How KESIMPTA® (ofatumumab) Offers an SC Treatment Option for Patients Looking to Switch Therapies

[Dr Avila]

We often hear patients expressing interest in changing their therapies for relapsing multiple sclerosis, or RMS. Today we are here to discuss a real-world patient who was on an relapsing MS infusion therapy and was interested in learning more about other disease-modifying therapies, or DMTs. This is a case that highlights shared decision-making between Dr Cabot and her patient, Jack, to find an appropriate therapy to help Jack reach his treatment goals

[Dr Cabot]

Now, Dr Avila, I want to talk about a patient of mine—let's call him Jack—who was on an infusion therapy for a couple of years. But he had recently brought up his interest in learning more about treatment options that might better align with his lifestyle

[Dr Avila]

Thank you for the context, Dr Cabot. Would you tell us more about Jack's story?

[Dr Cabot]

Yes, Jack is a 35-year-old male with relapsing MS. He initially presented with left hand weakness and vertigo. His MRI showed multiple lesions, which were characteristic for demyelinating disease, and he was initially started on an injectable disease modifying therapy, and then switched to an oral disease modifying therapy

I started seeing Jack at this point, and we switched him to an infusion therapy. At the time of his appointment, Jack expressed an interest in switching therapies

[Dr Avila]

When you were discussing other treatment options with Jack, which characteristics or aspects were important to him?

[Dr Cabot]

Jack expressed to me that he felt it was difficult for him to schedule infusions and travel to and from the infusion center for his treatments. Because of this, he wanted to find a treatment that allowed him the flexibility of administering at home

[Dr Avila]

I have similar experiences with my patients because many of my patients live in rural areas and need to drive hours to the nearest infusion site. This may not be feasible for some, so

at-home administration is a topic of discussion for my patients

Which therapy did you recommend Jack switch to when he mentioned his concerns?

[Dr Cabot]

Jack and I reviewed a variety of different options. After aligning on his treatment goals and personal preferences, we decided to get him started on KESIMPTA

[Dr Cabot]

KESIMPTA is indicated for the treatment of relapsing forms of 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

You can see Important Safety Information on KESIMPTA within this video and on the adjacent panel

[Dr Avila]

What made you consider KESIMPTA for Jack and other relapsing MS patients like him?

[Dr Cabot]

Jack, in particular, communicated that the route of administration and the ability to self-administer were 2 of the most important factors for him. As Jack's physician, listening to his lifestyle preferences was very important to me in this shared decision-making process

With KESIMPTA, when the patient is ready to administer, it typically takes 1 minute a month. The once-monthly dosing begins after the initial dosing period, which consists of 20-mg subcutaneous doses at weeks 0, 1, and 2

[Dr Avila]

I hear from many of my patients that they are happy with this aspect of KESIMPTA

[Dr Avila]

As a health care professional, I value efficacy first and foremost. So, I would want to choose a treatment approach where I felt confident in therapy's efficacy

When we look at efficacy data, KESIMPTA demonstrated a reduction in relapsing MS disease activity in Phase 3 trials, reducing MRI activity, T1 and T2 lesions, relapses, and delaying disability progression compared to teriflunomide

[Dr. Avila]

Early and continued relapse reduction was observed over the study period. These results are based on a post hoc analysis of pooled data from ASCLEPIOS I and II where KESIMPTA demonstrated reductions in the annual relapse rate within the first 3 months, and time intervals over 2 years. No conclusions can be drawn

Why was this data important for you and Jack? How did you explain the efficacy of KESIMPTA to him?

[Dr Cabot]

One thing I told Jack and I like to tell all my patients when explaining efficacy data is the fact that KESIMPTA was studied in a head-to-head trial versus teriflunomide. This is reassuring to both practitioners and patients like Jack, especially when the data showed statistical superiority in terms of efficacy

[Dr Avila]

Definitely. The head-to-head efficacy is one of the big reasons why some of my patients and I have chosen KESIMPTA

How is Jack doing now since starting KESIMPTA?

[Dr Cabot]

So far, Jack has expressed that he is doing well on KESIMPTA, which makes me happy. In his most recent appointment, his MRI, labs, and symptoms were stable, and he showed no changes in his spine lesions. As a health care professional, hearing that the patient feels good about the decision, but also seeing that they're doing well clinically is a really great feeling

[Dr Avila]

I agree, it is very rewarding to see patients doing well on a different therapy

With disease-modifying therapies for RMS, many health care professionals and patients prioritize safety. Patients usually feel knowledgeable and comfortable with their current therapies. So, when they do switch for route of administration preferences, one of the main questions they have is around the safety profile of the new agent they are considering to switch to

[Dr. Avila]

The most common adverse reactions with incidence greater than 10% in patients taking KESIMPTA were upper respiratory tract infections, headache, injection-related reactions, and local injection-site reactions

The overall rate of infections and serious infections in patients treated with KESIMPTA was similar to teriflunomide

In this chart, you can see adverse reactions with an incidence of at least 5% with KESIMPTA and a greater incidence than teriflunomide

What did the safety profile of KESIMPTA mean to your patient Jack?

[Dr Cabot]

For Jack and for many of my patients, safety is a huge component when making a treatment decision. As I mentioned previously, KESIMPTA was studied in head-to-head trials against teriflunomide, and so to not only show efficacy but also that KESIMPTA had a similar safety profile to a first-line oral medication is appealing to patients

[Dr Cabot]

Not only that, but the availability of the long-term safety profile of KESIMPTA vs teriflunomide up to 5 years is important to me as a health care professional, and to patients like Jack as well. The data demonstrated that no new safety signals arose within KESIMPTA

The most common adverse events were infections; the most frequent infections in the overall safety population were COVID-19, nasopharyngitis, upper respiratory tract infections, and urinary tract infections

Despite this, it's important to note that ALITHIOS is an ongoing trial and that the data presented are at an interim analysis. No conclusions of clinical outcomes can be drawn

[Dr Avila]

I agree. Having an agent with a head-to-head safety profile against an active comparator and the availability of long-term safety data can be encouraging for patients, especially when they see similarity in the rates of adverse events in the ALITHIOS trial

[Dr Avila]

Continuing on the topic of safety, one concern we hear from patients is the idea of an injection

Injection-related reactions with systemic symptoms occurred most commonly within 24 hours of the first injection, but were also observed with later injections

With KESIMPTA, the incidence of systemic injection-related reactions was highest with the first injection occurring in 14.4% of patients, then decreasing with subsequent injections occurring in 4.4% in the second, and less than 3% of patients in the third injection

Symptoms observed included fever, headache, myalgia, chills, and fatigue, and were predominantly mild to moderate in severity in 99.8% of patients

The 4-year results of ALITHIOS was consistent with those reported in ASCLEPIOS I and II, including continuous KESIMPTA patients and those switching from the teriflunomide arm

How would you present the injection data to a patient and what would you highlight?

[Dr Cabot]

In my experience, nurses play a huge role in patient education around KESIMPTA. We have pamphlets that our nurses give to every patient that highlight key safety points, including injection-related reactions, to make patients feel informed with starting treatment

[Dr Avila]

At my practice site, unfortunately, I do not have a nurse who focuses on patient education. So I usually educate patients on safety and also on administration

Tell us more about the administration of KESIMPTA and how would you describe it to Jack when he was switching over to KESIMPTA

[Dr Cabot]

So, for Jack's case, he had made it clear to me that he was looking to switch his therapy to better align with his desired lifestyle

[Dr Cabot]

Jack mentioned that he wanted a therapy that he could self-administer so that he would not have to schedule appointments and travel to an infusion center

Taking that into consideration, I let Jack know that KESIMPTA is available as a subcutaneous auto-injector, called the Sensoready Pen, that can be administered at home

It's a preloaded device with an audible and visual cue to help with administration

When a patient is ready to administer, it typically takes only one minute a month. Once-monthly dosing begins after the initial dosing period, which consists of 20-mg subcutaneous doses at weeks 0, 1, and 2

[Dr Avila]

For needle-averse patients, the design of the Sensoready Pen allows the user not to see the needle

For example, I had a patient who when initially diagnosed he said I don't want anything to do with injectables. I said, listen, I understand how you feel, but let me demonstrate how KESIMPTA is administered. Once he was able to see the pen for himself, he wanted to give it a try. He has been on KESIMPTA now for 6 months and has been doing well with the self-administration

For some patients, it really helps to see the pen before making a decision, especially for the needle-averse patients

[Dr Avila]

Now that we've discussed KESIMPTA, how was your experience with starting Jack on KESIMPTA?

[Dr Cabot]

That's a great question Dr Avila. KESIMPTA has this great program called the Alongside Bridge Program, which covers patients for up to 12 months while coverage is being pursued

It's much easier for me to start a medication like KESIMPTA for patients like Jack because the bridge program has been very easy to navigate. I can prescribe the medication and feel confident that, you know, if I write it, at least I'll get some feedback very quickly on how things are going

[Dr Avila]

I have also had the same experience with the bridge program. It has been very helpful with coverage and getting KESIMPTA to my patients quickly

[Dr Avila]

Thank you for sharing your experience with your patient, Jack. His patient case really resonates with what I commonly see in my practice site. Before we wrap this up, what would you say KESIMPTA has to offer patients looking to switch therapies?

[Dr Cabot]

With KESIMPTA, we get the flexibility of self-administration.

What about you? What would you say KESIMPTA has to offer for your patients?

[Dr Avila]

I use KESIMPTA in many of my patients. And the main thing that stands out to me with KESIMPTA is the route of administration and the flexibility that the subcutaneous route may provide.

Ultimately, it is very important to consider that the decision of changing a patient's treatment is a shared decision

[Voiceover:]

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 the last dose.