Therapeutic Advances in Gastroenterology (Feb 2022)

Effectiveness of golimumab in patients with ulcerative colitis: results of a real-life study in Switzerland

  • Kathrin Perrig,
  • Niklas Krupka,
  • Sebastian Bruno Ulrich Jordi,
  • Jean-Benoît Rossel,
  • Luc Biedermann,
  • Thomas Greuter,
  • Philipp Schreiner,
  • Stephan R. Vavricka,
  • Pascal Juillerat,
  • Emanuel Burri,
  • Dorothee Zimmermann,
  • Michel H. Maillard,
  • Michael Christian Sulz,
  • Stephan Brand,
  • Gerhard Rogler,
  • Benjamin Misselwitz

DOI
https://doi.org/10.1177/17562848221074188
Journal volume & issue
Vol. 15

Abstract

Read online

Background: Tumor necrosis factor (TNF) inhibitors have improved treatment of ulcerative colitis (UC), but loss of response remains a frequent problem. The anti-TNF agent, golimumab, was approved in Switzerland for the treatment of UC in 2014. This study aims to summarize the experience of golimumab in a real-world setting in Switzerland. Methods: We analyzed real-world data from 1769 UC patients from the Swiss Inflammatory Bowel Disease Cohort (SIBDC) study and performed a chart review of golimumab-treated patients. We extracted the partial Mayo score at t 0 (baseline), t 1 (2–16 weeks), t 2 (17–35 weeks), and t 3 (36–89 weeks). The primary endpoint was clinical response at t 1 , defined as marked improvement in partial Mayo score and objective parameters. Clinical remission was defined as resolution of symptoms and normalization of objective parameters. Results: Our chart review included 103 UC patients with golimumab treatment (5.8% of all SIBDC UC patients); only 16 (15.5%) were anti-TNF naïve. Sixty-three patients remained on golimumab (61.2%) after 180 days, 51 (44.7%) after 365 days, and 34 (33%) after 630 days after the start of treatment. Upon golimumab treatment, the partial Mayo score decreased from 4 [interquartile range (IQR): 2–6] at t 0 to 2 (IQR: 0–4) at t 1 , 1 (IQR: 0–3.5) at t 2 , and 1 (IQR: 0–3) at t 3 ( p < 0.001 for all comparisons with t 0 ). The primary endpoint, clinical response at t 1 , could be evaluated in 52 patients and was met in 15 individuals (28.8%). Clinical remission at t 1 was observed in 8 out of 52 patients (15.4%). Golimumab was generally well tolerated, one patient developed meningitis. The most frequent reasons to stop treatment were primary and secondary non-response. Conclusion: Golimumab was used in 5.8% of Swiss UC patients, mainly in biologic-experienced individuals. Golimumab treatment was associated with a sustained reduction of symptoms and clinical response in approximately 30% of patients. [ClinicalTrials.gov identifier: NCT00488631]