What you need to know about Saphnelo™
The U.S. Food and Drug Administration (FDA) approved Saphnelo to treat adults with moderate to severe systemic lupus erythematosus (SLE ) on August 2, 2021. SLE is the most common form of lupus. Saphnelo is the third therapy for lupus to receive regulatory approval since 2011. We have answered some of the most common questions we receive about Saphnelo below.
What is Saphnelo™ (anifrolumab-fnia)?
Saphnelo, a human monoclonal antibody, is a type 1 interferon (INF) receptor antagonist that inhibits a key protein in the immune system called the IFNAR receptor. This protein acts like a transmitter, amplifying signals from tiny messengers called type I interferons. This activates many parts of the immune system and can trigger major inflammation. Various studies have found that between 50% and 80% of adults with lupus, and up to 90% of children with the disease, have evidence of elevated type I interferon stimulation which is measured by a test called the interferon signature. This signature is associated with risk for more severe lupus features.
How does Saphnelo work?
Saphnelo dampens the excessive type I interferon signature that is found in many lupus patients. Like many aspects of lupus, there is nothing intrinsically bad about type I interferon signals. Interferons are there for a good purpose, which is to signal the immune system to be activated when an infection is detected. In lupus, the balance has been destabilized so that too many unnecessary interferon signals are getting through leading to inflammation in different parts of the body that can cause a person to become ill. Saphnelo binds to the main receptor (a protein called the IFNAR receptor) that transmits the signals from type I interferons throughout the body. Saphnelo has been shown to dampen these signals and to improve the symptoms of lupus.
Who developed Saphnelo?
Saphnelo (anifrolumab-fnia, previously known as MEDI-546) was developed by a company called MedImmune. AstraZeneca acquired MedImmune in 2007 and has been responsible for the clinical development of Saphnelo.
What does the FDA approval of Saphnelo mean for people with lupus?
In clinical trials, volunteers with moderate to severe lupus activity were given Saphnelo in addition to their usual treatments and some were given a placebo (a treatment with no effects) in addition to their usual treatments. These studies were “double-blind” meaning that the participants and the doctors who were testing the drugs did not know whether they were using Saphnelo or the placebo. More patients who received Saphnelo showed improvement than those who received the placebo. Saphnelo showed benefits on overall lupus disease activity, skin lupus (rash), and joints, and the ability to taper down steroid doses. There were consistent clinical benefits across all measured patient subgroups, including age, sex, age at onset and race, compared to placebo.
Like all treatments for lupus that inhibit the immune system, Saphnelo might increase risk for infections and some patients taking Saphnelo have sometimes developed an outbreak of shingles. Therefore, this treatment should be monitored by an experienced clinician, preferably a rheumatologist with experience treating lupus patients. However, data from the clinical trials did not show increased serious adverse events or increased serious infections compared to placebo.
How is Saphnelo different from other recently approved lupus treatments?
Saphnelo is the only available treatment for lupus that targets the type I interferon receptor IFNAR and inhibits signals from all the different type I interferons. Some of its effects on the immune imbalances in lupus are likely to be unique but other aspects of its impact may overlap with other treatments.
Where can I find out more information about Saphnelo?
AstraZeneca created a website to provide information about Saphnelo at saphnelo.com.
What is the target population for receiving Saphnelo? Will it work for everyone?
Saphnelo was developed for treating moderate to severe systemic lupus erythematosus (SLE). Data from clinical studies showed that people with lupus treated with Saphnelo added to their usual treatment had improvements in overall lupus symptoms, in skin lupus (rash), and joints, and in the ability to taper steroid doses.
Saphnelo has not been studied in combination with other biologic therapies, including B-cell-targeted therapies such as Benlysta, and therefore is not recommended for use in combination with these therapies. Saphnelo is not indicated for people with severe active lupus nephritis or severe active central nervous system lupus. Do not use Saphnelo if you are allergic to anifrolumab-fnia or to any of the ingredients.
No treatment will work for everybody with lupus. Finding the best treatment or combination of treatments that is best for each unique lupus patient will require a certain amount of trial and error under medical supervision. However, the science of lupus treatments is rapidly evolving. It is hoped that in the near future we will improve the ability to select optimal treatments in advance for particular people and quickly get them to optimal doses based on sophisticated blood tests.
Is Saphnelo approved for use in children with lupus?
At this time, the FDA has only approved Saphnelo for use in adults with moderate to severe systemic lupus erythematosus (SLE).
Will there be any further clinical trials on Saphnelo?
Saphnelo continues to be evaluated in the TULIP SLE Phase III long-term extension trial. Additionally, subcutaneous anifrolumab is being evaluated in a Phase III trial in SLE.
AstraZeneca will continue to explore Saphnelo for other indications including trials in lupus nephritis (LN) and cutaneous lupus erythematosus (CLE), myositis and pediatric patients with SLE.
What are the side effects of using Saphnelo?
The most frequent adverse events (side effects) in people who received Saphnelo in the three clinical trials included nasopharyngitis (commonly referred to as the cold), upper respiratory tract infections, bronchitis, infusion-related reactions, and herpes zoster (shingles). In the most recent (Phase 3) clinical trials, called TULIP-1 and -2 all cases of herpes zoster were only on the skin and most resolved with medication. None were severe enough to cause people to stop receiving Saphnelo. In patients taking Saphnelo there was no increase in serious infections or in overall serious adverse events.
How is Saphnelo administered?
Similar to other biologic treatments, Saphnelo is administered by infusion. It is administered every four weeks by an injection into a vein in the arm, usually at a hospital or clinic. It usually takes about 30 minutes to give the full dose of Saphnelo.
Should I receive vaccinations if I am taking Saphnelo?
You should not receive live or live-attenuated vaccines during treatment with Saphnelo. If you have not yet received the COVID-19 vaccine talk to your doctor about having that before starting any new treatment that might have a strong impact on the immune system. A clinical study is underway sponsored by the Oklahoma Medical Research Foundation (OMRF) to assess the impact of this treatment on the effectiveness of the influenza vaccine. Researchers have observed that people with lupus who had an elevated type I interferon signal produced less neutralizing antibody to influenza vaccine, and this was directly or indirectly associated with increased flares and more autoantibody production after immunization. The current, small pilot study will examine the impact of anifrolumab (Saphnelo) on the development of neutralizing antibodies to the influenza vaccine in people with lupus.
How much does Saphnelo cost?
We don't know at this time and will update as information becomes available.
Is there any co-pay or patient assistance program for Saphnelo?
Access and out-of-pocket costs are determined by individual health insurance coverage. For eligible, commercially insured people, AstraZeneca provides co-pay savings programs to help with costs at the pharmacy. And for people without coverage and those with Medicare/Medicaid who need extra help paying for Saphonelo, their healthcare provider can contact Access 360 at [1-833-360-HELP] to determine what options may be available.
If there is a concern about paying for Saphnelo, healthcare providers can contact Access 360 at [1-833-360-HELP] to determine what options may be available.