Efficacy and Safety of Ustekinumab in Patients with Inflammatory Bowel Diseases in Real Clinical Practice

Abstract

Relevance. Therapy of Crohn's disease (CD) and ulcerative colitis (UC) still remains an urgent problem in modern gastroenterology. Unfortunately, currently there are not enough medications to achieve clinical, endoscopic, histological remission of inflammatory bowel diseases (IBD). The aim is to retrospectively evaluate the efficacy and tolerability of ustekinumab (UST) therapy in patients with moderate and severe CD and UC in real clinical practice. Material and methods. To assess the effectiveness and safety of UST, we included in the study 54 patients with IBD (42 – BC, 12 – UC) who received at least one UST injection from December 2019 to November 2021 at the A.S. Loginov Moscow Clinical Scientific and Practical Center (MCSC). The average age is 35.5 years. Anamnesis of the disease – from 1 to 26 years – 9.5 (95% CI 7.9–11.1). The vast majority (92.6%) of them received previous therapy with genetically engineered biological drugs (GIBD). Results. A rapid clinical response on the third day of treatment, characterized by a decrease in stool frequency, a decrease in the intensity of abdominal pain syndrome and an improvement in general well-being, was observed in 46 (85.2%) of 54 patients. Four months after the first oral injection, 19 patients (CD – 16, UC – 3) underwent a full examination at the A.S. Loginov MCSC. Subsequently, therapy was canceled for three of them for reasons: primary inefficiency, secondary inefficiency, unknown. A decrease in disease activity was noted in all patients during therapy: the initial values of the indices of all patients were from 8 to 11 points, after four months only two patients with CD had a Best index of 9, the rest had an interval from 2 to 5, in three patients with UC the Mayo index was 4 points. The mean baseline value of the CDAI decreased after four months compared to the baseline from 9.31 (95% CI 8.52–10.11) points to 3.81 (95% CI 2.66–4.97) (p < 0.001), the Mayo index – from 9.33 (95% CI 3.6–15.07) to 3.33 (95% CI 0.46–6.2) points (p = 0.11), respectively. In no case has the appearance of adverse events that could cause the withdrawal of the drug been noted. Conclusion. Clinical observation of a group of patients with CD and UC, as well as previous multicenter studies, demonstrated the high effectiveness of UST in induction and maintenance therapy of a cohort of patients with severe and moderate forms of CD and UC resistant to basic drugs and GIBP