These biologics work by targeting something called tumor necrosis factor protein, or TNF. 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 common TNFi biologics are adalimumab (Humira®), certolizumab pegol (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®, Simponi Aria®), and infliximab (Remicade®).
These biologics are molecules that are specially designed to target TNF and block it at the source. They can cool down your immune response that’s out of control in AS in order to ease your AS symptoms. They may have the potential also to protect your joints from damage.
The ACR treatment guidelines strongly recommend using TNFi’s for patients who have a lack of response to at least two NSAIDs, or cannot tolerate NSAIDs due to side effects. The guidelines do not favor any specific TNFi, although they noted that infliximab (Remicade®) or adalimumab (Humira®) would be preferable for Ankylosing Spondylitis patients who also have inflammatory bowel disease or recurrent iritis (inflammation of the colored ring around your eye’s pupil).
Personal considerations such as out-of-pocket cost, comorbidities, and side effects may make TNFi therapy the best option. Make sure you have a talk with your physician about why a certain treatment option is best for you. Treatments like TNFi drugs are very case-specific.
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 given as a 40 mg self-administered subcutaneous (under the skin) injection every other week.
Certolizumab pegol (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®) is given as a 50 mg self-administered subcutaneous injection every week or 25 mg self- administered injection twice weekly.
Golimumab (Simponi®) is given as a 50 mg self-administered subcutaneous injection once monthly.
Golimumab (Simponi Aria®) 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 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 medications 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.
Side Effects of TNFi Biologics
Side effects of TNFi drugs might include injection site reactions, 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.
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. Untreated hepatitis B may worsen while taking TNFi’s. You should be tested for TB and hepatitis before starting one of these medications.
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, you will need to discuss the various options with your rheumatologist regarding the use of any biologics.
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.
If you’re planning to have surgery, talk to your rheumatologist first. You may need to go off your biologic for some time before you have the surgery.
TNFi Biologics 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. These medications can interact with vaccines and certain foods and medications. Make sure you talk to your doctor about current medications, planned vaccinations, and any diet changes you make (use of vitamins, herbal products).
Adalimumab (Humira®) specifically interacts with blood thinners (i.e. warfarin (Coumadin®).
Existing Conditions and TNFI biologics
- 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 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 treatment of hepatitis C.
- Previously Treated Lymphoproliferative Disorder: TNFi’s may increase your chances of lymphoma. While an increased risk of lymphoma in Ankylosing Spondylitis patients taking TNFi’s compared to a non-AS population has been shown in studies, studies with Ankylosing Spondylitis patients taking these biologics showed a minimal risk of developing lymphoma if at all.
People who have or have had multiple sclerosis (MS) should not take TNFi drugs.
Be sure to tell your doctor if you are: pregnant or 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 TNFi biologics.
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 bone marrow suppression, a low white blood cell count, or effects on the liver.