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Understanding Biologic Drugs

January 17, 2017 — Biologic drugs have been making headlines as potentially promising new therapies for treating atopic dermatitis (AD). Several have shown positive results in clinical trials and one, dupilumab, is being reviewed for approval by the Food and Drug Administration (FDA) and is expected to come to market in 2017. Biologic medications are already being used to treat diseases including rheumatoid arthritis, psoriasis and Crohn’s disease, as well as others. So, what are biologic drugs and what do people need to know if they are considering them to treat their AD?

Biologic Drugs are Derived from Living Cells
Most drugs, like aspirin, are made through chemical reactions between different compounds. Like a recipe, once the ingredients, proportions and processes have been tested and optimized, they are easy to replicate. They are also very stable products and typically do not require special handling.

On the other hand, biologic drugs are derived from living organisms and produced genetically, by culturing specific proteins from those cells – basically biologic drugs are large, complex protein molecules. Producing biologic drugs is a sophisticated process that results in a product that is sensitive to environment and handling. Biologics are difficult to reproduce exactly because they are made from living cells.

Biologic Drugs have Specific Therapeutic Targets
Biologic drugs are designed to have a very specific result. In the case of dupilumab, the goal is to reduce the inflammation that can cause AD symptoms such as itching and redness. It does this by blocking two specific proteins from attaching to its cell receptors, which would trigger inflammation.

Biologic Drugs are Injectable
Because they are made from proteins, biologic drugs must be administered by injection. If they were taken orally, as in a pill or capsule, stomach acids would break the proteins down, making them ineffective. It’s possible that in the future there will be biologic medications that can be taken orally.

Biologic Drugs are Not Inexpensive
In general, because biologic drugs are expensive to develop, and require complex production and distribution processes, they are not cheap. There is no pricing information available yet about dupilumab. An organization called the Institute for Clinical and Economic Review (ICER), an independent nonprofit that evaluates treatments for serious diseases and develops recommendations about cost and access, is reviewing treatments for AD, including dupilumab, and will produce a final report in 2017. National Eczema Association is actively working to ensure that the patient perspective is central to ICER’s process.

Biologic Drugs Offer Real Hope
If approved by the FDA, dupilumab will be prescribed for adults with moderate to severe AD. These patients have had few treatment options until now. People who have participated in the clinical trials for dupilumab have, in some cases, reported fast and significant improvement of their AD symptoms, with few side effects.

For more than 10 years there were no new treatment options available for people with AD. In December 2016, the FDA approved a new topical medication for mild to moderate AD, Eucrisa. The approval of a biologic therapy with the potential to treat the worst cases of AD would be a sea change for people living with AD and their families.