Biologics and RA: Risks and Rewards

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UCB This content is selected and controlled by WebMD's editorial staff and is brought to you by UCB. Next Article: Skip to Article Content Treating Rheumatoid Arthritis: The Role of Biologics Understanding Your Treatment Options Ways to control inflammation and stop progression of the disease. 6 Mistakes to Avoid When You Have RA From not seeing a rheumatologist to not getting to right medication, what to avoid. Is It Time for a Biologic? What your rheumatologist looks for in treating your RA. How Biologics Work What is a biologic? How do these medications stop progression of RA? Biologics at a Glance Injection or infusion? Use this medication chart to see how biologics are given. RA and Your Health Heart disease. Eye problems. What to watch for when you have RA. 10 Important Actions When You Have RA What you need to know to cope with RA every day. Choosing the Right Biologic for You The differences between biologics, and talking to your doctor about the options. Risks and Benefits of Biologics How to evaluate the benefits of biologics with the risk of side effects. Combination Therapy Your questions answered about taking more than one RA drug. Why Do You Need a Rheumatologist? How to find the right doctor to treat your RA. Paying for Biologics Why biologics are expensive, and where to find assistance programs. Vitamins and Minerals for RA Are you getting enough of what your body needs? Making Physical Therapy Work for You 5 steps to successful PT for RA. 4 Foods That Fight Inflammation There’s no "RA diet," but these foods may help lower inflammation. False Biologics for RA: Understanding Risks and Benefits WebMD Feature

By Joanne Barker

Reviewed By Brunilda Nazario, MD

Medications called biologic response modifiers have given new hope to people with rheumatoid arthritis (RA) and the doctors who treat them. Until the late ’90s, people with RA looked at a future of pain, lost function, and eventual disability. Biologics have changed that outlook.

Many people now live with significantly less pain and more function, but may worry about side effects. Here's a look at the risks and benefits of biologics.

Biologics in Action

Ed Clough’s story demonstrates how biologics have changed the RA picture. He was first diagnosed in the early ’90s and advised to take ibuprofen for pain. “It didn’t do much,” he says.

Then, for no apparent reason, his RA went into remission. A few years later, it came back with a vengeance. “The pain in my fingers and wrists got so bad I couldn’t button my shirt or lift a gallon of milk without dropping it,” he says. “Things I never used to think about.” 

The return of Clough’s RA coincided with the FDA’s 1998 approval of the first two biologic agents on the U.S. market. The drugs were so new that Clough’s doctor had to put him on a special list to qualify for the treatment. “Within weeks of the first injection, I could manage everyday activities again,” Clough says. “I played golf without pain for the first time in years.”

What Are Biologics?

Biologics are a class of drug that target specific parts of the immune system. With RA, the immune system goes into overdrive and attacks healthy cells. So bringing the immune system under control is key to managing the disease.

This approach is not new, exactly. Some disease-modifying antirheumatic drugs (DMARDs) that have been around for decades. But many work by suppressing the whole immune system, rather than specific parts of it.

“Biologics are the first agents developed specifically with RA in mind,” says Theodore R. Fields, MD, clinical director of the Early Arthritis Initiative at the Hospital for Special Surgery. “Some were originally developed as chemo drugs, others to treat tuberculosis. The new agents target specific chemicals in the immune system so you see more benefits without as much collateral damage.”

RA Treatment Revolution

“Biologics have elevated the goals of treatment,” says Arthur Kavanaugh, MD, professor of clinical medicine in the Rheumatology Division at the University of California, San Diego. “We’re treating the disease earlier and more aggressively with much higher expectations for patient outcomes.” 

Researchers now recognize that the first year is a critical time to treat RA. Often much of the bone and joint damage occurs early, within a few weeks of onset. Biologics do not reverse existing damage, but can protect the joints against continued damage and have been shown to slow the progression of the disease. They are considered a possible treatment for patients who have uncontrolled RA despite the use of DMARDs.

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Register Now Important Safety Information you should know about CIMZIA®(certolizumab pegol).What is the most important information I should know about CIMZIA?

CIMZIA is a medicine that affects your immune system. CIMZIA can lower the ability of the immune system to fight infections. Serious infections have happened in patients taking CIMZIA, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections.

Your doctor should test you for TB before starting CIMZIA Your doctor should monitor you closely for signs and symptoms of TB during treatment with CIMZIACertain Types of Cancer

There have been cases of unusual cancers in children and teenage patients using tumor necrosis factor TNF-blocking agents. CIMZIA is not approved for use in pediatric patients. For people taking TNF-blocker medicines, including CIMZIA, the chances for getting lymphoma or other cancers may increase. People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.

What is CIMZIA?

CIMZIA is a medicine called a tumor necrosis factor (TNF) blocker. CIMZIA is used in adult patients to:

Lessen the signs and symptoms of moderately to severely active Crohn's disease (CD) in adults who have not been helped enough by usual treatments Treat moderately to severely active RABefore starting CIMZIA, tell your doctor about all of your medical conditions, including if you: Think you have an infection. You should not start taking CIMZIA if you have any kind of infection Are being treated for an infection Have signs of an infection, such as a fever, cough, or flu-like symptoms Have any open cuts or sores on your body Get a lot of infections or have infections that keep coming back Have diabetes Have HIV Have TB, or have been in close contact with someone with TB Were born in, lived in, or traveled to countries where there is more risk of getting TB. Ask your doctor if you are not sure Live or lived in certain parts of country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may develop or become severe if you take CIMZIA. If you do not know if you have lived in these types of areas, ask your doctor Have or have had hepatitis B Have or have had any type of cancer Have congestive heart failure Have seizures, any numbness or tingling, or a disease that affects your nervous system such as multiple sclerosis Are scheduled to receive a vaccine. Do not receive a live vaccine while taking CIMZIA Are pregnant, planning to become pregnant, or breastfeeding. CIMZIA has not been studied in pregnant or nursing women Are allergic to any of the ingredients in CIMZIA Are taking any medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. Your doctor will tell you if it is okay to take your other medicines while taking CIMZIAEspecially, tell your doctor if you take:Kineret® (anakinra), Orencia® (abatacept), Rituxan® (rituximab), Tysabri® (natalizumab). You have a higher chance for serious infections when taking CIMZIA with these medicinesA TNF blocker: Remicade® (infliximab), Humira® (adalimumab), Enbrel® (etanercept) or Simponi® (golimumab)

You should not take CIMZIA while you take one of these medicines.

How should I use CIMZIA?

CIMZIA is available as a lyophilized powder for reconstitution or in a prefilled syringe. If your doctor prescribes the lyophilized pack, CIMZIA should be injected by a healthcare provider. If your doctor prescribes the prefilled syringe, see the section "Patient Instructions for Use" at the end of the Medication Guide for complete instructions for use. Do not give yourself an injection of CIMZIA unless you have been shown how by your doctor or nurse–or they can train someone you know to help you with your injection. CIMZIA is given by an injection under the skin. Your doctor will tell you how much CIMZIA to inject and how often, based on your condition to be treated. Make sure to keep all of your injection and follow-up appointments with your doctor.

After starting CIMZIA, if you get an infection; any sign of an infection including a fever, cough, or flu-like symptoms; or have open cuts or sores on your body, call your doctor right away. CIMZIA can make you more likely to get infections or make any infection that you may have worse.

What are the possible side effects of CIMZIA?

CIMZIA can cause serious side effects including:

Heart failure, including new heart failure or worsening of heart failure you already have. Symptoms may include shortness of breath or swelling of your ankles or feet Nervous system problems such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes. Symptoms include dizziness, numbness or tingling, problems with your vision, and weakness in your arms or legs Allergic reactions. Signs of an allergic reaction include a skin rash, swollen face, or trouble breathing Hepatitis B virus reactivation in patients who carry the virus in their blood. In some cases, patients have died as a result of the hepatitis B virus being reactivated. Your doctor should monitor you carefully during treatment with CIMZIA if you carry the hepatitis B virus in your blood. Tell your doctor if you have any of the following symptoms: feel unwell, poor appetite, tiredness (fatigue), fever, skin rash, or joint pain Blood Problems. Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Symptoms include a fever that doesn't go away, bruising or bleeding very easily, or looking very pale Immune reactions including a lupus-like syndrome. Symptoms include shortness of breath, joint pain, or a rash on the cheeks or arms that worsens with sun exposure

Call your doctor right away if you develop any of the above side effects or symptoms.

The most common side effects of CIMZIA are: upper respiratory infections (flu, cold), rash, and urinary tract infections (bladder infections).

Other side effects have happened in some people including new psoriasis or worsening of psoriasis you already have and injection site reactions. Tell your doctor about any side effect that bothers you or does not go away. These are not all of the side effects with CIMZIA. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see the Medication Guide for CIMZIA and discuss it with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Important Safety Information Regarding Fungal Infections

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