P383 Ustekinumab as an opportunity for refractory Ulcerative Colitis patients.
Iborra, M.(1);Soutullo, C.(1);Gimeno, M.(1);Bastida, G.(1);Aguas, M.(1);Cerrillo, E.(1);Sáez-González, E.(1);Garrido, A.(1);Mínguez, A.(1);Bordetas, J.(1);Nos, P.(1);
(1)Hospital Universitario y Politécnico La Fe, Gastroenterology Department, Valencia, Spain;
Background
There are limited data in real-life of ustekinumab (USK) used in ulcerative colitis (UC). The aim of this study was to assess the effectiveness and safety in clinical practice of USK in UC in the medium and long-term.
Methods
Observational study in UC patients who received USK at the recommended dose based on weight ~6 mg/kg IV week 0.90 mg SC week 8 and maintenance 90 mg SC every 8 or 12 weeks and with 1 year of follow-up. The partial Mayo score (PMS) was used to assess clinical remission (PMS≤ 2). The PMS, C-reactive protein (CRP) and faecal calprotectin (FC) values were recorded at baseline and after 8, 16, 24 and 52 weeks. Dose adjustment was performed by the measure of UST trough levels by ELISA, when patient lost clinical and/or biochemical response and the levels were low (<1.3 µg/ml). Demographic, clinical, biochemical and endoscopic data, previous treatments, adverse events (AEs), surgeries and hospitalizations, were documented.
Results
Twenty-three patients with UC were analysed. (Table 1). All patients had received previous biological treatment: 52% ≥2 anti-TNF, 65% vedolizumab and 30% JAK inhibitors. Treatment discontinuation occurred in 3 patients (13%). The persistence was 83% and 79% at 6 and 12 months (Figure 1). During follow-up, 12 patients (52%) maintained standard dose of USK. Dose adjustment was performed in 13 patients (56%): 3 (13%) required intravenous UST reinduction and 10 (43%) required dose escalation (8 by shortening the interval between doses and 2 by switching to intravenous USK administration). Clinical remission was reached in 61%, 58%, 56%, 79% of the patients after 8, 16, 24, 52 weeks, respectively. Normal CRP (<5mg/L) and FC (<150 µg/g) levels were achieved in 76%, 93% and 80% and in 35%, 31% and 40% of patients after 8, 24, 52 weeks, respectively. Five of 6 patients who had endoscopy before and after treatment showed endoscopic Mayo subscore ≤1. There were 2 AEs, 1 hospitalization, and 1 colectomy during follow-up.
Conclusion
This study demonstrates the safety as well as the clinical, biological and endoscopic effectiveness of USK adjusted by levels in real life in a highly refractory UC cohort.