at week 4, 40 mg q.2.w. for patients with a disease flare or nonresponse
Serious Side Effects/Safety Issues
  • Infections and reactivation of latent infections
  • Administration site reactions
  • Malignancy
  • Serious infections
  • Infusion and serious allergic reactions
  • Serious infections
  • Malignancy
  • Infusion and serious allergic reactions
  • Serious infections
  • Malignancies, particularly lymphoma
  • Administration-site reactions

CD = Crohn’s disease; CS = corticosteroids; IL = interleukin; IV = intravenous; SC = subcutaneous; TNF = tumour necrosis factor; q.2.w. = every two weeks; q.8.w. = every eight weeks; q.12.w. = every 12 weeks.

a

Health Canada indication.

Source: Ustekinumab product monograph,4 vedolizumab product monograph,24 infliximab product monograph,18,19 and adalimumab product monograph.20

From: 1, INTRODUCTION

Copyright © CADTH 2017.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

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