Comparison of the Pharmacokinetics of CT-P13 Between Crohn's Disease and Ulcerative Colitis
Authors
Eun Soo Kim ; Sung Kook Kim ; Dong Il Park ; Hyo Jong Kim ; Yoo Jin Lee ; Ja Seol Koo ; Eun Sun Kim ; Hyuk Yoon ; Ji Hyun Lee ; Ji Won Kim ; Sung Jae Shin ; Hyung Wook Kim ; Hyun-Soo Kim ; Young Sook Park ; You Sun Kim ; Tae Oh Kim ; Jun Lee ; Chang Hwan Choi ; Dong Soo Han ; Jaeyoung Chun ; Hyun Soo Kim ; IBD Research Group in the Korean Association for the Study of Intestinal Diseases
Citation
JOURNAL OF CLINICAL GASTROENTEROLOGY, Vol.57(6) : 601-609, 2023-07
Biosimilar Pharmaceuticals* / therapeutic use ; Colitis, Ulcerative* / chemically induced ; Colitis, Ulcerative* / drug therapy ; Crohn Disease* / drug therapy ; Gastrointestinal Agents / therapeutic use ; Humans ; Infliximab / therapeutic use ; Prospective Studies ; Remission Induction ; Treatment Outcome
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.