Adherence, Persistence, and Patient Satisfaction Data With KESIMPTA

[Voice Over]

The speakers have been paid by Novartis Pharmaceuticals Corporation (NPC) to conduct this presentation.

[Dr Singer]

Dr Markowitz, great to see you. I'd like to chat about your clinical experience with adherence, persistence, and patient satisfaction with KESIMPTA. So, what are your goals when treating RMS, and how does adherence and persistence help you achieve your goals with your patients?

[Dr Markowitz]

So my treatment goals are really about trying to prevent clinical attacks, preventing new lesions on MRI scan, and really trying to slow the disability, because this is the biggest problem that we have in the MS field.So I want to make sure that when I put somebody on a medication, they adhere to whatever the protocol is. So, we know if you put people on a drug, and they adhere to that regimen, they can have the best likelihood of getting the benefit that we hope.

[Dr Singer]

Yeah, I totally agree. I mean, my goal in treating patients with relapsing MS is to get the disease as quiet as possible for as long as possible. And I always think about the long game plan as well when trying to keep my patients on treatment and find the right treatment that's working for them.Some of us in the MS community have used a hashtag called #makingMSboring, and so my goal is really to achieve disease control. So that means trying to diagnose patients as soon as possible, get them on an effective medication, and for many patients it means putting them on a high-efficacy treatment like KESIMPTA.

[Dr Singer]

KESIMPTA is indicated for the treatment of relapsing forms of MS. And this includes clinically isolated syndrome, relapsing remitting disease, as well as active secondary progressive disease in adults. Prior to initiating KESIMPTA, make sure to rule out active hepatitis B viral infection, because that would be a contraindication. You can see additional important safety information on the adjacent panel and throughout this video as well.

[Dr Singer]

Dr Markowitz, we both mentioned that managing MS for us means reducing progression as much as possible for as long as possible for our patients. So, what are your thoughts about the efficacy data for KESIMPTA, and which of the end points in terms of efficacy do you find most impactful for healthcare providers like ourselves and patients?

[Dr Markowitz]

So the main efficacy end points that we have are reduction in relapses, MRI lesion reduction, disability progression. Those are the main points. If you look at the study against teriflunomide, it was very impressive from the standpoint of MRI activity suppression, as well as clinical relapse suppression. And, you know, the numbers, maybe it's, you know, 98% reduction on MRI and 58% reduction in clinical relapses.

[Dr Singer]

I would also like to get your take, though, on safety of KESIMPTA So what factors stand out the most about safety data, and why is this important?

[Dr Markowitz]

So, you know, any drug that we put a patient on at this point, we have to be concerned, what are the side effects and safety concerns? And any immunosuppressive-type medication we worry mostly about infection risk. But when we look at the clinical trial data, we're pretty reassured that really comparing it to a medication, you know, like-- teriflunomide, we didn't really see any huge signals of infection risk compared to the active treatment with KESIMPTA.

[Dr Singer]

Yeah, I'm always interested to see what the risk of infections are in the clinical trial, in particular respiratory infection and other serious infections. With KESIMPTA, we see that these rates are comparable to teriflunomide. Discontinuation rates due to adverse events were also similar between KESIMPTA and teriflunomide.

[Dr Singer]

So, let's take a moment to consider the long-term safety data for KESIMPTA. When I look at the 5-year safety data, I see that the most common adverse events were infections, but most infections resolved without discontinuing KESIMPTA treatment. The nature and frequency of the most common adverse events were comparable to those reported in ASCLEPIOS I and II. In the overall population, the proportion of patients with adverse events leading to discontinuation was consistent with those observed in the pivotal trials with KESIMPTA. The actual incidence of serious infection, Dr Markowitz, was 5.38% in the overall population over 5 years.

[Dr Markowitz]

That's actually wonderful news, right? You know, you're thinking about putting a patient on treatment for a long term. So, what's very reassuring to us is that we didn't see anything new in terms of the new adverse events.

[Dr Singer]

Dr Markowitz, so many of our patients living with MS are concerned about the route of administration, and they have some concerns about self-injected medication. So, what can you say about the tolerability data from KESIMPTA?

[Dr Markowitz]

So one of the big concerns people have is, you know, A) doing an injection themselves, right? That's gonna be the first issue. And then the second is the kind of allergic-type symptoms that people will have after they do the injection. And so when you look at the data, um, from the clinical trials, you know, people had a higher rate of these allergic-type symptoms from the first injection, but with subsequent injections that dramatically decreased. And by the third injection, only 3% of the patients were actually complaining of any sort of allergic-type symptoms. We discuss this with patients. They may have, you know, a concern about doing an injection themselves. The ones who've been doing injections previously, it's really easy to get them on the medication, because it's only once a month. But the ones who maybe, you know, are either naïve to taking medications, that might be a little bit more of a concern that they have. But, you know, the fact that it's once a month and that the injection allergic-type symptoms goes away after really the second or third injection. So, you know, when I look at my patient population, they have really followed what the clinical trial patients are like as well. So, you know, I'm reassured by that, and my patients really appreciate that

[Dr Singer]

Yeah, thanks for sharing that. I agree, Dr Markowitz. I think many people living with MS, when you think about self-injection therapy, they may have some kind of bias. Some people have been on self-injected medications in the past, good experience or maybe negative experience. And then some people are naïve to injection therapy. And but I think most patients, when you talk about the tolerability of KESIMPTA in terms of the actual injections-- most patients are willing to give it a try.

[Dr Singer]

So now that we have this long-term data, what do you think about safety concerns long-term, and how do you monitor patients subsequently once they go on KESIMPTA?

[Dr Markowitz]

Yes, so, you know, every patient's a little different, how we think about them, what their disease course is, et cetera. But across the board, for the most part, what I do with my patients is, I'm gonna see them roughly about six weeks after they start the treatment. And at that visit, I'm gonna assess, you know, any tolerability issues with the injections, any side effect, any MS symptoms that are going on, et cetera. And then I'll have them come back roughly three months, and that three-month visit's gonna be maybe checking their labs-- setting up a new MRI scan for them to do, because I want a new baseline MRI to go forward to compare on subsequent scans. And then we'll see them roughly every three months. I work with a team, so we may, you know, alternate. I'll see them one visit. My nurse practitioner might see them another visit. We just alternate like that, but they're gonna be seen in my office roughly every three months.They'll get scans roughly at six-month intervals for the first year just to make sure everything's quiet, and then if all is good, in the second year, we'll see them roughly every six months. They'll get annual scans after that, and that's kind of how we think about managing them in terms of blood testing and MRI scans and clinical visits

[Dr Markowitz]

Dr Singer, how do you assess adherence to KESIMPTA?

[Dr Singer]

So we don't have a perfect way to monitor this, so really a lot of it's talking to the patient. So one of the things I ask is, like, "What day of the month do you do your injection?" And if they can quickly tell me what day it is, then I know they're on a certain plan going monthly. The other thing we can look at is insurance. So I talk to them, you know, "Are there any insurance issues or shipping issues?" Because then they're pretty candid about getting their medication on time or what those obstacles might be that we can help them with. And but I think most patients are pretty motivated to take their medication. I think one of the other things that's important is for adherence is to show people their MRI scans. And I find that very useful. So during appointments, I'll show 'em the images of their brain and the spinal cord. I find this particularly useful in younger patients who, you know, may not have any disability. They recovered from their relapse and are doing great, and they may not be as motivated to take the medication without feeling symptoms of MS on a daily basis. So showing the scan I think really can help with adherence. We talk about goals of treatment to prevent progressive disability. I think there are other people that have some obstacles such as their symptoms such as fatigue and depression. And I find good symptom management, if we can get those under control, they're more motivated to be adherent to their treatment

[Dr Markowitz]

Yeah, great points. So, you know, in addition, we would also try and ascertain from family members, you know, maybe people who come to the visit, whether it be caregivers, husband, wife, kids, whatever, to kind of get a sense about whether or not the patient's really taking the medication because sometimes the patient will say, "Yeah, I'm taking it consistently." But then you find out from, you know, a family member, "Oh no, that is not the case." So it's really important to engage them. Plus, they can provide a level of support into their world. They can encourage them to take their medication, you know, help them if they don't remember, you know, things like that. And in addition, we have a pharmacy team who can also determine whether a patient's taking the medication, because, you know, are they calling for their refills when they need to be? I get calls from my pharmacy team all the time to say, you know, "So-and-So hasn't picked up their medication. You know, what do we need to do about this?" And then we may bring 'em into the office and find out really what's going on so that we can kind of get them back on track. So all very important pieces to figure out

[Dr Singer]

Good points. So, Dr Markowitz, we do have some idea of how people have been doing in terms of being persistent on KESIMPTA? Persistence was assessed in two real-world studies, and this is retrospective data, 75% of patients on KESIMPTA remained on treatment at one year versus 43% of those on platform injectable medications. In addition, 82% of patients taking KESIMPTA remained on treatment at one year versus 68% of those on orals

[Dr Markowitz]

Dr Singer, what does the persistence data for KESIMPTA compared to platform injectables and orals in patients with relapsing MS tell us as treating physicians?

[Dr Singer]

Well, I'm not surprised about the results of persistence. In clinical practice, you know, we've been doing this for a long time, Dr Markowitz. And so I think it is consistent with this other data that we're seeing

[Dr Markowitz]

Yeah, I think the persistence data is pretty consistent with what I see in my practice as well

[Dr Singer]

In a real-world survey of 105 patients, about 90% of patients similarly found the KESIMPTA Sensoready® Pen was easy and simple to use

[Dr Singer]

So, Dr Markowitz, how does the typical administration time of one minute once a month fit into the lifestyle of your patients?

[Dr Markowitz]

Right. So some patients express that they, you know, have the preference for self-administration once monthly. Some find that works better into their lifestyle. But then some others, you know, prefer to do an infusion. That's just, you know, the variability of one person's preference over another. And that's fine. My KESIMPTA patients will tell me that they can set a calendar, you know, a day once a month on their calendar, and say, "Okay, this is the day I'm going to actually administer my medication." And that works extremely well for them. They may have reminders on their phone that kinda pop up and say, you know, "Today's your day," or, you know, "Tomorrow's your day," or things like that. And it works extremely well

[Dr Singer]

Yeah. I think a lotta my patients also like the idea of self-administering KESIMPTA at home, which is a very attractive option for a lotta people, particularly people with busy lives. Other people may prefer also KESIMPTA on the go.

[Dr Markowitz]

So hopefully, that helped give you insight into my clinical practice, my goals in treating relapsing patients, and how adherence and persistence play into my treatment plans. So, Dr Singer, what do you think? Is there anything else you'd like to add or comment on?

[Dr Singer]

Yeah, I think all the real-world data is very interesting. I like the data specifically about persistence. And uh you know, a lotta my patients have done very well with the KESIMPTA Sensoready® Pen. I think the option of taking it at home, your treatment on a once-a-month basis, and only one minute for the injection really helps fit into people's lifestyles as they look to go forward with their journey with MS

Narrator

Important Safety Information

Infections

• Delay KESIMPTA administration in patients with an active infection until the infection is resolved. Vaccination with live-attenuated or live vaccines is not recommended during treatment with KESIMPTA and after discontinuation, until B-cell repletion

Injection-Related Reactions

• Management for injection-related reactions depends on the type and severity of the reaction

Reduction in Immunoglobulins

• Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with KESIMPTA until B-cell repletion. Consider discontinuing KESIMPTA if a patient develops a serious opportunistic infection or recurrent infections if immunoglobulin levels indicate immune compromise

Fetal Risk

• May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for at least 6 months after stopping the last dose