Clinical trial NCT06269185: Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis
Official title: Comparison of Short and Long-term Efficacy Between Infliximab and Adalimumab on Patients With Ulcerative Colitis - a Retrospective Observational Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Inflammatory Bowel Diseases
Keywords: infliximab
adalimumab
anti-TNF therapy
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2024-02-21
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age 18-100 years.
* Diagnosis of ulcerative colitis confirmed by endoscopy and histology.
* Mild, moderate and severe disease activity.
* Initiation of IFX or ADA-treatment at one of the centers of the study.

Exclusion Criteria:

* Clinical remission.
* Previous colonic surgery (resection of colonic segment or colectomy).
* Primary indication for anti-TNF therapy by other disease than UC.
* Prior use of any anti-TNF or other biologic or small molecule therapy.
* Rescue therapy (i.e. infliximab used on hospitalized patients receiving intravenous corticosteroids).

Primary outcomes:
measure: Percentage of patients achieving steroid-free clinical remission
timeFrame: One year after start of anti-TNF therapy
Secondary outcomes:
measure: Percentage of patients achieving clinical response
timeFrame: Three months after start of anti-TNF therapy
measure: Percentage of patients achieving clinical remission
timeFrame: Three months after start of anti-TNF therapy
measure: Percentage of patients achieving biochemical remission
timeFrame: Three months after start of anti-TNF therapy
measure: Percentage of patients achieving clinical remission
timeFrame: One year after start of anti-TNF therapy
measure: Percentage of patients achieving biochemical remission
timeFrame: One year after start of anti-TNF therapy
measure: Percentage of patients achieving endoscopic response
timeFrame: 3-12 months after start of anti-TNF therapy
measure: Percentage of patients achieving endoscopic remission
timeFrame: 3-12 months after start of anti-TNF therapy
Other outcomes:
measure: Remission rates in the subpopulations of UC-patients with severe, moderate and mild disease respectively
timeFrame: Three months and one year after start of anti-TNF therapy
Locations:
city: Göteborg
country: Sweden
facility: Västra Götalandsregionen
Study officials:
affiliation: Sahlgrenska University Hospital / Mölndal
name: Börje Jonefjäll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.