The U.S. Food and Drug Administration (FDA) has approved a new daily pill to treat moderate to severe plaque psoriasis, offering people with thick, scaly skin lesions another alternative to injectable medications.
“It’s the first in its class to be oral. That’s a big deal,” says Ife J. Rodney, MD, the founding director of Eternal Dermatology + Aesthetics in Fulton, Maryland.
Adam Friedman, MD, a professor and the chair of dermatology at GW Medical Faculty Associates, agrees. “For the first time, we have a targeted oral therapy hitting the IL-23 pathway, which we know is one of the most effective mechanisms in this disease,” he says. “Historically, that level of precision, and in turn, effectiveness, has been reserved for injectables, but now we can offer it in a pill.”
How Icotyde Works to Treat Plaque Psoriasis
Icotyde performed well in four phase 3 clinical trials that included 2,500 patients. After 16 weeks on the medication, about 70 percent of patients developed clear or nearly-clear skin, and 55 percent had a 90 percent reduction in their psoriasis severity.
Johnson & Johnson, which makes Icotyde, tested the drug in patients ages 12 and up. “It is approved down to age 12, which is a good option for kids,” says Cindy Wassef, MD, a dermatologist at Premier Health Associates in Randolph, New Jersey.
Icotyde takes time to kick in. “The medicine requires a few weeks to start exerting its effect,” says Joshua Zeichner, MD, the director of cosmetic and clinical research at Mount Sinai Hospital in New York City. “Studies have shown that it gives significant benefits that are long-lasting with continued use.”
Side Effects Were Minimal
In all the phase 3 clinical trials, side effects for patients treated with Icotyde were within 1.1 percent of what people on a placebo experienced through 16 weeks on the medication. There were no new safety issues reported through 52 weeks on the medication.
“It’s effective, targeted, oral, and safe,” Dr. Friedman says. “The label also requires less rigorous, and often overkill, laboratory tests prior to starting, which can be a roadblock for some. Overall that means less time undertreated, faster control of disease, and ultimately better outcomes.”
Icotyde Offers an Alternative to Injectable Biologic Medications
Skyrizi, Tremfya, and Ilumya each have slightly different dosing; patients needs to take an injection every 8 to 12 weeks.
“A once-daily pill is very appealing compared to some of the injectables and biologics,” Dr. Rodney says. “Not everyone likes an injection.”
People with psoriasis who prefer a pill to an injection also have the option of taking Otezla (apremilast) or Sotyktu (deucravacitinib).
“For some people, taking a pill is super easy; others prefer an injection that’s less frequent. Either way, it’s good to have choices,” Rodney says.
Price and Availability
Johnson & Johnson has not released details about when Icotyde will be available to patients or how much it will cost.