Comparison of the Pharmacokinetics of CT-P13 between Crohn's Disease and Ulcerative Colitis
- Authors
- Kim, E.S.; Kim, S.K.; Park, D.I.; Kim, H.J.; Lee, Y.J.; Koo, J.S.; Kim, E.S.; Yoon, H.; Lee, J.H.; Kim, J.W.; Shin, S.J.; Kim, H.W.; Kim, H.-S.; Park, Y.S.; Kim, Y.S.; Kim, T.O.; Lee, J.; Choi, C.H.; Han, D.S.; Chun, J.; Kim, H.S.
- Issue Date
- Jul-2023
- Publisher
- Lippincott Williams and Wilkins
- Keywords
- Crohn' s disease; CT-P13; pharmacokinetics; ulcerative colitis
- Citation
- Journal of Clinical Gastroenterology, v.57, no.6, pp.601 - 609
- Indexed
- SCIE
SCOPUS
- Journal Title
- Journal of Clinical Gastroenterology
- Volume
- 57
- Number
- 6
- Start Page
- 601
- End Page
- 609
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/192871
- DOI
- 10.1097/MCG.0000000000001715
- ISSN
- 0192-0790
- Abstract
- Background: We aimed to compare trough infliximab levels and the development of antidrug antibody (ADA) for 1 year between Crohn's disease (CD) and ulcerative colitis (UC) patients who were biologic-naive, and to evaluate their impact on clinical outcomes. Methods: This was a prospective, multicenter, observational study. Biologic-naive patients with moderate to severe CD or UC who started CT-P13, an infliximab biosimilar, therapy were enrolled. Trough drug and ADA levels were measured periodically for 1 year after CT-P13 initiation. Results: A total of 267 patients who received CT-P13 treatment were included (CD 168, UC 99). The rates of clinical remission (72% vs. 32.3%,P<0.001) at week 54 were significantly higher in CD than in UC. The median trough drug level (μg/mL) was significantly higher in CD than in UC up to week 14 (week 2, 18.7 vs. 14.7,P<0.001; week 6, 12.5 vs. 8.6,P<0.001; week 14, 3.4 vs. 2.5,P=0.001). The median ADA level (AU/mL) was significantly lower in CD than in UC at week 2 (6.3 vs. 6.5,P=0.046), week 30 (7.9 vs. 11.8,P=0.007), and week 54 (9.3 vs. 12.3,P=0.032). Development of ADA at week 2 [adjusted odds ratio (aOR)=0.15,P=0.026], initial C-reactive protein level (aOR=0.87,P=0.032), and CD over UC (aOR=1.92,P<0.001) were independent predictors of clinical remission at week 54. Conclusion: Infliximab shows more favorable pharmacokinetics, including high drug trough and low ADA levels, in CD than in UC, which might result in better clinical outcomes for 1-year infliximab treatment in CD patients.
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