Patient Reported Outcomes and Clinical Disability Outcomes in MS demonstrate the same rates of worsening when performed in neurology clinic, patient registry, and a clinical trial

Jason Freeman, MD, MBA: Welcome to AAN 2023. I'm your host, Dr Jason Freeman, Medical Director, Novartis Medical Affairs, providing you with updates from AAN 2023. The information herein is provided for disease educational purposes only and is not intended to be nor does it imply medical or diagnostic advice. Joining me today is Dr Hunter Davis. We will discuss key takeaways from the abstract titled “Patient Reported Outcomes and Clinical Disability Outcomes in MS demonstrate the same rates of worsening when performed in neurology clinic, patient registry, and a clinical trial.” So, Dr Davis, thanks for being here today.

Hunter Davis, PharmD: Thanks for having me.

Jason Freeman, MD, MBA: Why are patient-reported outcomes, or PROs, important to monitor in MS?

Hunter Davis, PharmD: It's a great question. I think an increasingly important question, and as our treatments have continued to evolve in MS, it's important that we continue to evolve and improve upon the measurements we use in the disease and one of those is patient-reported outcomes. PROs, or patient-reported outcomes, will really allow us to better assess things that are truly meaningful to patients. Additionally, they're going to complement the things we're already studying and have traditionally used to measure the disease like EDSS [Expanded Disability Status Scale] and will hopefully provide additional information for us to better understand how the disease is affecting our patients.

Jason Freeman, MD, MBA: Just for our audience, can you define what a PRO is?

Hunter Davis, PharmD: Yeah. So, patient-reported outcomes are non-traditional measures that we use to measure things that affect the patient themselves. So, just as it sounds, these are measures or outcomes that are reported directly by the patient to the physician or the researcher.

Jason Freeman, MD, MBA: Just thinking about it, things like the data that you might get from your Apple Watch or your Fitbit.

Hunter Davis, PharmD: Right, and specifically a challenge in the clinic is how infrequently we are seeing patients and so one benefit for patient-reported outcomes is the ability to monitor and assess patients in their daily lives between the times we see them in the clinic.

Jason Freeman, MD, MBA: So, can you then summarize the study design and some of the study results?

Hunter Davis, PharmD: Absolutely. This study was an assessment of patient-reported outcomes, specifically the Multiple Sclerosis Impact Scale, or MSIS, and its equivalence to one of our traditional clinical trial endpoints, EDSS, for measuring disability. Data was collected in this study in NHS neurology clinics as well as from self-reported PROs from the MS-SMART trial. What they found and the results of this study was that there was no significant difference in the traditional EDSS scores in the clinic for patients and those using self-reported patient outcomes.

Jason Freeman, MD, MBA: Why is this data important?

Hunter Davis, PharmD: It's a great question. This data is important specifically because it sheds light on the validity of these PROs. In this study, we were looking at the Multiple Sclerosis Impact Scale and how it correlates with our very traditional and widely accepted endpoint of EDSS. It's important that we have an understanding of the validity of these PROs so that we can use them and incorporate them into future clinical trials. We want to be able to capture data that's truly meaningful to patients on a day-to-day basis and, hopefully, eventually these will support physician treatment decision-making by providing additional information that has just been difficult to assess outside of the clinic.

Jason Freeman, MD, MBA: So how does this data impact routine clinical care, clinical decision-making, and/or clinical trials and clinical trial design in MS?

Hunter Davis, PharmD: I think this is a natural question. We believe that the future will include more patient-reported outcomes. The importance of these patient-reported outcomes will only continue to grow, and the utilization will continue to grow. More and more patient-reported outcomes will be validated. So, perhaps it may not affect routine clinical care immediately, but moving into the future, these will improve our clinical trials, our ability to gather more information that has historically been difficult to capture, and will help our physicians with their treatment decision-making process, catering that specifically to patients.

Jason Freeman, MD, MBA: Dr Davis, thank you for your time today. We appreciate you being here and sharing your knowledge about this abstract. Very, very helpful.

Jason Freeman, MD, MBA: Thank you for watching AAN 2023 updates from Novartis US Medical Affairs.

Transcript Edited for Clarity