Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt

Обзор

To study the efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt

Подробное описание

Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is a chronic inflammatory disorder that requires long-term management. Biological therapies have significantly improved outcomes in patients with moderate to severe disease; however, variability in treatment response remains a challenge.

This study aims to evaluate and compare the efficacy of different biological treatments in patients with IBD in Upper Egypt after one year of therapy. Clinical outcomes, including disease activity and remission rates, will be assessed to determine treatment effectiveness.

Вмешательства

• Биопрепарат adalimumab, infliximab, ustekinumab, golimumab, and vedolizumab
  Efficacy of different biological treatment on patient with inflammatory bowel disease

Первичные конечные точки

• Efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt [Срок оценки: 1 year]

Критерии участия

• Inclusion Criteria: 1) Age ≥ 18 years; 2) Patients with moderate-to-severe ulcerative colitis, defined as a clinical Mayo score >6 with an endoscopic score of 2-3 3) Patients with moderate-to-severe Crohn's disease, defined as a Crohn's Disease Activity Index (CDAI) >220 with a Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥7 4) Patients receiving adalimumab, infliximab, ustekinumab, or vedolizumab; 5) Patients who had been on the current biologic therapy for between 6 weeks and 12 months; and 6) Biologic-naïve patients (no prior biologic therapy). Patients who did not continue their treatment for 12 months due to primary or secondary treatment failure will be considered not to have achieved endoscopic remission. Additionally, patients who were hospitalized, received corticosteroids, or underwent surgery due to medication failure before 12 months of therapy will be considered treatment failures.
• Exclusion Criteria:

• Patients with prior biologic therapy (biologic-experienced);
• Patients with incomplete outcome or therapy data;
• Patients receiving other concomitant biologic or small-molecule therapies for other conditions, such as rheumatological diseases;
• Pregnant patients;
• Patients with intermittent suspension of therapy during the 12-month period.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Jin Y, Lin Y, Lin LJ, Zheng CQ. Meta-analysis of the effectiveness and safety of vedolizumab for ulcerative colitis. World J Gastroenterol. 2015 May 28;21(20):6352-60. doi: 10.3748/wjg.v21.i20.6352. PMID 26034371
• Osterman MT, Lichtenstein GR. Infliximab in fistulizing Crohn's disease. Gastroenterol Clin North Am. 2006 Dec;35(4):795-820. doi: 10.1016/j.gtc.2006.09.007. PMID 17129814
• Vermeire S, Gils A, Accossato P, Lula S, Marren A. Immunogenicity of biologics in inflammatory bowel disease. Ther Adv Gastroenterol. 2018 Jan 21;11:1756283X17750355. doi: 10.1177/1756283X17750355. eCollection 2018. PMID 29383030
• Laredo C, Rodriguez A, Oleaga L, Hernandez-Perez M, Renu A, Puig J, Roman LS, Planas AM, Urra X, Chamorro A. Adjunct Thrombolysis Enhances Brain Reperfusion following Successful Thrombectomy. Ann Neurol. 2022 Nov;92(5):860-870. doi: 10.1002/ana.26474. Epub 2022 Aug 23. PMID 36054449
• Alulis S, Vadstrup K, Borsi A, Nielsen A, Rikke Jorgensen T, Qvist N, Munkholm P. Treatment patterns for biologics in ulcerative colitis and Crohn's disease: a Danish Nationwide Register Study from 2003 to 2015. Scand J Gastroenterol. 2020 Mar;55(3):265-271. doi: 10.1080/00365521.2020.1726445. Epub 2020 Mar 2. PMID 32116064
• Neurath MF. Cytokines in inflammatory bowel disease. Nat Rev Immunol. 2014 May;14(5):329-42. doi: 10.1038/nri3661. Epub 2014 Apr 22. PMID 24751956
• Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005. PMID 17653185
• Biskup L, Semeradt J, Rogowska J, Chort W, Durko L, Malecka-Wojciesko E. New Interleukin-23 Antagonists' Use in Crohn's Disease. Pharmaceuticals (Basel). 2025 Mar 22;18(4):447. doi: 10.3390/ph18040447. PMID 40283885

Идентификаторы

NCT: NCT07495644 · Biological Treatment for IBD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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