The hills are alive . . . and so are biologics! That song probably wouldn’t be as catchy, though.

Biologics are an ever-growing class of complex medications that harness the power of biological sources such as cells and tissues to carry out their mechanisms of action. They’re successfully being used against some of the most historically challenging diseases to treat, including autoimmune diseases and certain types of cancer.

In the fight against autoimmune disease, biologic agents are formulated to target and calm overactive inflammatory immune responses that are the hallmark of conditions such as:

• psoriasis
• psoriatic arthritis and rheumatoid arthritis
• ankylosing spondylitis
• inflammatory bowel disease
• systemic lupus erythematosus

Perhaps you have an autoimmune disease and have been prescribed a biologic treatment. Or perhaps you’re just curious to know more about them and Googled, “How do biologics work?” Either way, read on to find out. This article covers it all — how biologics affect the immune system, the different kinds of biologic medications, advantages and disadvantages of treatment, and more! (Source)

How Do Biologics Work?

To answer the question, “How do biologics work to treat autoimmune diseases?” we first have to talk about how the immune system works.

When the immune system recognizes a threat — a virus, for example — it mounts a response by producing antibodies that “attack” that threat. In the case of autoimmune disease, the body mistakenly identifies its own healthy cells and tissues as a threat. This results in an excessive immune system activation and near constant barrage of inflammation.

The biologics used to treat autoimmune diseases are man-made antibodies that target specific proteins involved in the inflammation cascade, thereby decreasing inflammation throughout the body. This can alleviate symptoms and damage caused by the disease.

Because these unique drugs are made from biological sources — such as bacteria, viruses, proteins, carbohydrates, blood cells, genetic material, and tissues taken from humans and animals — they’re able to act on the body’s immune responses in different, more targeted ways than conventional medications. (Source, Source) 

Types of Biologics

There are hundreds of biologic drugs on the market today that fall into many different categories, including:

• monoclonal antibodies
• blood factor derivatives
• vaccines
• enzymes

Biologic therapy used to treat autoimmune diseases are monoclonal antibodies. Monoclonal antibodies (mAbs) are man-made versions of antibodies produced by the immune system in response to threats. Depending on what the monoclonal antibody has been created to do, it may disrupt cellular signals, kill diseased cells, or keep immune responses in check.

Some of the most common mAbs used to treat autoimmune diseases include TNF alpha and interleukin inhibitors. TNF alpha and interleukins are cytokines, a type of protein produced by the immune system that — among other things — is responsible for regulating inflammation in the body. Both interleukins and TNF alpha are known as “immunomodulatory” proteins because they’re necessary to activate an immune response.

TNF alpha and interleukins are often dysregulated and/or overproduced in people with autoimmune disease. These inhibitors work by doing just what their name suggests — they inhibit, or block, the inflammatory action of the two proteins, which then reduces inflammation in the body.

TNF alpha inhibitors include:

• infliximab (Remicade®)
• certolizumab (Cimzia®)
• adalimumab (Humira®)
• golimumab (Simponi®)
• etanercept (Enbrel®)

Common examples of interleukin inhibitors include:

• anakinra (Kineret®)
• tocilizumab (Actemra®)
• ustekinumab (Stelara®)
• secukinumab (Cosentyx®)

Interestingly, the ending of these drugs’ names often indicate what kind of cell was used to make them. Drugs ending in –umab are derived entirely from mice; those ending in –ximab are partially mouse, partially human (chimeric); those ending in –zumab have small bits of mouse proteins added to human proteins (humanized); and those ending in –umab have fully human origins. (Source)

Biologics targeting B cells and T cells — immune system cells (lymphocytes) that work together to produce antibodies and destroy unhealthy cells — have also been successfully used to treat autoimmune diseases. Abatacept (Orencia®) and rituximab (Benlysta®) are two such medications. (Source)

The type of biologic your health care provider recommends will depend on your symptoms and diagnosis, among other factors. (Source, Source, Source, Source) 

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How Are Biologics Different From Other Drugs?

Conventional medications — those that are created from non-living sources and are often synthetically derived — are made up of much smaller molecules than biologics. Biologics are composed of large molecules that are formulated to activate (or deactivate, depending on the specific mechanism of action) a component of the body’s immune response. Small-molecule drugs typically don’t trigger the immune system — they’re often able to fly under its radar, so to speak. (Source)

Because biologics are highly complex and unique in their composition, they’re not as easy to characterize or duplicate as a conventional drug. They are more difficult to manufacture, distribute, and store, too, which results in them being more expensive than their conventional counterparts.

While generic versions of biologic medications don’t technically exist — because making an exact replica of any biologic material is impossible — drug manufacturers do produce biosimilars. These drugs are made to mimic biologics in all of the most important ways. According to the U.S. Food and Drug Administration (FDA), “A biosimilar is a biologic that is highly similar to and has no clinically meaningful differences in terms of safety, purity, and potency (safety and effectiveness) from an existing FDA-approved biologic, called a reference product.” (Source)

The introduction of biosimilars has brought the price of both similar and reference products down significantly, a trend that experts expect to continue into the future. Lowering the costs of these drugs is incredibly important to make them more accessible to everyone who could benefit from them. (Source, Source) 

How Do You Take a Biologic or Biosimilar?

Most biologics and biosimilars are administered either via an injection (a shot) or an infusion (intravenously). Although effective, injections and infusions are harder to manage than oral medication, and some people find it difficult to stick to their treatment plan.

Figuring out how to develop oral biologics that will successfully survive the gastrointestinal tract’s natural defenses and be absorbed into the body is a top priority for pharmaceutical companies. Many experts in the industry are hopeful this breakthrough is just around the corner. (Source)

What Are the Benefits and Disadvantages of Biologics?

The targeted nature of biologics is their biggest advantage. Instead of suppressing the entire immune system, biologics can target specific components of the immune response. This allows the other parts of the immune system that are working normally to continue operating unhindered.

Regardless of their targeted nature, however, biologics are still immunosuppressant drugs, so people taking them are more susceptible to illnesses and have an increased risk of infections as a result. This is true of any immune-suppressing drug used to treat autoimmune disease, however, including conventional disease-modifying antirheumatic drugs (DMARDs) such as methotrexate. (Source, Source)

Biologics can even trigger the onset of autoimmunity or an autoimmune disease in some people. (Source)

Although highly effective, biologics are used with caution due to their potentially serious side effects, especially when given to those who haven’t responded well to other interventions and medications as first-line treatment.

The Bottom Line

Biologics are a complex class of medications that are made from biological sources such as cells, tissues, viruses, genetic material, and bacteria. Each different type of biologic is formulated to act on some part of the body’s immune response in a specific way.

Biologics used to treat autoimmune diseases neutralize proteins and cells responsible for the inflammatory response, calm inflammation throughout the body, and relieve symptoms associated with inflammation.

Although they can be highly effective, biologics are not without potentially serious side effects. Because they suppress the immune system, users are at an increased risk of infection. Biologics may also have the potential to provoke an autoimmune response.

If you’ve been diagnosed with an autoimmune disease (or suspect you may have one), find out how our Care Team can work with you and your other care providers to create a personalized healing plan.