nogrЭкспериментальная и клиническая гастроэнтерологияExperimental and Clinical Gastroenterology1682-8658«Global Media Technologies»10.31146/1682-8658-ecg-217-9-34-41nogr-2444Research ArticleКЛИНИЧЕСКАЯ ГАСТРОЭНТЕРОЛОГИЯCLINICAL GASTROENTEROLOGYДолгосрочная эффективность терапии ведолизумабом у пациентов с болезнью КронаLong-term efficacy of vedolizumab therapy in patients with Crohn’s diseasehttps://orcid.org/0000-0002-7778-8049ПедаЕ. С.PedaE. S.peda_es@gnck.ruhttps://orcid.org/0000-0003-1697-4670НанаеваБ. А.NanaevaB. A.noemail@neicon.ruhttps://orcid.org/0000-0001-7250-0977КнязевО. В.KnyazevO. V.noemail@neicon.ruhttps://orcid.org/0000-0002-8803-7566АлександровТ. Л.AlexandrovT. L.noemail@neicon.ruhttps://orcid.org/0000-0003-2013-8798БарановаТ. А.BaranovaT. A.noemail@neicon.ruФГБУ «НМИЦ колопроктологии имени А. Н. Рыжих» Минздрава РоссииРоссияRyzhikh Natianal Medical Research Centre for Coloproctology of the Ministry of Health of the RussiaRussian FederationФГБУ «НМИЦ колопроктологии имени А. Н. Рыжих» Минздрава России; ГБУЗ Московский Клинический Научный Центр имени А. С. Логинова ДЗМРоссияRyzhikh Natianal Medical Research Centre for Coloproctology of the Ministry of Health of the Russia; Moscow Clinical Scientific Center named after LoginovRussian Federation202317012024093441Copyright © Педа Е.С., Нанаева Б.А., Князев О.В., Александров Т.Л., Баранова Т.А., 20242024Педа Е.С., Нанаева Б.А., Князев О.В., Александров Т.Л., Баранова Т.А.Peda E.S., Nanaeva B.A., Knyazev O.V., Alexandrov T.L., Baranova T.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.nogr.org/jour/article/view/2444

Введение: В настоящее время возможности в терапии болезни Крона (БК) расширяются. Для лечения воспалительных заболеваний кишечника (ВЗК) доступны различные классы генно-инженерной биологической терапии (ГИБТ). Ведолизумаб, обладая избирательным характером действия, имеет более высокий профиль безопасности препарата, что позволяет предположить меньшую иммуногенность и, как следствие, долгосрочную эффективность. Материалы и методы: На базе ФГБУ «НМИЦ колопроктологии» было проведено ретроспективное исследование, в которое включены 54 пациента, получавших терапию препаратом ведолизумаб. В ходе работы оценивалась выживаемость терапии, а также влияние демографических характеристик, локализации, фенотипа заболевания и других факторов на эффективность терапии. Результаты: Исследование показало 86,0% (95%ДИ 72,8-93,1) выживаемость терапии в течение 15 месяцев и 75,9% (95% ДИ 58,8-86,7) в течение двух лет. При оценке влияния пола, коморбидности, локализации поражения, фенотипа заболевания, статуса курильщика и применения ГКС во время индукции ведолизумабом не было получено статистически значимых отличий. При проведении анализа выявлено, что значимыми факторами, влияющими на эффективность терапии, являются возраст дебюта БК менее 21 года и показатель индекса SES-CD более 7, а также предшествующая терапия с применением двух и более анти-ФНО препаратов. Обсуждение: Несмотря на небольшой объем выборки, полученные выводы позволяют прогнозировать эффективность терапии, что может повлиять на выживаемость.

Introduction: Currently, the possibilities in the treatment of Crohn’s disease (CD) are expanding. Various classes of genetically engineered biological therapy are available for the treatment of inflammatory bowel diseases (IBD). Vedolizumab, having a selective nature of action, has a higher safety profile of the drug, which suggests lower immunogenicity and, as a consequence, long-term efficacy. Materials and methods: A retrospective study was conducted on the basis of the National Medical Research Centre of Coloproctology named after A. N. Ryzhikh, which included 54 patients treated with vedolizumab. In the course of the work, the survival of therapy was evaluated, as well as the influence of demographic characteristics, localization, phenotype of the disease and other factors on the effectiveness of therapy. Results: The study showed 86.0% (95% CI 72.8-93.1) survival of therapy for 15 months and 75.9% (95% CI 58.8-86.7) for two years. No statistically significant differences were obtained when assessing the effect of gender, comorbidity, lesion localization, disease phenotype, smoker status and the use of glucocorticosteroids during vedolizumab induction. During the analysis, it was revealed that significant factors affecting the effectiveness of therapy are the age of CD debut less than 21 years and the SES-CD index index more than 7, as well as previous therapy with the use of two or more anti-TNF drugs. Discussion: Despite the small sample size, the findings allow us to predict the effectiveness of therapy, which may affect survival.

болезнь КронаБКведолизумабантитела к α4β7-интегринуCrohn’s diseaseCDvedolizumabantibodies to α4β7-integrinReferencesBernstein C.N., Hitchon C. A., Walld R., Bolton J. M., Sareen J., Walker J. R., Graff L. A., Patten S. B., Singer A., Lix L. M., El-Gabalawy R., Katz A., Fisk J. D., Marrie R. A.; CIHR Team in Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Increased Burden of Psychiatric Disorders in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2019 Jan 10;25(2):360-368. doi: 10.1093/ibd/izy235.Bernstein C.N., Hitchon C. A., Walld R., Bolton J. M., Sareen J., Walker J. R., Graff L. A., Patten S. B., Singer A., Lix L. M., El-Gabalawy R., Katz A., Fisk J. D., Marrie R. A.; CIHR Team in Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Increased Burden of Psychiatric Disorders in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2019 Jan 10;25(2):360-368. doi: 10.1093/ibd/izy235.Berg D.R., Colombel J. F., Ungaro R. The Role of Early Biologic Therapy in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2019 Nov 14;25(12):1896-1905. doi: 10.1093/ibd/izz059.Berg D.R., Colombel J. F., Ungaro R. The Role of Early Biologic Therapy in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2019 Nov 14;25(12):1896-1905. doi: 10.1093/ibd/izz059.Sulz M.C., Burri E., Michetti P., Rogler G., Peyrin-Biroulet L., Seibold F.; on behalf of the Swiss IBDnet, an official working group of the Swiss Society of Gastroenterology. Treatment Algorithms for Crohn’s Disease. Digestion. 2020;101 Suppl 1:43-57. doi: 10.1159/000506364.Sulz M.C., Burri E., Michetti P., Rogler G., Peyrin-Biroulet L., Seibold F.; on behalf of the Swiss IBDnet, an official working group of the Swiss Society of Gastroenterology. Treatment Algorithms for Crohn’s Disease. Digestion. 2020;101 Suppl 1:43-57. doi: 10.1159/000506364.Shukla T., Sands B. E. Novel Non-biologic Targets for Inflammatory Bowel Disease. Curr Gastroenterol Rep. 2019 Apr 23;21(5):22. doi: 10.1007/s11894-019-0689-2.Shukla T., Sands B. E. Novel Non-biologic Targets for Inflammatory Bowel Disease. Curr Gastroenterol Rep. 2019 Apr 23;21(5):22. doi: 10.1007/s11894-019-0689-2.Retnakumar S.V., Muller S. Pharmacological Autophagy Regulators as Therapeutic Agents for Inflammatory Bowel Diseases. Trends Mol Med. 2019 Jun;25(6):516-537. doi: 10.1016/j.molmed.2019.03.002.Retnakumar S.V., Muller S. Pharmacological Autophagy Regulators as Therapeutic Agents for Inflammatory Bowel Diseases. Trends Mol Med. 2019 Jun;25(6):516-537. doi: 10.1016/j.molmed.2019.03.002.Nakase H. Optimizing the Use of Current Treatments and Emerging Therapeutic Approaches to Achieve Therapeutic Success in Patients with Inflammatory Bowel Disease. Gut Liver. 2020 Jan 15;14(1):7-19. doi: 10.5009/gnl18203.Nakase H. Optimizing the Use of Current Treatments and Emerging Therapeutic Approaches to Achieve Therapeutic Success in Patients with Inflammatory Bowel Disease. Gut Liver. 2020 Jan 15;14(1):7-19. doi: 10.5009/gnl18203.Rosario M., Dirks N. L., Milch C., Parikh A., Bargfrede M., Wyant T., Fedyk E., Fox I. A Review of the Clinical Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Vedolizumab. Clin Pharmacokinet. 2017 Nov;56(11):1287-1301. doi: 10.1007/s40262-017-0546-0.Rosario M., Dirks N. L., Milch C., Parikh A., Bargfrede M., Wyant T., Fedyk E., Fox I. A Review of the Clinical Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Vedolizumab. Clin Pharmacokinet. 2017 Nov;56(11):1287-1301. doi: 10.1007/s40262-017-0546-0.Vermeire S., Loftus E. V. Jr, Colombel J. F. et al. Long-term Efficacy of Vedolizumab for Crohn’s Disease. J Crohns Colitis. 2017 Apr 1;11(4):412-424. doi: 10.1093/ecco-jcc/jjw176.Vermeire S., Loftus E. V. Jr, Colombel J. F. et al. Long-term Efficacy of Vedolizumab for Crohn’s Disease. J Crohns Colitis. 2017 Apr 1;11(4):412-424. doi: 10.1093/ecco-jcc/jjw176.Huang Z., Ba Y., Kamble P., Wang S., DOP48 Use of biologic therapies with different mechanisms of action (MOA) in the first-line (1L) treatment of Crohn’s Disease (CD) in the US. Journal of Crohn’s and Colitis. 2021 May;15(Supplement_1): S084-S085. doi: 10.1093/ecco-jcc/jjab073.087.Huang Z., Ba Y., Kamble P., Wang S., DOP48 Use of biologic therapies with different mechanisms of action (MOA) in the first-line (1L) treatment of Crohn’s Disease (CD) in the US. Journal of Crohn’s and Colitis. 2021 May;15(Supplement_1): S084-S085. doi: 10.1093/ecco-jcc/jjab073.087.Bohm M, Xu R, Zhang Y, Varma S, Fischer M, Kochhar G, Boland B, Singh S, Hirten R., Ungaro R., Shmidt E., Lasch K. et al; VICTORY Collaboration.Comparative safety and effectiveness of vedolizumab to tumour necrosis factor antagonist therapy for Crohn’s disease. Aliment Pharmacol Ther. 2020 Aug;52(4):669-681. doi: 10.1111/apt.15921.Bohm M, Xu R, Zhang Y, Varma S, Fischer M, Kochhar G, Boland B, Singh S, Hirten R., Ungaro R., Shmidt E., Lasch K. et al; VICTORY Collaboration.Comparative safety and effectiveness of vedolizumab to tumour necrosis factor antagonist therapy for Crohn’s disease. Aliment Pharmacol Ther. 2020 Aug;52(4):669-681. doi: 10.1111/apt.15921.Eriksson C., Marsal J., Bergemalm D., Vigren L., Björk J., Eberhardson M., Karling P., Söderman C.; SWIBREG Vedolizumab Study Group; Myrelid P., Cao Y., Sjöberg D., Thörn M., Karlén P., Hertervig E., Strid H., Ludvigsson J. F., Almer S., Halfvarson J. Long-term effectiveness of vedolizumab in inflammatory bowel disease: a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG). Scand J Gastroenterol. 2017 Jun-Jul;52(6-7):722-729. doi: 10.1080/00365521.2017.1304987.Eriksson C., Marsal J., Bergemalm D., Vigren L., Björk J., Eberhardson M., Karling P., Söderman C.; SWIBREG Vedolizumab Study Group; Myrelid P., Cao Y., Sjöberg D., Thörn M., Karlén P., Hertervig E., Strid H., Ludvigsson J. F., Almer S., Halfvarson J. Long-term effectiveness of vedolizumab in inflammatory bowel disease: a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG). Scand J Gastroenterol. 2017 Jun-Jul;52(6-7):722-729. doi: 10.1080/00365521.2017.1304987.Rayer C., Nachury M., Bourreille A. et al. Efficacy of ustekinumab, vedolizumab, or a second anti-TNF agent after the failure of a first anti-TNF agent in patients with Crohn’s disease: a multicentre retrospective study. BMC Gastroenterol. 2022 Dec 1;22(1):498. doi: 10.1186/s12876-022-02583-5.Rayer C., Nachury M., Bourreille A. et al. Efficacy of ustekinumab, vedolizumab, or a second anti-TNF agent after the failure of a first anti-TNF agent in patients with Crohn’s disease: a multicentre retrospective study. BMC Gastroenterol. 2022 Dec 1;22(1):498. doi: 10.1186/s12876-022-02583-5.

The authors declare that there are no conflicts of interest present.