One-year real life data of our patients with moderate-severe Crohn's disease who underwent ustekinumab therapy.

Aim: The aim of this study was to present one-year real-life data of our patients with CD who showed unresponsiveness and/or intolerance to biological agents and then received ustekinumab treatment through an early access program.

Materials and methods: The retrospective study reviewed the 52-week clinical data of 10 patients with moderate or severe CD who underwent ustekinumab therapy.

Results: The 10 patients comprised 7 (70%) men and 3 (30%) women with a mean age of 38 ± 11.3 years. Mean disease duration was 13.5 ± 8.5 years. Mean pretreatment CDAI score was 273.5 ± 92 and mean pretreatment HBI score was 11.6 ± 3.8. At the end of the 8-week intravenous induction treatment, 5 (55%) patients showed clinical remission according to the CDAI and HBI scores. Additionally, 62.5% of the patients were in clinical remission at the end of week 52 according to the CDAI and HBI scores. No drug-related side effects were observed in any patient throughout the treatment.

Conclusion: Ustekinumab appears to be effective and safe in the treatment of moderate and severe CD, particularly in cases of unresponsiveness and intolerance to biological agents such as anti-TNF, and in the achievement of clinical remission.