- 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.
MetadatenAuthor: | Alica KubeschORCiDGND, Laurenz Rueter, Karima Farrag, Thomas Krause, Klaus Stienecker, Johannes HausmannORCiDGND, Natalie FilmannORCiDGND, Axel Uwe Dignass, Jürgen SteinORCiDGND, Irina Ursula BlumensteinORCiDGND |
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URN: | urn:nbn:de:hebis:30:3-527476 |
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DOI: | https://doi.org/10.3390/jcm8122140 |
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ISSN: | 2077-0383 |
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Pubmed Id: | https://pubmed.ncbi.nlm.nih.gov/31817134 |
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Parent Title (English): | Journal of Clinical Medicine |
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Publisher: | MDPI |
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Place of publication: | Basel |
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Document Type: | Article |
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Language: | English |
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Year of Completion: | 2019 |
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Date of first Publication: | 2019/12/04 |
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Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Release Date: | 2020/02/12 |
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Tag: | Crohn’s disease; IBD; biologics; efficacy; real-world data; ustekinumab |
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Volume: | 8 |
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Issue: | 12, Art. 2140 |
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Page Number: | 11 |
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First Page: | 1 |
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Last Page: | 11 |
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Note: | This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited |
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HeBIS-PPN: | 460971786 |
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Institutes: | Medizin / Medizin |
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Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Open-Access-Publikationsfonds: | Medizin |
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Licence (German): | Creative Commons - Namensnennung 4.0 |
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