When people have stubborn, widespread, or disabling psoriasis, doctors turn to cutting-edge treatments called biologics. Unlike older prescription drugs made from chemicals, biologics are derived from human or animal proteins. Delivered by injection (or, in one case, by intravenous infusion), these next-generation treatments target the cells and proteins that cause psoriasis symptoms.
As a treatment for psoriasis, biologics provide “a highly effective, very safe approach,” says Steven Feldman, MD, PhD, professor and director of the Center for Dermatology Research at Wake Forest University School of Medicine. With biologics, “we’re closer to treating the underlying cause of the immune imbalance,” he explains. By contrast, older, chemical-based medicines like methotrexate and cyclosporine have broader effects, posing liver or kidney problems, for example, he says.
Psoriasis is an autoimmune disorder in which a person’s genes set off a faulty immune response. As if under attack, the immune system activates infection-fighting white blood cells called T-cells in the skin. This over-the-top reaction eventually leads to skin inflammation and rapid overgrowth of skin cells. Plaque psoriasis, the most common type, produces red patches covered in silvery-white scales–a hallmark of this skin condition. Many people with psoriasis develop psoriatic arthritis, another autoimmune condition that causes stiff, swollen joints.
Biologics provide relief by suppressing certain immune cells or proteins that play a role in the development of these conditions. The result? Clearer skin and reduced inflammation. (A number of these biologics are also approved for the treatment of conditions such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis.)
Under American Academy of Dermatology guidelines, patients need not “fail” other treatments to be prescribed a biologic, says Dr. Feldman. “Because of their high efficacy and good safety, they may be the best first choice for patients with severe disease.”
Today, there are several different types of biologics. Some of these drugs target a protein called tumor necrosis factor-alpha. Too much TNF-alpha leads to inflammation (which causes joint pain and swelling) and overproduction of skin cells (creating a scaly appearance). There is a T-cell inhibitor that prevents white blood cells from being activated, which, in turn, reduces inflammation. Other categories of biologics target proteins involved in the inflammatory process, such as interleukin (IL) 12 and 23. There are also drugs that block IL-17, which plays a role in the body’s inflammatory and immune responses.
With 11 biologics approved for the treatment of psoriasis and psoriatic arthritis in patients in the United States (plus a handful of “biosimilars” that mimic the effects of some of these drugs), there are plenty of treatment options on the market:
- Cimzia (certolizumab pegol). Approved by the U.S. Food and Drug Administration (FDA) in 2013, this psoriatic arthritis biologic is injected beneath the skin. Injections at the start of treatment and two and four weeks later–so-called starter doses–are followed by maintenance injections every two to four weeks, depending on the prescribed dosage. Common side effects are cold and flu infections, rash, and urinary tract infections.
- Cosentyx (secukinumab). Approved for psoriasis in 2015 and psoriatic arthritis in 2016, this self-injectable requires weekly starter doses in the first month of treatment followed by injections every four weeks. Common side effects include diarrhea, colds, and other upper respiratory infections.
- Enbrel (etanercept). This is one of the first biologics approved for psoriasis and psoriatic arthritis. In 2016, Enbrel gained FDA approval for the treatment of children 4 and older with plaque psoriasis. This biologic requires weekly dosing for pediatric psoriasis and adult psoriatic arthritis. Adult psoriasis is treated with twice-weekly injections for three months followed by once-weekly maintenance dosing. People may experience injection-site reactions, such as redness and swelling, as well as upper respiratory infections. Its biosimilar is Erelzi (etanercept-szzs).
- Humira (adalimumab). Approved in 2005 for psoriatic arthritis and in 2008 for psoriasis, Humira is generally administered every other week. This biologic is associated with infection (such as sinusitis), injection-site reactions, headache, and rash. Its biosimilars are Amjevita (adalimumab-atto) and Cyltezo (adalimumab-adbm).
- Orencia (abatacept). This is one of the newer biologics, approved in 2017 for the treatment of psoriatic arthritis. It can be administered intravenously (by IV) in a health care facility, and it’s also available as a weekly self-injectable. Headache, upper respiratory infection, sore throat, and nausea are common side effects.
- Remicade (infliximab). Remicade is administered by IV infusion in a medical facility for three starting doses, then every eight weeks. Each session lasts around two hours. Remicade gained approval for psoriasis and psoriatic arthritis more than a decade ago. Common side effects include respiratory infections, headache, coughing, and stomach pain. Its biosimilars are Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda).
- Siliq (brodalumab). Approved in 2017 for the treatment of psoriasis, this self-injectable is administered every two weeks after three weekly starter doses. People using Siliq may experience joint pain, headache, tiredness, diarrhea, mouth and throat pain, nausea, muscle soreness, injection-site reactions, flu, low white blood cell count, and fungal infections of the skin.
- Simponi (golimumab). This once-a-month injection for psoriatic arthritis gained FDA approval in 2009. Common side effects: upper respiratory infection, injection-site reactions, viral infections such as flu.
- Stelara (ustekinumab). In October 2017, the FDA approved Stelara for plaque psoriasis in children 12 and older. It has been approved for use in adults with psoriasis since 2009. And it gained approval for the treatment of adults with psoriatic arthritis in 2013. This injectable is administered every 12 weeks after two starting doses. Common side effects include upper respiratory infections, headache, and fatigue.
- Taltz (ixekizumab). Taltz was approved in 2016 for the treatment of psoriasis. Patients receive a double-dose to start and injections every two weeks for 12 weeks and then maintenance injections every four weeks. Injection-site reactions, nausea, fungal infections, and upper respiratory infections are common side effects.
- Tremfya (guselkumab). Approved in 2017, this plaque psoriasis treatment begins with two starting doses at the beginning of treatment and at week four. Maintenance injections are recommended every eight weeks. People using Tremfya may experience upper respiratory infections, headache, injection-site reactions, joint pain, diarrhea, stomach flu, fungal skin infections, and herpes simplex infections.
Because these drugs act by suppressing the immune system, each carries a warning of serious infection and other health risks. Depending on the drug, risks may include allergic reaction, nervous system problems, cancers, fungal infection, and new or worsening heart failure, among other problems.
“Some of the biologics make users more susceptible to certain infections, such as tuberculosis, viral hepatitis, and fungal infections, so this needs to be considered before starting [treatment],” says Adam Friedman, MD, associate professor of dermatology at George Washington University School of Medicine & Health Sciences.
Overall, though, the risk of serious infection is small–roughly in the range of one to three out of 100 patients, depending on the drug, according to Dr. Feldman. Indeed, data from long-term safety and patient outcome studies suggest these drugs are safe for long-term use.
However, compared with traditional treatments, biologics are very expensive. A year of treatment can run $20,000 to upwards of $60,000, Dr. Feldman says. Of course, the out-of-pocket cost to patients would depend on their insurance coverage and the availability of financial help through patient assistance programs. But insurance coverage–or lack thereof–can be the deciding factor in selecting a treatment.
While every patient needs to consider the risk factors, biologics can be extremely effective. Some patients see results as early as four weeks, says Dr. Friedman, while others can expect clearer skin within three to four months.