Population Pharmacokinetic Model for the Use of Intravenous or Subcutaneous Infliximab in Patients with Inflammatory Bowel Disease: Real-World Data from a Prospective Cohort Study
Background/Aims: Infliximab treatment failure in patients with inflammatory bowel disease may result from sub-optimal infliximab trough level. An understanding of pharmacokinetics (PKs) is important to maintain an optimal trough level. PK studies of the switch to subcutaneous (SC) infliximab from in...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Gastroenterology Council for Gut and Liver
2025-05-01
|
| Series: | Gut and Liver |
| Subjects: | |
| Online Access: | http://gutnliver.org/journal/view.html?doi=10.5009/gnl240503 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849312789632385024 |
|---|---|
| author | Joo Hye Song Sung Noh Hong Myeong Gyu Kim Minjung Kim Seong Kyung Kim Eun Ran Kim Dong Kyung Chang Young-Ho Kim |
| author_facet | Joo Hye Song Sung Noh Hong Myeong Gyu Kim Minjung Kim Seong Kyung Kim Eun Ran Kim Dong Kyung Chang Young-Ho Kim |
| author_sort | Joo Hye Song |
| collection | DOAJ |
| description | Background/Aims: Infliximab treatment failure in patients with inflammatory bowel disease may result from sub-optimal infliximab trough level. An understanding of pharmacokinetics (PKs) is important to maintain an optimal trough level. PK studies of the switch to subcutaneous (SC) infliximab from intravenous (IV) infliximab using real-world data are lacking. We aimed to develop a population PK model of IV and SC infliximab to predict individual infliximab exposure during maintenance therapy. Methods: We used data from prospectively collected data on IV and SC infliximab concentrations in patients with inflammatory bowel disease receiving maintenance treatment from February 2020 to December 2022 at Samsung Medical Center. Population PK analysis was conducted by using a two-compartment model with first-order absorption and first-order elimination. Goodness-of-fit plots and visual predictive check were used to evaluate the PK model. Results: A total of 2,132 samples from 181 patients (149 Crohn’s disease and 32 ulcerative colitis) were analyzed. We developed an infliximab population PK model using body mass index, albumin, C-reactive protein level, and the anti-drug antibody level and validated its predictive performance. Conclusions: It may be possible to predict the infliximab trough level of both IV and SC infliximab in patients with inflammatory bowel disease during maintenance treatment by using our model in real-world practice. |
| format | Article |
| id | doaj-art-0fa0aec7a1cd4871b1a0251fef54300a |
| institution | Kabale University |
| issn | 1976-2283 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Gastroenterology Council for Gut and Liver |
| record_format | Article |
| series | Gut and Liver |
| spelling | doaj-art-0fa0aec7a1cd4871b1a0251fef54300a2025-08-20T03:52:57ZengGastroenterology Council for Gut and LiverGut and Liver1976-22832025-05-0119337638710.5009/gnl240503gnl240503Population Pharmacokinetic Model for the Use of Intravenous or Subcutaneous Infliximab in Patients with Inflammatory Bowel Disease: Real-World Data from a Prospective Cohort StudyJoo Hye Song0Sung Noh Hong1Myeong Gyu Kim2Minjung Kim3Seong Kyung Kim4Eun Ran Kim5Dong Kyung Chang6Young-Ho Kim7Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, KoreaDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, KoreaCollege of Pharmacy, Graduate School of Pharmaceutical Sciences, Ewha Womans University, Seoul, KoreaCollege of Pharmacy, Graduate School of Pharmaceutical Sciences, Ewha Womans University, Seoul, KoreaCollege of Pharmacy, Graduate School of Pharmaceutical Sciences, Ewha Womans University, Seoul, KoreaDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, KoreaDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, KoreaDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, KoreaBackground/Aims: Infliximab treatment failure in patients with inflammatory bowel disease may result from sub-optimal infliximab trough level. An understanding of pharmacokinetics (PKs) is important to maintain an optimal trough level. PK studies of the switch to subcutaneous (SC) infliximab from intravenous (IV) infliximab using real-world data are lacking. We aimed to develop a population PK model of IV and SC infliximab to predict individual infliximab exposure during maintenance therapy. Methods: We used data from prospectively collected data on IV and SC infliximab concentrations in patients with inflammatory bowel disease receiving maintenance treatment from February 2020 to December 2022 at Samsung Medical Center. Population PK analysis was conducted by using a two-compartment model with first-order absorption and first-order elimination. Goodness-of-fit plots and visual predictive check were used to evaluate the PK model. Results: A total of 2,132 samples from 181 patients (149 Crohn’s disease and 32 ulcerative colitis) were analyzed. We developed an infliximab population PK model using body mass index, albumin, C-reactive protein level, and the anti-drug antibody level and validated its predictive performance. Conclusions: It may be possible to predict the infliximab trough level of both IV and SC infliximab in patients with inflammatory bowel disease during maintenance treatment by using our model in real-world practice.http://gutnliver.org/journal/view.html?doi=10.5009/gnl240503infliximab; pharmacokinetic model; intravenous; subcutaneous; inflammatory bowel diseases |
| spellingShingle | Joo Hye Song Sung Noh Hong Myeong Gyu Kim Minjung Kim Seong Kyung Kim Eun Ran Kim Dong Kyung Chang Young-Ho Kim Population Pharmacokinetic Model for the Use of Intravenous or Subcutaneous Infliximab in Patients with Inflammatory Bowel Disease: Real-World Data from a Prospective Cohort Study Gut and Liver infliximab; pharmacokinetic model; intravenous; subcutaneous; inflammatory bowel diseases |
| title | Population Pharmacokinetic Model for the Use of Intravenous or Subcutaneous Infliximab in Patients with Inflammatory Bowel Disease: Real-World Data from a Prospective Cohort Study |
| title_full | Population Pharmacokinetic Model for the Use of Intravenous or Subcutaneous Infliximab in Patients with Inflammatory Bowel Disease: Real-World Data from a Prospective Cohort Study |
| title_fullStr | Population Pharmacokinetic Model for the Use of Intravenous or Subcutaneous Infliximab in Patients with Inflammatory Bowel Disease: Real-World Data from a Prospective Cohort Study |
| title_full_unstemmed | Population Pharmacokinetic Model for the Use of Intravenous or Subcutaneous Infliximab in Patients with Inflammatory Bowel Disease: Real-World Data from a Prospective Cohort Study |
| title_short | Population Pharmacokinetic Model for the Use of Intravenous or Subcutaneous Infliximab in Patients with Inflammatory Bowel Disease: Real-World Data from a Prospective Cohort Study |
| title_sort | population pharmacokinetic model for the use of intravenous or subcutaneous infliximab in patients with inflammatory bowel disease real world data from a prospective cohort study |
| topic | infliximab; pharmacokinetic model; intravenous; subcutaneous; inflammatory bowel diseases |
| url | http://gutnliver.org/journal/view.html?doi=10.5009/gnl240503 |
| work_keys_str_mv | AT joohyesong populationpharmacokineticmodelfortheuseofintravenousorsubcutaneousinfliximabinpatientswithinflammatoryboweldiseaserealworlddatafromaprospectivecohortstudy AT sungnohhong populationpharmacokineticmodelfortheuseofintravenousorsubcutaneousinfliximabinpatientswithinflammatoryboweldiseaserealworlddatafromaprospectivecohortstudy AT myeonggyukim populationpharmacokineticmodelfortheuseofintravenousorsubcutaneousinfliximabinpatientswithinflammatoryboweldiseaserealworlddatafromaprospectivecohortstudy AT minjungkim populationpharmacokineticmodelfortheuseofintravenousorsubcutaneousinfliximabinpatientswithinflammatoryboweldiseaserealworlddatafromaprospectivecohortstudy AT seongkyungkim populationpharmacokineticmodelfortheuseofintravenousorsubcutaneousinfliximabinpatientswithinflammatoryboweldiseaserealworlddatafromaprospectivecohortstudy AT eunrankim populationpharmacokineticmodelfortheuseofintravenousorsubcutaneousinfliximabinpatientswithinflammatoryboweldiseaserealworlddatafromaprospectivecohortstudy AT dongkyungchang populationpharmacokineticmodelfortheuseofintravenousorsubcutaneousinfliximabinpatientswithinflammatoryboweldiseaserealworlddatafromaprospectivecohortstudy AT younghokim populationpharmacokineticmodelfortheuseofintravenousorsubcutaneousinfliximabinpatientswithinflammatoryboweldiseaserealworlddatafromaprospectivecohortstudy |