Effectiveness of Golimumab in Patients With Ulcerative Colitis: Results of a Real-life Study in Switzerland

NCT ID: NCT05405465

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-06-01

Brief Summary

TNF inhibitors have improved treatment options for patients with inflammatory bowel disease (IBD) and three TNF inhibitors, infliximab, adalimumab and golimumab are available for treatment of ulcerative colitis in Switzerland. However, these drugs have been tested under ideal conditions in randomized controlled trials. Real-world data are needed to complement this information. It is the aim of the investigators to study, whether patients with ulcerative colitis can be effectively treated with golimumab in a real world setting in Switzerland.

The investigators used data from the Swiss IBD cohort study (SIBDC) in Switzerland and identified all SIBDC patients with UC treated with Golimumab and performed a retrospective chart review. The investigators acquired patient reported outcomes and objective measures for inflammation at baseline, at 6-10 weeks and at 6 and 12 months after golimumab treatment. Primary endpoint was clinical response (i.e. meaningful improvement) at 6-10 weeks. Secondary endpoints were clinical response at 6 and 12 months and clinical remission (i.e. free of symptoms of disease).

Detailed Description

Ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab were identified. The investigators performed a retrospective chart review and assessed patient reported outcomes and objective measures of inflammation to assess response and remission.

As clinical response in UC the investigators defined a composite end point of: Marked improvement in partial Mayo score AND improvement in one or more of the following parameters (acquired during chart review):

• Endoscopy data
• Ultrasonography
• Calprotectin (cut off 100microg/g)
• CRP
• Anemia resolution

Marked improvement was defined as: Clinical response based on partial Mayo Score (including physician global assessment): decrease in partial Mayo score ≥ 2 points and ≥ 30% from baseline and a decrease in rectal bleeding subscore ≥ 1 point or absolute rectal bleeding score ≤ 1. Improvement in lab work was defined as a reduction of the difference between baseline values and the next limit of normal by ≥ 30%. Improvement in endoscopy/ ultrasonography was defined as a reduction of colitis in the same technique compared to baseline substantiated by images (endoscopy) or measurements of diameter of the bowel wall.

As clinical remission in UC we defined normalization (i.e. absence of pathology) of patient reported outcomes (Frequency of stool, blood in stool) AND no evidence of residual disease activity in all of the following parameters:

• Endoscopy data
• Ultrasonography
• Calprotectin (cut off 100microg/g)
• CRP and anemia

Conditions

Ulcerative Colitis; Flare Up, Symptom

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

UC patients with exposure to golimumab

The investigators retrospectively analyzed all ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab.

Exposure to golimumab

Intervention Type: DRUG

Retrospective chart review to assess patient related outcomes and objective measures of inflammation at baseline, 6-10 weeks, 6 months, 12 months.

Interventions

Exposure to golimumab

Retrospective chart review to assess patient related outcomes and objective measures of inflammation at baseline, 6-10 weeks, 6 months, 12 months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient of the Swiss IBD cohort study
• Diagnosis of ulcerative colitis
• Past treatment with golimumab (at least one dose)

Exclusion Criteria

• none

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Gastroenterology, University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

Golimumab Real-world study

Identifier Type: -

Identifier Source: org_study_id