KESIMPTA® (ofatumumab) Coffee Breaks: KESIMPTA Efficacy and Safety in Treatment Decision-Making

Dr Jeffery

* While we are lucky to have so many treatments for relapsing multiple sclerosis, or RMS, available today, it can be difficult to prioritize a therapy among all these choices. Some health care providers and patients may be reluctant to start on certain therapies because of safety concerns, even when there is high disease activity or poor prognostic factors.

Stephanie, let's talk about which patients might be appropriate for a therapy like KESIMPTA.

Dr Jeffery

So, Stephanie, tell me about your practice and how you approach treating newly diagnosed patients.

Stephanie

* Absolutely, and I definitely think this is an important topic in the MS community because there are differing opinions.

* I feel very strongly that people shouldn't experience disease activity while on medication, so I try to minimize their disease activity and place patients newly diagnosed with RMS on what I think will be the most effective therapy for them. This is often a treatment that demonstrated high efficacy in clinical trials, for example, KESIMPTA when compared to teriflunomide.

Dr Jeffery

* My goal for any of my relapsing MS patients on treatment is to minimize the number of relapses and new lesions, and to slow down disability progression.

* We also have to think about the long term when it comes to patient care and look for data that show efficacy beyond the time frame of the clinical trials, especially when it comes to disability progression.

Stephanie

Yes, and in my opinion, patients with high lesion burden, for example someone who has enhancing or multiple T2 lesions in their brain or their spinal cord, could be appropriate candidates for KESIMPTA, whether they are currently on a disease-modifying therapy, or DMT, or are newly diagnosed.

Dr Jeffery

* Yeah, I think patients with significant T1 and T2 lesion activity or those at higher risk of progression would benefit from a therapy like KESIMPTA. 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.

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

Dr Jeffery

* I know we are familiar with the efficacy data for KESIMPTA, which demonstrated a reduction in RMS disease activity in Phase 3 trials, significantly reducing magnetic resonance imaging, or MRI, T1 or T2 lesions, relapses, and delaying disability progression compared to teriflunomide.

* In my opinion, KESIMPTA is a first-line agent for the majority of my patients for these reasons.

Stephanie, you mentioned that you'd also consider a high efficacy treatment option like KESIMPTA because it compared to teriflunomide for newly diagnosed patients. Would you share an example of a patient who you felt was appropriate for KESIMPTA?

Stephanie

* Sure! I had a patient who I felt was an appropriate candidate for starting KESIMPTA. She was actually one of our first patients to try it. So, she was a test case for us in how to use KESIMPTA in the real world. She had a busy life as a pilot in the military. However, she ended up developing optic neuritis that led to temporary blindness and cervical spine lesions that unfortunately ended her military career.

She was terrified that optic neuritis could happen again, which prompted a big discussion about the need for a therapy that could significantly reduce relapses. I also explained that she had active lesions. We both wanted a therapy that was demonstrated to reduce lesion activity.

Dr Jeffery

* Were there any other considerations besides disease activity when choosing a disease-modifying therapy?

Stephanie

* Yes. Another consideration was her travel schedule. My patient started college after the military and because she was traveling back and forth between home and college during breaks, it would be difficult for her to find and rely on a single infusion center. She also didn't want to take any time away from classes to get an infusion. We both agreed a self-administered therapy would work best for her schedule and lifestyle.

I explained the options and the potential risks. We reviewed the Important Safety Information, including the warnings and precautions—infections, hepatitis B, PML, vaccine, injection-related reactions, reduction in immunoglobulins, and fetal risk. And after all these considerations, we both felt KESIMPTA was the most appropriate option. So far, being on KESIMPTA has reduced relapses and slowed her disability progression.

Dr Jeffery

* Thank you for sharing. I think KESIMPTA is appropriate for patients with active lesions in those locations, since KESIMPTA does a good job at reducing inflammatory disease activity.

* Another situation where I'd consider KESIMPTA is if disease activity persists on the patient's current DMT.

* For example, if a patient starts to have disability progression, or if we see a new lesion while on their current medication, that would be a red flag. That's why we repeat MRIs periodically and ask them how they are doing on a day-to-day basis.

* If a patient had a relapse on their current DMT, incomplete recovery following a relapse, disability progression, or if they feel bad or have intolerable side effects, then these play into the decision-making process for switching to another treatment option, such as KESIMPTA.

Stephanie

I agree. If I saw increased disease activity on another DMT, I would also recommend switching treatments, though we put in a lot of effort to choose the right agent in the first place to reduce the likelihood of switching.

Stephanie

* Dr Jeffery, I'm sure you'd agree that we often have a treatment approach in mind based on a patient's clinical picture but need to get buy-in from the patient first.

* It helps me to ask them questions about their route-of-administration preferences, what types of therapies they are interested in, convenience, safety, and what they are willing to do.

* How do you discuss treatment options and align on a plan with your patients?

Dr Jeffery

* You're right. I typically do have an approach in mind. I usually start by narrowing down the list of DMTs to the ones that are best suited for the patient based on their clinical picture and their special circumstances. I discuss the agents that I feel are appropriate with the patient and indicate which one might be the best for that particular person. I then describe the typical patient experience on each DMT, and they choose the one that feels right for them.

* I want my patients to understand the benefits, potential and otherwise, and the potential risks. When you have that discussion with the patient, you get buy-in. They know and are looking for the management plan that you just laid out for them, and the contingency plans if certain things happen.

Stephanie

That's a good point. I believe that we need to help the patient achieve both their goals and ours when recommending a treatment. If my patient feels like they have a voice in the matter, they are more likely to take their treatment.

Dr Jeffery

* I mentioned earlier that some patients and health care providers might have questions about the safety of therapies like KESIMPTA. How do you discuss the side effect profile of KESIMPTA with your patients?

Stephanie

* So, safety is definitely a concern for all my patients when we discuss choosing a DMT. With KESIMPTA, my patients frequently ask me about the risk of infection. I tell them that the most common side effect of KESIMPTA is upper respiratory infections. Systemic and local injection-related reactions, headache, urinary tract infections, back pain, and decreased blood IgM were also common in the Phase 3 trials. I also tell my patients that there is an increased risk of infection when taking anti-CD20s.

* I also tell them to watch for related symptoms, and as a guide, provide them with a list of some of the most common symptoms that may occur if they contracted any of those infections. If it's an upper respiratory infection, I ask them to stay home unless it becomes a breathing problem, or if they feel something is wrong.

* In general, being able to tolerate side effects is also an important part of adherence. If the medications make you feel bad, then it makes you less likely to take them.

Dr Jeffery

* To your point, Stephanie, my patients are also concerned about the risk of infection. They are worried that their immune system will be suppressed due to a B-cell–targeting therapy like KESIMPTA. I tell them KESIMPTA doesn't target existing antibody-producing B cells and largely spares T cells, so they still have working components of the immune system.

* Although KESIMPTA has the potential for an increased risk of infections, the overall rate of infections and serious infections was similar to patients who were treated with teriflunomide in the Phase 3 clinical trials, and the risk of serious infections was low.

* I also tell them that we'll regularly monitor immunoglobulin levels.

Stephanie

* Yes. While other health care providers may do it differently, we check lab work every 3 months to ensure everything looks OK and that there aren't any obvious signs of infection. Specifically, we check immunoglobulins every 6 months, since checking during treatment is recommended in the KESIMPTA prescribing information.

Dr Jeffery

* Right. And usually, I tell my patients about the common side effects of KESIMPTA. Patients may have some degree of injection-related side effects. Some have injection-related reactions that decrease after subsequent doses.

But overall, most of my patients tolerate KESIMPTA. Pooled data from both clinical trials showed that treatment discontinuation rates due to adverse events were similar between KESIMPTA at 5.7% and teriflunomide at 5.2%.

Stephanie

* I think, overall, patients oftentimes feel anxious when they first get diagnosed with RMS. It is common for someone with RMS to feel like they have zero control over their own body. I can't tell you how many tissues we go through when we are doing an initial visit or a diagnostic visit. They don't know what they're doing with their lives.

Dr Jeffery

Yeah, I agree. I've been impressed with the safety and efficacy data for KESIMPTA. But what really influences my decision-making is my patients' experiences with KESIMPTA.

Dr Jeffrey

* So, Stephanie, even though we might have a strong opinion about which DMT is best suited for a particular patient based on their disease activity, a patient might be unable to consistently take their medication if we don't understand their preferences and get their buy-in to our approach...

* [Transition to fade...conclusion implies you have to watch the next video to hear about onboarding and adherence]

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.