Infliximab Exposure Associates With Radiologic Evidence of Healing in Patients With Crohn’s Disease
| Autor: | Severine Vermeire, Valérie Laurent, Anthony Buisson, Guy Lambrecht, Edouard Louis, Céline Savoye-Collet, Hedia Brixi, Sylvie Chevret, Laurent Peyrin-Biroulet, Filip Baert, Marieke Pierik, Jordi Rimola, Matthieu Allez, Philippe Van Hootegem, Philip Caenepeel, Alexandre Aubourg, Jérôme Filippi, Benjamin Pariente, Magaly Zappa, Jacques Moreau, Peter Bossuyt, Geert R. D'Haens, Yoram Bouhnik, Janneke van der Woude, David Laharie, Martine De Vos, Ragna Vanslembrouck, Yves De Bruecker, Sofie Devuysere, Denis Franchimont, Fazia Mana, Bas Oldenburg, Erwin Dreesen |
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| Přispěvatelé: | Service d'imagerie médicale [CHU Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Equipe Quantification en Imagerie Fonctionnelle (QuantIF-LITIS), Laboratoire d'Informatique, de Traitement de l'Information et des Systèmes (LITIS), Université Le Havre Normandie (ULH), Normandie Université (NU)-Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Université Le Havre Normandie (ULH), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA), Gastroenterology and Hepatology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male musculoskeletal diseases medicine.medical_specialty TAILORIX [SDV]Life Sciences [q-bio] education Anti-TNF Agent anti-TNF agent Gastroenterology 03 medical and health sciences 0302 clinical medicine Crohn Disease Gastrointestinal Agents Interquartile range response to therapy Internal medicine medicine Humans Prospective Studies prognostic factor Response to Therapy Crohn's disease Hepatology Receiver operating characteristic business.industry Prognostic Factor Area under the curve Biomarker Middle Aged medicine.disease Magnetic Resonance Imaging Infliximab 3. Good health Treatment Outcome 030220 oncology & carcinogenesis Pharmacodynamics Biomarker (medicine) Trough level biomarker 030211 gastroenterology & hepatology Female business medicine.drug |
| Zdroj: | Clinical Gastroenterology and Hepatology Clinical Gastroenterology and Hepatology, WB Saunders, 2021, 19 (5), pp.947-954 e2. ⟨10.1016/j.cgh.2020.04.052⟩ Clinical gastroenterology and hepatology, 19(5), 947-954.e2. W.B. Saunders Ltd |
| ISSN: | 1542-3565 |
| Popis: | BACKGROUND & AIMS: Higher infliximab trough levels are associated with clinical and endoscopic remission in patients with Crohn's disease (CD). We investigated pharmacodynamic features of infliximab and radiological healing. METHODS: We performed a substudy of the TAILORIX trial (patients with active luminal CD in Europe, treated with infliximab), analyzing baseline and week 54 magnetic resonance enterography (MRE) data. MREs were scored using the MaRIA score by blinded central readers. Radiologic response and remission were defined, based on MaRIA criteria in all segments, as scores below 11 and 7, respectively. We collected data on infliximab trough levels, biomarkers, and endoscopic findings. Our primary aim was to evaluate pharmacodynamic features associated with radiologic response and remission, based on MRE assessments at baseline and at 54 weeks after initiation of infliximab therapy. RESULTS: We analyzed data from 36 patients (50% female; median age 35.7 years; interquartile age range, 25.6-48.6 years; median disease duration, 1.5 months; interquartile duration range, 0.6-22.4 months). At week 54 of treatment, 36.4% of patients had a radiologic response, 30.3% of patients were in remission, and 71% had endoscopic features of remission. At baseline, there was a correlation between the CD endoscopic index of severity and MaRIA scores (κ = 0.46; P = .008), but we found no correlation at week 54 (κ = 0.06; P = .75). Radiologic remission correlated with infliximab trough level at week 14 (P = .049) when the infliximab trough level cut-off value was set at 7.8 μg/mL (area under the curve, 0.74; 75% sensitivity; 86% specificity; 90% negative predictive value; 57% positive predictive value). Radiologic response correlated with infliximab trough levels at week 14 (P = .048) when the infliximab trough level cut-off value was set at 7.8 μg/mL (area under the curve, 0.73; 70% sensitivity; 90% specificity; 86% negative predictive value; 78% positive predictive value) and with continuous pharmacologic evidence of response (infliximab trough levels above 5.0 μg/mL at all time points) (P = .034). CONCLUSIONS: In a substudy of data from the TAILORIX trial of patients with active luminal CD, we identified a relationship between exposure to infliximab and radiologic evidence of outcomes. ispartof: CLINICAL GASTROENTEROLOGY AND HEPATOLOGY vol:19 issue:5 pages:947-+ ispartof: location:United States status: published |
| Databáze: | OpenAIRE |
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