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Anti-TNF (tumor necrosing factor) treatment with infliximab (IFX) and adalimumab (ADA) are established first-line biological therapies used in treatment of patients with ulcerative colitis (UC). There are no head-to-head comparative studies between these two drug but meta-analysis of randomized controlled trials states that IFX might be more effective than ADA for the induction of clinical remission. However, several observational studies conclude that ADA seem to have similar effect as IFX in treating patients with UC but these studies have limitations.
The overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab (IFX) and adalimumab (ADA) in treating bio-naive patients with UC in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-TNF treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab | Bio-naive patients with ulcerative colitis who starts treatment with infliximab |
| |
| Adalimumab | Bio-naive patients with ulcerative colitis who starts treatment with adalimumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Infliximab is an antiinflammatory drug (anti-TNF therapy) commonly used in treatment of ulcerative colitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving steroid-free clinical remission | Partial Mayo score ≤2 with no subscore >1 and no use of steroids between 6 and 12 months after start of anti-TNF therapy (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity). | One year after start of anti-TNF therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving clinical response | A decrease in the partial Mayo score from baseline of 2 or more points, along with either a rectal bleeding subscore of 0 or 1 or a decrease in the rectal bleeding subscore of 1 point or more (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity). | Three months after start of anti-TNF therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rates in the subpopulations of UC-patients with severe, moderate and mild disease respectively | Partial Mayo score ≤2 with no subscore >1 (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity). | Three months and one year after start of anti-TNF therapy |
Inclusion Criteria:
Exclusion Criteria:
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We will perform a retrospective multicenter observational cohort study according to the Newcastle-Ottawa Scale (NOS) quality instrument. Bionaive patients (i.e. no prior anti-TNF or other biologic treatment) with active UC, who started treatment with IFX or ADA at four major out-patient IBD-units (Inflammatory Bowel Disease) in the region Västra Götaland in Sweden, will be included in the study. Data regarding exposure for the two compared drugs, baseline characteristics and outcomes after three months and one year will be recieved by a structured review of medical records.
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| Name | Affiliation | Role |
|---|---|---|
| Börje Jonefjäll, PhD | Sahlgrenska University Hospital / Mölndal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Västra Götalandsregionen | Gothenburg | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29205421 | Background | Bonovas S, Lytras T, Nikolopoulos G, Peyrin-Biroulet L, Danese S. Systematic review with network meta-analysis: comparative assessment of tofacitinib and biological therapies for moderate-to-severe ulcerative colitis. Aliment Pharmacol Ther. 2018 Feb;47(4):454-465. doi: 10.1111/apt.14449. Epub 2017 Dec 4. | |
| 31945470 | Background |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Adalimumab | Drug | Adalimumab is an antiinflammatory drug (anti-TNF therapy) commonly used in treatment of ulcerative colitis |
|
| Percentage of patients achieving clinical remission | Partial Mayo score ≤2 with no subscore >1 (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity). | Three months after start of anti-TNF therapy |
| Percentage of patients achieving biochemical remission | Fecal Calprotectin <250 mg/kg | Three months after start of anti-TNF therapy |
| Percentage of patients achieving clinical remission | Partial Mayo score ≤2 with no subscore >1 (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity). | One year after start of anti-TNF therapy |
| Percentage of patients achieving biochemical remission | Fecal Calprotectin <250 mg/kg | One year after start of anti-TNF therapy |
| Percentage of patients achieving endoscopic response | A decrease in endoscopic Mayo score of 1 or more points (Endoscopic Mayoscore, range 0-3, with higher value indicating more severe disease activity). | 3-12 months after start of anti-TNF therapy |
| Percentage of patients achieving endoscopic remission | Endoscopic Mayo score 0-1 (Endoscopic Mayoscore, range 0-3, with higher value indicating more severe disease activity). | 3-12 months after start of anti-TNF therapy |
| Singh S, Murad MH, Fumery M, Dulai PS, Sandborn WJ. First- and Second-Line Pharmacotherapies for Patients With Moderate to Severely Active Ulcerative Colitis: An Updated Network Meta-Analysis. Clin Gastroenterol Hepatol. 2020 Sep;18(10):2179-2191.e6. doi: 10.1016/j.cgh.2020.01.008. Epub 2020 Jan 13. |
| 20500733 | Background | Gies N, Kroeker KI, Wong K, Fedorak RN. Treatment of ulcerative colitis with adalimumab or infliximab: long-term follow-up of a single-centre cohort. Aliment Pharmacol Ther. 2010 Aug;32(4):522-8. doi: 10.1111/j.1365-2036.2010.04380.x. Epub 2010 May 25. |
| 26986449 | Background | Sandborn WJ, Sakuraba A, Wang A, Macaulay D, Reichmann W, Wang S, Chao J, Skup M. Comparison of real-world outcomes of adalimumab and infliximab for patients with ulcerative colitis in the United States. Curr Med Res Opin. 2016 Jul;32(7):1233-41. doi: 10.1185/03007995.2016.1168290. Epub 2016 Mar 30. |
| 30329067 | Background | Pouillon L, Baumann C, Rousseau H, Choukour M, Andrianjafy C, Danese S, Peyrin-Biroulet L. Treatment Persistence of Infliximab Versus Adalimumab in Ulcerative Colitis: A 16-Year Single-Center Experience. Inflamm Bowel Dis. 2019 Apr 11;25(5):945-954. doi: 10.1093/ibd/izy322. |
| 32616683 | Background | Lee YI, Park Y, Park SJ, Kim TI, Kim WH, Cheon JH. Comparison of Long-Term Outcomes of Infliximab versus Adalimumab Treatment in Biologic-Naive Patients with Ulcerative Colitis. Gut Liver. 2021 Mar 15;15(2):232-242. doi: 10.5009/gnl19433. |
| 25389599 | Background | Ma C, Huang V, Fedorak DK, Kroeker KI, Dieleman LA, Halloran BP, Fedorak RN. Outpatient Ulcerative Colitis Primary Anti-TNF Responders Receiving Adalimumab or Infliximab Maintenance Therapy Have Similar Rates of Secondary Loss of Response. J Clin Gastroenterol. 2015 Sep;49(8):675-82. doi: 10.1097/MCG.0000000000000265. |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D061067 | Antibodies, Monoclonal, Humanized |