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Long-term clinical effectiveness of ustekinumab in patients with Crohn's disease who failed biological therapies: a national cohort study



Ustekinumab (UST) was recently approved in Europe for the treatment of moderate to severe Crohn's disease (CD). Long-term real-world data are currently scarce in CD patients previously exposed to several biologics.


This is an observational, national, retrospective multicenter study. Patients received intravenous UST ~ 6mg/kg at baseline, with 90mg subcutaneously thereafter every 8 weeks. Response and remission rates were assessed at week 8, 16 and 52.


Data from 152 patients were analysed. All patients were exposed at least one anti-TNFα agent, with 69.7 % even two anti-TNFα and vedolizumab. After one year, 42.1 % and 25.7% experienced clinical response and clinical remission, respectively; 38.8% and 24.3% achieved steroid-free clinical response and remission, respectively at one year. Thirty-eight point eight per cent of patients discontinued therapy during the 12 months of follow-up. Colonic location was predictive of clinical response at one year, while low BMI at baseline was a negative predictor of clinical remission. Resolution of arthralgia was associated with clinical response over time. De novo arthralgia were reported by 17.9% of patients at week 8 and 13.5% at week 52. No impact of ustekinumab on arthralgia was observed in patients with concomitant ankylosing spondyloarthritis (n=17). Others adverse events were reported in 7.2% of patients.


This real-world cohort study confirms the effectiveness of ustekinumab in CD patients previously exposed to several biologics. Ustekinumab was well tolerated with adverse events.


Liefferinckx C1, Verstockt B2,3, Gils A4, Noman M2,3, Van Kemseke C5, Macken E6, De Vos M7, Van Moerkercke W8, Rahier JF9, Bossuyt P10, Dutré J11, Humblet E12, Staessen D13, Peeters H14, Van Hootegem P15, Louis E5, Franchimont D1, Baert F16, Vermeire S2,3; Belgian Inflammatory Bowel Disease Research and Development Group (BIRD group). J Crohns Colitis. 2019 Apr 16. pii: jjz080. doi: 10.1093/ecco-jcc/jjz080. [Epub ahead of print]

Author Information

1.  Department of Gastroenterology, Hôpital Erasme, ULB, Brussels, Belgium.

2.  Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.

3.  Department of Chronic Diseases, Metabolism and Ageing, Leuven, Belgium, KU Leuven, Belgium.

4.  Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.

5.  Department of Gastroenterology, Centre Hospitalier Universitaire Sart-Tilman, ULG, Liège, Belgium.

6.  Department of Gastroenterology, Universiteit ziekenhuis Antwerpen, UZA, Belgium.

7.  Department of Gastroenterology, Universitair ziekenhuis Gent, Gent, Belgium.

8.  Department of Gastroenterology, AZ Groeninge, Kortrijk, Belgium.

9.  Deparment of Gastroenterology, Centre Hospitalier Universitaire Mont-Godinne, UCL, Yvoir, belgium.

10.  Department of Gastroenterology, Imeldaziekenhuis, Bonheiden, Belgium.

11.  Department of Gastroenterology, Ziekenhuis Netwerk Antwerpen, Antwerpen, Belgium.

12.  Department of Gastroenterology, Ziekenhuis Oost-Limburg - Campus Sint-Jan, Genk, Belgium.

13.  Department of Gastroenterology, GZA Sint-Vincentius ziekenhuis, Antwerpen, Belgium.

14.  Department of Gastroenterology, Algemeen Ziekenhuis Sint-Lucas, Gent, Belgium.

15.  Department of Gastroenterology, Algemeen Ziekenhuis Sint-Lucas, Brugge, Belgium.

16.  Department of Gastroenterology, AZ Delta, Roeselare-Menen, Belgium.

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