Journey to Kesimpta: Real-World HCP and Patient Experience

[Voice Over Narrator]

Over 150 years ago, a French neurologist named the debilitating disease he'd been observing and treating, "sclérose en plaque disseminée"

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Today, this illness is called multiple sclerosis, or MS, a disease often distinguished by clearly defined relapses that profoundly affect patients' lives and that is further complicated by ongoing MS activity patients may not be aware of

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While relapsing MS, or RMS, has not changed over time, our understanding and approach to managing the disease has

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Over 20 therapeutic options, with varying mechanisms of action and clinical endpoints studied, exist. But even with such progress, we continue to ask new questions, such as… What steps can we take to bring a new product to market in RMS with a unique set of attributes?

[Voice Over Narrator]

And that's where our journey begins

[Voice Over Narrator]

KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis, or 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 (incidence greater than 10%) are upper respiratory tract infection, injection-related reactions, headache, and local injection-site reactions. Please see additional Important Safety Information by watching this entire video and by referring to the adjacent panel and accompanying full Prescribing Information, including Medication Guide. And continue watching at the end of this video to hear full Important Safety Information for KESIMPTA

[Voice Over Narrator]

Throughout the development of ofatumumab, Novartis was centered on addressing the unique needs of patients in achieving our goal of providing a clinically proven and flexible treatment option for patients with RMS. Guided by a patient-first approach, our early research in Phase 2 and modeling studies supported the identification of the most suitable dose, frequency, and administration method for ofatumumab in RMS

[Voice Over Narrator]

Moreover, the APLIOS study, which assessed the efficacy of ofatumumab when administered using a pre-filled syringe vs an auto-injector pen, was intended to enhance the patient's experience by enabling the ease and convenience of at-home or on-the-go self-administration using the Sensoready Pen auto-injector. This advancement enabled patients to manage their RMS at home via self-administration, which may better fit into their lifestyles6

[Voice Over Narrator]

Based on the Phase 3 clinical study data, KESIMPTA received US approval as the first and only 20 mg, at-home, subcutaneously self-administered therapy for the treatment of RMS in August 2020

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The ease of administration of KESIMPTA is appreciated by both patients and HCPs and is supported by real-world patient satisfaction data

[Brittany]

I am a busy bee, and I like to go, go, go. So having more control of my injection days allows me to stay up-to-date with what I gotta do, where I gotta go, who I gotta meet, and all in between

[Zenovia]

KESIMPTA is very helpful because I have to take it just once a month. You pick your injection date, it's the same every month, it doesn't take, for me, a lot of time to take the injection

[Caylee]

KESIMPTA fits my schedule, so how I fill my time is up to me. Now more of my time is coaching time

[Dr Shin]

This medication represents a shift in the treatment paradigm, offering ease of use with quick and straightforward administration, just once a month. It's exciting to show patients just how simple it is to use the KESIMPTA pen. I've seen my patients' eyes light up when they realize how easy to use the KESIMPTA pen is

[Voice Over Narrator]

In the 2 pivotal trials, systemic and local injection reactions were reported in 21% and 11% of patients treated with KESIMPTA, compared to 15% and 6% of patients treated with teriflunomide who received matching placebo injections, respectively. KESIMPTA can result in systemic injection-related reactions and hypersensitivity reactions, which may be serious or life-threatening. Overall, KESIMPTA has a demonstrated tolerability profile with 99.8% of injection-related reactions reported as mild to moderate in severity, and incidence being highest with the first injection but decreasing with subsequent injections. KESIMPTA does not require premedication before injection, and no first dose observation is needed. Overall, most patients have expressed high satisfaction with KESIMPTA

[Dr Coyle]

In my clinical experience, patients feel that by and large, the KESIMPTA injection is very well-tolerated without the need for any premedication. This is invaluable for so many of my patients and is a central reason why they choose this treatment. It sets the stage for KESIMPTA to be more flexibly administered outside the confines of a doctors' office in a way that fits my patients' lifestyles

[Dr Berkovich]

What I hear from my patients is that treatment with KESIMPTA is a positive experience and continues to be a positive experience because of its demonstrated safety profile

[Voice Over Narrator]

Due to the once-monthly self-administration for the use at home or on the go, KESIMPTA offers patients the flexibility to treat their RMS in a way that fits within a variety of lifestyles

[Dr Berkovich]

Patients will still have to go to the doctor for labs, MRIs, and potential follow-up appointments. But, as far as the administration goes, there now exists the flexibility to safely administer KESIMPTA at home or on the go using the Sensoready Pen, which is a great option for a wide variety of patients with relapsing MS

[Dr Coyle]

Among the anti-CD20s, I think the at-home self-administration of KESIMPTA, not having to leave your home to receive treatment, and the quick injection once a month makes this therapy quite appealing. My patients like the fact that they can administer KESIMPTA on their own terms, and I think that's a major reason why they choose it

[Zenovia]

I wanted to get back to an injectable. The injection was just once a month, I could do it at home. I wanted to control as much as I could so it checked a lot of boxes for me

[Andy]

For me, KESIMPTA was easy to use, I only had to take it once a month, I could take it at home by myself, and so it could fit into my lifestyle

[Voice Over Narrator]

Because of these combined attributes, some health care professionals may feel comfortable using KESIMPTA at different stages in their patients' treatment journeys, including in their treatment-naïve patients

[Dr Berkovich]

KESIMPTA may be a great choice for many patients because of its proven safety and efficacy profile as shown in the ASCLEPIOS studies. And when you look at the broad population of patients with RMS studied in these trials, you'll see that treatment-naive patients or those previously treated with commonly used first-line therapies such as interferon and dimethyl fumarate—comprised 80% of participants

[Dr Shin]

My treatment preference, and one I frequently discuss with my patients and peers, is to start a high efficacy therapy like KESIMPTA earlier in a patient's treatment course

[Dr Hauser]

I once had a patient who struggled to adhere well to her MS treatment. Through Novartis's use compassionate program, I was able to secure KESIMPTA for her, even before the clinical trial results were known. She is still on KESIMPTA and it works for her

[Dr Coyle]

And that's our goal. To minimize the risk of progression in patients with relapsing MS in a manner that fits into their lifestyles. This is so that they can hopefully continue to actively participate in their lives, their careers, etc, on a daily basis

[Voice Over Narrator]

Through it all, Novartis is, and will continue to be, committed to improving the standard of care for patients with MS. KESIMPTA allows patients the flexibility to manage their disease in a manner that fits into their daily lives. Based on the patient and HCP feedback we've heard, Novartis' intended goal of developing a promising RMS treatment with patients at the forefront have been realized, supported by the identification of the right dose, right frequency, and right route of administration. As of April 2024, more than [39,000] patients in the US and more than [108,000] patients worldwide, have been prescribed KESIMPTA to treat their RMS. Novartis is proud of our commitment to helping patients with RMS, which fueled our Journey to KESIMPTA. And we look forward to what the future may hold for our patients as this journey continues. Please continue watching this video to hear the full Important Safety Information for KESIMPTA

[Voice Over Narrator]

Thanks for your attention, and please continue watching to hear the full Important Safety Information.

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, by watching this entire video and by referring to the adjacent panel of this video