Biologic therapies, or biotherapies, are medications that are derived from living organisms to treat diseases. They can be produced in a lab or derived from humans or animals to suppress or modify the immune system. They are unlike broad-spectrum immunosuppressants because they laser focus on the target(s) that are responsible for inflammation. This means fewer systemic side effects.
In lupus, the immune system’s B cells and T cells (also called lymphocytes) become hyperactive and attack healthy tissues. A biologic therapy targets very specific pathways such as B-cells or interferon receptors to reduce inflammation. Because biologic therapies are larger and more complex, they are generally administered via IV infusion or subcutaneous injections.
There are currently three FDA (Food and Drug Administration)-approved biologic therapies clinically indicated for use in Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN).
-     Belimumab (BENLYSTA®) – targets a B-lymphocyte stimulator (BlyS). Approved for use in SLE and LN.
-     Anifrolumab (SAPHNELO®) – blocks the receptor for type 1 interferons, which are a major cause of inflammation. Approved for use in SLE.
-     Obinutuzimab (GAZYVA®) – an anti-CD20 therapy which depletes CD20 positive B lymphocytes. Approved for use in LN and is under review for SLE.
In addition, Rituximab (Rituxan), which targets CD20 +B cells, is also used off-label for lupus, often for cases where other treatments aren’t working. Off-label means that a doctor wants to use an FDA-approved drug for unapproved use. Rituxan is FDA approved for rheumatoid arthritis and some cancers, but not for lupus. However, some lupus patients respond well to Rituxan.
There are also many biologic therapies in late-phase clinical trials. Some have even been granted fast-track designation by the FDA. One such therapy is Nipocalimab (by Johnson & Johnson) which reduces circulating IgG antibodies by blocking IgG receptors on inflammatory cells.Â
Another therapy being investigated is CAR T (Chimeric Antigen Receptor T-cell). CAR T therapy is a form of biologic therapy. It uses a patient’s own genetically modified immune cells to target the lupus and is currently being investigated for severe refractory lupus.
It is also important to note that there are several clinical trials in the pipeline for biologic therapies for Cutaneous Lupus (CL).
Biologic treatments are changing the treatment landscape for lupus. They offer a new hope, less side effects, and the potential for achieving lasting remission for lupus patients.
To stay on top of the latest and most accurate information about lupus, please visit lupusgreaterohio.org and sign-up for the newsletter. Or you can sign up for RAY® (Research Accelerated by You) https://www.lupus.org/research/enroll-in-a-lupus-registry. In addition, you can learn more about clinical trials by visiting clinicaltrials.gov.
This article has been medically reviewed by Stanley Ballou, MD.
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