Ryan Haumschild, PharmD, MS, MBA: I want to pivot back to you, Dr Williams, to discuss what the difference is when we’re thinking about these patients in terms of active and inactive disease and why that’s significant. If you could, highlight FDA labeling for some of the MS [multiple sclerosis] agents we’re going to discuss, in indication, and where it’s not indicated, but where innovations will exist in the future?

Mitzi Joi Williams, MD FAAN: Absolutely. This has become extremely important, trying to distinguish if someone has active vs inactive disease. When we think about how we categorize MS, we’re realizing that often many things are going on at the same time. There is relapse and inflammation going on at the beginning, but there’s also degeneration and progression that can also be occurring simultaneously. It is a balance of which one is more prominent in that particular person, and that can help drive which treatment options we have. When we think about active, active disease means someone is either having clinical activity like relapses, those symptoms that come on and go over a short period of time. Or activity can also mean changes on MRIs, seeing some inflammation there. People who have active disease either have clinical relapses, or MRI activity, or both. Then inactive means someone may have that slow indolent progression without any evidence of inflammatory activity.

Recently the FDA has recognized the category of active secondary progressive MS, and now most of our treatments are indicated for that type of MS. Whereas previously, if someone had secondary progressive disease, treatment was not indicated. Now the only group that has an extreme need for addressing treatment options is those who have inactive disease. So they’re not having relapses, they’re not having MRI changes, but they may still be having progression, and currently medication is not indicated for them.

Ryan Haumschild, PharmD, MS, MBA: An excellent overview and the unmet need there in terms of when to treat, when not to treat, and how we’re trying to provide better therapeutic options for all those patients. I do want to build off one thing you said though, and it was disease activity. I think that’s such an important point. Maybe, Dr Hickman, you can be the one to build upon that. What is high disease activity in these patients, and in general, how is disease activity determined for a patient when you’re looking to treat them?

Amanda Hickman, PharmD, MPH, MSCS: Absolutely, because that could determine what treatments you start talking to the patient about when they’re first diagnosed. This is starting to get a bit into the art of caring for patients with MS, but we do learn some telltale signs in patients who could be suspicious of having more aggressive MS, which is another term that could be used for high activity. Some populations are more prone to this. If they’re male, if they’re African American, or if they’re diagnosed at a later age, they could be prone to a more active form of MS. You can also look at the symptoms they have over time. Do they have a high burden of lesions on their MRI? Do they have an incomplete recovery from their first relapse, or do they have multiple relapses within a short period of time? Also if they have bowel or bladder symptoms, or a focus on the spinal cord for their lesions, these are all things that could indicate they may be patients who need a bit more heavy-handed treatment than those who maybe aren’t due for a relapse in 5, 10 years or something.

Ryan Haumschild, PharmD, MS, MBA: I think it’s important as we stratify patients to identify those and create that part of the disease state plan for each patient, even the treatment pathway, so we’re considering disease activity as a key component. I think you really highlighted that piece for me. I do want to shift, Amanda, again back to you, because you’ve got great experience, and I’m hoping to interject that into our discussion today. In your experience, what type of impact does MS have on a patient’s quality of life? I know we talked about that, but even further building upon their activities of daily living because we saw there are so many different types. We think about the reduction in mobility for some patients can be impactful, even sometimes when we’re looking at mental health and anxiety, that plays into it. If you would, maybe characterize some of those key aspects of the quality of life of patients.

Amanda Montague, Ed.M.: Sure. I think along with a diagnosis of MS comes a lot of uncertainty, and that is probably the most challenging thing for folks who first get diagnosed. I see Mitzi nodding, so I think that’s probably right. Part of that challenge though is not knowing what the future’s going to look like. For a lot of folks, I think there are the physical manifestations of MS, as you said, the mobility issues. There are a lot more hidden symptoms of MS, like fatigue and cognition, which can impact people’s ability to stay employed. When we’re thinking of MS striking folks often at the prime of their lives, you’re thinking about how that’s impacting not just the individual, but the entire family, and the uncertainty that causes in terms of employment, in terms of sometimes having to be a care partner at a very young age to your partner in life. So the quality-of-life issues run really deep. I think you bring up a great point, Ryan, in terms of the mental health issues, which often also accompany MS for sure, with depression being primary among them. That also I think is undertreated probably, unfortunately, for many folks living with MS.

Ryan Haumschild, PharmD, MS, MBA: You highlight an area that I think continues to need focus because a patient as part of their journey wants to know how well are they going to be able to function. “Am I going to be able to be with my family, play with my kids, be able to work, and be productive?” I think even employer groups nowadays. AJMC®, we have a huge employer group and benefit plan that monitor the work we’re doing, and I think as we develop this, we need to make sure we are looking at presenteeism. Are people able to show up to their work? Are they adding the value that they’re looking for? If that’s being impacted, how do we quantify that and consider that as part of our treatment recommendations as well? I think as you’re on that journey, you have to have validated tools. Dr Williams, as we’re evaluating different therapies, I turn to you. As you’re looking at this across the board, developing a treatment plan with your patient through a shared decision-making framework, what are some of the validated tools you utilize to help determine quality of life for patients specifically with MS?

Mitzi Joi Williams, MD FAAN: There are several validated tools, such as the SF-36 [36-Item Short Form Health Survey], and the MSQOL-54 [Multiple Sclerosis Quality of Life-54 item questionnaire], that are used primarily in our clinical trials to help examine quality of life. I do think there are some likely abbreviated tools that are needed for clinical practice because oftentimes it can be very difficult. In a visit we’re addressing disease-modifying therapy, we’re addressing acute issues. We may be addressing mental health issues, and so there is a need for tools for us to use in clinical practice. I would say myself and probably many of my colleagues don’t use a lot of quality-of-life tools in practice just because of time constraints, and if we have patients with cognitive difficulty, how do we get those things done? I do ask a lot of questions of my patients about their quality of life, so I guess I have my own validated tools in my head. But I think it’s exciting that we’re looking at these things because traditionally we’ve only looked at relapses, MRI, and disability progression, and now there’s a huge focus on how are people doing on a day-to-day basis. How do we make sure that our treatments and our plans not only address the disease itself, but we want to impact people and how they present in their workplaces and their families on a regular basis.

Ryan Haumschild, PharmD, MS, MBA: I love that kind of patient-centric approach. I think that’s what makes you such a great clinician. Starting to consider those things outside of hard end points and contextualize them is important. As you mentioned, shared decision-making. Patients living with this disease want to be engaged in their care journey, and that’s a great way to tease out some of those differences.

Transcript edited for clarity.