Mihika B Dave1, Alpa J Dherai1, Devendra C Desai2, Bhamini G Keny1, Dhanashri N Shetty1, Satish Kulkarni3,4, Kiran Peddy5, Tester F Ashavaid1. 1. Department of Biochemistry, P. D. Hinduja Hospital, Veer Savarkar Marg, Mahim, Mumbai, 400 016, India. 2. Division of Gastroenterology, P. D. Hinduja Hospital, Veer Savarkar Marg, Mahim, Mumbai, 400 016, India. devendracdesai@gmail.com. 3. MGM Hospital, Navi Mumbai, 402 107, India. 4. Apollo Hospital, Navi Mumbai, 402 107, India. 5. Citizens Specialty Hospital, Hyderabad, 500 019, India.
Abstract
BACKGROUND AND AIMS: Infliximab (IFX) monitoring has been proposed for effective therapeutic management of inflammatory bowel disease (IBD). There is no data on infliximab levels and its antibody measurement in Indian patients. We assessed the clinical efficacy of IFX level and antibodies to infliximab (ATI) monitoring in IBD patients. METHODS: Infliximab trough level and antibody testing was done in 50 and 30 IBD patients, respectively using commercially available enzyme-linked immunosorbent assay (ELISA) kits. The levels were correlated with the disease status, albumin, and C-reactive protein (CRP) levels. The clinical efficacy of level-based change in patient management was evaluated. RESULTS: Of 50 patients, IFX levels were therapeutic in 8, sub-therapeutic in 40, and supra-therapeutic in 2. High ATI titer was present in 8/30 patients. The IFX level did not correlate with the dose of 5 or 10 mg/kg. Based on IFX level and ATI estimation, management was changed in 35 patients: increase in dose in 7, decrease in dosing interval in 17, increase in interval in 2, surgery in 2, change in biologic in 5, and cessation of IFX in 2 patients. Therapy modification based on IFX level improved the clinical response in 25 patients, of whom 5 are in remission at a median duration of 2 years. CONCLUSION: Most (80%) of the IBD patients had subtherapeutic IFX levels while high ATI titers were found in 27% of the patients. There was no correlation between infliximab dose and drug levels. Therapy modification based on drug level benefitted the majority. Our results suggest that measurement of IFX level assists in attaining therapeutic levels and improves clinical response.
BACKGROUND AND AIMS: Infliximab (IFX) monitoring has been proposed for effective therapeutic management of inflammatory bowel disease (IBD). There is no data on infliximab levels and its antibody measurement in Indian patients. We assessed the clinical efficacy of IFX level and antibodies to infliximab (ATI) monitoring in IBDpatients. METHODS:Infliximab trough level and antibody testing was done in 50 and 30 IBDpatients, respectively using commercially available enzyme-linked immunosorbent assay (ELISA) kits. The levels were correlated with the disease status, albumin, and C-reactive protein (CRP) levels. The clinical efficacy of level-based change in patient management was evaluated. RESULTS: Of 50 patients, IFX levels were therapeutic in 8, sub-therapeutic in 40, and supra-therapeutic in 2. High ATI titer was present in 8/30 patients. The IFX level did not correlate with the dose of 5 or 10 mg/kg. Based on IFX level and ATI estimation, management was changed in 35 patients: increase in dose in 7, decrease in dosing interval in 17, increase in interval in 2, surgery in 2, change in biologic in 5, and cessation of IFX in 2 patients. Therapy modification based on IFX level improved the clinical response in 25 patients, of whom 5 are in remission at a median duration of 2 years. CONCLUSION: Most (80%) of the IBDpatients had subtherapeutic IFX levels while high ATI titers were found in 27% of the patients. There was no correlation between infliximab dose and drug levels. Therapy modification based on drug level benefitted the majority. Our results suggest that measurement of IFX level assists in attaining therapeutic levels and improves clinical response.
Entities:
Keywords:
Antibodies to infliximab; Biologicals; Biosimilars; Crohn’s disease; Infliximab; Therapeutic drug monitoring; Ulcerative colitis