P383 One-year experience with ustekinumab in therapy-refractory or -intolerant patients with ulcerative colitis. (25th January 2019)

• Record Type: Journal Article
• Authors: Ochsenkühn, T; Tillack, C; Schnitzler, F; Szokodi, D; Janelidze, S
• Is Part Of: Journal of Crohn's and colitis. Volume 13(2019)Supplement 1
• Page Start: S298
• Page End: S299
• Publication Date: 2019-01-25
• Subjects: Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjy222.507
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background: We had lately shown that the IL12/23 antibody ustekinumab can be used as rescue therapy in ulcerative colitis (UC) and most recently first results of the Phase 3 approval trial UNIFI were released, showing a sound effect of ustekinumab in refractory UC after 8 weeks. Our aim was to report the clinical and endoscopical 1-year outcomes achieved with ustekinumab treatment in our patients. Methods: In total, 19 patients who had received ustekinumab between 2016 and 2017 as rescue off-label therapy in our IBD centre were followed-up to 1 year. All patients received ustekinumab as approved for Crohn's disease. The primary outcome was achievement of clinical remission and mucosal healing at 1 year. Data of the last endoscopy before study start were used as a comparator. Clinical remission was defined as score of ≤5 points in the modified Truelove and Witts colitis activity index (CAI), mucosal healing defined as Mayo endoscopy subscore of 0 or 1. Results: All 19 UC patients who were treated with ustekinumab, had previously been steroid refractory or dependant and had recently failed all of the following drugs: purine-analogues, anti-TNF and anti-integrin antibodies. Of those, 42% (8/19) had failed infliximab plus either golimumab or adalimumab, and 26% (5/19) had also failed i.v. ciclosporine. At the start of ustekinumab, 12 of 19 patients (63.2%) had moderately or severely active disease and, in contrary, 36.8% (7/19) were in remission, but had intolerable side effects under TNF- or integrin-blocking treatment, which had to be stopped. In 4 patients ustekinumab was stopped due to refractory disease, in one at 3 months, in one at 6 months, and in two at 9 months. In another patient, therapy was stopped due to drowsiness at Week 4. Three patients underwent colectomy, 2 were received other studies medications. Including these 5 patients who dropped out, clinical remission was achieved in 68.4% (13/19) of patients at 12 months, whereas only 36.8% (7/19) of patients were in remission at the start of the study. The CAI at the start of the therapy in 19 patients ranged between 1 and 12, with a median of 7.5 points. In 14 patients who continued ustekinumab throughout 1 year, the median CAI at 12 months fell to 2 points (range 0–5.5). In 14 patients, we were able to perform colonoscopy at 1 year: MAYO endoscopy scores fell from a median of 2 points (range 1–3) and a mean of 2.3 points at start of the observation to a median of 1 point (range 0–3) and a mean of 1.3. Conclusions: Ustekinumab is an effective short- and long-term medication in therapy-refractory or -intolerant ulcerative colitis. It is therefore likely, which large ongoing long-term trials will confirm our findings and ustekinumab will become a new therapeutic option for refractory UC.