P409 Non-medical reverse switch between the originator infliximab and its biosimilar in patients with inflammatory bowel disease: clinical outcomes and therapeutic drug monitoring

Abstract Background Proactive therapeutic drug monitoring (pTDM) may potentially improve disease control and treatment outcomes in inflammatory bowel disease. Methods Using a prospectively maintained database we compared 135 patients following a pTDM protocol aiming at an Infliximab trough level (IFXTL) between 5-10 µg/mL with sequential measurements of Fc, with 108 patients from a retrospective group under conventional management (noTDM). We evaluated the rates of Fc remission (<250 µg/g), and other clinical outcomes at 2-years of follow up. Results pTDM associated with higher rates of Fc remission (69.6% vs 50.0%; P=0.002), and steroid-free clinical remission (78.4% vs 55.2%, P=0.028) with a trend for clinical remission (79.3% vs 68.5%, P=0.075). There was no difference in treatment discontinuation (P=0.195), hospitalization (P=0.156), and surgery (P=0.110). Higher IFXTL associated with Fc remission at week 14 (6.59 vs 2.96 µg/mL, P<0.001), and at the end follow-up (8.10 vs 5.03 μg/mL, P=0.001). Fc remission associated with higher rates of clinical remission (85.8% vs 56.8% P<0.001), steroid-free clinical remission (86.9% vs 50.0% P<0.001), and lower rates of IFX discontinuation (8.8% vs 36.8%, P<0.001), and hospitalization (13.5% vs 33.7%, P<0.001) with a non-significant trend for surgery (6.1% vs 12.6%, P=0.101). Conclusion PTDM was more effective than conventional management in inducing Fc remission which associated with improved clinical outcomes.

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Faculty Opinions recommendation of Clinical Outcomes With Therapeutic Drug Monitoring in Inflammatory Bowel Disease: A Systematic Review With Meta-Analysis.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.733815374.793569699 ◽

2020 ◽

Author(s):

Jack Satsangi

Keyword(s):

Systematic Review ◽

Inflammatory Bowel Disease ◽

Therapeutic Drug Monitoring ◽

Clinical Outcomes ◽

Bowel Disease ◽

Drug Monitoring ◽

Meta Analysis ◽

Therapeutic Drug ◽

Inflammatory Bowel

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A Systematic Review on Cost-effectiveness Analyses of Therapeutic Drug Monitoring for Patients with Inflammatory Bowel Disease: From Immunosuppressive to Anti-TNF Therapy

Inflammatory Bowel Diseases ◽

10.1093/ibd/izaa073 ◽

2020 ◽

Author(s):

Jiaqi Yao ◽

Xinchan Jiang ◽

Joyce H S You

Keyword(s):

Systematic Review ◽

Inflammatory Bowel Disease ◽

Cost Effectiveness ◽

Therapeutic Drug Monitoring ◽

Clinical Outcomes ◽

Bowel Disease ◽

Drug Monitoring ◽

Standard Care ◽

Therapeutic Drug ◽

Inflammatory Bowel

Abstract Background There is a growing body of primary evidence on the cost-effectiveness of applying therapeutic drug monitoring (TDM) for inflammatory bowel disease (IBD) management with various drug therapies and strategies. Objectives The aim of this study was to conduct a systematic review on model-based cost-effectiveness analyses of applying TDM for IBD management. Methods Literature search was conducted (up to October 2019) in Medline (Ovid), Embase (Ovid), Web of Science, Scopus, CINAHL Complete, and the Centre for Reviews and Dissemination. Studies published in the English language that met inclusion criteria were included: (1) patients with IBD, (2) TDM-based treatment was compared with a comparator, (3) types of analysis were cost-benefit, cost-consequence, cost-effectiveness, cost-utility, or cost analysis, and (4) analyses conducted by model-based evaluation. The study quality was assessed using Consolidated Health Economic Evaluation Reporting Standards. Results Six studies on drug monitoring for IBD patients (1 azathioprine and 5 infliximab) published in 2005 to 2019 were included. All studies targeted on patients with Crohn’s disease and reported TDM strategies to save cost when comparing with standard care. Four analyses evaluated both economic and clinical outcomes. Three analyses found the TDM strategies (for treatment initiation, advancement of therapy, or proactive monitoring) to improve clinical outcomes. One study found TDM strategies (reflex testing and concurrent testing) to gain lower quality-adjusted life years than standard care. Four of six (66.7%) studies achieved good to excellent rankings in quality assessment. Conclusions Compared with standard treatment without TDM, the TDM-guided strategies were consistently found to be cost-saving or cost-effective.

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