Claire Liefferinckx1, Bram Verstockt2,3, Ann Gils4, Maja Noman2,3, Catherine Van Kemseke5, Elisabeth Macken6, Martine De Vos7, Wouter Van Moerkercke8, Jean-Francois Rahier9, Peter Bossuyt10, Joris Dutré11, Evelien Humblet12, Dirk Staessen13, Harald Peeters14, Philippe Van Hootegem15, Edouard Louis5, Denis Franchimont1, Filip Baert16, Séverine Vermeire2,3. 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, Leuven, Belgium. 5. Department of Gastroenterology, Centre Hospitalier Universitaire Sart-Tilman, ULG, Liège, Belgium. 6. Department of Gastroenterology, Universitair Ziekenhuis Antwerpen, UZA, Antwerpen, Belgium. 7. Department of Gastroenterology, Universitair Ziekenhuis Gent, Gent, Belgium. 8. Department of Gastroenterology, AZ Groeninge, Kortrijk, Belgium. 9. Department 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.
Abstract
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.
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 CDpatients 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 CDpatients 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.
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