Biologics for Sjögren’s Disease

Biologics are a newer kind of drug made from living cells rather than simple chemicals. They are lab-made proteins that target specific parts of the immune system.¹

In Sjögren’s, biologics are used in select cases, usually when the disease is highly active or affects the organs. This article explains how they work, which are used, and what to expect.¹

How does this drug class work?

The immune system has many parts. Biologics are designed to target a specific part rather than dampening the whole system at once. In Sjögren’s, they are used to reduce high disease activity and to help protect organs that the disease is attacking.¹

Like other Sjögren’s drugs, biologics do not cure the disease. They aim to lower disease activity in people who need more than standard treatment.

Examples

Biologics used in Sjögren’s include:^1,2

• Rituximab (Rituxan®) – A biologic used for some people who have high disease activity or organ involvement. It is approved by the US Food and Drug Administration (FDA) for conditions such as rheumatoid arthritis and certain blood cancers, not for Sjögren’s.
• Belimumab (Benlysta®) – A biologic also used for some people with high disease activity or organ involvement.

None of these biologics is FDA-approved specifically for Sjögren’s. They are used off-label. A doctor may prescribe them “off-label” when evidence suggests they help. Talk to your doctor about what is right for you.¹

What to expect

Biologics are usually given by infusion into a vein or by injection, not as pills. Rituximab is given slowly into a vein at an infusion center, and the first dose can take several hours. Your care team will watch you closely during treatment.²

What are the possible side effects?

Side effects can vary depending on the specific drug you are taking. With biologics like rituximab, possible effects include:²

• Infusion reactions – You may have fever, chills, itching, or other reactions during or after an infusion.
• Higher infection risk – Because biologics affect the immune system, infections are more likely.
• Other reactions – Back or joint pain, flushing, or night sweats can occur.

Rituximab also carries serious risks, including severe infusion reactions, serious infections, and reactivation of hepatitis B. It has strong FDA warnings for these reasons. Your doctor will check for these before and during treatment.²

These are not all the possible side effects of biologics. Talk to your doctor about what to expect when taking biologics. You should also call your doctor if you have any changes that concern you when taking biologics.

Emerging biologic treatments

Biologics are also where some of the most important Sjögren’s research is happening. Today, no drug is FDA-approved to treat Sjögren’s disease itself, so the search for one matters a great deal. Two investigational biologics have reached late-stage testing:^1,3,4

• Ianalumab – A lab-made antibody that received FDA Breakthrough Therapy designation for Sjögren’s in January 2026, based on phase 3 trial results. Its maker planned to begin seeking FDA approval in early 2026.
• Nipocalimab – A lab-made antibody that received FDA Breakthrough Therapy designation for moderate-to-severe Sjögren’s in November 2024, based on a phase 2 study.

Neither drug is FDA-approved for Sjögren’s yet. If one is approved, it could become the first treatment targeted to the disease itself, not just its symptoms. These designations are meant to speed up the study and review of promising treatments, but they are not the same as approval.^1,3,4

Other things to know

Before beginning treatment for Sjögren’s disease, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you take. This includes over-the-counter drugs.

Talk to your doctor

Biologics are reserved for select, more serious cases, and they work differently for each person. Talk with your doctor about whether a biologic fits your situation, what monitoring you will need, and whether a clinical trial of a new treatment might be an option.