- Biologics are derived from living organisms or contain components of living organisms.
- These highly advanced drugs are used to treat a wide range of autoimmune disorders.
- The FDA has approved biologic drugs for psoriasis, eczema, and other skin diseases.
The immune system is a complex network of cells and proteins that travel between them. Since each protein may be responsible for several functions, biologic treatments for autoimmune diseases are designed to target specific proteins and disrupt the functions they carry.
This targeted form of therapy distinguishes biologics from conventional approaches that affect the entire immune system, and has changed disease outcomes for many patients. Here’s what you need to know about these new therapeutic options and their use for treating common autoimmune skin diseases.
What are biologics?
Biologic treatments specifically target and block abnormalities in the immune system responsible for inflammatory diseases like psoriasis and atopic dermatitis.
These plant-based, laboratory-grown medications are created from living organisms. In general, they modify the immune system’s response to disease by blocking abnormal T-cell (a type of white blood cell) activity that “tells” the body to create inflammation.
“Biologics are game changers,” notes Dr. Adam Friedman, Professor of Dermatology at George Washington University School of Medicine and Health Sciences. “This class of drugs has revolutionized treatment, not just for immune-related skin diseases but for other autoimmune disorders like Crohn’s disease and rheumatoid arthritis as well.”
Biologics fall into several categories, based on their mode of action and specific protein targets:
- Tumor necrosis factor (TNF) antagonists stop the disease from progressing by targeting TNF, which is a type of chemical that triggers inflammation.
- Monoclonal antibody therapy uses antibodies designed to target specific antigens or proteins. The goal of therapy is to stimulate the immune system into attacking pro-inflammatory proteins.
- Anti-cytokines therapy targets cytokine proteins like interferons and interleukins, which play a role in cellular communication within the immune system. They’re involved in the inflammatory response and defending the body against viral infections.
- Growth factor modulators target proteins that stimulate the growth of specific tissues.
- Protein kinase inhibitors block the action of protein kinases, which create a process that can turn a protein on or off, with an impact on the way it functions.
Biologics are generally prescribed by dermatologists, gastroenterologists, rheumatologists, and oncologists.
According to the FDA, “biological products often represent the cutting-edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available.”
Use of biologics in skin autoimmune diseases
When an immune disorder assaults the body, the immune system attacks its own tissues in the joints, muscles, internal organs, or skin. Biologic therapy offers very real treatment benefits for several skin autoimmune diseases.
“Psoriasis, atopic dermatitis, and hidradenitis suppurativa are similar diseases,” explains Dr. Jennifer Dennis-Wall of Biorasi, a clinical research organization in Miami that focuses on autoimmune diseases. “These conditions are all considered to be autoimmune diseases — that is, diseases that involve an inappropriate response of the immune system.”
Several different types of psoriasis have been identified, of which plaque psoriasis is the most common. The area around these plaques may become inflamed and might crack or bleed. Most people will notice these scaly, itchy patches on joints like knees or elbows, but distressingly, they may also appear on the face, hands, arms, scalp or nails.
The FDA has approved several biologics and biosimilar drugs to treat psoriasis. Biosimilar products are “generic” copies of the original drugs and are considered as safe and effective as the originals. The earliest biologics used to treat psoriasis include Enbrel (etanercept) and Remicade (infliximab), which entered the market in 1998. Each now has a biosimilar (Erelzi and Inflectra), which were approved in 2016.
Another drug, Humira (adalimumab), was approved in 2002 and two biosimilars are now available — Amjevita and Cyltezo. Finally, Stelara (ustekinumab) and Simponi (golimumab) both became available in 2009. These have all tested well in clinical trials in terms of efficacy and safety and have been in use for a few years now.
In addition, Dr. Dennis-Wall notes that several newer agents have become available since 2014, including Otezla (apremilast), Cosentyx (secukinumab), Taltz (ixekizumab), Siliq (brodalumab), Tremfya (guselkumab) and Ilumya (tildrakizumab).
Also called atopic dermatitis, this common inflammatory skin disease occurs more often in children than in adults. Eczema is characterized by skin that is cracked, swollen, red and itchy. When topical therapies or anti-inflammatory medications no longer work effectively, biologic therapy may be a good option.
Several studies have demonstrated the effectiveness of several monoclonal antibodies in treating atopic dermatitis. Thus far, only one (dupilumab) has been approved by the FDA to treat this condition, for which there is no cure. Note, people who opt for this novel drug need to be aware that an inflammation of the eye resembling conjunctivitis can occur with its use.
Also known as acne inversa, this inflammatory skin condition has a distressing effect on quality of life. It is a chronic, relapsing and severely painful disorder that usually affects the sweat glands and hair follicles under the arms, in the groin, under the breasts, and in the genital area.
Treatment for hidradenitis suppurativa (HS) includes antibiotics, corticosteroids, and methotrexate, with varying degrees of success. Humira (adalimumab), introduced three years ago for the treatment of psoriasis, has now been approved by the FDA to treat HS. In some patients, use of this biologic has resulted in long-term disease resolution.
Dr. Dennis-Wall notes that other manufacturers of biologics are continuing to study their efficacy to gain approval for their use in HS as well.
Do biologics cause side effects?
For many people, biologics represent hope in improving a condition that other treatments have failed to address. As such, it’s highly likely that the usefulness of biologics for people with immune-related dermatologic disorders will increase. However, these life-changing therapies are not without side effects and risks.
In general, biologics are administered as a subcutaneous (under the skin) injection or as an infusion. Some people experience injection site reactions, including soreness or stinging, or flu-like symptoms following treatment.
Due to the nature of these drugs to strongly dampen immune function, Dr. Dennis-Wall cautions that serious side effects that result in infection or immune dysfunction can occur.
Revolutionizing disease management
Dr. Friedman points to the sheer number of biologics now available, observing that this underscores the clear importance of personalized medicine.
However, these are powerful immune system modulators and as such, patients must be carefully screened and monitored for any potential adverse events. “Mindful and purposeful use is key in order to gain the most out of these treatments,” sums up Dr. Friedman.
» For more information on biologic treatments for psoriasis and other skin conditions, meet our Medical Review Team.