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To study the efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab, infliximab, ustekinumab, golimumab, and vedolizumab | Biological | Efficacy of different biological treatment on patient with inflammatory bowel disease |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt | The primary endpoints of this study are the percentages of hospitalization, surgery, corticosteroid-free remission, and endoscopic remission in patients with inflammatory bowel disease receiving biological therapies at week 52. Patients will be considered on corticosteroids if they received a course of prednisolone, budesonide, or any other steroid medication more than six weeks after initiating the current biological therapy, excluding the induction corticosteroid course, and those who did not receive any steroid courses after this period will be considered in corticosteroid-free remission. Endoscopic remission is defined as the number of patients achieving endoscopic remission, with an Endoscopic Mayo score of 0-1 for ulcerative colitis and a Simple Endoscopic Score for Crohn's Disease (SES-CD) of 0-2 for .Surgical outcomes include patients who underwent IBD-related surgeries six weeks or more after starting the current biologic for an IBD-related issue or complications | 1 year |
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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:
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This study is a retrospective, observational study involving chart reviews of patients with inflammatory bowel disease (IBD) at Luxor International Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary George Benyamin Tanious, Resident physician | Contact | +20 1555227403 | meromary2111998@gmail.com | |
| Mohamed Abd Elhakim omran, Assistant literature | Contact | +20 1067663269 | Drmohhakim1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Abaas Sabah, Professor | Assiut University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26034371 | Background | 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. | |
| 17129814 | Background | 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. |
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| 29383030 | Background | 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. |
| 36054449 | Background | 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. |
| 32116064 | Background | 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. |
| 24751956 | Background | Neurath MF. Cytokines in inflammatory bowel disease. Nat Rev Immunol. 2014 May;14(5):329-42. doi: 10.1038/nri3661. Epub 2014 Apr 22. |
| 17653185 | Background | Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005. |
| 40283885 | Background | 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. |
| 31648971 | Background | GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):17-30. doi: 10.1016/S2468-1253(19)30333-4. Epub 2019 Oct 21. |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D000069285 | Infliximab |
| D000069549 | Ustekinumab |
| C529000 | golimumab |
| C543529 | vedolizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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