Giorgia Bodini1, Vincenzo Savarino1, Laurent Peyrin-Biroulet2, Chiara de Cassan3, Pietro Dulbecco1, Isabella Baldissarro1, Valentina Fazio1, Elisa Giambruno1, Edoardo Savarino4. 1. Division of Gastroenterology, Department of Internal Medicine, University of Genoa, Genoa, Italy. 2. Inserm U954 and Department of Hepato-Gastroenterology, University Hospital of Nancy, Université de Lorraine, Vandoeuvre-lès-Nancy, France. 3. Division of Gastroenterology, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy. 4. Division of Gastroenterology, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy. Electronic address: edoardo.savarino@unipd.it.
Abstract
BACKGROUND: Whether therapeutic drug monitoring of biologic therapy can predict the efficacy of adalimumab to prevent postoperative Crohn's disease recurrence is unknown. AIM: To investigate whether adalimumab trough levels and anti-adalimumab antibodies correlate with endoscopic and clinical outcomes in a series of patients treated with prophylactic adalimumab monotherapy after resective surgery. METHODS: Post hoc analysis of a randomized, mesalamine-controlled trial. Adalimumab trough levels and antibodies were analysed every 8 weeks for 2 years using an homogeneous mobility shift assay. RESULTS: At two years, 1/6 patient had clinical recurrence and 1/6 patient had endoscopic and clinical recurrence. At baseline (9.5 vs. 14.4 mcg/mL) and during follow-up [7.5 (4.4-9.8) vs. 13.9 (8.9-23.6)mcg/mL, p<0.01], median adalimumab trough levels in patients with clinical or endoscopic recurrence were lower than in those who maintained remission. Persistent antibodies-against-adalimumab were detected in the patient with both endoscopic and clinical recurrence. CONCLUSION: Measurement of adalimumab trough levels and anti-adalimumab antibodies after surgery could be useful to further reduce postoperative recurrence.
RCT Entities:
BACKGROUND: Whether therapeutic drug monitoring of biologic therapy can predict the efficacy of adalimumab to prevent postoperative Crohn's disease recurrence is unknown. AIM: To investigate whether adalimumab trough levels and anti-adalimumab antibodies correlate with endoscopic and clinical outcomes in a series of patients treated with prophylactic adalimumab monotherapy after resective surgery. METHODS: Post hoc analysis of a randomized, mesalamine-controlled trial. Adalimumab trough levels and antibodies were analysed every 8 weeks for 2 years using an homogeneous mobility shift assay. RESULTS: At two years, 1/6 patient had clinical recurrence and 1/6 patient had endoscopic and clinical recurrence. At baseline (9.5 vs. 14.4 mcg/mL) and during follow-up [7.5 (4.4-9.8) vs. 13.9 (8.9-23.6)mcg/mL, p<0.01], median adalimumab trough levels in patients with clinical or endoscopic recurrence were lower than in those who maintained remission. Persistent antibodies-against-adalimumab were detected in the patient with both endoscopic and clinical recurrence. CONCLUSION: Measurement of adalimumab trough levels and anti-adalimumab antibodies after surgery could be useful to further reduce postoperative recurrence.
Authors: Zipporah Iheozor-Ejiofor; Morris Gordon; Andrew Clegg; Suzanne C Freeman; Teuta Gjuladin-Hellon; John K MacDonald; Anthony K Akobeng Journal: Cochrane Database Syst Rev Date: 2019-09-12
Authors: Lorant Gonczi; Zsuzsanna Kurti; Mariann Rutka; Zsuzsanna Vegh; Klaudia Farkas; Barbara D Lovasz; Petra A Golovics; Krisztina B Gecse; Balazs Szalay; Tamas Molnar; Peter L Lakatos Journal: BMC Gastroenterol Date: 2017-08-08 Impact factor: 3.067