Long-term Clinical Effectiveness of Ustekinumab in Patients with Crohn's Disease Who Failed Biologic Therapies: A National Cohort Study

Autor: Liefferinckx, Claire, Verstockt, Bram, Gils, Ann, Noman, Maja, Van Kemseke, Catherine, Macken, Elisabeth, De Vos, Martine, Van Moerkercke, Wouter, Rahier, Jean-François, Bossuyt, Peter, Dutré, Joris, Humblet, Evelien, Staessen, Dirk, Peeters, Harald, Van Hootegem, Philippe, Louis, Edouard, Franchimont, Denis, Baert, Filip, Vermeire, Séverine, Belgian Inflammatory Bowel Disease Research and Development Group (BIRD group)
Přispěvatelé: Belgian Inflammatory Bowel Disease Research and Development Group [BIRD group], UCL - (MGD) Service de gastro-entérologie, UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie
Rok vydání: 2019
Předmět:
Zdroj: Journal of Crohn's and colitis
Journal of Crohn's & colitis, Vol. 13, no. 11, p. 1401-1409 (2019)
Journal of Crohn's and Colitis, 13 (11
ISSN: 1876-4479
1873-9946
Popis: Background: 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 for CD patients previously exposed to several biologics. Methods: This 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. Results: Data 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. Conclusions: This 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. Podcast: This article has an associated podcast which can be accessed at https://academic.oup.com/ecco-jcc/pages/podcast.
SCOPUS: ar.j
info:eu-repo/semantics/published
Databáze: OpenAIRE
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