The subject of this video is “Clinical Trial Results for ENSPRYNG.” ENSPRYNG is a prescription medicine used to treat neuromyelitis optica spectrum disorder, also known as NMOSD in adults who are aquaporin-4, also known as AQP4, antibody positive.
It is not known if ENSPRYNG is safe and effective in children. ENSPRYNG may cause serious side effects, including infections, increased liver enzymes, and low neutrophil counts.
All required vaccinations should be completed before starting ENSPRYNG. Do not take ENSPRYNG if you are allergic to satralizumab-mwge or any of the ingredients in ENSPRYNG, have an active hepatitis B infection, or have active or untreated inactive (latent) TB.
Please see Important Safety Information at the end of this video. If you have any questions, please talk to your healthcare provider or refer to the ENSPRYNG Prescribing Information and Medication Guide.
This video features an accredited neurologist and a real person who is treating her NMOSD with ENSPRYNG.
Hello, my name is Kila. I was misdiagnosed with MS back in 2014. After a series of tests and hospital visits, they determined I actually had AQP4 positive NMOSD. It was very frustrating. So, if you were diagnosed with NMOSD or misdiagnosed like I was, I know what you are going through as you look to learn more about this rare disease and consider your treatment options. This is one video in a series. I wish I would’ve had these videos to turn to when I was first diagnosed with NMOSD. Today’s topic covers the clinical trial results for ENSPRYNG.
In plain English, that means we will review the studies that were done with real NMOSD patients treated with ENSPRYNG. Today, we are fortunate to have a doctor with us who will share these results with you and explain what they mean.
I totally see NMOSD as a disease that is manageable. I take ENSPRYNG, as prescribed by my doctor, so that I can reduce my risk of relapse. Now, let’s hear what Dr. Javed has to say about these important clinical trials.
DR. ADIL JAVED:
Thanks, Kila. Hello, my name is Dr. Javed. I’m a neurologist. As Kila pointed out, I’m here to talk about the two clinical studies that were done for ENSPRYNG. ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are aquaporin-4 antibody positive. Before a drug goes to the market, it gets tested on real patients in a clinical trial. As we review these two studies on the next few slides, I will explain the data the same way I would when I explain to one of my patients. First, let’s take a look at the goals of these clinical trials. A clinical trial tests how well a medical treatment works in people and can determine whether a new treatment is beneficial and safe.
As you can see on the slide, there were two clinical trials done for ENSPRYNG. The two trials were conducted to determine whether taking ENSPRYNG alone or taking ENSPRYNG with immunosuppressive therapy, also known as IST, could lower the risk of relapse in adults with NMOSD versus placebo.
The goal of both trials was to measure how many patients were relapse-free at specific points in time with treatment. In our next slide, we will look at what kind of patients were chosen to participate in the clinical trials. This is very important. The idea is to test as diverse a patient population as possible. Men, women, various ethnicities and ages.
Differences between people such as gender, age, ethnicity and where they live can produce different reaction to the same treatment. Therefore, it is important to have a diverse sample size that is representative and inclusive but not restrictive. The two trials include patients from various countries all around the world. The trials were conducted on both men and women, but women represented a larger percentage of patients.
The study included patients who are either aquaporin-4-IgG positive or negative. In addition, patients had to have at least one confirmed relapse within the last year. Study 1 did not include patients who were recently taking other treatments before starting the trial. Study 2, on the other hand, only included patients who were taking certain ISTs, such as azathioprine, mycophenolate mofetil, or oral corticosteroids before starting the trial.
I encourage my patients to ask a lot of questions. I urge you to do the same. When your doctor discusses a treatment with you, don’t be afraid to ask who it was tested on, how was it studied, how many clinical studies were done. ENSPRYNG is the only NMOSD therapy proven in two clinical studies. Let’s review the patients that were included in Study Number 1.
The study looked at 95 different patients. Each patient was randomly given either ENSPRYNG or a placebo. Sixty-four of the patients were aquaporin-4-IgG positive. Forty-one received ENSPRYNG. Twenty-three were given a placebo.
Thirty-one aquaporin IgG negative. Now, let’s go over the patients from Study Number 2. This study included 76 patients in total. The patients were randomly given either ENSPRYNG plus IST or a placebo plus IST.
Fifty-two of the patients were aquaporin-4-IgG positive. Twenty-six received ENSPRYNG. Twenty-six were given a placebo. Twenty-four were aquaporin-4-IgG negative. ENSPRYNG is only approved for aquaporin-4-IgG positive adults. I would say the number one concern of my patients with NMOSD is reducing the risk of relapse.
Let’s see how ENSPRYNG performed in reducing the risk of relapse in Study 1. Looking at the results from Study 1, we can see that ENSPRYNG significantly reduced the risk of relapse by 74% in patients who are aquaporin-4-IgG positive. After 96 weeks of Study 1, more ENSPRYNG patients (77%) were relapse-free than with placebo, which had just 41%.
Eight out of 10 aquaporin-4-IgG positive patients on ENSPRYNG were relapse-free while 4 out of 10 were relapse-free with placebo. Before we review the data from Study 2, I’d like to point out a difference between the two studies. Study 1 measured ENSPRYNG as a treatment alone versus placebo. Study 2 was done on patients who took ENSPRYNG plus IST versus patients who took placebo plus IST.
If you are a patient on immunosuppressive therapies, the data from Study 2 would be important for your doctor to know. If you are a patient who is not on immunosuppressive therapy, then your doctor will be more interested in the data from Study 1. Now, let’s look at the risk of relapse data from Study 2.
As you can see from the slide, ENSPRYNG significantly reduced the risk of relapse by 78% in patients who are aquaporin-4-IgG positive. The numbers show that more patients taking ENSPRYNG plus IST were relapse-free than patients taking placebo plus IST. 91% for ENSPRYNG versus 57% for the placebo. The time frame of Study 2 was the same as Study 1. After 96 weeks of testing, 9 out of 10 patients on ENSPRYNG plus IST were relapse-free versus 6 out of 10 on placebo plus IST.
I hope all the data didn’t overwhelm you. In my opinion, there are a few key takeaways from this. The numbers show that ENSPRYNG does help reduce the risk of relapse whether a patient is taking ISTs or not. And the best way to know if ENSPRYNG can be a part of your treatment plan is to talk to your doctor and discuss all the benefits and risks of ENSPRYNG.
I urge you to become your own advocate and take advantage of all the resources out there that go into even more detail about living with NMOSD. Now that we have reviewed the data from the clinical studies, let’s hear how that translates into everyday life of a real NMOSD patient. Let’s hear from Kila. Thank you for your time.
Thanks, Dr. Javed. My doctors and I are happy with my results on ENSPRYNG. Of course, everyone’s experience with ENSPRYNG is different. I know a relapse could always be a possibility, so I keep in good contact with my neurologist, and we talk about all the different issues that I may be having.
Living with NMOSD, I feel it is important for me to do something for myself every day. I love to take my dogs on walks. Some days I just go maybe a block, and then other days I feel better, and we can go further. I feel like I am on the right track with my treatment program.
To me, that is everything. I know this video had a lot of data and information to absorb in just one sitting. But the more you know about NMOSD and treatments like ENSPRYNG, the more effective your conversations can be with your doctor. Working together, you can decide the best ways to move forward.
I hope you found this video informative and helpful. Check out all the other videos in the series relating to ENSPRYNG at www.enspryng.com. They’re a valuable resource you can view anytime. You can even watch them more than once as a refresher. Thanks for listening and stay tuned for Important Safety Information.