Role of ustekinumab in treatment of ulcerative colitis: a narrative review

The therapeutic armamentarium for gastroenterologists in treating ulcerative colitis (UC) has been rapidly growing since the introduction of monoclonal antibodies directed against anti-TNFs. Ustekinumab is a monoclonal antibody binding the shared p40 subunit of IL-12 and IL-23, and the inhibition of these two cytokines, implicated in host response to microbial pathogens, has demonstrated clinical efficacy in different immune-mediated diseases, including moderate-to-severe UC. This narrative review summarizes the newest clinical evidence regarding the efficacy, effectiveness and safety of ustekinumab in moderate-to-severe UC, including specific situations (pregnancy, breastfeeding, elderly/pediatric populations, extraintestinal manifestations, acute severe UC, pouchitis and dual biological therapy). Finally, positioning is discussed in light of the existing evidence. Ustekinumab (UST) is a biological drug that has been recently licensed as a novel therapy for ulcerative colitis, one of the two main conditions that constitute inflammatory bowel diseases. UST has been previously successfully used in psoriasis and psoriatic arthritis, two conditions in which dysregulation of the immune system causes inflammation in the skin and joints, and Crohn's disease, a type of inflammatory bowel disease. This led to great interest in the use of UST for treating patients with moderate and severe ulcerative colitis. UST is administered with a weight-based intravenous infusion followed by subcutaneous administration every 8 weeks, which can be performed at home and is effective in reducing symptoms of the disease with a particularly favorable safety profile. These features make UST a suitable option for treating especially elderly and frail patients, as well as patients who did not benefit or had side effects with other biological therapies and patients who also suffer from psoriasis or psoriatic arthritis. This narrative review summarizes the newest clinical evidence of the efficacy, effectiveness and safety of ustekinumab in moderate-to-severe ulcerative colitis, including specific situations and the consequent positioning of this drug.