Herrlinger, K. R. and Diculescu, M. and Fellermann, K. and Hartmann, H. and Howaldt, S. and Nikolov, R. and Petrov, A. and Reindl, W. and Otte, J. M. and Stoynov, S. and Strauch, U. and Sturm, A. and Voiosu, R. and Ammendola, A. and Dietrich, B. and Hentsch, B. and Stange, E. F. (2013) Efficacy, safety and tolerability of vidofludimus in patients with inflammatory bowel disease: The ENTRANCE study. JOURNAL OF CROHNS & COLITIS, 7 (8). pp. 636-643. ISSN 1873-9946,
Full text not available from this repository. (Request a copy)Abstract
Background: Vidofludimus (SC12267) is a novel oral immunomodulator inhibiting dihydroorotate dehydrogenase (DHODH) and the expression of proinflammatory cytokines including interleukin-17 (IL17A and IL17F) and interferon-gamma. The objective of the study was to explore the efficacy, safety and tolerability of vidofludimus in steroid-dependent inflammatory bowel disease (IBD). Methods: The open label uncontrolled ENTRANCE study (ClinicalTrials.gov NCT00820365) has been conducted at 13 study centers in Germany, Bulgaria and Romania. Thirty-four steroid-dependent patients with a confirmed diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) were treated with a once daily 35 mg oral dose of vidofludimus over 12 weeks. Steroids were tapered during the first 8 weeks followed by a steroid-free treatment period of 4 weeks. Complete response was defined as steroid-free clinical remission at week 12; partial response was defined as being in remission at steroid dose equal or lower than the individual patient's threshold dose for relapse. Results: Of the thirty-four patients enrolled in this trial 26 were evaluable for primary efficacy assessment. After completion of the 12 weeks treatment phase 8 out of 14 (57.1%) patients with CD and 6 out of 12 (50.0%) patients with UC were in steroid-free remission (complete responders). Another 4 (28.6%) patients in CD and 5 (41.7%) patients in UC were partial responders. Vidofludimus was well tolerated, no drug-related serious adverse events were observed. Conclusions: This trial provides first evidence of clinical efficacy of vidofludimus in IBD. Although the safety and tolerability profile seems favorable, long-term controlled studies are needed to further investigate its potential as novel IBD therapy. (C) 2012 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | DEPENDENT ULCERATIVE-COLITIS; CROHNS-DISEASE; CONTROLLED-TRIAL; CORTICOSTEROID-THERAPY; ORAL METHOTREXATE; AZATHIOPRINE; INFLIXIMAB; REMISSION; 6-MERCAPTOPURINE; MULTICENTER; Vidofludimus; Ulcerative colitis; Crohn's disease; IBD; Clinical trial |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin I |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 03 Apr 2020 05:12 |
| Last Modified: | 03 Apr 2020 05:12 |
| URI: | https://pred.uni-regensburg.de/id/eprint/16209 |
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