Hi, this is Teri. I am a 3rd generation Alzheimer’s Survivor and a co-caregiver of a parent who is surviving and thriving despite having Alzheimer’s Disease.
Recently, we have talked about what Alzheimer’s is, different types of Alzheimer’s Disease & what causes Alzheimer’s Disease. Last week we talked about one of the first FDA-approved medications, Leqembi. This week we will learn more about another FDA-approved medication, Kisunla (pronounced kih-SUHN-lah).
I will remind you, that I am not a doctor. I am not a medical professional. I am a person who can take detailed medical information, research it, and create content & imagery that will make it easier for you to understand a specific concept. You should NEVER use my content to make medical decisions for yourself or your loved one. However, you can take the content I provide to begin conversations with your doctor.
What is Kisunla?
Donanemab, sold under the brand name Kisunla, was approved last month by the FDA for the treatment of early-stage symptomatic Alzheimer's disease. A monthly IV infusion, Kisunla is designed to target and slow the progression of Alzheimer's symptoms such as memory loss and thinking problems.
Kisunla is manufactured by Lilly and is intended to treat adults experiencing early symptomatic Alzheimer's disease, with confirmed amyloid pathology. Like Leqembi, Kisunla is a monoclonal antibody. Kisunla has a significant difference that may appeal to patients, doctors, and insurers: Lilly says patients can stop the drug after it clears the protein. Kisunla has a significant difference that may appeal to patients, doctors, and insurers: Lilly says patients can stop the drug after it clears the protein, amyloid, which clumps into plaques in the brains of people with Alzheimer’s.
Lilly tells us that once you’ve removed the protein targets, you stop taking the medication. Lilly explains that this will reduce the overall cost and inconvenience of the treatment as well as the risk of side effects. The company said that 17 percent of patients receiving donanemab in the 18-month-long clinical trial were able to discontinue the drug at six months, 47 percent stopped within a year and 69 percent stopped within 18 months. Their cognitive decline continued to slow even after they stopped. The company is still evaluating how long that slowing will continue past the duration of the trial.
What is a monoclonal antibody?
Monoclonal antibodies (mAbs) are laboratory-made proteins that are a type of targeted therapy used to treat a variety of diseases, including some types of cancer and COVID-19. Monoclonal antibodies are highly specific because they are derived from a single clone of a cell. It is then engineered to closely reflect the structure of naturally produced human proteins. This means that the body handles them similarly. The body does not metabolize monoclonal antibodies like it would a synthetic medication. The body easily accepts mABs as they are created in a lab from living sources that produce antibodies, such as human B cells. Or immunized animals.
How are monoclonal antibodies produced?
The traditional monoclonal antibody production process usually starts with a generation of mAb-producing cells (i.e. hybridomas) by fusing myeloma cells with desired antibody-producing splenocytes (e.g. B cells). Again, these B cells are typically sourced from humans or animals, usually rodents.
Humanized mAbs can be used to target and neutralize specific proteins that induce an immune response, such as those associated with inflammation in psoriasis and other autoimmune disorders. Kisunla is an example of a humanized mAb used to treat Alzheimer's disease.
Advantages of mAbs:
- Precision - mAbs are more precise than other treatments, which can improve effectiveness and reduce side effects. For example, monoclonal antibody therapy can target cancer without damaging healthy cells.
- Safety - mAbs are safer and less toxic than chemotherapy drugs, which can improve patient survival and well-being.
- Quality - mAbs quality is consistent across production batches, which is important for both therapy and diagnostics.
- Quantity - mAbs can be produced in large quantities.
- Other advantages - mAbs also have fewer off-target adverse effects, fewer drug-drug interactions, and higher specificity.
Disadvantages of mAbs:
- long lead times for traditional mAbs manufacture methods (hybridoma)
- relatively high cost of goods
- laborious process, hybridoma cell generation has low yields
- selectivity is hard to achieve for peptide targets with few amino acid residues
- contamination and risk of loss for hybridoma cultures
- limited uses due to the mode of action
It is not uncommon to have an infusion reaction when taking mAbs. It is like an allergic reaction. Symptoms can include fever, chills, weakness, headache, nausea, vomiting, diarrhea, low blood pressure, and rashes, and are more common when the drug is first given. This is your body’s response to taking a biological medication and will usually subside as you get used to it.
Who can take Kisunla?
Now that we understand what Kisunla is and how it works. Who can take Kisunla?
In theory, anyone experiencing mild cognitive impairment or the early stages of Alzheimer’s Disease. However, to qualify for treatment with Kisunla, patients must meet the same criteria used in the clinical trials that led to its approval:
- Be between the ages of 50 and 90
- Have a confirmed presence of beta-amyloid plaques in the brain
- Have mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease
- Have a body mass index (BMI) between 17 and 35
Potential patients must undergo diagnostic testing to confirm the presence of beta-amyloids before starting treatment, which is usually done with a PET scan and/or a spinal tap. Kisunla has not been tested on people with more advanced Alzheimer's or those without symptoms, so they do not qualify for treatment.
Side Effects of Kisunla
The following information was cut and pasted from Lilly’s Kinsula website:
INDICATION AND SAFETY SUMMARY WITH WARNINGS
Warnings - Kisunla can cause Amyloid-Related Imaging Abnormalities or "ARIA." This is a common side effect that does not usually cause any symptoms, but serious symptoms can occur. ARIA can be fatal. ARIA is most commonly seen as temporary swelling in an area or areas of the brain that usually goes away over time. Some people may also have spots of bleeding on the surface of or in the brain and infrequently, larger areas of bleeding in the brain can occur. Although most people do not have symptoms, some people have headache, dizziness, nausea, difficulty walking, confusion, vision changes, and seizures.
Some people have a genetic risk factor (homozygous apolipoprotein E ε4 gene carriers) that may cause an increased risk for ARIA. Talk to your healthcare provider about testing to see if you have this risk factor.
You may be at higher risk of developing bleeding in the brain if you take medicines to reduce blood clots from forming (antithrombotic medicines) while receiving Kisunla. Talk to your healthcare provider to see if you are on any medicines that increase this risk.
Your healthcare provider will do magnetic resonance imaging (MRI) brain scans before and during your treatment with Kisunla to check you for ARIA. You should carry information that you are receiving Kisunla, which can cause ARIA, and that ARIA symptoms can look like stroke symptoms. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.
There are registries that collect information on treatments for Alzheimer's disease. Your healthcare provider can help you become enrolled in these registries.
Warnings - Kisunla can cause serious allergic and infusion-related reactions. Do not receive Kisunla if you have serious allergic reactions to donanemab-azbt or any of the ingredients in Kisunla. Symptoms may include swelling of the face, lips, mouth, or eyelids, problems breathing, hives, chills, irritation of skin, nausea, vomiting, sweating, headache, or chest pain. You will be monitored for at least 30 minutes after you receive Kisunla for any reaction. Tell your healthcare provider right away if you have these symptoms or any reaction during or after a Kisunla infusion.
Last week when talking about Leqembi I pointed out how I wanted to be careful to not over-dramatize these side effects. As I have said in previous Blogs, I am a study buddy for a loved one participating in a research program with (BAN2401) Leqembi. My loved one has experienced Aria-E and Aria-H. To read those comments, please go back to last week’s blog. Here is the link: https://alzheimerssurvivor.com/blogs/what-is-an-alzheimers-survivor/leqembi
How do I get started?
OK, so you heard all about the scary potential of experiencing a brain bleed and potential brain swelling. You understand that by taking no action, you are guaranteeing continued cognitive decline. And you want to start the evaluation process to see if you are a good candidate for Leqembi treatment. How do you get started? There are 2 options:
Schedule an appointment with your neurologist to learn more.
- If you do not have a neurologist or if you want to be sure you are working with a Kisunla-friendly neurologist, send me an email (teri@protonmail.com). I will need to know where you are located. With that information, I will get back to you with a couple of options.
- This is a great option if you have insurance that will pay for all or part of the testing and medication.
Schedule an appointment with an Alzheimer’s Research facility.
- Research doctors have the same qualifications as neurologists in private practice. However, most research studies do not guarantee that you will receive the medication in the first round. You may receive a placebo first and the study medication later.
- Research studies often offer protocols that are not available to the public yet.
- If you do not have insurance, this is a great solution to get the medication you need to slow cognitive decline.
- Research studies offer protocols at no charge. You will pay nothing.
How much does it cost?
Kisunla Limited-Duration Treatment Examples
Length of Treatment |
|||
30-Minute Infusions |
6 |
13 |
19 |
Course of Therapy Cost |
$12,522 |
$32,000 |
$48,696 |
Note: The price of each vial of Kisunla is $695.65. |
The total cost of Kisunla will vary by patient based on when they complete treatment. The FDA's dosing instructions state that prescribers can consider stopping the dosing of Kisunla based on the removal of amyloid plaques to minimal levels as observed on amyloid PET imaging. The potential to complete treatment after a limited-duration course of therapy, along with 30-minute infusions once per month, could result in lower patient out-of-pocket treatment costs and fewer infusions compared to other amyloid-targeting therapies.
Patients' out-of-pocket costs for treatment with Kisunla will depend on their length of treatment and their insurance. Coverage and reimbursement for Kisunla are now available for eligible patients on Medicare under a National Coverage Determination with Coverage with Evidence Development. Also, as of October 2023, broad coverage and reimbursement for amyloid PET scans are available for eligible patients on Medicare. More than 98% of eligible.
Is it worth it?
I think it is!
I do not understand why someone who is experiencing memory loss would not do everything in their power to limit or reverse their cognitive health. I can guarantee that if I am diagnosed with mild cognitive impairment or Alzheimer’s disease, I will find a way to receive Leqembi, Kinsula, or a similar mAB as a multi-step treatment protocol. I would work with an Alzheimer’s Disease researcher to be sure every bit of information is captured and used to advance Alzheimer’s treatment for the younger generations.
I have already taken what I believe are the first steps. I follow Dr. Dale Bredeson's protocol. I have completely changed my diet, lost 50+ lbs over the last 18 months, refined my supplementation protocol, and started a daily exercise program to support my brain health.
Is it worth it to you?
Only you can decide.