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

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).

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis; Flare Up, Symptom
• Intervention / Treatment: Drug: Exposure to golimumab

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

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Division of Gastroenterology, University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from the Swiss IBD cohort study with ulcerative colitis treated with golimumab.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
UC patients with exposure to golimumab; The investigators retrospectively analyzed all ulcerative colitis patients from the Swiss IBD cohort study treated with golimumab.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response at week 6-10	Clinical response at week 6-10	6-10 weeks after first golimumab dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response at 6 months	Clinical response at 6 months	6 months after first golimumab dose
Response at 12 months	Clinical response at 12 months	12 months after first golimumab dose
Remission at week 6-10	Clinical remission at week 6-10	6-10 weeks after first golimumab dose
Remission at 12 months	Clinical remission at 12 months	12 months after first golimumab dose
Remission at 6 months	Clinical remission at 6 months	6 months after first golimumab dose

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Golimumab; Clinical Response; Clinical Remission; TNF-inhibitors
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Recurrence; Ulcer; Colitis; Colitis, Ulcerative; Symptom Flare Up; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Tumor Necrosis Factor Inhibitors; Golimumab
• Other Study ID Numbers: Golimumab Real-world study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No