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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

Department of Medicine 1, Goethe University Hospital, 60590 Frankfurt a.M., Germany
Interdisciplinary Crohn-Colitis Centre Rhein-Main, 60594 Frankfurt a. M., Germany
Gastroenterological practice, 34117 Kassel, Germany
Gastroenterological practice, 36039 Fulda, Germany
Institute of Biostatistics and Mathematical Modeling, University Hospital, Goethe University, 60590 Frankfurt a. M., Germany
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;
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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