BACKGROUND: The development program (UNIFI) has shown promising results of ustekinumab in ulcerative colitis (UC) treatment that should be confirmed in clinical practice .
AIMS: To evaluate the durability, effectiveness and safety of ustekinumab in UC in real-life .
METHODS: Patients included in the prospectively maintained ENEIDA registry who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score (PMS) > 2] were included . Clinical activity and effectiveness were defined based on PMS . Short-term response was assessed at week 16 .
RESULTS: A total of 95 patients were included . At week 16 , 53% of patients had response (including 35% of patients in remission). In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with lower likelihood of achieving remission . Remission was achieved in 39% and 33% of patients at weeks 24 and 52, respectively . Thirty-six percent of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks . The probability of maintaining ustekinumab treatment was 87% at week 16 , 63% at week 56, and 59% at week 72; primary failure was the main reason for ustekinumab discontinuation . No variable was associated with risk of discontinuation . Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection .
CONCLUSIONS: Ustekinumab is effective both in the short and the long-term in real-life, even in a highly refractory cohort . Higher inflammatory burden at baseline correlated with lower probability of achieving remission . Safety was consistent with the known profile of ustekinumab.