Key takeaways:

  • Benlysta (belimumab) and Saphnelo (anifrolumab-fnia) are the two biologics currently FDA approved for lupus. Rituxan (rituximab) is a biologic that's sometimes prescribed off-label for lupus symptoms. These medications aren't first-choice options for lupus, but can help lessen symptoms if other treatments aren't effective.

  • Belysta, Saphnelo, and Rituxan each come as an infusion given into a vein (IV). All three are administered in a medical office. But Benlysta is also available as an under-the-skin injection you can give yourself at home.

  • Many biologics are being studied for their potential to treat lupus. Some are existing biologics that treat other conditions. Others are new medications we haven't seen before. We expect to see more biologic lupus treatments approved in the coming years.

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BenlystaSaphneloRituxan
Table of contents
Benlysta
Saphnelo
Rituxan
Meds in the pipeline
Other treatments
Bottom line
References
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Lupus can be tricky to manage. Symptoms may come and go. And things like stress, low sleep, and even certain foods can trigger lupus flare-ups at any time.

Typically, you'll see a rheumatologist for lupus treatment. Rheumatologists are healthcare professionals that specialize in treating inflammatory or autoimmune conditions. Lupus isn't a curable condition. But your rheumatologist will work with you to find medications that help manage your symptoms. And this may include a biologic medication.

Biologics are medications that come from living sources. They aren't typically first-choice treatments for lupus. They're usually prescribed if other medications aren't working well on their own. Below, we'll discuss three biologics for lupus as well as what's coming down the pipeline in the future.

1. Benlysta

Benlysta (belimumab) is the first biologic therapy that was FDA approved for lupus. It's approved for systemic lupus erythematosus (SLE), the most common form of lupus. It's also approved for kidney damage caused by lupus (lupus nephritis).

Benlysta is a type of biologic known as a monoclonal antibody. It works by lowering the levels of B cells in the body. B cells are part of your immune system that become overactive and lead to lupus symptoms. Lowering B-cell levels can help reduce lupus symptoms and prevent flare-ups. Benlysta also reduces the need for prednisone, a corticosteroid treatment for lupus that can cause weight gain and other side effects when taken long term.

Benlysta comes in two dosage forms: an injection under the skin (subcutaneous) or an infusion given into the vein (IV). The IV infusion is given over 1 hour in an infusion clinic or medical office. It's approved for adults and children ages 5 years and older. You'll receive your first three doses of IV Benlysta every 2 weeks. After that, you'll receive an infusion every 4 weeks (once a month).

The Benlysta subcutaneous injection is given once weekly. You'll receive the first dose in your rheumatologist's office. After that, you can give it to yourself at home. But it's only approved for adults.

Common Benlysta side effects include nausea, diarrhea, and injection- or infusion-related reactions. It can also raise your risk of infection, since it weakens your immune system. So it's important to keep an eye out for any signs or symptoms of infection, such as fever, cough, or pain when peeing, and seek medical care if they appear.

How to save on the cost of Benlysta

There are ways to save on Benlysta, which is only available as a reference ("brand-name") medication.

  • Save with a copay savings card. If you have commercial insurance, you may be eligible to receive Benlysta at no cost using a savings card from the manufacturer.

  • Save with patient assistance programs. If you're uninsured or underinsured, you may be eligible for Benlysta's patient assistance program, which offers the medication free of cost.

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2. Saphnelo

Saphnelo (anifrolumab-fnia) is a biologic that was FDA approved in 2021 for treating moderate-to-severe SLE in adults. Prior to Saphnelo, there hadn't been a new lupus treatment approval in 10 years.

Similar to Benlysta, Saphnelo is a monoclonal antibody. But it works differently. Saphnelo blocks the type 1 interferon (IFN) receptor. Type 1 IFN seems to cause more severe lupus symptoms, including kidney problems. By blocking it, Saphnelo helps reduce the severity of SLE symptoms and lower the amount of corticosteroids needed by people who receive it.

Saphnelo is only available as an IV infusion. You'll likely receive the 30-minute infusion once every 4 weeks in a medical office or clinic. The most common Saphnelo side effects are upper respiratory infections, such as the common cold, and infusion-related reactions. More severe infections are also possible, so report any signs or symptoms of an infection to your rheumatologist right away.

How to save on the cost of Saphnelo

Since Saphnelo is only administered in a medical office, it's not a prescription you'll pick up at a local pharmacy. Instead, your rheumatologist will have the medication in the office, and it will likely be covered by your medical insurance instead of your pharmacy benefits. But there are still savings programs available to cover the cost of Saphnelo treatments regardless of your insurance status.

3. Rituxan

Rituxan (rituximab) is a biologic medication that's used off-label for lupus. Rituxan is FDA approved for rheumatoid arthritis and certain types of cancer, not for lupus. But it's been prescribed for lupus for over 10 years, even though clinical trials on Rituxan for lupus were not successful.

Rituxan is a monoclonal antibody that targets and destroys B cells. As mentioned, since B cells contribute to lupus, lowering their levels can help lessen lupus symptoms.

A 2023 clinical review found that Rituxan seems to be most effective for skin-related SLE symptoms in people without kidney problems caused by lupus. And another small study showed that rituxan may be effective for lupus-related kidney problems if other treatments haven't worked.

Rituximab is typically given as an IV infusion in a healthcare setting. It's also available as an under-the-skin injection. Your rheumatologist will determine the best dosage and frequency of treatment for you, since there isn't an approved dosing regimen for lupus.

4. Biologics in the pipeline for lupus

Many biologic medications are currently being studied as new lupus treatments. Some of these medications are already FDA approved for other conditions. Others are new medications that haven't been approved yet. Typically, medications need to be studied through phase 3 trials before they're approved for a certain condition, like lupus.

Emerging biologic medications in the pipeline for lupus include:

  • Cosentyx (secukinumab), which is FDA approved for treating psoriatic arthritis and other autoimmune conditions. It's a monoclonal antibody that blocks an immune system protein called interleukin-17A. It's currently in a phase 3 trial for lupus nephritis.

  • Gazyva (obinutuzumab), which is FDA approved for certain types of leukemia and lymphoma. It's also a monoclonal antibody that targets and destroys B cells. It works similarly to Rituximab, but it may work better for those who develop a resistance to Rituxan. It's currently being studied in phase 3 trials for lupus.

  • Telitacicept, which is a new medication. It helps block the formation of B cells in the body to improve lupus symptoms. Telitacicept is also being tested in a phase 3 trial for lupus.

  • Chimeric antigen receptor T-cell (CAR-T) therapy, which is a type of gene therapy. It changes T cells in the immune system to target certain cells in the body. CAR-T therapy used to target B cells has had significant results in early studies of lupus and kidney disease caused by lupus. But it's still in the early stages of development.

  • AlloNK, which is a new type of treatment. It's a therapy made from natural killer (NK) cells, which are part of the immune system. AlloNK is intended to improve the efficacy of other treatments, such as Rituxan and Gazyva. It's currently being studied in combination with these treatments.

In addition to the biologics listed above, many other medications are being studied for lupus. Some of them are in earlier stages (phase 1 or phase 2 trials), so it's unclear whether they will become available. But many represent promising new lupus therapies in the years to come.

What are some alternatives to biologics for treating lupus?

In most cases, you'll start with other medications to manage lupus symptoms before trying a biologic.

Hydroxychloroquine (Plaquenil) is recommended as a first-choice therapy for lupus. Corticosteroids, such as prednisone, are typically taken during flare-ups, but you may also take them in low doses at other times.

Immunosuppressants and calcineurin inhibitors, along with biologics, are considered add-on treatments if hydroxychloroquine isn't effective on its own. These include medications such as methotrexate, azathioprine (Imuran), and cyclosporine (Sandimmune).

The bottom line

Biologics are medications that come from living sources. They're typically administered as an injection under the skin or an infusion into the vein. Benlysta (belimumab) and Saphnelo (anifrolumab-fnia) are the two FDA-approved biologics for lupus. Rituxan (rituximab) is another biologic that's used off-label for lupus.

Biologics aren't typically first-choice options for treating lupus. But they can help reduce symptoms and lower the amount of corticosteroids needed if other treatments aren't effective on their own.

There are many more biologics currently being researched for lupus. Some are already approved for other health conditions. Others are new medications we haven't seen before. The future looks promising for effective lupus treatment options.

References

Aloub, K. O. A., et al. (2022). Efficacy and safety of rituximab therapy for lupus nephritis among SLE female patients; a retrospective hospital-based study. Open Access Rheumatology: Research and Reviews.

Arnold, J., et al. (2022). Efficacy and safety of obinutuzumab in systemic lupus erythematosus patients with secondary non-response to rituximab. Rheumatology.

View All References (26)
expand_more

AstraZeneca Pharmaceuticals, LP. (2024). Saphnelo - anifrolumab injection, solution [package insert].

ClinicalTrials.gov. (n.d.). Search results for lupus erythematosus.

ClinicalTrials.gov. (n.d.). Search results for lupus, obinutuzumab.

ClinicalTrials.gov. (n.d.). Search results for lupus, secukinumab.

ClinicalTrials.gov. (n.d.). Search results for lupus, telitacicept.

Connolly, L. (2024). A breakthrough for lupus treatment? Study explores CAR T-cell therapy for autoimmune disease. University of California Davis Health.

Fanouriakis, A., et al. (2024). EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Annals of Rheumatic Diseases.

Genentech. (2022). Rituxan hycela - rituximab and hyaluronidase injection, solution [package insert].

Genentech, Inc. (2023). Rituxan - rituximab injection, solution [package insert].

GlaxoSmithKilne. (2020). FDA approves GSK's BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US.

GlaxoSmithKilne. (2024). Benlysta - belimumab injection, powder, lyophilized, for solution [package insert].

Khalili, L., et al. (2023). Lupus clinical trials and the promise of future therapies. Rheumatology and Immunology Research.

Lupus Foundation of America. (2013). Drug spotlight on Rituxan (rituximab).

Lupus Foundation of America. (2020). What is lupus?

Lupus Foundation of America. (2023). Medications used to treat lupus.

Lupus Foundation of America. (2024). Investigational therapy AlloNK receives FDA fast track status for lupus nephritis treatment.

Morand, E. F., et al. (2019). Trial of anifrolumab in active systemic lupus erythematosus. The New England Journal of Medicine.

Müller, F., et al. (2024). CD19 CAR T-cell therapy in autoimmune disease - a case series with follow-up. The New England Journal of Medicine.

National Cancer Institute. (n.d.). Definition of CAR T-cell therapy.

National Institute of Arthritis and Musculoskeletal and Skin Diseases. (2022). Systemic lupus erythematosus (lupus): Diagnosis, treatment, and steps to take.

Neves, A., et al. (2023). Promising experimental treatments for lupus nephritis: Key talking points and potential opportunities. Research and Reports in Urology.

Postal, M., et al. (2021). Type I interferon in the pathogenesis of systemic lupus erythematosus. Current Opinion in Immunology.

Sans-Pola, C., et al. (2023). Off-label use of rituximab in patients with systemic lupus erythematosus with extrarenal disease activity: A retrospective study and literature review. Frontiers in Medicine.

She, Z., et al. (2022). The role of B1 cells in systemic lupus erythematosus. Frontiers in Immunology.

Tanaka, Y., et al. (2022). Rituximab in the real-world treatment of lupus nephritis: A retrospective cohort study in Japan. Modern Rheumatology.

Tiburca, L., et al. (2022). The treatment with interleukin 17 inhibitors and immune-mediated inflammatory diseases. Current Issues in Molecular Biology.

GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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GoodRx Holdings Inc. published this content on 27 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 June 2024 19:11:00 UTC.