Other Biologics Used “Off-Label”

One of the treatments used for AxSpA spectrum conditions is medication. There are different kinds of medication, and what works for one person may not be effective for another. One class of medications that can be used in the treatment of AxSpA spectrum conditions is called disease-modifying antirheumatic drugs, or DMARDs. DMARDs are often used for inflammatory or immune diseases. There are two main kinds of DMARDs: traditional (also called synthetic) and biologics.1

There are medications, including DMARDs, approved for ankylosing spondylitis (AS), but these drugs aren’t necessarily approved by the FDA for other AxSpA conditions. When these drugs are used to treat AxSpA conditions that aren’t AS, this is called being used “off-label.” This is legal and common. Doctors use medications off-label when they have been shown to clinically significantly improve symptoms in studies and clinical practice.

There are certain biologics used for AxSpA spectrum conditions, including etanercept, adalimumab, golimumab, infliximab, and secukinumab/ixekizumab. Knowing more about these drugs can help you make informed decisions.

Etanercept (Enbrel)

Etanercept, known as the brand name drug Enbrel, is a tumor necrosis factor (TNF) blocker. It interferes with the immune system to help stop the inflammatory response. Etanercept has been used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and polyarticular juvenile arthritis.2 People with early and active nr-AxSpA who have not shown improvement with NSAIDs have found relief with etanercept treatment.3

This drug is given as an injection under the skin, which is known as a subcutaneous injection. It may be administered by your health care provider, or you may be taught how to self-inject at home.

Etanercept can lower your immune system and its ability to fight off infections, making careful monitoring important. Prior to taking etanercept, you should be tested for tuberculosis (TB), as well as any other infections.2During treatment, you will be monitored closely for any signs or symptoms of infection.

Common side effects include injection site reactions like redness or swelling and upper respiratory infections.2 Other side effects can include blood problems (clotting issues, low white blood cell count), heart failure or worsening of existing heart failure, psoriasis, autoimmune reactions, allergic reactions, nervous system problems like multiple sclerosis or seizures, and reactivation of hepatitis B infection.2

Tell your doctor about any other medications, supplements, and vitamins you are taking, including over-the-counter medications and herbal or natural supplements. Sometimes these can interfere with medications, including etanercept.

For more information, read the full prescribing information of etanercept.

Adalimumab (Humira)

Adalimumab is another TNF blocker. It has been used to help treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and polyarticular juvenile arthritis. It has been shown to improve symptoms and decrease inflammation in people with nr-AxSpA but has not been approved for the condition.4

Adalimumab is given as an injection under the skin. Your doctor may administer the shot or teach you how to inject yourself at home.

This drug works by affecting the immune system and the inflammatory response; it can also lower your immune system’s ability to fight infection. Before starting treatment with adalimumab, tell your doctor if you have any illnesses or infections. You will be tested for TB before starting this drug and should be closely monitored for signs and symptoms of illness or infection.

Side effects can include an increased risk of cancer, injection site reactions, headache, rash, upper respiratory infections, liver problems, heart failure or worsening of existing heart failure, nervous system problems, blood problems like trouble clotting, allergic reactions, and hepatitis B infection for those who carry the virus.5

Talk with your doctor about any medication, supplement, or vitamins you may be taking. These can interact with adalimumab. If you notice any side effects or anything out of the ordinary while taking this medication, call your doctor.

For more information, read the full prescribing information of adalimumab.

Golimumab (Simponi)

Golimumab is also a TNF blocker and works in similar ways to adalimumab and etanercept, with regards to the immune system. It can be prescribed for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis. It has also been shown to significantly improve symptoms in people with active nr-AxSpA, but the drug has not been approved to treat it.6

Before starting treatment with golimumab, tell your doctor if you have any infections or illnesses, including diabetes.7 This drug can affect your immune system’s ability to fight off infections and illness, and you will be tested for certain illnesses like TB before going on this medication, and closely monitored while taking this drug.

This drug is given as a subcutaneous injection, either by your doctor or yourself or a caregiver. Do not inject yourself or have a caregiver inject you unless you have been trained in how to properly do so by your doctor.

As with any medication, golimumab can cause side effects. Common side effects of this drug can include upper respiratory infections, injection site reactions, and viral infections like flu or cold sores.7 Other side effects can include allergic reactions, psoriasis, blood problems, liver problems, nervous system problems, heart failure, and hepatitis B infection for carriers.7 Talk with your doctor about any side effects that you might be having, or if there’s anything out of the ordinary going on.

For more information, read the full prescribing information of golimumab.

Infliximab (Remicade)

Infliximab is a TNF-alpha blocker that interferes with the immune system and the inflammatory response. It targets TNF-alpha, which makes the immune system attack healthy cells and tissues.8 This drug has been approved to treat Crohn’s disease, rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, and ulcerative colitis.8 Since the drug interferes with the immune system, it may lower the immune system’s ability to fight off infections and illnesses.

This drug is given intravenously, through a vein in your arm. You will be monitored by a health care provider during the infusion, which will last about 2 hours.

As with any drug, infliximab may cause side effects. Common side effects include respiratory infections, infusion reactions like fever, chills, chest pain, and low or high blood pressure, and headache.8 Other side effects can include psoriasis, allergic reactions, blood problems, liver problems, nervous system disorders, lupus-like syndromes, heart problems, and serious infections.8

Talk with your doctor about the risks of this medication. Let them know about any illnesses or conditions you might have, and if you are pregnant, plan to become pregnant, or are breastfeeding. Tell the doctor about all medications, supplements, and vitamins you are taking, both prescription and over-the-counter.

For more information, read the full prescribing information of infliximab.

Secukinumab/Ixekizumab (Cosentyx/Taltz)

Secukinumab (Cosentyx) and ixekizumab (Taltz) are interleukin 17 (IL-17) inhibitors.9 This means they block a protein called interleukin 17, which is part of inflammatory and immune responses.9 If this protein is blocked, it interferes with the inflammatory response, helping to minimize or prevent some of the inflammation that occurs in various conditions and the subsequent damage and symptoms that occur.

These drugs are prescribed for a variety of inflammatory diseases, including ankylosing spondylitis and psoriatic arthritis. They have not been approved for nr-AxSpA. Both drugs are subcutaneous injections administered by a health care provider, or if they have trained you in proper injection technique, self-injected.

Side effects of these medications can include injection site reactions, upper respiratory infections, serious allergic reactions, Crohn’s disease or ulcerative colitis, diarrhea, oral herpes, and other infections.10,11 Talk with your doctor before starting these medications and let them know about your medical history and any illnesses, conditions, or infections you might have. These drugs can weaken your immune system, so you will be closely monitored for signs and symptoms of disease or infection.

For more information, read the full prescribing information of secukinumab here, and the full prescribing information of ixekizumab here.

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