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P383 One-year experience with ustekinumab in therapy-refractory or -intolerant patients with ulcerative colitis

T. Ochsenkühn1, C. Tillack2, F. Schnitzler3, D. Szokodi2, S. Janelidze2

1Isarklinikum München, Gastroenterology, Munich, Germany, 2IBD center Munich, Munich, Germany, 3Gastroklinik Pasing, Munich, Germany

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.

Conclusion

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.