Background
Ustekinumab has proved its efficacy and safety in moderate-to-severe Crohn′s disease (CD). However, the real practice setting differs from clinical trials. Our aim was to evaluate the effectiveness and safety of ustekinumab in a cohort of real-life practice patients with CD mostly refractory to anti-TNF α agents.
Methods
Observational retrospective single-center study. All patients undergoing treatment with ustekinumab at the Digestive Diseases Department of the Regional University Hospital of Málaga and at least 16 weeks of follow-up after induction were included. The primary outcome was steroid-free clinical remission (Harvey-Bradshaw Index ≤4) at 24 and 52 weeks. Secondary objectives were combined biological remission (fecal calprotectin levels <250 mcg/g and C-reactive protein <10 mg/dl), safety and persistence of ustekinumab during the follow-up period.
Results
A total of 89 patients with CD treated with ustekinumab (59,6% women; median disease duration 10 years) were included. The median follow-up was 60 weeks and 55 patients reached one year of follow-up. A 39,3% of the patients had history of previous abdominal surgery and 27% had been treated with 2 or more biologics. A 25,8% and 12,4% of the patients were on steroids and immunosupresants at the induction. The percentages of steroid-free clinical remission at 24 and 52 weeks were 42% and 54% respectively (Figure 1). Combined biological remission at 24 and 52 weeks was achieved in 33% and 45% of the patients respectively. Ustekinumab persistence was 88% at 12 months of follow-up (Figure 2). There were 14 suspensions mainly due to lack of response. Only 13 adverse events were documented in 9 patients (11.5%), none of them serious.
Figure 1. Steroid-free clinical and biological remission percentages of ustekinumab at 16,24,52,76 and 104 weeks.
Figure 2. Kaplan-Meier curve showing the durability of ustekinumab throughout the follow-up period.
Conclusion
Ustekinumab was effective and safe in a high proportion of patients with CD that were resistant to conventional immunosuppressant and antitumor necrosis factor drugs in this real-life practice cohort.
Resumen
El drenaje de colecciones intraabdominales postquirúrgicas guiado por ecoendoscopia es una técnica cada vez más utilizada en la práctica clínica. El objetivo de nuestro estudio es describir nuestra experiencia en el drenaje guiado por ecoendoscopia de colecciones postoperatorias intraabdominales. Para ello, se evaluó retrospectivamente los pacientes con colecciones postoperatorias sintomáticas que fueron sometidos a un drenaje guiado por ecoendoscopia en nuestro centro entre los años 2017 y 2022. Se realizaron 10 drenajes ecoguiados de colecciones postquirúrgicas en 9 pacientes. El éxito técnico fue del 100% y el éxito clínico del 80%. Ocurrieron complicaciones en el 20% de los casos, que se pudieron resolver eficazmente mediante endoscopia. En nuestra experiencia, el drenaje guiado por ecoendoscopia es una opción segura y eficaz en el drenaje de colecciones postoperatorias intraabdominales, con alta tasa de éxito técnico y clínico y un reducido porcentaje de complicaciones.
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