Table 5Inclusion Criteria for the Systematic Review

Patient PopulationAdult 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 (corticosteroids or immunomodulators) or one or more TNF alpha antagonist, or who were corticosteroid dependent.
Subgroups:
  • Disease severity at baseline
  • No prior experience with a TNF alpha antagonist or conventional therapy
  • Previous therapy with a TNF alpha antagonist or conventional therapy:
    • Failure or intolerance to a TNF alpha antagonist or conventional therapy
    • No failure or intolerance to a TNF alpha antagonist or conventional therapy.
InterventionUstekinumab single IV induction infusion based on body weight at week 0; followed by 90 mg SC 8 weeks later, then every 8 or 12 weeks thereafter.
Induction recommended IV dose (approximately 6 mg/kg):
  • 260 mg if body weight is ≤ 55 kg
  • 390 mg if body weight is > 55 kg to ≤ 85 kg
  • 520 mg if body weight is > 85 kg.
Comparators
  • Adalimumab
  • Infliximab
  • Vedolizumab
OutcomesEfficacy outcomes:
  • Clinical remission (e.g., using the CDAI score)a
  • Clinical response (e.g., using the CDAI score)
  • Health-related quality of life, functional and disability outcomes (e.g., IBDQ, SF-36) a
  • Mucosal healing determined by histology or endoscopy
  • Need for surgery for Crohn’s disease a
Harms outcomes:
  • Mortality
  • SAEs
  • WDAEs
  • AEs, including but not limited to
    • Infusion or injection-site reactions
    • Hypersensitivity reactions
    • Infections
    • Malignancies
    • Major cardiovascular events
    • Neurological AEs (new onset or exacerbation of MS, PN, or GBS)
Study DesignPublished and unpublished phase III RCT

AE = adverse events; CDAI = Crohn’s Disease Activity Index; GBS = Guillain–Barré syndrome; IBDQ = Inflammatory Bowel Disease Questionnaire; IV = intravenous; MS = multiple sclerosis; PN = peripheral neuropathy; RCT = randomized controlled trial; SAE = serious adverse events; SC = subcutaneous injection; SF-36 = Short Form (36) Health Survey; TNF = tumour necrosis factor; WDAE = withdrawal due to adverse events.

a

These outcomes were identified as being of particular importance to patients in the input received by CADTH from patient groups.

From: 2, OBJECTIVES AND METHODS

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