ABSTRACT
BACKGROUND: Ustekinumab is approved for ulcerative colitis (UC). AIMS: To assess the durability of ustekinumab in patients with UC and its short-term effectiveness, durability and tolerability in clinical practice. METHODS: Retrospective, multicentre study of patients who had received their first ustekinumab dose at least 16 weeks before inclusion. Patients were followed until treatment discontinuation or last visit. Only patients with active disease at the start of ustekinumab treatment were considered in the effectiveness analysis. Patients who stopped ustekinumab before their last visit were considered not to be in subsequent remission. RESULTS: We included 620 patients; 155 (25%) discontinued ustekinumab during follow-up (median 12 months). Rate of discontinuation was 20% per patient-year of follow-up. Anaemia at baseline (hazard ratio, HR 1.5; 95% confidence interval [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 discontinuation. At the end of induction, 226 (40%) patients were in steroid-free clinical remission. Moderate-severe vs mild disease activity at baseline (odds ratio [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 clinical remission at week 16. One hundred and seventy-six patients (28%) had at least one adverse event. We observed no negative impact of ustekinumab on extraintestinal manifestations and/or immune-mediated diseases. CONCLUSIONS: Ustekinumab durability in UC was relatively high, and treatment was effective in highly refractory patients. The safety profile was consistent with previous studies.
ABSTRACT
Resumen Los pacientes con colitis ulcerosa (CU) y enfermedad de Crohn (EC) presentan un mayor riesgo de cáncer colorrectal (CCR), debido a la inflamación crónica, la susceptibilidad genética y los factores de riesgo ambientales. Sin embargo, las neoplasias no epiteliales son infrecuentes. Presentamos el caso de un varón de 83 años con una CU de larga evolución, que presenta una lesión polipoide. Una vez resecada, se diagnosticó de un leiomiosarcoma de alto grado. En la literatura, únicamente se han publicado tres casos previos de leiomiosarcoma en pacientes con CU, por lo que este reporte representaría el cuarto caso. La asociación directa de la CU y el leiomiosarcoma no ha sido bien establecida. No obstante, se sugiere que la inmunosupresión y la inflamación crónica son factores de riesgo.
Abstract Ulcerative colitis (UC) and Crohn's disease (CD) patients present an increased risk of colorectal cancer (CRC) due to chronic inflammation, genetic susceptibility and environmental risk factors. In contrast, non-epithelial neoplasms are uncommon. We discuss the case of an 83-year-old male with a long-standing UC, presenting with a polypoid lesion. Once resected, the lesion was identified as a high-grade leiomyosarcoma. A review of the literature revealed that only three previous cases of leiomyosarcoma among patients with UC have been published. Thus, this one would represent the fourth case where this rare non-epithelial neoplasm was detected in a patient with UC. The direct association of UC and leiomyosarcoma has not been well established; however, immunosuppression is suggested to be a risk factor for leiomyosarcoma in the literature.