Gut Liver.
2022 Sep;16(5):764-774. 10.5009/gnl210335.
Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study
- Affiliations
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- 1Department of Internal Medicine and Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea
- 2Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea
- 3Department of Internal Medicine, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang, Korea
- 4Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
- 5Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea
- 6Department of Gastroenterology and Inflammatory Bowel Disease Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
- 7Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Korea
- 8Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea
- 9Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea
- 10Kyungpook National University Hospital, Daegu, Korea
- 11Medical Affairs, Janssen Korea Ltd.
- 12Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea
- KMID: 2533185
- DOI: http://doi.org/10.5009/gnl210335
Abstract
- Background/Aims
Golimumab has been used for patients with ulcerative colitis (UC) since 2013. However, there is limited data on the effectiveness and safety of the real-world use of golimumab in Asian patients.
Methods
This was a multicenter, prospective, observational study. We enrolled patients with moderate-to-severe UC who were administered subcutaneous golimumab at 46 medical centers between May 2014 and November 2019. The primary outcome was the effectiveness and safety of golimumab at week 22. Clinical outcomes and adverse events were assessed according to partial Mayo score at weeks 0, 2, 6, 14, and 22.
Results
A total of 130 patients were included (mean age: 45.7±16.0 years). The clinical response/ remission rates at weeks 2, 6, 14, and 22 were 40.4%/22.9%, 56.0%/35.8%, 70.6%/49.5%, and 67.9%/48.6%, respectively. Based on full Mayo score at week 14, clinical response and remission rates were 84.2% and 39.5%, respectively. Mucosal healing rate was 65.8%. In multivariate analysis with logistic regression, longer disease duration was significantly associated with a higher clinical response rate (adjusted odds ratio [aOR], 1.136; 95% confidence interval [CI], 1.006 to 1.282; p=0.040 at week 6; aOR, 1.256; 95% CI, 1.049 to 1.503; p=0.013 at week 22). A higher baseline Mayo endoscopic subscore was significantly associated with a lower clinical response rate at week 6 (aOR, 0.248; 95% CI, 0.089 to 0.692; p=0.008). The incidence of adverse drug reactions was 4.6% (6/130, nine events). No serious unexpected adverse drug reactions or deaths were reported.
Conclusions
Golimumab was effective and safe as an induction and maintenance treatment for Korean patients with moderate-to-severe UC.
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