Therapeutic Drug Monitoring as a Tool for the Clinical Outcome Prediction in Vedolizumab-Treated Patients: An Italian Pilot Study
Jessica Cusato,
Davide Giuseppe Ribaldone,
Michela Helga Falzone,
Alessandra Manca,
Miriam Antonucci,
Alice Palermiti,
Giorgio Maria Saracco,
Linda Ceccarelli,
Francesco Costa,
Andrea Bottari,
Ginevra Fornaroli,
Gian Paolo Caviglia,
Antonio D’Avolio,
Lorenzo Bertani
Affiliations
Jessica Cusato
Laboratory of Clinical Pharmacology and Pharmacogenetics, Department of Medical Sciences, Amedeo di Savoia Hospital, University of Turin, Corso Svizzera, 164, 10149 Turin, Italy
Davide Giuseppe Ribaldone
Unit of Gastroenterology, Department of Medical Sciences, University of Turin, 10124 Turin, Italy
Michela Helga Falzone
Unit of Gastroenterology, Department of Medical Sciences, University of Turin, 10124 Turin, Italy
Alessandra Manca
Laboratory of Clinical Pharmacology and Pharmacogenetics, Department of Medical Sciences, Amedeo di Savoia Hospital, University of Turin, Corso Svizzera, 164, 10149 Turin, Italy
Miriam Antonucci
SCDU Infectious Diseases, Amedeo di Savoia Hospital, ASL Città di Torino, 10149 Turin, Italy
Alice Palermiti
Laboratory of Clinical Pharmacology and Pharmacogenetics, Department of Medical Sciences, Amedeo di Savoia Hospital, University of Turin, Corso Svizzera, 164, 10149 Turin, Italy
Giorgio Maria Saracco
Unit of Gastroenterology, Department of Medical Sciences, University of Turin, 10124 Turin, Italy
Linda Ceccarelli
IBD Unit, Department of General Surgery and Gastroenterology, Pisa University Hospital, 56124 Pisa, Italy
Francesco Costa
IBD Unit, Department of General Surgery and Gastroenterology, Pisa University Hospital, 56124 Pisa, Italy
Andrea Bottari
Gastroenterology Unit, University of Pisa, 56126 Pisa, Italy
Ginevra Fornaroli
Gastroenterology Unit, University of Pisa, 56126 Pisa, Italy
Gian Paolo Caviglia
SCDU Infectious Diseases, Amedeo di Savoia Hospital, ASL Città di Torino, 10149 Turin, Italy
Antonio D’Avolio
Laboratory of Clinical Pharmacology and Pharmacogenetics, Department of Medical Sciences, Amedeo di Savoia Hospital, University of Turin, Corso Svizzera, 164, 10149 Turin, Italy
Lorenzo Bertani
IBD Unit, Department of General Surgery and Gastroenterology, Pisa University Hospital, 56124 Pisa, Italy
Over the years, vedolizumab (VDZ) has emerged as a more effective target therapy for inflammatory bowel disease. The aim of this work was to analyze a cohort of inflammatory bowel disease patients, evaluating the association between VDZ serum concentrations at 6 months from starting therapy and their clinical and biochemical indexes within one year of treatment, correlating drug levels with response and clinical remission. Forty patients treated with VDZ were enrolled. Drug concentrations were quantified through ELISA methods. VDZ levels correlated with hemoglobin levels at twelve months of therapy (p = 0.03) and with clinical remission at twelve months of therapy (p = 0.03); patients who reached clinical remission showed higher VDZ concentrations. A VDZ cut-off value of 43.1 μg/mL was suggested, predicting clinical remission at twelve months of therapy. A statistically significant association between VDZ levels at T6 and calprotectin p = 0.04). Furthermore, the optimal threshold value of VDZ levels at T6 associated with calprotectin <250 μg/g at T12 was identified: through levels higher than 45.2 µg/mL, we were able to predict remission one year after therapy. In the final regression multivariate model, no factor was retained as a predictor of clinical remission at one year of treatment. In conclusion, this is the first pilot study reporting a possible VDZ serum cut-off value able to predict not only the clinical remission at twelve months of therapy but also the calprotectin level, which is very important, as it is a surrogate marker of mucosal healing.
