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

Perrig, Kathrin; Krupka, Niklas; Jordi, Sebastian Bruno Ulrich; Rossel, Jean-Benoît; Biedermann, Luc; Greuter, Thomas; Schreiner, Philipp; Vavricka, Stephan R; Juillerat, Pascal; Burri, Emanuel; Zimmermann, Dorothee; Maillard, Michel H; Sulz, Michael Christian; Brand, Stephan; Rogler, Gerhard; Misselwitz, Benjamin (2022). Effectiveness of golimumab in patients with ulcerative colitis: results of a real-life study in Switzerland. Therapeutic advances in gastroenterology, 15, p. 17562848221074188. Sage 10.1177/17562848221074188

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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].

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine > Gastroenterology
04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine > Visceral Surgery
04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine

UniBE Contributor:

Krupka, Niklas, Jordi, Sebastian Bruno Ulrich, Juillerat, Pascal, Misselwitz, Benjamin

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1756-283X

Publisher:

Sage

Language:

English

Submitter:

Pubmed Import

Date Deposited:

21 Feb 2022 11:46

Last Modified:

05 Dec 2022 16:09

Publisher DOI:

10.1177/17562848221074188

PubMed ID:

35154389

Uncontrolled Keywords:

TNF inhibitor golimumab inflammatory bowel disease ulcerative colitis

BORIS DOI:

10.48350/165819

URI:

https://boris.unibe.ch/id/eprint/165819

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