P782 Ustekinumab in Ulcerative colitis: a real-life effectiveness study across multiple Belgian centers (SULTAN)
Holvoet, T.(1)*;Truyens, M.(2);Reenaers, C.(3);Baert, F.(4);Vandenbranden, S.(5);Cremer, A.(6);Pouillon, L.(7);Dewint, P.(8);Van Moerkercke, W.(9);Rahier, J.F.(10);Vandermeulen, L.(11);Van Dongen, J.(12);Peeters, H.(13);Lambrecht, G.(14);Vijverman, A.(15);Lobaton, T.(16);
(1)VITAZ, Gastroenterology, Sint Niklaas, Belgium;(2)Ghent University Hospital, Gastroenterology, Ghent, Belgium;(3)CHU Liege, Gastroenterology, Liege, Belgium;(4)AZ Delta, Gastroenterology, Roeselaere, Belgium;(5)OLV Aalst, Gastroenterology, Aalst, Belgium;(6)Hôpital Erasme, Gastroenterology, Brussels, Belgium;(7)Imelda, Gastroenterology, Bonheiden, Belgium;(8)AZ Maria Middelares, Gastroenterlogy, Gent, Belgium;(9)AZ Groeninge, Gastroenterology, Kortrijk, Belgium;(10)CHU Namur, Gastroenterology, Namur, Belgium;(11)UZ Brussel, Gastroenterology, Brussel, Belgium;(12)AZ Sint Maarten, Gastroenterology, Mechelen, Belgium;(13)AZ Sint Lucas, Gastroenterology, Gent, Belgium;(14)AZ Damiaan, Gastroenterology, Oostende, Belgium;(15)CHR de la citadelle, Gastroenterology, Liege, Belgium;(16)Ghent University Hospital, Gastroenterology, Gent, Belgium; BIRD
Ulcerative colitis (UC) is a chronic inflammatory disease affecting the colon.1 Ustekinumab (UST), a monoclonal antibody against the p40 subunit of interleukin (IL) 12 and 23 has shown in the UNIFI trials to be effective and safe in patients with moderate-to-severe UC.2 Real-life data are still limited.3
The aim of this study was to assess the real-world effectiveness and safety of UST in patients with UC across Belgian hospitals.
In this multicentric, retrospective observational study, patients with UC who received UST from September 2020 onwards were included. Clinical and biochemical response was assessed at baseline, week 8, 16 and 52. The primary endpoint was steroid-free remission defined as partial Mayo score of ≤ 2 with no subscore > 1 at week 16. Secondary endpoints included clinical and biochemical response (defined respectively as a decrease in partial Mayo score ≥ 3 points and ≥ 3 plus a decrease in rectal bleeding score ≥ 1 or an absolute rectal bleeding score ≤ 1 and a decline of 50% or more in CRP and/or fecal calprotectin).
107 patients with moderate-severe UC (86% patients with ≥ S2 severity) were included across 16 participating centers. Median disease duration was 10 years (1-73y) and 69 (64%) of patients had previously failed 2 or more biologicals. At week 16, 35 patients reached the primary endpoint of steroid-free clinical remission (33%), while 67 had a clinical response (62.6%) (Fig 1). There was a statistically significant decline in partial mayo score (median at baseline 6.0 range (1-9); W16 2.0 (0-9, p<.001), CRP (3.85 mg/L (0.4-181) vs 3.15 (0.88-10.3); p<.001) and calprotectin (1040 (13-6000) vs 300 (3.8-2980); p<.001) (Fig 2 and 3). Biochemical response was seen in 41 patients (38%). No predictors for steroid-free remission could be identified.
At the end of follow-up at week 52, 75 patients were still treated with UST (70%). Reasons for discontinuation were primary non-response (N=18 (17%), loss of response (N=8 (7.5%) and adverse events (N=2 (1.9%)). No predictor for UST failure could be identified. Eight patients needed to be referred for colectomy (7.5%). In 7 patients dose optimization via IV reinduction occurred. No difference in occurrence of extra-intestinal manifestations was noted during treatment, severe infections occurred in 1 patient (0.9%). No other new safety signals were observed.
In this multi-centric, real-life cohort with highly refractory UC patients, UST was associated with a clinical response rate of 63% at 16 weeks while steroid-free remission was achieved in 33% of patients. No important new safety signals were observed.