FDA Approves Plaque Psoriasis Drug Ilumya

New biologic for adults with moderate to severe plaque psoriasis may be available this summer.

Plaque Psoriasis

Plaque psoriasis is the most common form of the autoimmune disease

April 11, 2018

For the millions of Americans who have plaque psoriasis, the most common type of psoriasis, a new treatment option is coming to market.

The Food and Drug Administration (FDA) has approved the drug Ilumya (tildrakizumab-asmn) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Ilumya is a biologic drug administered at a dose of 100 milligrams by subcutaneous injection every 12 weeks, after the completion of initial doses at weeks 0 and 4.

Two Successful Trials

The FDA’s approval follows the successful completion of two phase 3 trials, involving more than 1,800 people in the United States, Canada, Australia, Japan, Europe, and Israel. The results, which were published in July 2017 in the journal The Lancet, measured improvement of symptoms based on factors such as redness, thickness, surface area, and severity of the plaques.

“Tildrakizumab-asmn is a new medication that adds to our arsenal of a growing list of medications approved to treat plaque psoriasis,” says Ross Radusky, MD, a dermatologist at SoHo Skin and Laser Dermatology in New York City. “The landscape of treating psoriasis has changed dramatically in the past 10 years.”

More Targeted Treatments

According to Dr. Radusky, medicine’s understanding of psoriasis has grown more precise and sophisticated,


and so have the latest treatments.

“Before, we spoke about psoriasis in very generic and broad terms. Our treatments reflected this: They shut down broad swaths of our immune system,” says Radusky. “Tildrakizumab is a medication that belongs to the category of biologics: genetically engineered proteins and chemicals designed to zero in on specific aspects of the inflammation cascade.”

Ilumya Versus Tremfya

Ilumya, which comes from Sun Pharmaceutical Industries, will hit the U.S. market nearly a year after Tremfya (guselkumab). Tremfya is also an injectable, but it is administered every 8 weeks rather than 12, and it can be injected at home by the patient after the first injection. Ilumya is administered by a physician.

“In clinical trials, guselkumab did a better job at disease clearance compared with placebo than did tildrakizumab when compared with placebo,” says Radusky. “It’s important to recognize there has not been a head-to-head study, and therefore, a direct comparison cannot be made.”

“Patients poorly controlled on topical, oral, injectable, or phototherapy treatments may want to consider tildrakizumab for the management of their moderate to severe plaque psoriasis,” Radusky says.

He suggests that it may also be appropriate for people who are managed on a class of biologic medications that target a different part of the inflammatory process. For example, people who are not responding to Taltz (iIxekizumab), a medication that blocks the IL-17A cytokine receptor, may want to ask their dermatologist if a different drug target is right for them.

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