Giorgia Bodini1, Edoardo G Giannini2, Vincenzo Savarino2, Lorenzo Del Nero2, Sara Lo Pumo2, Matteo Brunacci2, Nicola De Bortoli3, Anjali Jain4, Salvatore Tolone5, Edoardo Savarino6. 1. Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy. Electronic address: giorgia.bodini@edu.unige.it. 2. Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy. 3. Gastroenterology Unit, Department of Internal Medicine, University of Pisa, Pisa, Italy. 4. Department of Research and Development, Prometheus Laboratories Inc., San Diego, CA, USA. 5. Department of Surgery, Second University of Naples, Naples, Italy. 6. Gastroenterolgy Unit, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
Abstract
BACKGROUND: The use of therapeutic drug monitoring has been proposed as a useful tool in the management of patients with loss of response to biological therapy in patients with inflammatory bowel disease. AIMS: To evaluate whether early, post-induction anti-tumor necrosis factor trough levels and the presence of different types of anti-drug antibodies may impact long-term clinical remission in patients with inflammatory bowel disease. METHODS: We prospectively assessed anti-tumor necrosis factor trough levels and both persistent and transient anti-drug antibodies. The Harvey-Bradshaw Index and the partial Mayo score were evaluated at each visit or in case of relapse. RESULTS: At week 14, median infliximab trough levels were significantly lower in patients who experienced loss of response at week 48 as compared to patients in stable remission (1.3mcg/mL [range 0-10.2mcg/mL] vs. 10.1mcg/mL[range 0-42.8mcg/mL], P<0.0004). ROC curve identified an infliximab trough levels of 6.2mcg/mL as the cut-off value with the highest accuracy (c-index=0.864) for loss of response at week 48. At week 14 we observed a correlation between anti-drug antibodies concentration and infliximab trough levels (rs=-0.513, P=0.04). CONCLUSIONS: The results highlight the usefulness of assessing early biological TL in order to predict patients' long-term outcome.
BACKGROUND: The use of therapeutic drug monitoring has been proposed as a useful tool in the management of patients with loss of response to biological therapy in patients with inflammatory bowel disease. AIMS: To evaluate whether early, post-induction anti-tumor necrosis factor trough levels and the presence of different types of anti-drug antibodies may impact long-term clinical remission in patients with inflammatory bowel disease. METHODS: We prospectively assessed anti-tumor necrosis factor trough levels and both persistent and transient anti-drug antibodies. The Harvey-Bradshaw Index and the partial Mayo score were evaluated at each visit or in case of relapse. RESULTS: At week 14, median infliximab trough levels were significantly lower in patients who experienced loss of response at week 48 as compared to patients in stable remission (1.3mcg/mL [range 0-10.2mcg/mL] vs. 10.1mcg/mL[range 0-42.8mcg/mL], P<0.0004). ROC curve identified an infliximab trough levels of 6.2mcg/mL as the cut-off value with the highest accuracy (c-index=0.864) for loss of response at week 48. At week 14 we observed a correlation between anti-drug antibodies concentration and infliximab trough levels (rs=-0.513, P=0.04). CONCLUSIONS: The results highlight the usefulness of assessing early biological TL in order to predict patients' long-term outcome.
Authors: Konstantinos Papamichael; Adam S Cheifetz; Gil Y Melmed; Peter M Irving; Niels Vande Casteele; Patricia L Kozuch; Laura E Raffals; Leonard Baidoo; Brian Bressler; Shane M Devlin; Jennifer Jones; Gilaad G Kaplan; Miles P Sparrow; Fernando S Velayos; Thomas Ullman; Corey A Siegel Journal: Clin Gastroenterol Hepatol Date: 2019-03-27 Impact factor: 11.382
Authors: Lívia Moreira Genaro; Luís Eduardo Miani Gomes; Ana Paula Menezes de Freitas Franceschini; Hugo Dugolin Ceccato; Rafael Nascimento de Jesus; Amanda Pereira Lima; Cristiane Kibune Nagasako; João José Fagundes; Maria de Lourdes Setsuko Ayrizono; Raquel Franco Leal Journal: Am J Transl Res Date: 2021-12-15 Impact factor: 4.060