Understanding Your Lupus Care: What Is A Biologic?
What is a biologic?
A biologic is a pharmaceutical drug product or vaccine manufactured in, extracted from, or synthesized from biological sources.
www.canada.ca/en/health-canada/services/drugs-health-products/biologics
What’s the difference between a biologic and a conventional drug?
Biologics are different from conventional chemical drugs in several ways.
Biologics activate certain proteins or cells in your immune system to create specific responses to targets, while many conventional systemic drugs activate your entire immune system in a more generalized manner.
- Chemical drugs are small molecules with low molecular weight.
- A biologic molecule is much larger and may have thousands of atoms, making them larger and complex in their structure.
- Most biologics are given by injection or by intravenous (IV) infusion and monitored closely. Because they are usually given by injection or IV, they may cause a reaction at the site of injection or infusion.
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Also, because biologic drugs are made from living organisms, they may be more at risk for contamination, so they usually need to be refrigerated. |
How do different types of biologics work?
Biologics are relatively new drugs that can greatly improve the lives of people with many conditions and diseases. Many biologics are now available, and more are being studied in research trials.
Biologics may offer the best treatments for a variety of medical diseases and conditions that have been difficult to treat in the past.
There are several types of biologics that work in different ways:
Monoclonal antibodies
are biologic proteins that can bind to specific proteins in the body or to specific cells.
Cytokines
are biologic proteins that can speed up or slow down your defense system (immune system).
Growth factor biologics
are hormones or chemical messengers in your body that regulate the growth and survival of cells.
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Biologic enzymes
are proteins that control chemical reactions, cell signaling and growth.
Biologic immunomodulators
can block or speed up the immune system.
Two Biologics recently approved for treatment are:
SAPHNELO is a prescription medicine used to treat adults with moderate to severe
systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.
SAPHNELO (anifrolumab for injection) is indicated in addition to standard therapy for the treatment of adult patients with active, autoantibody positive, systemic lupus erythematosus (SLE).
The safety and efficacy of SAPHNELO have not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.
BENLYSTA is used in addition to standard therapy to reduce disease activity in adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) and for the treatment of active lupus nephritis (LN).
The safety and efficacy of BENLYSTA have not been evaluated in patients with severe active central nervous system lupus.
What are the side effects of biologics?
Different biologics have different side effects, but some side effects are common to most biologics. These include an increased risk of infection and both body and skin reactions after receiving the biologic.
- You may be at increased risk for an infection while taking a biologic. Signs of infection include fever, chills, cough or flu-like symptoms. In some cases, the biologic may be stopped until you recover from an infection.
- Injection site reactions usually occur shortly after a biologic injection and can include pain, swelling, redness or itching. These reactions can be treated with a cold compress, an over-the-counter (OTC) antihistamine, and an OTC pain and fever medication. It helps to use a different injection site each time. Over time, these side effects usually go away. IV infusion side effects can include reactions at the site of the infusion, similar to injection site reactions. There may also be body reactions — called systemic reactions — like flushing, rash, nausea, chills and headache. More severe reactions are possible, but uncommon. They may include a drop in blood pressure that causes dizziness or fainting, difficulty breathing or chest pain. Treatment may be given to reduce or prevent an infusion reaction before giving a biologic infusion with an antihistamine, anti-nausea or anti-inflammatory medication. After a biologic infusion, patients are instructed to wait under observation to make sure a severe reaction does not occur.
Biologic medications that work by suppressing the immune system can cause a higher risk for colds and other upper respiratory tract infections, as well as worsen an existing, long-term infection, so you may be checked for a long-term infection like tuberculosis, hepatitis or other infectious diseases before you start treatment.
Some biologics have been associated with an increased risk for some types of cancer. In the past, studies have found a slightly increased risk for lymphoma and skin cancer. Because a biologic may affect your immune system, you may be advised not to have certain vaccinations that use a live virus. To date, biologics have not been studied widely during pregnancy or breastfeeding to confirm that they are safe. In cases where there may be a risk from a biologic that risk must be weighed against the benefits of treatment.
Please note that every individual is different, which is why it is important to speak with your healthcare team to determine if a biologic is right for you.