title: Clinical, endoscopic and radiographic outcomes with ustekinumab in medically-refractory Crohn's disease: real world experience from a multicentre cohort.
abstract: Ustekinumab is a monoclonal antibody targeting interleukins-12 and -23, with efficacy in Crohn's disease (CD) demonstrated in clinical trials.
  
  
  
  To assess the real-world clinical, endoscopic and radiographic response and remission outcomes achieved with ustekinumab in medically-refractory CD.
  
  
  
  A retrospective multicentre cohort study was performed on CD patients receiving ustekinumab between 2011 and 2016. The primary outcome was achievement of clinical and objective steroid-free response and remission at 3, 6 and 12 months. Clinical response and remission were defined by reduction in Harvey Bradshaw Index (HBI) of ≥3 points and an HBI ≤4 points respectively. Objective response was defined by improvement in endoscopic or radiographic CD, as assessed by ileocolonoscopy, contrast-enhanced ultrasound or CT/MR enterography. Objective remission was defined by endoscopic mucosal healing or complete resolution of inflammatory parameters on radiographic assessment.
  
  
  
  A total of 167 CD patients were treated with ustekinumab. 95.2% (159/167) previously failed anti-TNF therapy. Median follow-up was 45.6 weeks (IQR: 24.4-88.9). At 3 months, clinical response was achieved in 38.9% (65/167) and remission in 15.0% (25/167) of patients. At 6 months, clinical response was achieved in 60.3% (91/151) and remission in 25.2% (38/151) of patients. At 12 months, clinical response was achieved in 59.5% (66/111) and remission in 27.9% (31/111) of patients. Endoscopic or radiographic response was demonstrated in 54.5% (67/123) at 6 months and 55.8% (48/86) of patients at 12 months.
  
  
  
  Ustekinumab is an effective therapeutic option for inducing and maintaining clinical, endoscopic and radiographic response in patients with Crohn's disease failing anti-TNF therapy.
authors.affiliation: Division of Gastroenterology, University of Calgary, Calgary, Alberta, Canada.
authors.forename: C
authors.identifier: 0000-0002-4698-9948
authors.initials: C
authors.lastname: Ma
authors.affiliation: Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: R N
authors.initials: RN
authors.lastname: Fedorak
authors.affiliation: Division of Gastroenterology, University of Calgary, Calgary, Alberta, Canada.
authors.forename: G G
authors.initials: GG
authors.lastname: Kaplan
authors.affiliation: Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: L A
authors.initials: LA
authors.lastname: Dieleman
authors.affiliation: Division of Gastroenterology, University of Calgary, Calgary, Alberta, Canada.
authors.forename: S M
authors.initials: SM
authors.lastname: Devlin
authors.affiliation: Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: N
authors.initials: N
authors.lastname: Stern
authors.affiliation: Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: K I
authors.initials: KI
authors.lastname: Kroeker
authors.affiliation: Division of Gastroenterology, University of Calgary, Calgary, Alberta, Canada.
authors.forename: C H
authors.identifier: 0000-0002-1551-9054
authors.initials: CH
authors.lastname: Seow
authors.affiliation: Division of Gastroenterology, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: Y
authors.initials: Y
authors.lastname: Leung
authors.affiliation: Division of Gastroenterology, University of Calgary, Calgary, Alberta, Canada.
authors.forename: K L
authors.initials: KL
authors.lastname: Novak
authors.affiliation: Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: B P
authors.initials: BP
authors.lastname: Halloran
authors.affiliation: Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: V W
authors.initials: VW
authors.lastname: Huang
authors.affiliation: Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: K
authors.initials: K
authors.lastname: Wong
authors.affiliation: Division of Gastroenterology, University of Calgary, Calgary, Alberta, Canada.
authors.forename: P K
authors.initials: PK
authors.lastname: Blustein
authors.affiliation: University of Birmingham, Birmingham, UK.
authors.forename: S
authors.initials: S
authors.lastname: Ghosh
authors.affiliation: Division of Gastroenterology, University of Calgary, Calgary, Alberta, Canada.
authors.forename: R
authors.initials: R
authors.lastname: Panaccione
mesh_terms: D000328:Adult; D003113:Colonoscopy; D003424:Crohn Disease / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000601:surgery; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D014057:Tomography, X-Ray Computed; D014463:Ultrasonography; D000069549:Ustekinumab / Q000627:therapeutic use*
chemical_list: D000069549:Ustekinumab