Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Comparison of Short and Long-term Efficacy Between Infliximab and Adalimumab on Patients With Ulcerative Colitis - a Retrospective Observational Multicenter Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06269185
• Other study ID #: 2024_IFXvsADAinUC
• Status: Recruiting
• Start date: March 6, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Vastra Gotaland Region
• Contact: Börje Jonefjäll, PhD
• Phone: +46703753933
• Email: borje.jonefjall[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Sweden	Västra Götalandsregionen	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	Percentage of patients achieving biochemical remission	Fecal Calprotectin <250 mg/kg	Three months after start of anti-TNF therapy
Secondary	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
Secondary	Percentage of patients achieving biochemical remission	Fecal Calprotectin <250 mg/kg	One year after start of anti-TNF therapy
Secondary	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
Secondary	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