

Experience of using ustekinumab in patients with inflammatory bowel diseases in the Sverdlovsk region
https://doi.org/10.33667/2078-5631-2025-13-7-10
Abstract
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.
About the Authors
A. V. OschepkovRussian Federation
Oshchepkov Andrey V., proctologist, oncologist, chief freelance proctologist of the Ministry of Health of the Sverdlovsk Region, deputy chief physician for surgery
Yekaterinburg
A. V. Bogdanov
Russian Federation
Bogdanov Alexey V., proctologist, oncologist, head of Oncology Dept of Ssurgical Treatment Methods (Dept of Abdominal Oncology and Proctology), assistant at Dept of Ssurgical Diseases2, assistant at Dept of Surgery, Proctology and Endoscopy
Yekaterinburg
E. V. Kozenko
Russian Federation
Kozenko Elena V., proctologist at Oncology Dept of Surgical Treatment Methods (Dept of Abdominal Oncology and Proctology), assistant at Dept of Surgery, Proctology and Endoscopy
Yekaterinburg
References
1. Shelygin Yu.A., Ivashkin V.T., Belousova E.A., Reshetov I.V., Maev I.V., Achkasov S.I. et al. Ulcerative colitis (K51), adults. Koloproktologia. 2023; 22 (1): 10–44. (In Russ.). DOI: 10.33878/2073-7556-2023-22-1-10-44
2. Shelygin Yu.A., Ivashkin V.T., Achkasov S.I., Reshetov I.V., Maev I.V., Belousova E.A. et al. Clinical guidelines. Crohn’s disease (К50), adults. Koloproktologia. 2023; 22 (3): 10–49. (In Russ.). DOI: 10.33878/2073-7556-2023-22-3-10-49
3. Ivanov R.A. Importance and prospects of studying survival of genetically engineered biological therapy for psoriasis in children. Medical alphabet. 2022; (8): 80–85. (In Russ.). DOI: 10.33667/2078-5631-2022-8-80-85
4. Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR et al. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016 Nov 17; 375 (20): 1946–1960. DOI: 10.1056/NEJMoa1602773. PMID: 27959607
5. Grova M, Vitello A, Mannino M, Casà A, Renna S, Macaluso FS, Orlando A. Role of ustekinumab in treatment of ulcerative colitis: a narrative review. Immunotherapy. 2023 Dec; 15 (18): 1539–1552. DOI: 10.2217/imt-2023–0106. Epub 2023 Nov 29. PMID: 38018475.
6. Ghosh S, Feagan BG, Ott E, Gasink C, Godwin B, Marano C et al Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis Through 5 Years in Crohn's Disease and 4 Years in Ulcerative Colitis. J Crohns Colitis. 2024 Aug 6; 18 (7): 1091–1101. DOI: 10.1093/ecco-jcc/jjae013. PMID: 38310565; PMCID: PMC11302965.
7. Mevius A, Brandes A, Hardtstock F, Wilke T, Ratsch BA, Orzechowski HD et al Persistence with Biologic Treatment in Patients with Inflammatory Bowel Disease: A German Claims Data Analysis. Digestion. 2021; 102 (2): 216–226. DOI: 10.1159/000503859. Epub 2019 Oct 22. PMID: 31639807
8. Sands BE, Sandborn WJ, Panaccione R, O'Brien CD, Zhang H, Johanns J et al. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2019 Sep 26; 381 (13): 1201–1214. DOI: 10.1056/NEJMoa1900750. PMID: 31553833
9. Sandborn WJ, Rebuck R, Wang Y, Zou B, Adedokun OJ, Gasink C, Sands BE, Hanauer SB, Targan S, Ghosh S, de Villiers WJS, Colombel JF, Feagan BG, Lynch JP. Five-Year Efficacy and Safety of Ustekinumab Treatment in Crohn's Disease: The IM-UNITI Trial. Clin Gastroenterol Hepatol. 2022 Mar; 20 (3): 578–590.e4. DOI: 10.1016/j.cgh.2021.02.025. Epub 2021 Feb 19. PMID: 33618023; PMCID: PMC8374005
10. Teeple A, Sah J, Mallampati R, Adams C, Waters D, Muser E. Persistence, Dosing, and Other Treatment Patterns Among Crohn's Disease Patients Initiating Biologics in United States. Crohns Colitis 360. 2021 Nov 5; 3 (4): otab076. DOI: 10.1093/crocol/otab076. PMID: 36777272; PMCID: PMC9802353
11. Zhao M, Sall Jensen M, Knudsen T, Kelsen J, Coskun M, Kjellberg J, Burisch J. Trends in the use of biologicals and their treatment outcomes among patients with inflammatory bowel diseases – a Danish nationwide cohort study. Aliment Pharmacol Ther. 2022 Mar; 55 (5): 541–557. DOI: 10.1111/apt.16723. Epub 2021 Dec 8. PMID: 34881439.
Review
For citations:
Oschepkov A.V., Bogdanov A.V., Kozenko E.V. Experience of using ustekinumab in patients with inflammatory bowel diseases in the Sverdlovsk region. Medical alphabet. 2025;(13):7-10. (In Russ.) https://doi.org/10.33667/2078-5631-2025-13-7-10