Introduction. Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are significant medical problems due to their chronic course and high complication rate. Ustekinumab, a genetically engineered biological drug that inhibits interleukins 12 and 23, has shown efficacy in international studies, while data on its use in the Russian population are still limited. Objective. To evaluate the long-term efficacy and safety of ustekinumab in patients with IBD in real-life clinical practice in the Sverdlovsk region. Materials and methods. An observational study was conducted on 184 patients with IBD (110 CD, 74 UC) who received ustekinumab from 2010 to 2025. Evaluation criteria: clinical response, clinical remission, frequency of therapy discontinuation, adverse events (AE). Quality of life questionnaires (IBDQ, SF-36) were used. Results. Efficacy: 58 % of patients received ustekinumab as first-line therapy, 38 % as second-line therapy. Clinical remission was achieved in most patients, 90 % continued treatment (median – 17.7 months). Only 4 % switched to other drugs (mainly vedolizumab). Safety: One case of Quincke's edema was registered. The discontinuation rate due to inefficiency was 3.3 %, allergy – 0.5 %. Quality of life: 85 % of patients noted improvement after 12 weeks of therapy. Discussion. Ustekinumab demonstrated high efficacy and safety, surpassing anti-TNF drugs in tolerability. The results are consistent with international data, confirming the feasibility of its use in the Russian population. Conclusions. Ustekinumab is a promising drug for long-term therapy of IBD due to high survival of therapy, minimal risk of AEs and positive impact on quality of life. Its expansion in regional practice is recommended.
Oschepkov et al. (2025) studied this question.