Efficacy, safety and tolerability of vidofludimus in patients with inflammatory bowel disease: The ENTRANCE study

K. R. Herrlinger*, M. Diculescu, K. Fellermann, H. Hartmann, S. Howaldt, R. Nikolov, A. Petrov, W. Reindl, J. M. Otte, S. Stoynov, U. Strauch, A. Sturm, R. Voiosu, A. Ammendola, B. Dietrich, B. Hentsch, E. F. Stange

*Korrespondierende/r Autor/-in für diese Arbeit
29 Zitate (Scopus)

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.

OriginalspracheEnglisch
ZeitschriftJournal of Crohn's and Colitis
Jahrgang7
Ausgabenummer8
Seiten (von - bis)636-643
Seitenumfang8
ISSN1873-9946
DOIs
PublikationsstatusVeröffentlicht - 01.09.2013

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