Biologics are a special type of powerful drug that slows or stops damaging inflammation.
Biologics and biosimilars are special types of disease-modifying antirheumatic drugs (DMARD). In most cases, they are prescribed when conventional DMARDs have not worked. These powerful drugs work very well for many people with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and other forms of autoimmune, inflammatory arthritis.
They are harder to make than conventional DMARDs, so they can cost more than many of the medicines you may take. Some come as a shot that you give yourself and some have to be given in the doctor’s office through an intravenous (IV) infusion.
They weaken your ability to fight germs, so you may get infections while taking biologics.
One biologic may work very well for some people, but not for others. And a biologic may work for you at first, but then stop working after a while. If the first one you try doesn’t work or stops working for you, your doctor will suggest other biologics or options.
How Biologics Work
Biologics are genetically engineered proteins that target specific parts of the immune system that fuel inflammation. Non-biologic drugs, like methotrexate, offer a more scattershot approach.
“If you are fighting a war, biologic drugs are the snipers,” explains Jeffrey Curtis, MD, MPH, director, University of Alabama (UAB) Arthritis Clinical Intervention Program and co-director, UAB Center for Education and Research on Therapeutics in Birmingham. “They take out one target. And if the target is the general [of the army], you will do well.”
Drug selection can be difficult because inflammatory diseases are often driven by several factors. Biologics are used singly or in combination with non-biologic drugs. Methotrexate is often combined with a biologic.
Benefits and Risks
All biologic drugs are designed to reduce inflammation and halt joint damage. They can be life-changing for many people with inflammatory forms of arthritis. But with those big pluses come some drawbacks.
Suppressing your immune system puts you at risk for infection. In addition, biologics are given as an injection or infusion, so there is always a risk of an injection site reaction or an infusion reaction.
There are four types of biologics, each which a unique inflammatory target, and each has risks and benefits.
Tumor Necrosis Factor-α (TNF) Inhibitors
Benefits: These drugs reduce inflammation and suspend disease progression. They are sometimes used in combination with other medications. You may notice an improvement in your symptoms within two or three doses. Etanercept, adalimumab and infliximab are approved for use in children; the only TNF inhibitor that can be used during pregnancy is certolizumab.
Risks: The increased risk for infection specifically includes tuberculosis and fungal infections. The risk of tuberculosis may be lower with etanercept than other TNF inhibitors. Long-term use of these medications increases the risk of certain cancers. Adalimumab may worsen pre-existing heart failure or multiple sclerosis. The anti-inflammatory effect of anti-TNF drugs can diminish over time because some people form antibodies against the drug; using methotrexate with the biologic may reduce this likelihood.
Benefits: B-cell inhibitors are often used to treat rheumatoid arthritis when other treatments have not been effective. The effects of one rituximab treatment (two infusions approximately two weeks apart) can last nearly a year.
Risks: The infusion itself can have risks, such as a change in blood pressure, chest pain, difficulty breathing, rash, dizziness and/or flu-like symptoms. Medications can be given before the infusion to prevent or control these reactions. After treatment, you will be more susceptible to getting colds or sinus infections.
Benefits: For people who don’t find relief from TNF inhibitors, interleukin inhibitors can be used. This class of drugs is effective and well tolerated by most people.
Risks: In rare instances, you may get a small hole in your gastrointestinal tract (called a bowel perforation). You should be aware of changes in body temperature, abdominal discomfort, unusual bowel movements, headaches or symptoms of infection.
Selective Co-stimulation Modulators
Example: abatacept (Orencia)
Benefits: Abatacept can be used as a first-line treatment for moderate to severe rheumatoid arthritis, but it is more often prescribed after other DMARDs (such as methotrexate) don’t work adequately. Some people who do not get relief from an anti-TNF respond to abatacept. It is one of the biologics that can be used in children to treat juvenile idiopathic arthritis. You may notice relief of inflammation, stiffness, joint pain and swelling after four to six weeks of treatment. Maximum response may not occur until after four to six months of treatment. Combined therapy with methotrexate is more effective than methotrexate alone. It has few interactions with other drugs.
Risks: Specific infections to be aware of include pneumonia, tuberculosis and influenza. Side effects include cough, sore throat, headaches and nausea. Infusion reactions can occur, and the health team will watch for signs of a reaction during your infusion.
Side Effects and Solutions
For most people, the benefit of taking an approved drug outweighs its possible side effects.
Although side effects can develop within the first six to nine months of treatment, the risk declines with continued use, especially if the drug is improving your condition.
Injection Site Reactions
Injection site reactions are fairly common, especially at the beginning of your treatment. Injection site reactions include
Most reactions clear up without treatment, but you can use a cold compress, topical corticosteroids, oral antihistamines or acetaminophen to ease discomfort. If symptoms persist past five days or get worse, call your doctor. You should also change the spot where you inject yourself each time.
If your biologic is given as an infusion, the clinic or facility will begin by getting your vital signs – temperature, blood pressure and pulse. A health professional will continue to monitor you during and after the infusion until you leave the facility.
Before your scheduled biologic infusion, you may receive “pre-meds,” such as an antihistamine, antiemetic (for nausea) or an anti-inflammatory drug (NSAID). These will prevent any mild reactions, such as
• Redness at infusion site
If any of the following more serious reactions occur, the infusion can be stopped and the reaction will be treated on site:
• Difficulty breathing
• Chest pain or tightness
• High or low blood pressure
• Swelling of face and hands
Because biologic therapies suppress the immune system, treatment leaves you more prone to infection. The most common are colds, upper respiratory tract infection, sinus infection, sore throat, bronchitis or urinary tract infections. Tips for avoiding infections:
• Wash hands frequently.
• Avoid crowded areas, enclosed spaces, public transportation and childcare facilities.
• Tell friends and family not to visit if they are sick.
• Talk to your doctor before scheduling vaccinations, dental appointments or manicures.
• Do not share cups, utensils or personal items.
• Do not swim in lakes, rivers, ponds or public pools. Avoid hot tubs.
• Ask your doctor about contact with your pets. It’s probably a good idea not to change cat litter or to clean up after the dog. Birds, fish, rodents, reptiles and farm animals should be avoided.
• Check with your doctor about whether it’s safe to work in the garden with soil or mulch.
• Avoid unpasteurized food, raw eggs or fish, soft cheeses and shellfish.
Headaches occur more commonly in patients taking biologics than the general public. Try placing a cold pack on your forehead for 10 to 15 minutes. Or you can try lying down in a dim room for a few minutes, taking a warm shower, or massaging your head and neck. Avoid looking at a computer or smartphone screen for extended periods. It might also help to reduce the amount of caffeine you consume.
There are a number of non-drug remedies you can try to combat queasiness.
• Place a cold compress on your forehead.
• Lie down in a dark, quiet room.
• Avoid heat, humidity and stuffy rooms.
• Breathe fresh air deeply through your nose; sometimes inhaling peppermint or drinking ginger tea helps.
• Suck on ice or sip cool water. Nibble on a saltine cracker if you think your stomach can handle it. Avoid sugary drinks or snacks.
Recognize New Symptoms
A key piece of advice is to listen to your body. The following symptoms are signs of an infection or a more serious condition and you should contact your doctor right away:
• Fever, sweat or chills.
• Muscle aches, weakness/numbness or tingling.
• Shortness of breath or chest pain.
• Rash or painful sores; warm, red or painful skin.
• Diarrhea or stomach pain.
• Burning during urination or urinating more than normal.
• Unusual fatigue.
• Vision problems or dizziness.
• Poor appetite or weight loss.
• Bleeding or bruising easily.
Biologic therapies can be life-changing, but you must take them safely.
All biologic drugs are administered as either an intravenous infusion or an injection, given in predetermined intervals depending on the specific drug. Only qualified health professionals should give infusions and initial injections. You can be taught to give yourself injections at home.
Basic safety instructions for self-injection include:
• Store the medicine refrigerated and out of light. Most biologics should be brought to room temperature before injection. Ask your doctor how long your prescribed biologic can be left at room temperature.
• Do not shake or freeze the drug or syringes.
• Be sure to use sterile technique. Wear gloves, keep the area free of contaminants, clean the injection area with alcohol, and discard the syringe and needle safely.
• Place the needle and syringe into an approved “sharps” container after use. Some pharmaceutical companies and infusion centers can provide these free of charge and dispose of them upon request.
Always tell your rheumatologist what medications and supplements you are taking. It’s also a good idea to fill all your prescriptions at the same pharmacy so they can keep you informed about any possible drug interactions.
Before any biologic is prescribed, your doctor will ask some medical history questions and may run a few tests.
If you have an infection, have had one recently, or have a history of chronic infection, your doctor will not begin treatment with a biologic. If you have an infection and are taking antibiotics, your doctor will wait until you’ve finished the antibiotic and the infection has cleared.
Tuberculosis (TB). Experts estimate that 90% of people who are infected with tuberculosis don’t know it because the bacteria can lie dormant in the body for years. Biologics can activate or reactivate the infection. You will have to have a skin or blood test for TB before starting any biologic.
Hepatitis B or C. Hepatitis reactivation can occur with any biologic. This is a particular risk with rituximab and hepatitis B virus. You will have a blood test to check for hepatitis infection.
Cancer, diabetes, a heart condition or nervous disorder. Treatment for these conditions (current or past) can put you at an even greater increased risk for infection or adverse event. Your doctor will want to know your full medical history and medicines you’ve taken.
Live vaccines are not recommended during treatment with any biologic drug. Flu vaccine injections are dead viruses and can be given at any time. If you need any live-virus vaccines, you’ll need to get them one to three months before starting immunosuppressant drugs.
Live-virus vaccines include
• FluMist, which comes in nasal form.
• Zostavax, for herpes zoster (shingles), is no longer given in the U.S.
• Measles, mumps and rubella vaccines.
• Typhoid, varicella, smallpox and yellow fever vaccines for people who need to travel.
Treatment with biologics will be postponed or stopped if you’re planning on having surgery. You will not be able to start or restart the biologic until after your sutures or staples are removed and there is no sign of infection.
Pregnancy and Breastfeeding
Long-term safety studies for fetuses and infants have not been determined for most biologics. Talk to your doctor if you are considering becoming pregnant.
If you are sensitive to latex or rubber, adalimumab is not recommended since the prefilled syringe contains these. If you are allergic to E. coli proteins or currently take etanercept, you should not take anakinra because these can cause adverse reactions in certain people.
Ohio and Mississippi River Valleys
Living in the Ohio or Mississippi River valley can increase your risk of exposure to certain kinds of fungal infections or developing histoplasmosis. Your doctor will need to know before starting biologics.
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