The APEX: Educating Patients about Self-Injection

Dr Nicholas

Good evening and welcome. During tonight's event, we'll share Rachel's experience with relapsing MS along with unique clinical perspectives from her physician, Dr Andrew Woo, who's been managing her care since 2017. Rachel has relapsing MS and is currently being treated with KESIMPTA.

Dr Nicholas

So we know that KESIMPTA is indicated for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease in adults. It's also important to note that KESIMPTA should not be given to patients with active hepatitis B virus infection

Dr Woo

So, let's talk about the route of administration and how that played in kind of your treatment decision making. What were your preferences regarding route of administration?

What was your thought process there?

Rachel W.

So, you know, you had explained to me that KESIMPTA is a once-a-month subcutaneous shot and it comes in a pen. I like that I can do my treatments at home and if needed, you know, someone could help me administer them.

So while I was generally, you know, pretty compliant on my previous daily oral medication, I do admit that I occasionally missed the dose.

I was apprehensive about the shots at first, 'cause I didn't like my previous injectable. But you know, after the first dose of KESIMPTA with that injection, I was okay with it.

Dr Williams

Absolutely. So how did you typically, Dr Woo, address concerns about injectables with your patients? As Rachel said, she had a previous one that she had some experience with. How did you kind of differentiate and discuss that with your patients?

Dr Woo

Well, I typically have the demo injector and pen in my office. Or I actually have it here if they don't have their, or if they don't take their pen.

So I carry it around with me. I have it in the office. So if I'm showing them on a virtual or live I actually demonstrate the pen. It's quite simple and if the patient is lively, I actually have them do it with me.

You pop off the cap, as many of you know, and it literally takes 5 to 8 seconds, and they can actually see the little chartreuse indicator and they could feel and hear the click. So it's audible and they actually feel the click as it releases. So it literally takes seconds. So it's helpful for them to actually see it and feel it.

So the KESIMPTA Sensoready Pen, it offers a one-minute-a-month dosing when the patient's ready to administer: it's ranked, it's easy to grip, it's in a preloaded device. They never see the needle. It's audible and has the visual cue to actually confirm delivery of the medication.

Dr Nicholas

So it's interesting. So Novartis performed a survey to investigate patient and nurse preferences regarding the Sensoready pen that Dr Woo described versus the autoinjector devices that are used for other DMTs in relapsing MS.

Dr Nicholas

And the survey data were collected from around 80 patients with multiple sclerosis and 50 MS nurses and was conducted across the United States, Germany, France, and Italy.

Dr Nicholas

And over 80% of patients preferred the attributes of the Sensoready pen to their current device. So about 84% versus 16%, with similar percentages among nurses: 86%. And again, patients (83%) preferring the Sensoready Pen.

Dr Nicholas

The highest ranked attributes for the Sensoready Pen over the other injectors were the ease of performing the self-administration. This was preferred by 91% of nurses and 79% of patients. And it's also important to note that no conclusions of clinical outcomes can be drawn from this data.

So Rachel, tell us about your experience with the Sensoready Pen.

Rachel

I actually thought it was going to hurt and it didn't at all. The fact that it's designed so I can't actually see the needle was very helpful. So I just watched the little indicator just to make sure that it's all in my, you know, sub-Q area and then I'm done.

Dr Nicholas

Why is it thought that the sub-Q delivery of KESIMPTA can provide a precise way of targeting B cells?

Dr Woo

Well, if you have really profound depletion of these CD20-expressing B cells, you know, theoretically that could lower host defenses against infections. So there's, you know, kind of a need to approach something that really efficiently depletes disease-driving B cells—but still maybe spares the protective cells that you need for infections.

So when you deliver subcutaneously, some of the preclinical data models suggest that preferential distribution to the lymph nodes where these B cell depletions is needed may actually be a different way to go about it.

Dr Nicholas

Dr Woo, once a patient has been assessed and signed up, what does the dosing schedule for KESIMPTA look like?

Dr Woo

You have the pen. You take it out of the fridge. You leave it, come to room temperature. And then the dosing is the first dose is at week zero, the second dose is at week one, the third dose is at week two. So you have this kind of loading schedule, and then after that then it's once a month.

And then now let's say you miss a dose.

What should you do? Well, you try to give the next dose as soon as possible instead of waiting for the next scheduled dose.

Dr Nicholas

So that's really helpful.

And Rachel, with the dosing schedule and the Sensoready Pen, how did that fit in your routine? And has that been helpful for some flexibility with life?

Rachel

I like that I only have to do the injection once a month in the comfort of my own home. And the rest of the month, you know, I get to forget about my RMS treatment, since I don't have a daily pill to remind me about it.

Humorously, I found that my dog's heartworm medication is on the same schedule as my KESIMPTA, so we take our medicine on the same day, once a month. So it's pretty easy to remember.

Dr Nicholas

That's good. So it's like a party for you and your dog once a month.

So Dr Woo. How do you, how do you, guide your patients through the first KESIMPTA injection?

Dr Woo

Guidance just means that's at the discretion of the HCP.

So, guidance can be that discussion with the patient live or virtual yourself, or with the help of the online tools, or with the KESIMPTA nurse.

And then next, prior to first administration of KESIMPTA, the HCP should also educate the patient on proper injection technique and the signs and symptoms of some of these injection-site reactions that are potentially, can occur and how to manage those potential injection-site reactions if they were to occur.

And then last, patients should be informed that if these injection-related reactions were to occur, they generally occur within 24 hours and predominantly following that first injection.

Now patients often wonder, 'Oh, well, I've been on other injectables, I've been in infusions before. Don't I need some type of premedication with either steroids or Benadryl or acetaminophen or something?' And the answer is actually in the studies: that didn't seem to make a huge difference. So there's no specific requirement for those things. That's what I'm referring to in the package insert, where it says that, that initial dose must be under the supervision of a physician.

That doesn't mean that no, the patient doesn't have to come to your office and you have to do it under the guidance—it's not any kind of first-dose observation. It's mainly referring to guidance as far as verbally or virtually, as far as those kinds of discussions have to take place.

Dr Nicholas

That's really helpful to know that guidance, it really just depends on each individual health care provider's preference and patient preference.

So, Rachel, did you try out that demo pen, or did you find any of the training materials that you received helpful to prepare for that first dose?

Rachel

So I did use the Bridge program. It was very helpful because of the whole insurance approval process. It took a little bit of time to complete, and I also got the big welcome kit in the mail with a brochure and the reading materials. And that was helpful for me to double check everything about the dosing frequency and make sure I knew the proper way to do the injection. And I watched the video and I used the demo pen. I've found both to be very helpful for me. They gave me an idea of what to expect, and the AlongsideTM program, they helped answer all the questions that I had about getting started.

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

Please see full prescribing information, including medication guide, accompanying this video and additional important safety information on the adjacent panel of this video