P334 Effectiveness and safety of ustekinumab in Crohn’s disease: short and long-term results of a multi-refractory cohort.

Aparicio-Serrano, A.(1);Zamora Olaya, J.M.(1);Ortiz Chimbo, D.S.(1);Rodríguez Tirado, M.I.(1);Gómez Pérez, A.(1);Soto Escribano, P.(1);Marín Pedrosa, S.(1);Iglesias Flores, E.(1);Benítez, J.M.(1);

(1)Reina Sofía University Hospital, Gastroenterology and Hepatology, Córdoba, Spain;


To evaluate the short and long-term effectiveness and safety of ustekinumab (UST) in a real-world multirefractory Crohn’s disease (CD) cohort.


An observational, retrospective and single-center study of CD patients treated with UST since June 2017, with at least 16 weeks of treatment. All patients were identified in the ENEIDA Registry. Demographic, disease, and outcome variables were collected. Clinical remission and response (measured by the physician global assessment and Harvey Bradshaw Index (HBI) score) as well as biological response (measured by C-reactive protein (CRP) and fecal calprotectin) were evaluated at weeks 16, 26, 52 and at the end of the follow-up. Kaplan-Meier survival curves were performed to analyze drug persistence and multivariate analysis to identify predictors of response. Treatment-related adverse events were assessed.


64 patients included, mean age of 49 years (35–60), 56.2% men and CD duration of 15.5 years (8-22). 53% had ileocolic involvement and 59% stricturing and/or penetrating disease. 40% presented perianal disease, 35% active smoking and 33% patients had extraintestinal manifestations. 92.2% had prior failure to biologics (44% failed at 1 and 48.5% failed ³2) and 9.4% had failed to vedolizumab. 57.8% required prior surgery for IBD. 40.6% initiated UST for treatment of postoperative recurrence. Baseline clinical activity was present in 87.5% patients (60% moderate-severe activity). Rates of clinical remission, response and no response were, respectively, 40.7%, 47.5% and 12% at week 16; 56.8%, 32.8% and 10.3% at week 26; 60%, 30% y 10% at week 52. At the end of the follow-up, more than 2/3 of patients (76.3%) had clinical response or remission (figure 1). Overall, a significant reduction of HBI score was observed from baseline to week 16 and maintained at W26 and W52 (figure 2). Likewise, a biological response was observed with a significant reduction of CRP (baseline of 26.7 mg/dL) at different times of evaluation (figure 3). 74.9% continued with UST for up to three years (figure 4). In the multivariate analysis, the only independent factor associated with non-response was previous therapy with vedolizumab (OR: 0.055 [IC95%: 0.005-0.551], p=0.001). The safety profile was favorable; only 2 patients (3.1%) stopped the drug due to side effects (arthralgias and bladder neoplasia). 

Figure 1. Remission, response, and no response rates.

Fig 1. Remission, response, and no response rates.

Fig 2. Evolution of HBI score from baseline to W52.

Fig 3. Evolution of CRP from baseline to W52. 

Fig 4. Persistence of ustekinumab during the follow-up period.


UST is effective and safe in a real-life refractory CD cohort, with a persistence of the drug of 75% at 3 years. Previous vedolizumab therapy is associated with UST treatment failure.