Lupkynis™ (voclosporin): What you need to know
Lupkynis™ (voclosporin) was approved by the U.S. Food and Drug Administration (FDA) to treat adults with lupus nephritis in January 2021. Lupus nephritis is a type of kidney disease caused by inflammation of the kidneys. It is one of the most serious complications of lupus. Although doctors can treat lupus nephritis with a variety of drugs, Lupkynis and Benlysta® are the only two drugs developed and approved specifically to treat this condition. We have answered some of the most common questions we receive about voclosporin below.
What is Lupkynis?
Lupkynis is a drug developed to treat lupus nephritis, a lupus-related kidney disease caused by inflammation. It is taken as a pill in combination with standard of care therapies and works by suppressing the immune system. The FDA approved voclosporin for the treatment of lupus nephritis in the U.S. on January 22, 2021.
How does Lupkynis work?
Lupkynis binds to a type of protein in the body called calcineurin. Calcineurin’s job is to activate T cells, an essential part of the body's immune system. By binding to calcineurin, Lupkynis stops T cells from triggering an autoimmune response, reducing inflammation in the kidneys. Large clinical trials of Lupkynis showed it was better and faster at preventing inflammation of the kidneys than standard of care treatment.
Who developed Lupkynis?
Lupkynis was developed to treat lupus nephritis (a lupus-related kidney disease) by Aurinia Pharmaceuticals, Inc. of Vancouver, British Columbia in Canada.
What does the FDA approval of Lupkynis for lupus nephritis mean for people with lupus?
Doctors will now have two FDA-approved therapies to treat lupus nephritis. The other approved therapy for lupus nephritis is Benlysta® (belimumab) developed by GSK. Doctors also treat lupus nephritis using other therapies that were originally developed and approved for other diseases and conditions, referred to as ‘off-label’ use. Learn more about treating lupus nephritis.
What are the differences between Lupkynis and Benlysta?
Lupkynis and Benlysta are both immunosuppressant drugs, which means that they both prevent the immune system from attacking healthy cells. But they are different in how they are taken and how they work.
Lupkynis is a pill. It works by binding to a type of protein called calcineurin. This stops the calcineurin from sending a signal to activate part of the immune system called a T cell. By stopping T cells from being activated, Lupkynis can prevent inflammation and damage to the kidneys.
Benlysta is given either directly into a vein (called intravenous infusion) in a doctor’s office or as a shot given under the skin (called subcutaneous injection). Benlysta is a type of protein called a monoclonal antibody. A monoclonal antibody is a type of protein made in the laboratory that is developed to find and attach to only one type of substance in the body. Benlysta works by stopping a part of the immune system called B cells from causing inflammation of the kidneys.
Where can I find out more information about Lupkynis?
You can visit Aurinia’s website to learn more about Lupkynis.
Who should take Lupkynis? Will it work for everyone?
Each case of lupus nephritis is unique, and Lupkynis may not be right for everyone. You will need to discuss with your doctor whether Lupkynis may be an appropriate treatment option for you.
Are there limitations in taking Lupkynis?
Some medications, such as ketoconazole, itraconazole, which are antifungals, and clarithromycin, an antibiotic, should not be taken with Lupkynis. Other medications, such as cyclophosphamides, a chemotherapy and immunosuppressive drug, were not studied along with Lupkynis. This means we don’t know the effects of taking the two medicines together. It is important to tell your doctor about all of the medications that you are taking, even over-the-counter medicines, vitamins, and herbal supplements. These may affect how Lupkynis works.
You should not eat grapefruit or drink grapefruit juice while taking Lupkynis.
Is Lupkynis approved for use in children with lupus nephritis?
At this time, Lupkynis is only approved for use in adults with lupus nephritis.
Will there be further clinical trials on Lupkynis?
Aurinia Pharmaceuticals is conducting an extension study of Lupkynis in lupus nephritis. The company also is planning a Phase 2/3 clinical trial of voclosporin ophthalmic solution as a potential treatment of dry eye syndrome.
Is Lupkynis effective for individuals with lupus who have organ involvement other than the kidneys?
At this time, Lupkynis is only approved to treat lupus nephritis. Lupkynis has not been studied for its ability to treat other organs affected by lupus.
What side effects have been found with Lupkynis?
Most people who took Lupkynis in the clinical trial did not have serious side effects. The number of people who had a serious adverse event, which means the medicine made them very sick, was 20.8% of the total number of people given Lupkynis. This is about 20 out of every 100 people who took Lupkynis in the clinical trial. Out of the people in the clinical trial who did not take Lupkynis, 21.3% reported a serious adverse event or about 21 out of every 100 people.
An infection was the most commonly reported serious adverse event for both groups. Among the group that took Lupkynis 10.1% (about 10 out of every 100 people) reported an infection. In the group that did not take Lupkynis, 11.2% (about 11 out of every 100 people) reported an infection.
Hypertension, or high blood pressure, is another common serious side effect of Lupkynis and may require antihypertensive therapy.
How is Lupkynis administered?
Lupkynis is a pill. The approved dose is 23.7 mg twice a day. Lupkynis is used in combination with standard of care treatment.
Should I receive vaccinations if I am taking Lupkynis?
Overall, vaccinations are considered to be safe and effective for people with lupus. However, people with lupus should not receive vaccines with a form of attenuated (weakened, but still live) virus and should not be exposed to recent recipients of live-vaccines such as oral polio virus. Always talk to your doctor before receiving a vaccine.
How much does Lupkynis cost?
We don't know at this time and will update as information becomes available.
Are there any co-pay or patient assistance programs available for Lupkynis?
To assist LUPKYNIS patients and the healthcare provider (HCPs) who prescribe the treatment, Aurinia has developed and launched Aurinia Alliance. Aurinia Alliance is a patient support program featuring dedicated nurse case managers who provide personalized educational resources and assistance in navigating insurance and Aurinia medication costs throughout each patient’s LUPKYNIS treatment journey. To learn more about Aurinia Alliance or LUPKYNIS, visit www.Lupkynis.com.
Are there other treatments being researched for lupus?
There are a number of pioneering biotechnology and pharmaceutical companies involved in the research and development of new therapies for lupus and lupus nephritis. Several promising treatments are now in various stages of development with some in the near-term pipeline. We can’t make new treatments a reality without your support. You can help by learning more about clinical trials and volunteering to participate in a clinical trial.
Why does it take so long to develop a treatment for lupus?
Lupus is a complex disease. It can affect multiple organ systems and symptoms can range in severity from one day to the next. Also, lupus affects each person differently, with varying responses to treatment. The complexity and multiple ways lupus can affect the body presents challenges in evaluating potential new therapies. With each research study, regardless of the outcome, there are new discoveries that help pave the way for new therapies.
What is the Lupus Foundation of America doing to further the development of new treatments for lupus?
The Foundation has funded studies that have contributed to every lupus research breakthrough of the past 40 years and has ongoing initiatives to standardize and improve clinical trial design, allowing future drug development studies to be completed successfully. Additionally, we actively work to inform people with lupus about clinical trial opportunities and engage people with lupus in ongoing research. An example of our engagement initiatives is RAY™: Research Accelerated by You, a lupus data platform where people with lupus and caregivers share information about their lupus experience to help researchers accelerate the development of new treatments and improve disease outcomes. The Foundation also convened an international group of lupus experts to help identify the barriers and solutions to the most difficult problems people with lupus face. These initiatives, along with the recent approval of treatments for lupus nephritis, will help provide a pathway toward approval of additional treatments specifically developed for lupus.