Anti-tumor Necrosis Factor Drug Concentration Is Not Associated with Disease Outcomes in Pouchitis: A Retrospective, International Study

International Consortium for Therapeutic Drug Monitoring (spECTRUM)

doi:10.1007/s10620-024-08821-y

Anti-tumor Necrosis Factor Drug Concentration Is Not Associated with Disease Outcomes in Pouchitis: A Retrospective, International Study

International Consortium for Therapeutic Drug Monitoring (spECTRUM)

Research output: Contribution to journal › Article › peer-review

Abstract

BACKGROUND: Therapeutic drug monitoring is important for optimizing anti-tumor necrosis factor-α (TNF-α) therapy in inflammatory bowel disease. However, the exposure-response relationship has never been assessed in pouchitis.

AIMS: To explore associations between anti-TNF-α drug concentration and pouchitis disease activity in patients with a background of ulcerative colitis.

METHODS: A retrospective, multicenter, cross-sectional study was conducted in adult patients with pouchitis requiring anti-TNF-α treatment. Rates of clinical and endoscopic remission were calculated, and drug concentrations during maintenance therapy were compared between remission and non-remission cohorts.

RESULTS: Sixty-three patients were included: median age, 48 years (IQR 36-59) and median time since pouchitis diagnosis, 7 years (IQR 2-13). Patients received infliximab, n = 27 (43%), adalimumab, n = 29 (46%), or both n = 7 (11%). Thirty-two (51%) patients received concomitant immunomodulation. Median infliximab trough concentrations (mg/ml) were similar between patients in clinical remission (n = 21) vs non-remission (n = 11), 5.3 vs. 4.4, p = 0.73. For adalimumab, median drug concentrations did not significantly differ between remission/non-remission groups based on clinical (n = 18/18), 11.4 vs 7.6, p = 0.32, or endoscopic assessment, (n = 7/29), 9.0 vs. 7.8, p = 0.78. Four patients had positive anti-drug antibodies with undetectable drug concentration.

CONCLUSION: In a cohort of patients with pouchitis, higher anti-TNF-α drug concentrations were not associated with more clinical or endoscopic remission.

Original language	English
Journal	Digestive Diseases and Sciences
DOIs	https://doi.org/10.1007/s10620-024-08821-y
Publication status	E-pub ahead of print - 27 Jan 2025

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10.1007/s10620-024-08821-y

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@article{8462a156f70f4125bd13b5186c4b8373,

title = "Anti-tumor Necrosis Factor Drug Concentration Is Not Associated with Disease Outcomes in Pouchitis: A Retrospective, International Study",

abstract = "BACKGROUND: Therapeutic drug monitoring is important for optimizing anti-tumor necrosis factor-α (TNF-α) therapy in inflammatory bowel disease. However, the exposure-response relationship has never been assessed in pouchitis.AIMS: To explore associations between anti-TNF-α drug concentration and pouchitis disease activity in patients with a background of ulcerative colitis.METHODS: A retrospective, multicenter, cross-sectional study was conducted in adult patients with pouchitis requiring anti-TNF-α treatment. Rates of clinical and endoscopic remission were calculated, and drug concentrations during maintenance therapy were compared between remission and non-remission cohorts.RESULTS: Sixty-three patients were included: median age, 48 years (IQR 36-59) and median time since pouchitis diagnosis, 7 years (IQR 2-13). Patients received infliximab, n = 27 (43%), adalimumab, n = 29 (46%), or both n = 7 (11%). Thirty-two (51%) patients received concomitant immunomodulation. Median infliximab trough concentrations (mg/ml) were similar between patients in clinical remission (n = 21) vs non-remission (n = 11), 5.3 vs. 4.4, p = 0.73. For adalimumab, median drug concentrations did not significantly differ between remission/non-remission groups based on clinical (n = 18/18), 11.4 vs 7.6, p = 0.32, or endoscopic assessment, (n = 7/29), 9.0 vs. 7.8, p = 0.78. Four patients had positive anti-drug antibodies with undetectable drug concentration.CONCLUSION: In a cohort of patients with pouchitis, higher anti-TNF-α drug concentrations were not associated with more clinical or endoscopic remission.",

author = "{International Consortium for Therapeutic Drug Monitoring (spECTRUM)} and Sailish Honap and B{\'e}n{\'e}dicte Caron and Ollech, {Jacob E} and Maya Fischman and Konstantinos Papamichael and {De Jong}, Djuna and Gecse, {Krisztina B} and Andrea Centritto and Samaan, {Mark A} and Irving, {Peter M} and Sparrow, {Miles P} and Konstantinos Karmiris and Thomas Chateau and Iris Dotan and Laurent Peyrin-Biroulet",

note = "{\textcopyright} 2025. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.",

year = "2025",

month = jan,

day = "27",

doi = "10.1007/s10620-024-08821-y",

language = "English",

journal = "Digestive Diseases and Sciences",

issn = "0163-2116",

publisher = "Springer New York LLC",

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TY - JOUR

T1 - Anti-tumor Necrosis Factor Drug Concentration Is Not Associated with Disease Outcomes in Pouchitis

T2 - A Retrospective, International Study

AU - International Consortium for Therapeutic Drug Monitoring (spECTRUM)

AU - Honap, Sailish

AU - Caron, Bénédicte

AU - Ollech, Jacob E

AU - Fischman, Maya

AU - Papamichael, Konstantinos

AU - De Jong, Djuna

AU - Gecse, Krisztina B

AU - Centritto, Andrea

AU - Samaan, Mark A

AU - Irving, Peter M

AU - Sparrow, Miles P

AU - Karmiris, Konstantinos

AU - Chateau, Thomas

AU - Dotan, Iris

AU - Peyrin-Biroulet, Laurent

PY - 2025/1/27

Y1 - 2025/1/27

N2 - BACKGROUND: Therapeutic drug monitoring is important for optimizing anti-tumor necrosis factor-α (TNF-α) therapy in inflammatory bowel disease. However, the exposure-response relationship has never been assessed in pouchitis.AIMS: To explore associations between anti-TNF-α drug concentration and pouchitis disease activity in patients with a background of ulcerative colitis.METHODS: A retrospective, multicenter, cross-sectional study was conducted in adult patients with pouchitis requiring anti-TNF-α treatment. Rates of clinical and endoscopic remission were calculated, and drug concentrations during maintenance therapy were compared between remission and non-remission cohorts.RESULTS: Sixty-three patients were included: median age, 48 years (IQR 36-59) and median time since pouchitis diagnosis, 7 years (IQR 2-13). Patients received infliximab, n = 27 (43%), adalimumab, n = 29 (46%), or both n = 7 (11%). Thirty-two (51%) patients received concomitant immunomodulation. Median infliximab trough concentrations (mg/ml) were similar between patients in clinical remission (n = 21) vs non-remission (n = 11), 5.3 vs. 4.4, p = 0.73. For adalimumab, median drug concentrations did not significantly differ between remission/non-remission groups based on clinical (n = 18/18), 11.4 vs 7.6, p = 0.32, or endoscopic assessment, (n = 7/29), 9.0 vs. 7.8, p = 0.78. Four patients had positive anti-drug antibodies with undetectable drug concentration.CONCLUSION: In a cohort of patients with pouchitis, higher anti-TNF-α drug concentrations were not associated with more clinical or endoscopic remission.

AB - BACKGROUND: Therapeutic drug monitoring is important for optimizing anti-tumor necrosis factor-α (TNF-α) therapy in inflammatory bowel disease. However, the exposure-response relationship has never been assessed in pouchitis.AIMS: To explore associations between anti-TNF-α drug concentration and pouchitis disease activity in patients with a background of ulcerative colitis.METHODS: A retrospective, multicenter, cross-sectional study was conducted in adult patients with pouchitis requiring anti-TNF-α treatment. Rates of clinical and endoscopic remission were calculated, and drug concentrations during maintenance therapy were compared between remission and non-remission cohorts.RESULTS: Sixty-three patients were included: median age, 48 years (IQR 36-59) and median time since pouchitis diagnosis, 7 years (IQR 2-13). Patients received infliximab, n = 27 (43%), adalimumab, n = 29 (46%), or both n = 7 (11%). Thirty-two (51%) patients received concomitant immunomodulation. Median infliximab trough concentrations (mg/ml) were similar between patients in clinical remission (n = 21) vs non-remission (n = 11), 5.3 vs. 4.4, p = 0.73. For adalimumab, median drug concentrations did not significantly differ between remission/non-remission groups based on clinical (n = 18/18), 11.4 vs 7.6, p = 0.32, or endoscopic assessment, (n = 7/29), 9.0 vs. 7.8, p = 0.78. Four patients had positive anti-drug antibodies with undetectable drug concentration.CONCLUSION: In a cohort of patients with pouchitis, higher anti-TNF-α drug concentrations were not associated with more clinical or endoscopic remission.

UR - http://www.scopus.com/inward/record.url?scp=85217575674&partnerID=8YFLogxK

U2 - 10.1007/s10620-024-08821-y

DO - 10.1007/s10620-024-08821-y

M3 - Article

C2 - 39869163

SN - 0163-2116

JO - Digestive Diseases and Sciences

JF - Digestive Diseases and Sciences

ER -

Anti-tumor Necrosis Factor Drug Concentration Is Not Associated with Disease Outcomes in Pouchitis: A Retrospective, International Study

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