Cost-Effectiveness of Therapeutic Drug Monitoring-Guided Adalimumab Therapy in Rheumatic Diseases: A Prospective, Pragmatic Trial

Abstract

Introduction: To assess the clinical and costeffectiveness of therapeutic drug monitoring (TDM) based on serum adalimumab levels compared to standard of care in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Methods: This was a non-inferiority, multicentric, non-randomized, pragmatic trial including adult patients diagnosed with moderate-to-severe, clinically stable rheumatic diseases treated with adalimumab. Consecutive patients were assigned 1:2 to the control (CG) or the intervention group (IG), based on the site of inclusion, and followed up for 18 months. Adalimumab serum levels were measured at each study visit and released to the IG only to modify dosing strategy. Data on disease activity, healthcare resource utilization and health-related quality of life (HRQoL) measured through the EQ-5D-5L were collected. Number of persistent and overall flares, time to first flare, days experiencing high disease activity, total direct costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER) were calculated.

Perspectives of Therapeutic Drug Monitoring of Biological Agents in Non-Infectious Uveitis Treatment: A Review

“…However, it should be noted that this intensification strategy may not be beneficial in some cases, for example when detectable levels of ADA are present at the time of treatment failure, indicating that molecules other than TNFα are acting as drivers of the inflammatory response. This reinforces the idea that TDM could help to individually optimise therapy to avoid unnecessary overtreatment and related adverse events and costs expenditures [ 86 , 87 ].…”

“…Despite this, the observational design of these studies added to the small size of the population studied, as well as the heterogeneity of the included NIU limits generalizations. Although we believe the data are in line with observations in other pathologies [ 12 , 14 , 86 , 87 , 88 ] and constitute a step forward in the difficult daily management of refractory NIU patients, they are insufficient to implement TDM in routine clinical practice.…”

“…The inter-individual variability introduced by these and other factors in the PK parameters of anti-TNFα drugs has an impact on the individual exposure to the drug and therefore on the clinical response [ 21 ]. Evidence supporting TDM of drug levels and ADAbs of TNFα inhibitors as an effective strategy to optimize biological therapy and increase treatment response rates in immune-mediated inflammatory diseases is growing [ 12 , 14 , 17 , 73 , 74 , 86 , 87 , 88 ]. However, opposing findings have also been reported [ 89 , 90 , 91 ].…”

Therapeutic Drug Monitoring (TDM) Implementation in Public Hospitals in Greece in 2003 and 2021: A Comparative Analysis of TDM Evolution over the Years

“…According to the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT), TDM can be used either for determining patient dosing regimens or for pharmacokinetic/pharmacodynamic monitoring [ 17 ]. In addition, TDM can enhance treatment cost-effectiveness [ 18 , 19 ]. However, there is insufficient data on TDM implementation in different countries worldwide.…”