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Open AccessArticle

Short and Long-Term Effectiveness of Ustekinumab in Patients with Crohn’s Disease: Real-World Data from a German IBD Cohort

1
Department of Medicine 1, Goethe University Hospital, 60590 Frankfurt a.M., Germany
2
Interdisciplinary Crohn-Colitis Centre Rhein-Main, 60594 Frankfurt a. M., Germany
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Gastroenterological practice, 34117 Kassel, Germany
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Gastroenterological practice, 36039 Fulda, Germany
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Institute of Biostatistics and Mathematical Modeling, University Hospital, Goethe University, 60590 Frankfurt a. M., Germany
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Department of Internal Medicine 1, Agaplesion Markus Krankenhaus, 60431 Frankfurt a. M., Germany
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2019, 8(12), 2140; https://doi.org/10.3390/jcm8122140
Received: 7 October 2019 / Revised: 25 November 2019 / Accepted: 29 November 2019 / Published: 4 December 2019
(This article belongs to the Section Gastroenterology & Hepatopancreatobiliary Medicine)
: Background and Aims: The IL-12/23 inhibitor ustekinumab (UST) opened up new treatment options for patients with Crohn’s disease (CD). Due to the recent approval, real-world German data on long-term efficacy and safety are lacking. This study aimed to assess the clinical course of CD patients under UST therapy and to identify potential predictive markers. Methods: Patients with CD receiving UST treatment in three hospitals and two outpatient centers were included and retrospectively analyzed. Rates for short- and long-term remission and response were analyzed with the help of clinical (Harvey–Bradshaw Index (HBI)) and biochemical (C-reactive protein (CRP), Fecal calprotectin (fCal)) parameters for disease activity. Results: Data from 180 patients were evaluated. One-hundred-and-six patients had a follow-up of at least eight weeks and were included. 96.2% of the patients were pre-exposed to anti- TNFα agents and 34.4% to both anti-TNFα and anti-integrin antibodies. The median follow-up was 49.1 weeks (95% CI 42.03-56.25). At week 8, 51 patients (54.8%) showed response to UST, and 24 (24.7%) were in remission. At week 48, 48 (51.6%) responded to UST, and 25 patients (26.9%) were in remission. Steroid-free response and remission at week eight was achieved by 30.1% and 19.3% of patients, respectively. At week 48, 37.6% showed steroid-free response to UST, and 20.4% of the initial patient population was in steroid-free remission. Conclusion: Our study confirms short- and long-term UST effectiveness and tolerability in a cohort of multi-treatment-exposed patients.
Keywords: IBD; Crohn’s disease; biologics; ustekinumab; real-world data; efficacy IBD; Crohn’s disease; biologics; ustekinumab; real-world data; efficacy
MDPI and ACS Style

Kubesch, A.; Rueter, L.; Farrag, K.; Krause, T.; Stienecker, K.; Hausmann, J.; Filmann, N.; Dignass, A.; Stein, J.; Blumenstein, I. Short and Long-Term Effectiveness of Ustekinumab in Patients with Crohn’s Disease: Real-World Data from a German IBD Cohort. J. Clin. Med. 2019, 8, 2140.

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