• Claire Liefferinckx, Bram Verstockt, Ann Gils, Maja Noman, Catherine Van Kemseke, Elisabeth Macken, Martine De Vos, Wouter Van Moerkercke, Jean-Francois Rahier, Peter Bossuyt, Joris Dutré, Evelien Humblet, Dirk Staessen, Harald Peeters, Philippe Van Hootegem, Edouard Louis, Denis Franchimont, Filip Baert, Séverine Vermeire, and Belgian Inflammatory Bowel Disease Research and Development Group [BIRD group].
• Department of Gastroenterology, Hôpital Erasme, ULB, Brussels, Belgium.
• J Crohns Colitis. 2019 Oct 28; 13 (11): 1401-1409.

BackgroundUstekinumab [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 for CD patients previously exposed to several biologics.MethodsThis is an observational, national, retrospective multicentre study. Patients received intravenous UST ~6 mg/kg at baseline, with 90 mg subcutaneously thereafter every 8 weeks. Response and remission rates were assessed at Weeks 8, 16, and 52.ResultsData from 152 patients were analysed. All patients were exposed to at least one anti-TNFα agent, with 69.7% were exposed to even two anti-TNFα and vedolizumab. After 1 year, 42.1% and 25.7% of patients had experienced clinical response and clinical remission, respectively, and 38.8% and 24.3% had achieved steroid-free clinical response and remission, respectively; 38.8% of patients discontinued therapy during the 12 months of follow-up. Colonic location was predictive of clinical response at 1 year, and low body mass index [BMI] at baseline was a negative predictor of clinical remission. Resolution of arthralgia was associated with clinical response over time. De novo arthralgia was reported by 17.9% of patients at Week 8 and 13.5% of patients at Week 52. No impact of UST on arthralgia was observed in patients with concomitant ankylosing spondylitis [n = 17]. Others adverse events were reported in 7.2% of patients.ConclusionsThis real-world cohort study confirms the effectiveness of UST in CD patients previously exposed to several biologics. Ustekinumab was well tolerated with respect to adverse events.PodcastThis article has an associated podcast which can be accessed at https://academic.oup.com/ecco-jcc/pages/podcast.Copyright © 2019 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

31 keywords...

hide…