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:10.1177/17562848221074188

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

Therap Adv Gastroenterol. 2022 Feb 9:15:17562848221074188. doi: 10.1177/17562848221074188. eCollection 2022.

Authors

Kathrin Perrig¹, Niklas Krupka², Sebastian Bruno Ulrich Jordi³, Jean-Benoît Rossel⁴, Luc Biedermann¹, Thomas Greuter¹, Philipp Schreiner¹, Stephan R Vavricka⁵, Pascal Juillerat², Emanuel Burri⁶, Dorothee Zimmermann⁷, Michel H Maillard⁸, Michael Christian Sulz⁹, Stephan Brand¹⁰, Gerhard Rogler¹, Benjamin Misselwitz¹¹

Affiliations

¹ Department of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
² Department of Visceral Surgery and Medicine, Inselspital Bern University Hospital, University of Bern, Bern, Switzerland.
³ Department of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, SwitzerlandDepartment of Visceral Surgery and Medicine, Inselspital Bern University Hospital, University of Bern, Bern, Switzerland.
⁴ Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
⁵ Center of Gastroenterology and Hepatology, Zurich, Switzerland.
⁶ Department of Gastroenterology and Hepatology, University Medical Clinic, Kantonsspital Baselland, Liestal, Switzerland.
⁷ Department of Gastroenterology, Kantonsspital Nidwalden, Stans, Switzerland.
⁸ Service of Gastroenterology and Hepatology, Lausanne University Hospital, Lausanne, Switzerland; Crohn and Colitis Center, Gastroentérologie Beaulieu SA, Lausanne, Switzerland.
⁹ Department of Gastroenterology, Kantonsspital Münsterlingen, Münsterlingen, Switzerland.
¹⁰ Department of Gastroenterology and Hepatology, Kantonsspital St. Gallen, St. Gallen, Switzerland.
¹¹ Department of Visceral Surgery and Medicine, Inselspital Bern University Hospital, University of Bern, Freiburgstr. 18, 3010 Bern, Switzerland.

Abstract

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 t₀ (baseline), t₁ (2-16 weeks), t₂ (17-35 weeks), and t₃ (36-89 weeks). The primary endpoint was clinical response at t₁, 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 t₀ to 2 (IQR: 0-4) at t₁, 1 (IQR: 0-3.5) at t₂, and 1 (IQR: 0-3) at t₃ (p < 0.001 for all comparisons with t₀). The primary endpoint, clinical response at t₁, could be evaluated in 52 patients and was met in 15 individuals (28.8%). Clinical remission at t₁ 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].

Keywords: TNF inhibitor; golimumab; inflammatory bowel disease; ulcerative colitis.

Associated data

ClinicalTrials.gov/NCT00488631