Tracking patient response to DMARD therapy has the potential to improve remission, but multiple barriers must be overcome before it’s widely adopted.
Therapeutic drug monitoring — the practice of using laboratory testing to measure blood levels of drugs — has garnered growing interest among rheumatologists in managing patients on disease-modifying antirheumatic drugs , but that hasn’t exactly translated to widespread practice.
So, the “one-size-fits-all” approach does not work for prescribing older or even some of the newer DMARDs for rheumatologic disorders, Balevic said.Among the few trials that examined TDM in rheumatology patients are the NOR-DRUM A and B trials in Norway.
“So, it’s probably a benefit to be able to detect these ADA early before the patient experiences a disease flare or infusion reaction,” Brun added. “It facilitates for the clinician to take action to, for example, increase the dosing or switch therapy.” “It’s reasonable to say that we’re at an early stage of the evidence,” he said. “If you look at the large trials that have been done in rheumatology, they’ve combined patients with many different types of conditions, and a lot of our recommendations in rheumatology are disease-specific — in rheumatoid arthritis, in vasculitis. There’s a lack of data in specific diseases to guide or examine what the role of TDM might be.
“Different studies may report different target drug levels, and this could be due to different underlying population, or a different matrix — a measure of whole blood vs plasma — or even the timing of the sample,” he said. Balevic led a“This really goes back to the clinician needing to draw on a lot of pharmacology training to interpret the literature,” Balevic added.
Breaking down the science, he noted that an ADA can bind to a monoclonal antibody, forming an immune complex that avoids detection. Drug-sensitive assays may detect high concentrations of ADAs but miss low or moderate concentrations. Drug-tolerant assays may be more likely to detect low concentrations at ADAs, but the clinical significance is unclear.“The costs vary a lot from assay to assay,” Brun said. “Some commercial assays can be really expensive.
Testing protocols are also uncertain, Garg added. “A few data points…are missing, like how we use the data over time,” she said. “If you do it for a given patient over several years, how often should you do it? How often do the levels fluctuate? How are the data used to inform dosing changes or monitoring changes?
She explained why the findings with infliximab may extend to adalimumab, which may be the second most immunogenic TNF inhibitor after infliximab. “The administration is different; it’s administered more often than infliximab; that would also make the results more uncertain to generalize to the other treatments, but I would guess there are also benefits of using TDM in other treatments.”Wallace has noted that TDM, with the current state of evidence, carries a number of potential risks.
RA - Rheumatoid Arthritis Rheumatoid Arthritis (RA) Therapeutic Drug Monitoring Disease-Modifying Antirheumatic Drugs Dmards DMARD Arthritis Joint Inflammation Biologic Therapy Biologics Clinical Research Clinical Trials Clinical Studies Pre-Clinical Trial Double-Blind Study Double-Blind Studies Single-Blind Study Single-Blind Studies
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