Abstract
Ustekinumab is a fully human IgG1 monoclonal antibody that has been approved for the treatment of moderate to severe Crohn's disease, and more recently moderate to severe ulcerative colitis. It binds with high affinity to the p40 subunit of human interleukin-12 and 23. This mechanism of action prevents the bioactivity of both interleukins, thus precluding their interaction with the cell surface receptor protein. The pivotal clinical trials (UNITI-1, UNITI-2 and IM-UNITI) demonstrated its clinical efficacy and safety, in naïve patients and also in those previously exposed to immunosuppressants and/or biologics. There is now an extensive experience with its use worldwide, corroborating its favorable profile even in patients with refractory disease. However, the number of medical treatment options available in inflammatory bowel disease are still limited. Hence, we should prioritize the treatments that have a greater probability of response in an individual patient. Our aim was to review and summarize all the available literature regarding the potential predictors of response to ustekinumab that can increase the success rate with this therapy in clinical practice.
Highlights
DO WE NEED PREDICTIVE FACTORS IN CROHN’S DISEASE?Inflammatory bowel diseases (IBD)—a term including both ulcerative colitis (UC) and Crohn’s disease (CD)— are two chronic, disabling conditions causing an uncontrolled inflammatory process in the gastrointestinal tract, with a relapsing and remitting course [1, 2]
It is considered that IBD appears in genetically predisposed subjects after the interaction with diverse environmental factors, it is described as a complex disease where there is an interaction between multiple factors that has not been fully elucidated so far
≥3 prior anti-tumor necrosis factor (TNF) agents None observed suggest a beneficial effect over placebo, a systematic review and meta-analysis did not show statistically significant differences for the induction of remission [relative risk (RR) 1.77; 95% confidence interval (CI) 0.93–3.37] [66]
Summary
Inflammatory bowel diseases (IBD)—a term including both ulcerative colitis (UC) and Crohn’s disease (CD)— are two chronic, disabling conditions causing an uncontrolled inflammatory process in the gastrointestinal tract, with a relapsing and remitting course [1, 2]. The recent experience reported including 407 patients from Spain showed opposite results, as ileocolonic and colonic disease extension were associated with lower clinical response rates at week 26 (OR, 0.56 95% CI, 0.32–0.96, and OR, 0.34 95% CI, 0.16–0.69, respectively) [31]. Another important aspect that can significantly influence the response to biologics is the presence of penetrating or stricturing complications. Both analysis performed in the Canadian cohort demonstrated that UST was less effective when stricturing complications have
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