Marla Dubinsky, MD, Speaks on Proactive Therapeutic Monitoring

During a recent podcast on Podcasts360, Marla Dubinsky, MD, discussed how her research on measuring drug concentrations and anti-drug antibodies along with algorithmic approaches to proactive therapeutic drug monitoring could help patients with inflammatory bowel disease achieve and maintain remission. 

The premise of her study was not only to check drug levels early but to monitor patients during the induction phase to ensure they are getting the right dose at the right time. 

“It’s not good enough to get drug concentrations because they alone don’t necessarily tell you the whole story. These dashboards [using iDose] allow you to integrate the drug concentration of that individual patient and count in all of the factors that influence the clearance of these drugs,” Dubinsky stated in the podcast.

By precisely dosing an individual based on how their body manages these therapies, you’re proactively optimizing the needs of the individual patient, which nobody has done before. 

Design of the study

In Dubinsky’s trial, any patient who entered the standard of care infusions for Infliximab to their IBD Clinical Center infusion unit were eligible for enrollment. The IBD Clinical Center offered a precision dosing dashboard (iDose) that will help direct the physician and the patient in knowing when the next dose will be. The patient’s physician decided the starting dose, which would be done in a clinical setting, trying to make this study as real-world as possible. 

Once the patient gets their first dose, they come back for the second infusion, which takes roughly two weeks. Before the patient receives the second dose, their drug concentration and anti-drug antibody levels are collected, which goes into the software model telling the physician when that specific patient should come back for their third infusion.

Not surprisingly, the software suggests that a large portion of the patients that started on the standard-of-care approved dose needed to come in earlier than the 4-week interval. Instead of coming in 28 days from their second dose for their third infusion, they had to visit the infusion unit after 17 days. 

The patients were then forecasted since they needed their third infusion earlier than what the standard-of-care dosing label indicated. When the patients came for their third infusion, their drug concentrations and anti-drug antibodies were collected, which went back into the system, just as they did for their second infusion. The software indicated that 80% of patients that started on the standard dose on the label for Infliximab were forecasted to need a regimen that is different from what the standard dose label says. 

Rather than the “step-up” dosing, Dubinsky believes that we should recoin the term to “top-down” dosing. This is when you start with the right dose for the patient’s burden of the disease and their individual characteristics. Then, you de-escalate to dosing that is lower and less frequent as the patient enters remission. 

Dubinsky and her team were reactively dose-escalating once a patient began flaring. The idea of proactive optimization and doing higher dosing when the patient most needs it will prevent loss of response, prevent the development of antibodies, and increase the durability of these drugs. Listen to Dr. Dubinsky’s full podcast on Proactive Therapeutic Monitoring here.

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