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DOP74 Short and long-term effectiveness and safety of ustekinumab in Ulcerative Colitis in real life: the ULISES study

2024; Oxford University Press; Volume: 18; Issue: Supplement_1 Linguagem: Inglês

10.1093/ecco-jcc/jjad212.0114

1876-4479

María Chaparro, Santiago Reinoso Hermida, Diana Acosta, A Fernández-Clotet, Manuel Barreiro‐de Acosta, Álvaro Hernández Martínez, M Arroyo, Marta Maia Boscá-Watts, M T Diz-Lois Palomares, Luís Menchén, J Martínez Cadilla, Eduardo Leo‐Carnerero, Carmen Muñoz Villafranca, Mónica Sierra‐Ausín, Yanira González, Sabino Riestra, Pau Sendra Rumbeu, M J Cabello Tapia, Irene García de la Filia, E Montil Miguel, Daniel Ceballos, Ramón Pajares Villarroya, Patricia Ramírez de la Piscina, María Dolores Martín‐Arranz, Laura Ramos, Alexandra Ruiz‐Cerulla, M P Teresa de Jesús, Eduardo San Miguel, Xavier Calvet, José María Huguet, Alma Keco‐Huerga, R H Lorente Poyatos, J F Muñoz, Ángel Ponferrada, Beatriz Sicilia, Pedro Delgado‐Guillena, Elvira Delgado, Francisco J. Rancel‐Medina, Horacio Alonso‐Galán, Javier P. Gisbert,

Chronic Lymphocytic Leukemia Research

Abstract Background Primary aim: To assess the durability of ustekinumab treatment in patients with ulcerative colitis (UC). Secondary aims: To assess the short-term effectiveness, the durability of response, and the tolerability of ustekinumab in clinical practice. Methods Retrospective, multicenter study including UC patients who had received the 1st ustekinumab dose at least 16 weeks before inclusion. Patients were followed-up from the 1st ustekinumab dose to treatment discontinuation or last visit. Only patients with active disease [Partial Mayo Score (PMS)>2] at ustekinumab start were considered in the effectiveness analysis. Clinical effectiveness was based on PMS. Patients who stopped ustekinumab before their last visit were considered not in remission at subsequent time points (negative imputation). Results 620 patients were included (table 1). 78% of patients who started ustekinumab maintenance treatment, did it with 90 mg every-8-weeks dose. 155 patients (25%) withdrew ustekinumab during follow-up [median=12 months (m)]. Incidence rate of ustekinumab discontinuation was 20% per patient-year of follow-up. The probability of maintaining ustekinumab is shown in figure 1A. Among patients who withdrew ustekinumab, the main reasons were primary non-response (39%) and loss of response (35%). Anaemia at baseline (HR=1.5, 95%CI=1.1-2.1), steroids at baseline (HR=1.5; 95%CI=1.06-2.08), and more severe clinical activity at baseline (HR=1.5; 95%CI=1.09-2.06) were associated with higher risk of ustekinumab discontinuation. Short and long-term effectiveness of ustekinumab is shown on figure 1B. Moderate-severe vs. mild disease activity at baseline (OR=0.3, 95%CI=0.2-0.5), male sex (OR=0.5; 95%CI=0.4-0.8), and increased number of previous biologics (OR=0.6, 95%CI=0.6-0.8) were associated with lower likelihood of steroid-free remission at week 16. A total of 57 (25%) patients among those with active disease at baseline and with steroid-free remission at week 16, lost response during a median follow-up of 8 m (IQR=3-16 m) (figure 1C). The dose was escalated in 72% of patients with loss of response, and 80% improved (67% remission); an intravenous reinduction was given in 3 patients, and none of them improved. A total of 176 patients (28%) had at least one adverse event, with infections being the most frequent (11%). No negative impact on extraintestinal manifestations and/or immunomediated diseases was seen. Conclusion Ustekinumab was effective in inducing remission even in highly refractory UC patients. A proportion of patients discontinue the treatment, mostly due to primary failure and loss of response. Dose escalation may be effective to regain response after loss of effectiveness. The safety profile was similar to previously reported.