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P209. Efficacy, safety and tolerability of vidofludimus in patients with inflammatory bowel disease: The ENTRANCE study

K.R. Herrlinger1, M. Diculescu2, K. Fellermann3, H. Hartmann4, S. Howaldt5, R. Nikolov6, A. Petrov7, W. Reindl8, J.M. Otte9, S. Stoynov10, U. Strauch11, A. Sturm12, R. Voiosu13, A. Ammendola14, B. Dietrich14, B. Hentsch14, E.F. Stange1

1Robert-Bosch-Hospital, Department of Gastroenterology, Hepatology and Endocrinology, Stuttgart, Germany; 2Elias University Emergency Hospital, Bucharest, Romania; 3University of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany; 4Gastroenterologische Gemeinschaftspraxis, Herne, Germany; 5Gastroenterologische Schwerpunktpraxis, Hamburg, Germany; 6MHAT Sv Ivan Rilski, Sofia, Bulgaria; 7MHAT Tokuda Hospital Sofia, Sofia, Bulgaria; 8Technical University Munich, Munich, Germany; 9University of Bochum, St. Josef-Hospital, Bochum, Germany; 10MHAT Tsaritsa Ioanna, Sofia, Bulgaria; 11University Hospital Regensburg, Medical Clinic I, Regensburg, Germany; 12University Hospital Charité, Campus Virchow, Berlin, Germany; 13Colentina Clinical Hospital, Bucharest, Romania; 144SC AG, Planegg-Martinsried, Germany

Aim: Vidofludimus (4SC-101, SC12267) is a novel oral inhibitor of interleukin-17 (IL-17) release. The primary objective of the study was to explore whether vidofludimus maintains remission in steroid-dependent IBD upon steroid weaning.

Methods: The single-arm uncontrolled ENTRANCE study (ClinicalTrials.gov NCT00820365) has been conducted at 13 study centres in Germany, Bulgaria and Romania. Thirtyfour steroid-dependent (defined according to ECCO guidelines) patients with a confirmed diagnosis of Crohn's disease (n = 18) or ulcerative colitis (n = 16) were treated with a 35 mg oral dose of vidofludimus once daily over a period of 12 weeks. Simultaneously, steroids were tapered during the first eight weeks of the trial followed by a steroid-free treatment period of 4 weeks. Complete response was defined as steroid-free clinical remission at week 12, while partial response was defined as being in remission at any steroid dose equal or lower than the individual threshold dose for relapse of the individual patient.

Results: Of the 34 patients enrolled in this trial 26 patients (14 CD, 12 UC) were evaluable for the per protocol analysis. After completion of the 12 weeks treatment phase 14 out of 26 (53.9%) patients were in remission off corticosteroids (complete responders). Another 9 (34.6%) patients were in remission at a corticosteroid dose equal or lower than their individual threshold dose (partial responders). In total, vidofludimus met the primary endpoint in 88.5% of patients (complete and partial response). Response rates did not differ between Crohn's disease and ulcerative colitis. Vidofludimus was well tolerated, no drug-related serious adverse events were observed.

Conclusions: This trial provides first evidence of clinical efficacy of vidofludimus in patients with Crohn's disease and ulcerative colitis. Considering the favorable safety and tolerability profile vidofludimus may have potential as a novel future remission maintenance therapy in IBD. These data substantiate the relevance of IL-17 suppression in IBD as a promising and innovative therapeutic approach.