Ustekinumab in Crohn's disease: real-world outcomes and predictors of response.

BACKGROUND Ustekinumab is a monoclonal antibody that inhibits interleukins (IL)- 12 and -23 and it is approved for the treatment of Crohn's disease (CD) and more recently also ulcerative colitis (UC). Our aim was to evaluate the effectiveness and safety of Ustekinumab, as well as to identify possible predictive factors of response in a real-life setting. METHODS Observational, retrospective, and multicenter study carried out in 4 hospitals in Andalusia. Adult patients with a confirmed diagnosis of CD treated with Ustekinumab from 2017 to 2019 were included. Clinical response was analyzed at 3, 6, and 12 months of treatment. Clinical disease activity was assessed with the Harvey Bradshaw index (HBI) and the Crohn's Disease Activity Index (CDAI), and the biochemical response was assessed with analytical parameters such as CRP and ESR. One-year ustekinumab drug-survival was analyzed. RESULTS 98 patients were analyzed (mean age 43 and 52% men). 56% had failed to ≥2 previous biologicals therapies. At 3 months, 69% of the patients were in response and 40.8% in remission. At 6 months, 56% were in clinical remission. At 12 months, 73.7% in clinical response and 60.5% in remission. Corticosteroid-free remission was 32.4%, 44%, 47.4% at 3, 6, and 12 months, respectively. The cumulative survival at one year of treatment with ustekinumab was 85.3%. Biochemical parameters, such as CRP and ESR showed a statistically significant decrease between baseline and control levels at 3, 6, and 12 months. A lower HBI at baseline and female sex were predictors of corticosteroid-free clinical remission in a univariate analysis. In the multivariate analysis, no variables were found as predictors of corticosteroid-free clinical remission Conclusion: Ustekinumab therapy is safe and useful inducing a clinical response in more than 50% of patients including patients who have failed other biological therapies.