Biologics for Treating Rheumatoid Arthritis

What Are Biologic Drugs?

Biologics are genetically engineered proteins. Unlike other RA medications that affect your entire immune system, biologics zero in on specific parts that control the inflammation process.

Why Take Biologics?

Aggressive treatment can help prevent long-term disability from rheumatoid arthritis. So if you have moderate to severe RA and don’t respond to traditional disease-modifying antirheumatic drugs (DMARDs), your doctor will probably say it’s time for a biologic. You might take it alone or along with other rheumatoid arthritis medications.

What Biologics Are Available to Treat RA?

What Are the Types of Biologics?

There are several. They include:

  • B-cell inhibitor. They affect B cells, which are white blood cells that carry a protein that can trigger your immune response.
  • Interleukin-1 (IL-1) blocker. Stops production of an inflammatory chemical your body makes
  • Interleukin-6 (IL-6) or interleukin-17 blocker. Stops inflammatory chemicals from attaching to cells
  • Janus kinase (JAK) inhibitor. Blocks proteins that trigger the inflammation process
  • T-cell inhibitor. Blocks communication between T cells, a type of white blood cell
  • Tumor necrosis factor (TNF) inhibitor. Blocks a chemical your body makes that drives the inflammation process

What Are Biosimilars?

A biosimilar is very similar to, but not an exact copy of, a biologic drug. You’ll know that your medication is a biosimilar if it has a dash after the generic name, followed by four letters.

Biologic drugs are harder to make than conventional medicines. While most traditional meds are made from chemicals and have known structures, biologics are more complex. They’re typically made from living materials, like animal, human, and bacteria cells.

It’s not possible to make a perfect copy of a biologic drug, because each drugmaker uses different cells and a different process to make each drug. That’s why biosimilars are a little different from the original drug.

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Drugmakers have to prove that biosimilars are just as safe and effective as the original and that they work the same way. You get the same dose the same way at the same strength.

Biologic drugs are much more expensive than other medicines. Even with health insurance, your out-of-pocket costs may add up to hundreds or even thousands of dollars every month.

Experts believe biosimilars may bring down the cost. Once the patent on a biologic drug runs out, other companies can make their own versions. These biosimilars usually come with lower price tags. The hope is that this will help more people get the drugs they need.

The FDA has approved 28 biosimilars. The drugs below can treat rheumatoid arthritis, although only a few are available on the market:

  • Avsola, Ixifi, Inflectra, and Renflexis, biosimilars of Remicade (infliximab)
  • Eticovo and Erelzi, biosimilars of Enbrel (etanercept)
  • Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, and Hyrimoz, biosimilars of Humira (adalimumab)

If you’re already taking a biologic drug, it’s possible the biosimilar won’t work as well. It could also cause a side effect that the biologic doesn’t. That’s because some people have an immune response to biologic drugs. The response can cause a reaction to a biosimilar drug. In a worst-case scenario, you may start to resist the original biologic, too.

Biosimilars that are safe to swap are called interchangeable biological products. The FDA is finalizing these guidelines for drugmakers.

What to Expect When You Take a Biologic

The FDA has approved these medications to treat rheumatoid arthritis. You might take a biologic alone or with another arthritis drug. As a general rule, you shouldn’t take different biologic therapies at the same time.

Abatacept (Orencia). This medication works by blocking T cells. You get it in a shot every week or by IV once a month. The most common side effects include headache, a cold, a sore throat, and nausea. Before you start taking it, your doctor should test you for infections such as tuberculosis and hepatitis. They should check you for infections while you’re taking it, too.

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Adalimumab (Humira), adalimumab-adaz (Hyrimoz), adalimumab-adbm (Cyltezo), adalimumab-afzb (Abrilada),  adalimumab-atto (Amjevita), adalimumab-bwwd (Hadlima), adalimumab-fkjp (Hulio).  These medications target tumor necrosis factor (TNF). You get them as a shot once every 2 weeks. The most common side effects are colds, a sinus infection, headache, and rash. Before you start taking it, your doctor should test you for infections like tuberculosis and hepatitis. They should check you for infections while you’re taking it, too.

Anakinra (Kineret). This medicine targets interleukin-1 (IL-1). You take it as a shot once a day. The most common side effects are pain or skin reactions in the area where you get the shot, colds, headache, and nausea. Before you start taking it, your doctor should test you for infections like tuberculosis and hepatitis. They should check you for infections while you’re taking it, too.

Certolizumab (Cimzia). This biologic targets tumor necrosis factor (TNF). You take it as a shot every 2-4 weeks. (Your doctor will decide how often you get it.) Its most common side effects are the flu or a cold, a rash, and urinary tract infections. Before you start taking it, your doctor should test you for infections like tuberculosis and hepatitis. They should check you for infections while you’re taking it, too.

Etanercept (Enbrel), etanercept-szzs (Erelzi), etanercept-ykro (Eticovo) . This medication targets tumor necrosis factor (TNF). You take it as a shot 1-2 times each week. The most common side effects are skin reactions or pain where you get the shot, sinus infections, and a headache. Before you start taking it, your doctor should test you for infections like tuberculosis and hepatitis. They should check you for infections while you’re taking it, too,

Golimumab (Simponi, Simponi Aria). These biologics target tumor necrosis factor (TNF). You’ll take Simponi as a monthly shot and Simponi Aria every 8 weeks by IV. The most common side effects are a runny nose; sore throat; hoarseness or laryngitis; pain, skin reactions, or tingling where you got the shot; and viral infections like the flu and cold sores. Before you start taking it, your doctor should test you for infections like tuberculosis and hepatitis. They should check you for infections while you’re taking it, too.

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Infliximab (Remicade), infliximab-abda (Renflexis), infliximab-axxq (Avsola), infliximab-dyyb (Inflectra), infliximab-qbtx (Ixifi). This medication targets tumor necrosis factor (TNF). You take it by IV. Your doctor will decide on the dose and how often you should take it. The most common side effects are respiratory infections (like sinus infections and a sore throat), headache, coughing, and stomach pain. Before you start taking it, your doctor should test you for infections like tuberculosis and hepatitis. They should check you for infections while you’re taking it, too.

Rituximab (Rituxan). This medication targets B cells. You take it as an infusion by IV. Your first two infusions will be 2 weeks apart. You can repeat the infusions every 6 months. The most common side effects are reactions to the infusion, chills, infections, body aches, tiredness, and a low white blood cell count. Before you start taking it, your doctor should test you for infections like tuberculosis and hepatitis. They should check you for infections while you’re taking it, too.

Tocilizumab (Actemra). This medication targets interleukin-6 (IL-6). You can take it by IV once a month. Or you can get shots every week or every other week. The most common side effects are a cold, sinus infection, a headache, high blood pressure, or liver problems. Before you start taking it, your doctor should test you for infections like tuberculosis and hepatitis. They should check you for infections while you’re taking it, too.

Tofacitinib (Xeljanz). This medicine targets Janus kinase (JAK) proteins. You take it as a pill either once or twice a day, depending on the dosage. The most common side effects are a cold, sinus infection, headache, high blood pressure, and liver problems. Before you start taking it, your doctor should test you for infections like tuberculosis. They should check for changes to your cholesterol levels or liver enzymes and track your while blood cell count while you take it, too.

Do Biologics Have Side Effects?

The most common are pain and rash where you got the shot. But they affect only a small number of people who take these drugs. Biologics can cause allergic reactions. Because some go directly into a vein, you’ll get the infusion at a place where your doctor can keep an eye on you. Reaction symptoms include flu-like illness, fever, chills, nausea, and headache.

As with any drugs that suppress your immune system, biologics can make you more likely to get infections and other diseases. See the doctor ASAP if you have a fever or unexplained symptoms. You may need to get vaccinations to prevent infections before you start a biologic. Talk to your doctor before getting a vaccination if you're on a biologic.

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Who Shouldn’t Take Them?

Biologics may cause some dormant chronic diseases (like tuberculosis) to flare. They may not be a good idea if you have multiple sclerosis or other conditions like severe congestive heart failure. Your doctor will give you a skin or blood test for tuberculosis before you start a biologic. You also need a test for chronic hepatitis B and C.

Although animal studies of biologics show they don’t affect fertility or hurt the baby, they can’t always predict what will happen to humans who take the drugs. Because we don’t know how they affect a developing child, pregnant women should use them only if the need is great.

Your doctor will tell you to stop your biologic before surgery. You can start again when your wounds have healed and your chance of getting an infection has passed.

WebMD Medical Reference Reviewed by Neha Pathak, MD on October 02, 2020

Sources

SOURCES:

Arthritis Foundation: “Biologics Overview,” “Rheumatoid Arthritis Treatment,” “Biosimilars: What You Should Know.”

FDA: “FDA’s Overview of the Regulatory Guidelines for the Development and Approval of Biosimilar Products in the US.”

American College of Rheumatology: “Tofacitinib Citrate (Xeljanz).”

MedlinePlus: “Biologics Don't Raise Cancer Risk in Rheumatoid Arthritis Patients.”

Agency for Healthcare Research and Quality: “Rheumatoid Arthritis Medicines: A Guide for Adults.”

UpToDate for Patients: “Patient Information: Rheumatoid Arthritis Treatment.”

The Johns Hopkins Arthritis Center: “Rheumatoid Arthritis Treatment.”

RxList.

News releases, FDA: “FDA approves Inflectra, a biosimilar to Remicade,” "Prescribing Information, Infliximab-dyyb (Inflectra)," “FDA approves Amjevita, a biosimilar to Humira,” “FDA Approves Erelzi, a Biosimilar to Enbrel,” “Biosimilars,” “Considerations in Demonstrating Interchangeability With a Reference Product,” “Biosimilar Product Information.”

Janssen Biotech Inc.

News release, Roche.

Amgen Prescribing Information, Amjevita.

UpToDate: “Rituximab: Principles of use and adverse effects in rheumatoid arthritis.”

Angus Worthing, MD, rheumatologist; chairman, American College of Rheumatology’s Government Affairs Committee.

Jonathan Krant, MD, section chief, rheumatology, Adirondack Health Systems.

FDA: “Information for Consumers (Biosimilars).”

Drugs -- Real World Outcomes: “Comparing Biologic Cost Per Treated Patient Across Indications Among Adult US Managed Care Patients: A Retrospective Cohort Study.”

Pharmacy & Therapeutics: “Biosimilars.”

Annals of Internal Medicine: “Bioequivalence of Biosimilar Tumor Necrosis Factor-α Inhibitors Compared With Their Reference Biologics: A Systematic Review.”

Annals of Rheumatic Diseases: “Antibodies to Infliximab in Remicade-Treated Rheumatic Patients Show Identical Reactivity Towards Biosimilars.”

Avalere Health: “Patient Out-of-Pocket Costs for Biosimilars in Medicare Part D.”

U.S. National Library of Medicine: “Biosimilars.”

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