Table 7Details of Included Maintenance Study

IM-UNITI
Designs & PopulationsStudy DesignPhase III superiority DB RCT
LocationsNorth America (including Canada), Europe, Asia, the Asia-Pacific region, South Africa, and Brazil (137 sites)
Randomized (N)N = 1,281 enrolled from induction studies
N = 397 randomized
Inclusion Criteria
  • Age ≥ 18 years
  • Moderate-to-severe active CD in clinical response to IV UST at week 8 of induction studies (UNITI-1 and UNITI-2)
Exclusion Criteria
  • Specific changes to patients’ concomitant medications due to CD (i.e., lack of efficacy) since week 0 of induction studiesa
  • Initiated protocol-prohibited medication since week 0 of induction studies
  • CD-related surgery since week 0 of induction studies
  • Signs or symptoms, or diagnosis of any medical condition which would have precluded enrolment in induction studies
DrugsInterventionUST 90 mg SC q.12.w. (with last dose at week 36)
UST 90 mg SC q.8.w. (with last dose at week 40)
Comparator(s)Placebo
DurationPhase
 Run-inNot applicable
 Double-blind44 weeks
 Follow-upExtension study database lock at week 272
OutcomesPrimary End PointClinical remission (CDAI score < 150 points) at week 44
Other End PointsMajor secondary outcomes:
  • Clinical response (reduction from week 0 and induction study in CDAI score ≥ 100 points) at week 44
  • Clinical remission at week 44 among patients in clinical remission to UST at week 0
  • Corticosteroid-free remission at week 44
  • Clinical remission at week 44 in the subset of patients who were refractory or intolerant to TNF antagonist therapy (i.e., patients from UNITI-1)
Other:
  • IBDQ
  • SF-36
  • WLQ, productivity VAS, time lost from work
  • Mucosal healing (endoscopic)
  • CD-related surgery
  • AEs, SAEs, WDAEs
NotesPublicationsFeagan et al. 201625

AE = adverse event; CD = Crohn’s disease; CDAI = Crohn’s Disease Activity Index; DB = double-blind; IBDQ = Inflammatory Bowel Disease Questionnaire; IV = intravenous; q.8.w. = every 8 weeks; q.12.w. = every 12 weeks; RCT = randomized controlled trial; SAE = serious adverse event; SC = subcutaneous; SF-36 = Short Form Health Survey; TNF = tumour necrosis factor; UST = ustekinumab; VAS = visual analogue scale; WDAE = withdrawal due to adverse event; WLQ = Work Limitations Questionnaire.

a

Changes to concomitant medications: increase in daily dose of oral corticosteroids of > 5 mg of prednisone (or equivalent increase in prednisone-equivalent dose of other corticosteroids), initiation of oral budesonide or increase in daily dose, initiation of parenteral or oral corticosteroids for CD except for dose equivalent substitutions among oral corticosteroids, and initiation or increased daily dose of MTX, 6-MP, or AZA, except for dose equivalent substitutions.

Source: Clinical Study Report for IM-UNITI.9

From: 3, RESULTS

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