The Food and Drug Administration (FDA) has approved a new drug for the treatment of moderate to severe plaque psoriasis.
About 8 million adults in the United States have psoriasis with the most common type being plaque psoriasis. The drug, called deucravacitinib, is the first TYK2 inhibitor approved for the treatment of any disease. It will be sold under the brand name Sotyktu.
“This is very exciting for the field and our patients. (Deucravacitinib) has a very specific target inside the immune cell called TYK2. TYK2 functions in the immune cell to transmit into the cell various specific ‘messages’ that is, TYK2 functions inside of the white blood cell to tell it to multiply and/or perform functions that ultimately result in increased inflammation in the skin (which is perceived by the patient as redness and/or flaky skin),” explained Dr. David Fiorentino, a professor of dermatology at Stanford University in California.
“Deucravacitinib is the first molecule to specifically block the function of TYK2,” Fiorentino said. “This is exciting because TYK2 only responds to a very limited set of ‘activating’ signals, and so its inhibition leaves intact many of the important functions of the immune system that we need.”
Unlike another class of medications known as JAK inhibitors, which can result in a broader degree of immunosuppression and infections, experts believe deucravacitinib is a safer option that still manages to block the signals that lead to inflammation.
Plaque psoriasis is the most common form of the disease, with 80 to 90 percent of people with psoriasis experiencing this condition. Psoriasis can form “plaques” that are inflamed patches of scaly skin that can be itchy and may be painful. On people with white skin, the plaques may appear red with a silvery sheen of dead skin scales. On people with more deeply colored skin, the plaques can take on a darker appearance and range from purple to gray or dark brown in color.
“Plaque psoriasis is a chronic condition that can affect the skin, joints, and nails. Psoriasis has a complex pathogenesis that involves genetic, autoimmune, and environmental factors,” Dr. Atieh Jibbe, an associate director of surgery in the Division of Dermatology at The University of Kansas Health System.
Jibbe said the new drug could be ground-breaking for those with plaque psoriasis who have been unable to tolerate other treatments.
“The psoriasis pathway involves multiple immune mediators that have been targeted with biologic therapies to treat this chronic condition,” she said. “Deucravacitinib could be revolutionary for those patients who have failed other biologic therapies in the past due to its unique target.”
In clinical trials, researchers said the drug showed significant improvements in symptom burden, quality of life, and skin clearance.
Dr. Tien Nguyen, is a dermatologist at MemorialCare Orange Coast Medical Center in Fountain Valley, California, who was involved in the clinical trials. He says the drug could make a difference to those living with plaque psoriasis and in particular those for whom injectable medications aren’t an option.
“It will make a big impact. There are patients with moderate to severe disease who are not candidates for injection or… they have a phobia for injectables,” Nguyen told Healthline. “All the injectables must be refrigerated, so people who travel, college students living in a dormitory, for example, might prefer a pill. There’s a lot of room for unmet needs. When patients cannot get access to shots an oral tablet, a pill can be another option.”
Fiorentino argues that the drug may not be as effective as some of the newer biologic agents available for the treatment of plaque psoriasis. However, he says the treatment may offer a cheaper alternative.
“I absolutely would consider using this agent, possibly even as a first-line agent, especially for those patients without fancy insurance or those that are skittish about self-injection. Perhaps the issue may not be whether or not I would use it, but, whether third-party payers will fund the use of this agent as first-line therapy for our patients,” he said.