TY  - JOUR
A1  - Kubesch, Alica
A1  - Rueter, Laurenz
A1  - Farrag, Karima
A1  - Krause, Thomas
A1  - Stienecker, Klaus
A1  - Hausmann, Johannes
A1  - Filmann, Natalie
A1  - Dignass, Axel Uwe
A1  - Stein, Jürgen
A1  - Blumenstein, Irina Ursula
T1  - Short and long-term effectiveness of ustekinumab in patients with Crohn’s disease: Real-world data from a German IBD cohort
T2  - Journal of Clinical Medicine
N2  - 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.
KW  - IBD
KW  - Crohn’s disease
KW  - biologics
KW  - ustekinumab
KW  - real-world data
KW  - efficacy
Y1  - 2019
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/52747
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-527476
SN  - 2077-0383
N1  - 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
VL  - 8
IS  - 12, Art. 2140
SP  - 1
EP  - 11
PB  - MDPI
CY  - Basel
ER  -