Safety of Biologic Drugs In Rheumatology

Safety of biologic drugs

Biologic drugs have recently revolutionized the treatment of many rheumatologic conditions such as rheumatoid arthritis, lupus, and psoriatic arthritis, to name a few. These powerful agents function by targeting a specific component of the immune system thought to be crucial in causing inflammation.

Specifically, TNF inhibitors (Humira, Enbrel, Remicade, Cimzia and Simponi) block activation of tumor-necrosis factor-α, Orencia inhibits the stimulation of T cells by the B cells, Rituxan inactivates certain B cells, Actemra blocks the activity of interleukin-6, and Xeljanz interferes with the JAK-STAT signaling pathway.

Biologic drugs have helped us achieve remission in many conditions that previously led to disability. For example, whereas rheumatoid arthritis used to lead to joint deformity and disability in a great number of the affected people in the past, nowadays the majority of people with this disease can enjoy a normal and pain-free life. Life threatening conditions, like kidney, lung or heart failure are also now treated successfully with these drugs.

However, safety of biologic drugs has been an issue, and at times, a topic of debate. Keep in mind that all medications, including Aspirin, Tylenol, or even vitamins, can have side effect. It is therefore important that biologic drugs are prescribed and managed by physicians who are well aware of potential side effects and well-equipped to recognize and treat them if necessary.

The majority of the data on the safety of biologic drugs come from people with rheumatoid arthritis. In this article I will summarize the major risks in this group. While it is possible that the risks are similar in other conditions, since the data is limited, little conclusion can be drawn.


Since biologic drugs target the immune system, it is not surprising that infection is a potential risk.

Bacterial infection:

An increased risk of bacterial infections, like pneumonia and skin infection, has been reported with all biologic drugs.

What this means for you: If you have a serious infection requiring antibiotics, hold your biologic drug until the infection has cleared. This allows your immune system to fight the infection.


If you were exposed to tuberculosis in the past, the organism may live in your body for years without causing disease. Once the immune system is lowered, tuberculosis can be reactivated. In severe cases it can affect not just the lungs, but potentially the entire body.

What this means for you: You will need a PPD (TB test) before starting most biologic drugs to make sure you have not been exposed to tuberculosis.

Viral infections:

Hepatitis B and C- Biologic drugs are used with caution in people with hepatitis.

JC virus- This is an infection affecting the brain. A very small risk has been observed (4 cases in rheumatoid arthritis patients, or 1 in 20,000 patients treated with Rituxan).

Herpes Simplex

Other infections

What this means for you: Get your vaccines before and while on biologic drugs. This includes Shingles, pneumonia vaccine and flu vaccine.


An early study suggested there may be a very small but increased risk of malignancy (specially lymphoma and nonmelanotic skin cancer) in people treated with TNF-inhibitors Remicade, Enbrel and Humira. However subsequent larger studies and reviews have not confirmed this risk. The data is not sufficient on the risk with Orencia, Actemra, or Xeljanz. Malignancy does not seem to be increased with Rituxan.

What this means for you: If you have a personal or family history of malignancy, alert your rheumatologist. This does not mean that you are not a candidate, but caution may be advised.


Cases of multiple sclerosis, optic neuritis, and Guillain-Barre syndrome have been reported with the use of TNF inhibitors.

What this means for you: If you have one of these conditions you may not be a good candidate for TNF inhibitor biologics.

Heart failure:

TNF inhibitors as well as Rituxan may exacerbate moderate to severe heart failure.

What this means for you: If you have moderate to severe heart failure (NYHA class III or IV) you may not be a candidate for some of the biologic drugs.

High cholesterol:

Actemra and Xeljanz may cause elevation of the bad cholesterol.

What this means for you: Your rheumatologist will periodically monitor your cholesterol level while on these drugs.

Drug-induced lupus:

New onset of lupus-like symptoms have been reported in people using TNF inhibitors. Symptoms usually resolve once the drug is discontinued.

What this means for you: Let your rheumatologist know if you develop new symptoms- including rashes, new joint pain, sores in the mouth, chest pain, etc.- while you are using these medications.

The bottom line:

Like any other medication, biologic drugs can be associated with a variety of potential side effects. And like with all other medications, their benefits should be balanced against their risks and individually assessed for every patient. When used correctly and safely, these drugs can save people’s lives.

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