TNFi Biologics (Humira®, Cimzia®, Enbrel®, Simponi®, Remicade®)

TNFi biologics work by targeting something called tumor necrosis factor proteins, or TNFa. TNF is a protein that sends signals to your body, eventually leading to inflammation that causes swelling, pain, and stiffness. By inhibiting, or stopping, TNF, these medications can reduce inflammation. That’s why they’re often called TNF inhibitors (or TNFi). Some of these drugs have been on the market for over ten years.

Some common TNFi biologics are:

• Adalimumab (Humira®)
• Certolizumab pegol (Cimzia®)
• Etanercept (Enbrel®)
• Golimumab (Simponi®, Simponi Aria®)
• Infliximab (Remicade®)

These biologics are molecules that are specially designed to target TNF and block it at the source.

Your doctor may prescribe TNFi biologics if you did not find effective results from using one DMARD like methotrexate. It really depends on your particular disease and situation. Out-of-pocket cost, other health conditions you have, and drug side effects may make TNFi therapy the best option for you. Your rheumatologist will determine which option is best for you based on your personal medical history.

How do I take my TNFi biologic?

You may be able to give yourself this medication, via injections, at home (known as “self-injection”), or via an infusion in the doctor’s office or other infusion site. A healthcare professional will indicate where on your body it is safe to administer these injections (usually the upper leg or stomach). Make sure to rotate the injection sites. If you have psoriasis, do not inject in the affected areas. If you’re afraid to inject yourself, talk to your nurse, clinic staff, or pharmacy about having someone there give you these shots.

Be sure you are confident on how to do this procedure before you inject the medication on your own. Don’t be afraid to ask for help!

You may also get your biologic as an infusion instead of a shot. A healthcare professional gives you the drug through an IV. You’ll get your treatment in your doctor’s office, at a special infusion center, or at your local hospital. You and your doctor can decide if an infusion is the right option for you. The infusions can last as little as 30 minutes, or could take up to several hours — depending on the drug, dose, and individual.

• Adalimumab (Humira®) is used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, Crohn’s disease and ulcerative colitis. It is given as a 40 mg self-administered subcutaneous (under the skin) injection every two weeks.
• Certolizumab pegol (Cimzia®) is indicated for rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, and ankylosing spondylitis. Cimzia® is given as a subcutaneous injection of 400 mg on weeks 0, 2, and 4, followed by 200 mg every two weeks or 400 mg every four weeks. Cimzia can also be given in a lyophilized (dehydrated and freeze-dried) formula that is given in the doctor’s office.
• Etanercept (Enbrel®) treats rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. It’s given as a 50 mg self-administered subcutaneous injection every week or 25 mg self- administered injection twice weekly.
• Golimumab (Simponi®) is used for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. It is given as a 50 mg self-administered subcutaneous injection once monthly.
• Golimumab (Simponi Aria®) is for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It is given via IV infusion in the clinic or infusion center on weeks 0 and 4, followed by IV infusion every eight weeks. Dose is based on weight.
• Infliximab (Remicade®) is indicated for rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, . is given via IV infusion in the clinic or infusion center at weeks 0, 2, and 6, then by infusion every four to eight weeks. Dose is based on weight.

The benefits of TNFi inhibitors are usually seen within a few weeks (but can take up to four to six weeks), unlike DMARDs, which can take up to a few months to have their effects.

What are the possible side effects of TNFI biologics?

Side effects of TNFi drugs might include injection site reactions (varies based on the drug), upper respiratory infections, laboratory abnormalities, and headache. The likelihood of experiencing these and any side effects vary from individual to individual, and should always be discussed with your doctor before beginning treatment.

TNFi biologic drugs increase your risk of infections. Used long term, they may also put you at higher risk for lymphoma or skin cancer. The label on your prescription will include a warning about cancer risk associated with the use of TNFi biologics.

Infliximab has been associated with the development of antinuclear and anti-double stranded DNA antibodies, nausea, abdominal pain, and infusion reactions. Serious side effects include increased risk of infection, especially tuberculosis and fungal infections. Infliximab use has been linked to a type of liver injury, and may reactivate hepatitis B virus. Untreated hepatitis B may worsen while taking TNFi drugs.

You should be tested for TB and hepatitis before starting any TNFi drug. Less common side effects include allergic reaction and development of other immune system disorders. If you have had cancer of any type, or have an increased risk for cancer due to your family history, talk about your options with your rheumatologist.

If you think that you might have an infection, check with your doctor before taking your drug. Biologic drugs make it harder for your body’s immune system to fight off infections. They may even make it harder for you to spot the early signs of infection, so talk to your doctor about what to look for. For more information, go here: www.rheumatology.org/I-Am-A/Patient-Caregiver/Treatments/Anti-TNF

If you’re planning to have surgery or think you may need surgery for an existing health problem, talk to your rheumatologist first. You may need to go off your biologic for some time before you have the surgery. That is because your risk of infection can be higher while you are on these drugs.

As always, talk to your rheumatologist about any of these possibly serious risks associated with TNFi biologic use, and what they may mean for you. There are always risks with using any medication, but there are bene ts too. Talk openly with your healthcare providers about all of your concerns.

Contraindications

Live and attenuated live vaccines, such as the shingles vaccine, yellow fever vaccine, and Flumist® (intranasal flu vaccine), should not be given when taking a TNFi biologic. Regular, killed vaccines like the intramuscular flu shot are safe for you, although you may not respond as well to the vaccine as someone who isn’t taking a DMARD or biologic.

TNFi medications can interact with vaccines and certain foods and other drugs you take for different health problems. Make sure you talk to your doctor about current medications, planned vaccinations, and any diet changes you make (like use of vitamins or herbal products).

Adalimumab (Humira®) specifically interacts with blood thinners (i.e. warfarin (Coumadin®).

Existing Conditions

Congestive Heart Failure (CHF): TNFi biologic therapy is not recommended for patients living with uncontrolled CHF, as it can lead to a worsening of this condition.

Previous Serious Infection: TNFi drugs have been found to increase the incidence of pneumonia, tuberculosis (TB), certain fungal diseases, and skin/soft tissue infection. You will be required to be tested for TB before starting any biologic drug.

Hepatitis C without Receiving Antiviral Therapy: The ACR, the U.S. association of rheumatologists, recommends that your physician speak with a gastroenterologist and hepatologist to consider the management of these two disease states. TNFi can be carefully administered while managing hepatitis C.

Previously Treated Lymphoproliferative Disorder: TNFis can increase your chances of lymphoma, although the overall risk is low. So these biologics are not recommended for anyone with a previous history of lymphoproliferative disorders.

People who have or have had multiple sclerosis should not take TNFi drugs.

Be sure to tell your doctor if you are: breastfeeding and/or have kidney or liver disease, cancer, CHF, blood or bone marrow problems, or any type of infection. Also mention any nervous-system problems such as Guillain-Barré syndrome or multiple sclerosis. They may indicate that you should not be on TNFis.

Women who are pregnant may use these medications, but this should be discussed with and monitored by your rheumatologist and obstetrician/gynecologist. If you think you’ve become pregnant while taking a TNFi, let your rheumatologist know right away.

When starting most biologics, you’ll need to take frequent blood tests to monitor the drug’s effects. Once you’re established on a biologic, however, your tests will become less frequent. Specifically, for TNFi biologics, blood tests will be done to check for bone marrow suppression, a low white blood cell count, or effects on the liver.