Talk KESIMPTA: Navigating Conversations With Patients About KESIMPTA as a Treatment Option

Video 1: Choosing a Self-Administered B-Cell Therapy With Your Patients With RMS

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Jasmin Patel, MD

It's important that, during the shared decision-making process, HCPs effectively communicate with our patients about their treatment choices

With that in mind, let's discuss how we introduce the key characteristics of KESIMPTA, the first and only self-administered subcutaneous B-cell treatment, to our patients with RMS

Jasmin Patel, MD

As a reminder, KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

KESIMPTA is contraindicated in patients with active hepatitis B virus (HBV) infection, or history of hypersensitivity to ofatumumab, or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema

Warnings and Precautions include infections, injection-related reactions and hypersensitivity reactions, reduction in immunoglobulins, and fetal risk. Most common adverse reactions include upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions

Please see additional Important Safety Information on the adjacent panel and at the end of this video, as well as the accompanying full Prescribing Information, including Medication Guide

Jasmin Patel, MD

Dr Hendin, can you tell us a bit about who you consider to be the ideal KESIMPTA patient?

Barry Hendin, MD

Because KESIMPTA is a B-cell therapy that provides powerful efficacy with superior ARR reductions up to 58% vs teriflunomide, an oral therapy, I frequently consider it as an appropriate treatment option for many of my patients with RMS

I highlight these data for my patients during our treatment decision-making discussions, particularly with treatment-naïve patients considering treatment for the first time, because they often need more explanation regarding treatment decisions

In my practice, patients are very receptive to learning about KESIMPTA

Barry Hendin, MD

But I don't stop there. In my opinion, the goals of treating RMS are reducing the number of relapses and slowing disability progression as soon as possible. Because NEDA-3 is a composite measure that assesses all these outcomes, it is an important factor to look at as well

So, I'll also share that, at year 6, 9 out of 10 treatment-naïve patients treated with KESIMPTA achieved NEDA-3

It's important to keep in mind that re-baselining was conducted at month 12 to allow for the accurate measure of the disease activity

This post hoc analysis considers patients without evidence of disease activity, which may also include patients with partially missing information, as NEDA-3

Jasmin Patel, MD

I agree, Dr Hendin. A patient's first treatment choice matters. I try to be proactive and initiate treatment with a high efficacy therapy such as KESIMPTA as soon as possible, even in my treatment-naïve patients. The first step is making sure the patient understands what a high efficacy therapy like KESIMPTA can offer, such as its established safety profile

Jasmin Patel, MD

With that in mind, Jean, what from the safety data do you highlight when you first introduce KESIMPTA?

Jean Bakke-Cain, CRNP

Though I tailor my discussions to each individual patient, when discussing KESIMPTA, I always highlight its established safety profile, proven over 6 years, along with my clinical experience with the drug. Once we've established KESIMPTA as their treatment of choice, I'll provide more education, similar to what is found in the "Patient Counseling Information" section found in the Prescribing Information

Barry Hendin, MD

Agree, Jean, and I like the approach you described. In addition to the proven safety profile, I also share that there were no new safety signals reported. Taken together, I find that these points help to further build confidence in the safety profile of KESIMPTA

Barry Hendin, MD

Also, I like to stress to my patients that the KESIMPTA Sensoready Pen is easy to use

I cover the differences in administration between currently available B-cell therapy options to reinforce the flexibility of KESIMPTA

To do this, I explain that they will still have to go to the doctor for labs, MRIs, and potential follow-up appointments. But, as far as the administration goes, KESIMPTA is the first and only B-cell therapy that you can independently self-administer in the comfort of your home

Barry Hendin, MD

Also, they can complete their treatment in just one minute a month when they are ready to administer

And when I take this approach, my patients better understand the flexibility that is afforded by KESIMPTA before making their treatment decision

Jasmin Patel, MD

I take a similar approach, Dr Hendin. I make distinctions based on flexibility because many of my patients like that they can self-administer KESIMPTA independently at home or have someone help them administer

Jean Bakke-Cain, CRNP

Pulls out demo pen and walks through pen demo during below discussion

Since we're talking about administration, another thing I find very helpful is demonstrating how to use the pen. I typically show how to use the pen on myself and then let my patients try for themselves. And I point out that the KESIMPTA Sensoready Pen:

• Has no visible needle

- It can just be pressed against the skin to start

- It's also thinner than subcutaneous needles for all ages, including pediatric needles

- There's only 0.4 mL per injection

- And it goes just under the skin, not into the muscle

• The pen also has a green progress indicator that stops moving when administration is complete

• The KESIMPTA Sensoready Pen provides 2 clicks: 1 click when administration starts, and another when it's almost done

• And lastly, it is also travel friendly since it can be kept at room temperature for up to a week

Barry Hendin, MD

We use the demo pen in my practice as well. And we find that patients are generally very receptive and feel more comfortable about self-administering KESIMPTA at home following the demonstration

Jasmin Patel, MD

But I don't stop there. I also highlight the convenient dosing schedule afforded by KESIMPTA

And to help build comfort, I give my patients a few tips on how to approach at-home self-administration

I instruct them to

• Pick a day and start with 1 dose a week for the first 3 weeks, then to skip the 4th week

• Take their first monthly maintenance dose on the fifth week

• Continue taking KESIMPTA once a month

• To keep things simple, I suggest they try to take KESIMPTA on the same date every month, which is typically easiest right when it arrives

Jasmin Patel, MD

Let's take a moment to discuss treatment access. In my practice, my aim is to get patients on RMS treatment as soon as possible in an attempt to manage their disease quickly and effectively. This is of importance to my patients as well

When discussing KESIMPTA with my patients, I mostly reinforce that KESIMPTA support programs make it easy to get started on treatment

What about you, Jean?

Jean Bakke-Cain, CRNP

Me too. The ability to easily and quickly get patients started on KESIMPTA is crucial in my decision to prescribe. And with KESIMPTA, I can often start my patients in days, not weeks

With that in mind, I often note the positive experiences of my patients with their commercial insurance and the Alongside^TM KESIMPTA Patient Support Program, letting them know that, once prescribed, KESIMPTA will be delivered right to their door every month

Jasmin Patel, MD

Thank you both for sharing your thoughts on how you discuss KESIMPTA with your patients

As we close, any final thoughts to summarize how you effectively describe KESIMPTA to your patients with RMS?

Barry Hendin, MD

We covered a lot of important factors that go into the shared decision-making process, so let's take a moment to review

Our patients need to understand not only the efficacy and safety profile of the drug they're taking but also how it will be administered so that they can decide if it's the most appropriate option for them

And for every patient considering KESIMPTA, it is useful to show them the demo pen to demonstrate its ease of use firsthand

I recommend that my colleagues use a similar approach to ensure patients truly understand what KESIMPTA offers them

Barry Hendin, MD

Thanks for your attention, and please continue watching for the Important Safety Information

Narrator

Important Safety Information

Contraindications

• KESIMPTA is contraindicated in patients with active hepatitis B virus infection, or a history of hypersensitivity to ofatumumab, or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema

Infections

• Serious, including life-threatening or fatal, infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies. 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 and Hypersensitivity 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 the last dose

• Please see additional Important Safety Information and full Prescribing Information, including Medication Guide, on the adjacent panel of this video

Video 2: Self-Administration With a Demonstrated Tolerability Profile

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Barry Hendin, MD

In my experience, it's helpful for patients to have added context about the safety and tolerability profile of a treatment so they understand more about what to expect

With that in mind, let's discuss how we reiterate the safety and tolerability of KESIMPTA, the first and only self-administered subcutaneous B-cell treatment, with our patients during follow-up discussions

Barry Hendin, MD

As a reminder, KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

KESIMPTA is contraindicated in patients with active hepatitis B virus infection, or history of hypersensitivity to ofatumumab, or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema

Warnings and Precautions include infections, injection-related reactions and hypersensitivity reactions, reduction in immunoglobulins, and fetal risk. Most common adverse reactions include upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions

Please see additional Important Safety Information on the adjacent panel and at the end of this video, as well as the accompanying full Prescribing Information, including Medication Guide

Barry Hendin, MD

Every patient with RMS has their own specific circumstances to consider when reviewing RMS treatment options. Because of this, I sometimes find it useful to give patients time to consider our initial discussions on the safety profile and tolerability of KESIMPTA. This gives them an opportunity to weigh their options before a treatment decision is formally made during a follow-up visit. Does this approach resonate with you?

Jean Bakke-Cain, CRNP

I agree, Dr Hendin. I find that patients tend to ask questions about what is most relevant to their situation. For example, they may want to better understand what possible adverse events to expect from KESIMPTA or if they need to take additional safety measures before or during treatment. It is really about how the safety profile applies to the patient and their preferences

In most cases, I like to first reiterate what I have seen in my clinical experience—that KESIMPTA has an established safety profile, demonstrated in 2 head-to-head studies vs teriflunomide

Once the patient and I have decided on KESIMPTA, it's important I advise the patient to read the FDA-approved patient labeling

In particular, I'll have patients contact me for any signs of infection and inform them that KESIMPTA may cause reactivation of hepatitis B or PML. I'll also tell my patients of typical symptoms with any infection or injection-related reaction and hypersensitivity reaction

I'll also counsel women of childbearing potential to use effective contraception while on KESIMPTA and for 6 months after the last treatment

If they become pregnant or plan to become pregnant that they contact me as soon as possible so I can help guide their therapy

I'll advise patients to complete any required live or live-attenuated vaccinations at least 4 weeks and, whenever possible at least 2 weeks, prior to initiation of KESIMPTA for inactivated vaccines

And that administration of live-attenuated or live vaccines is not recommended during KESIMPTA treatment and until B-cell recovery

Jasmin Patel, MD

I generally add that KESIMPTA has long-term safety data proven over [6] years. After that, I just try to address each patient concern as they come until the patient feels reassured in their decision

Barry Hendin, MD

Continuing our discussion on what patients can expect during treatment, Dr Patel, when does the topic of tolerability come up when you first describe KESIMPTA to your patients? And how do you approach this, both initially and during any follow-up appointments?

Jasmin Patel, MD

Before formally starting treatment, I like to let my patients know that no premedication is required when self-administering KESIMPTA, and no 1st dose observation by an HCP is needed

As mentioned in our prior video and while I'm on the topic of administration, it also helps to use the demo pen so patients can experience the ease of administration of KESIMPTA for themselves

Jean Bakke-Cain, CRNP

That hands-on experience is so important because patients will likely be administering KESIMPTA independently since it has the tolerability and design to support self-administration

These characteristics really help to establish for my patients the simplicity of at-home treatment with KESIMPTA, which is key. Because if a patient can't or won't take an RMS treatment due to tolerability issues, then it defeats the purpose of therapy

Jasmin Patel, MD

Agree, Jean. I'd like to add that during my follow-up visits with patients, I frequently reiterate for them what they can expect to experience while on treatment with KESIMPTA

In the clinical trials, injection-related reactions were mostly mild to moderate

The incidence of systemic injection-related reactions was highest with the first injection at 14.4% but decreased to less than 3% after the third KESIMPTA dose

Systemic injection-related reactions and local injection-site reactions were reported in 21% and 11% of patients treated with KESIMPTA, respectively, compared to 15% and 6% in the teriflunomide-treated patients

The most frequently reported symptoms included fever, headache, myalgia, chills, and fatigue

Jean Bakke-Cain, CRNP

I definitely agree with your point about letting patients know what others have experienced. I have found that this really helps bring comfort to my patients getting started on KESIMPTA

Barry Hendin, MD

I agree. While the real-world survey showed that about 90% of patients found the KESIMPTA Sensoready® Pen easy and simple to use and the monthly dosing schedule easy and convenient, I tend to focus patient conversations more so on my own clinical experience and speak to the number of KESIMPTA patients I have and how they are doing. I find that can be more relatable for patients than detailing study results. Then, once they start on KESIMPTA, I remain active in asking my patients on KESIMPTA how they are feeling on their therapy

Barry Hendin, MD

Thanks, Jasmin and Jean, for this valuable discussion

It's so important to reinforce what patients can expect during their treatment with KESIMPTA.

Again, that conversation will likely include the powerful efficacy and established safety profile of KESIMPTA, proven over 6 years

Plus, a demonstrated tolerability profile with no premedication needed

No 1st dose observation needed

And an easy-to-use pen

This all helps to ensure we are setting up patients for a successful initiation of treatment with KESIMPTA

Barry Hendin, MD

Thanks for your attention, and please continue watching for the Important Safety Information

Narrator

Important Safety Information

Contraindications

• KESIMPTA is contraindicated in patients with active hepatitis B virus infection, or a history of hypersensitivity to ofatumumab, or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema

Infections

• Serious, including life-threatening or fatal, infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies. 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 and Hypersensitivity 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 the last dose

• Please see additional Important Safety Information and full Prescribing Information, including Medication Guide, on the adjacent panel of this video

Video 3: Long-Term Compliance and Persistence

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Jean Bakke-Cain, CRNP

My patients with RMS often want to hear about the experience of others who have also chosen KESIMPTA as their treatment of choice. While some patients with RMS have specific questions on its efficacy or safety, I find that the ability to remain adherent to treatment is as important to my patients as it is to me and other clinicians

With that in mind, I like to discuss lifestyle, administration, and tolerability with my patients. These discussions can provide insight on whether a patient can see themselves staying adherent, which is imperative for us to see efficacy. Along with my personal experience, the KESIMPTA data gives me a good idea about what to expect

Jean Bakke-Cain, CRNP

As a reminder, KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

KESIMPTA is contraindicated in patients with active hepatitis B virus (HBV) infection, or history of hypersensitivity to ofatumumab, or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema

Warnings and Precautions include infections, injection-related reactions and hypersensitivity reactions, reduction in immunoglobulins, and fetal risk. Most common adverse reactions include upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions

Please see additional Important Safety Information on the adjacent panel and at the end of this video, as well as the accompanying full Prescribing Information, including Medication Guide

Jean Bakke-Cain, CRNP

Dr Hendin, how do you set expectations for compliance and persistence on KESIMPTA with your patients?

Barry Hendin, MD

Well, when my patients ask about the likelihood of staying on KESIMPTA, I find it helpful to tell them what I have seen throughout my practice, which aligns very well with the compliance data from the KESIMPTA clinical studies that showed that nearly 90% of patients remained on KESIMPTA through the study period

I then bring meaning to that discussion by emphasizing that the efficacy and safety profile demonstrated in clinical trials can only be expected if patients adhere to therapy as prescribed

What I hear from my patients tells me that adherence is largely dependent on how they view their therapy. I find that if they view their therapy as easy to take, if it fits into their lifestyles, and if it is tolerable, then my patients will request to start and are likely to stay on treatment longer

Jasmin Patel, MD

Once a patient is on KESIMPTA, I like to take a personal approach and ask them how they are doing with their therapy at each visit

And, much like Dr Hendin, I make sure to relay these learnings on adherence to KESIMPTA with my newly starting patients.

Jean Bakke-Cain, CRNP

There is now extended compliance data for KESIMPTA, demonstrating that nearly 8 out of 10 treatment-naïve patients are still on treatment after 6 years in the open-label extension study

Jasmin Patel, MD

Between my clinical experience with patients on KESIMPTA and the results from two real-world studies of persistency on KESIMPTA vs platform injectables and orals, I feel confident informing my patients of their ability to start and stay on KESIMPTA

Take the real-world persistence study of KESIMPTA vs platform injectables. 75% of patients taking KESIMPTA remained on treatment at 1 year vs 43% of those on platform injectables

Then, the real-world persistence study of KESIMPTA vs orals showed that 82% of patients taking KESIMPTA remained on treatment at 1 year vs 68% of those on orals

Jean Bakke-Cain, CRNP

Beyond patients asking about staying on their medication, I'll sometimes get questions about the ease of administration of KESIMPTA. Do you also get similar questions?

Barry Hendin, MD

Absolutely. I first like to relay that many of my patients are on KESIMPTA and their experiences have aligned with real-world data, which showed that about 90% of patients found the Pen easy and simple to use and that the monthly dosing is easy and convenient

Jean Bakke-Cain, CRNP

Thanks so much, Dr Patel and Dr Hendin, for your perspectives on how to discuss with patients what treatment compliance can look like on KESIMPTA

Through these discussions, we can equip our patients with the information they need to feel comfortable starting and staying on KESIMPTA

Thanks for your attention, and please continue watching for the Important Safety Information

Narrator

IMPORTANT SAFETY INFORMATION

Contraindications

• KESIMPTA is contraindicated in patients with active hepatitis B virus infection, or a history of hypersensitivity to ofatumumab, or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema

Infections

• Serious, including life-threatening or fatal, infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies. 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 and Hypersensitivity 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 the last dose

• Please see additional Important Safety Information and full Prescribing Information, including Medication Guide, on the adjacent panel of this video