At the end of 2019 results for a potential new lupus treatment, anifrolumab, were published showing that it had successfully passed its phase III trial demonstrating safety and efficacy.
LUPUS UK is excited about this potential new medicine for this complex and difficult-to-treat disease.
How does it work?
Basic research has shown that proteins called interferons, which we normally use to fight viral infections such as the flu, are increased in patients with lupus. Between 60% and 80% of adults with SLE have an increased type I interferon gene signature, which has been linked with lupus disease activity.
Anifrolumab was designed to block the effects of interferons. The treatment binds to part of the type I interferon receptor, blocking the activity of all type I interferons which are involved in the inflammatory pathways. This is quite different to the way other current lupus treatments work.
The results from the trials demonstrated that anifrolumab reduced overall disease activity, the extent and severity of skin rashes, and it helped patients reduce the amount of oral steroids they needed to take.
The treatment would be administered at the hospital monthly by a 30-minute injection into a vein in the arm.
What are the side effects?
In general the treatment was well tolerated in the trials. In fact, serious adverse events (getting other illnesses that need hospital treatment, such as pneumonia) were less common in people who received anifrolumab. Given the importance of interferons in viral infection, rates of these infections were checked carefully. Shingles, which is due to the Herpes Zoster virus, was more common in people taking anifrolumab, affecting about 1 in 14 people.
Will it allow me to stop my other treatments?
During the clinical trials anifrolumab was taken in addition to existing treatment for the patients who were enrolled.
One of the findings of the trials was that anifrolumab achieved a statistically significant reduction in the requirement to use oral steroids.
Anifrolumab may possibly replace some lupus medications or assist in the reduction of dosages. This will vary between individuals and be based on the clinical judgement of the prescribing clinician.
When will it be available?
Now that anifrolumab has passed its phase III trial successfully, the next step is for AstraZeneca (the developers of this treatment) to apply for it to be licensed for use in lupus patients.
In the UK, following licensing this potential drug will also have to be assessed by NICE before it could be made widely available on the NHS.
AstraZeneca says that it hopes it will be available for NHS patients in the UK in the next two to three years.
Who will be eligible for this treatment?
The phase III trial for this treatment included patients with moderately to severely active systemic lupus erythematosus (SLE). During the trials it demonstrated a significant improvement, especially for those with skin involvement.
It is not yet clear whether all lupus patients would be eligible for this treatment or not – this will be decided during the licensing process and the assessment by NICE.
The trial excluded patients who had significant active lupus in their kidneys (there is a separate trial to assess this type of lupus in progress). Patients with severe lupus affecting the brain were also excluded. This means that the treatment will probably not be recommended for these types of lupus until more data are available.
It may be worth noting that not all new treatments for lupus are available for everyone. Benlysta (belimumab) is the only other treatment developed specifically for lupus in the past 60 years but it currently has fairly strict criteria for access, partly because of its high cost to the NHS.
We will provide information about who may be able to access anifrolumab treatment when we learn more.
We are extremely grateful to Dr Ed Vital (Associate Professor and Honorary Consultant Rheumatologist) for his helpful contributions in the production of this article.