Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis

NCT06269185 | Completed FDA Drug

• 1 other identifier: 2024_IFXvsADAinUC
• Study Type: observational
• Target: 271
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Inflammatory Bowel Diseases

Keywords

infliximab; adalimumab; anti-TNF therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Percentage of patients achieving clinical response

  Three months after start of anti-TNF therapy

• Percentage of patients achieving clinical remission

  Three months after start of anti-TNF therapy

• Percentage of patients achieving biochemical remission

  Three months after start of anti-TNF therapy

• Percentage of patients achieving clinical remission

  One year after start of anti-TNF therapy

• Percentage of patients achieving biochemical remission

  One year after start of anti-TNF therapy

Other Outcomes (1)

• Remission rates in the subpopulations of UC-patients with severe, moderate and mild disease respectively

  Three months and one year after start of anti-TNF therapy

Study Arms (2)

Infliximab

Bio-naive patients with ulcerative colitis who starts treatment with infliximab

Drug: Infliximab

Adalimumab

Bio-naive patients with ulcerative colitis who starts treatment with adalimumab

Drug: Adalimumab

Interventions

Infliximab DRUG

Infliximab is an antiinflammatory drug (anti-TNF therapy) commonly used in treatment of ulcerative colitis

Infliximab

Adalimumab DRUG

Adalimumab is an antiinflammatory drug (anti-TNF therapy) commonly used in treatment of ulcerative colitis

Adalimumab

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Västra Götalandsregionen

Gothenburg, Sweden

Location

Related Publications (7)

• 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.

  PMID: 29205421 BACKGROUND

• 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.

  PMID: 31945470 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.

  PMID: 20500733 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.

  PMID: 26986449 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.

  PMID: 30329067 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.

  PMID: 32616683 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.

  PMID: 25389599 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Infliximab; Adalimumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized

Study Officials

• Börje Jonefjäll, PhD

  Sahlgrenska University Hospital / Mölndal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 21, 2024
• Study Start: March 6, 2024
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)