Where Do We Stand with Lupus Treatments?

By Dr. Ailda Nika,
RUSH Lupus Clinic

The face of lupus therapy is changing rapidly.

We are closing 2021 with additions to our armamentarium (the medicines, equipment, and techniques available to a medical practitioner) for allowing a higher proportion of lupus patients to achieve a low disease activity and aim for remission.

There are now three drugs approved by the U.S. Food and Drug Administration (FDA). This is great news. But what does that mean to the lupus patient?

What does FDA approved mean?
The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

Before a drug is approved for use by the FDA years of testing have gone into that drug. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the FDA to begin testing the drug in humans.

Only one in 1,000 of the compounds (drugs) that enter laboratory testing will ever make it to human testing.

As you can see, it’s incredibly difficult to get a drug approved by the FDA making the new treatments FDA approved for lupus the result of years of research.

What are these newly approved drugs?
Benlysta (generic name belimumab) became the first new lupus treatment approved by the U.S. Food and Drug Administration (FDA) in 50 years in March, 2011. Benlysta was approved by the FDA to treat lupus nephritis in December 2020.

BENLYSTA is a prescription medicine, given intravenously (IV) or subcutaneously, for adults with active systemic lupus erythematosus (SLE or lupus) or active lupus nephritis on other lupus medicines. BENLYSTA IV is approved in children aged 5 years and older with SLE on other lupus medicines. It is not known if BENLYSTA is safe and effective in people with severe active central nervous system lupus.

In January 2021, LUPKYNIS (generic name voclosporin) was approved by the FDA to treat lupus nephritis.

LUPKYNIS is the first and only FDA-approved oral medication specifically indicated for the treatment of lupus nephritis. It has been proven in clinical trials to help control lupus nephritis and protect the kidneys from further damage without high-dose steroids.

In August 2021, the FDA approved a new drug, SAPHNELO (generic name anifrolumab).

SAPHNELO is a prescription medicine used to treat adults with moderate to severe systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.

Will these drugs help me treat my lupus?
The drugs FDA approved for lupus showed effectiveness in clinical trials. Because lupus is extremely heterogeneous (diverse in character or content), decisions about add-on therapies or changes to therapies, should be tailored carefully, in each individual case.

Just like there is no single test for lupus, there is no one treatment that will help every lupus patient. If a drug works well in the majority of lupus patients in a clinical trial, the drug may not work in the minority of patients.

How does having more lupus treatments benefit patients?
Having different drugs to treat lupus, helps doctors fine-tune the right treatment combination based on the individual characteristics of each individual patients.

How physicians use these drugs in the treatment of lupus is a process. The new drugs can replace treatments lupus doctors have been prescribing.

For instance, Tacrolimus is an immunosuppressant that specifically targets immune T-cells. It is widely used after transplants and is effective as a short-term therapy for lupus nephritis patients.

LUPKYNIS can replace Tacrolimus and has reported less toxicity than Tacrolimus, and can be a very good addition to the treatment of lupus nephritis.

SAPHNELO, a medication given intravenously, seems to be particularly good for certain challenging lupus features, such as skin manifestations.

What’s the long-term value of the new FDA approved lupus treatments?
The long-term value of the new FDA approved lupus treatment is that more treatments are on the way. Even drugs that never achieve FDA approval teach researchers about lupus treatments.

Many other phase 2 and 3 clinical trials are still under way, trying to investigate different mechanisms of action such as IFN gene signature, an established pathway involved in lupus pathogenesis, JAK/STAT inhibition pathway, B cell therapies etc.

A variety of other agents and pathways, including entirely novel approaches are in development phases and seem promising.