First Once-Daily Oral Plaque Psoriasis Drug Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved Sotyktu (deucravacitinib), a once-daily oral pill by Bristol Myers Squibb, for adults who have plaque psoriasis (a chronic, systemic, immune-mediated disease) severe enough to make them candidates for systemic therapy and phototherapy. Sotyktu is the first oral treatment for plaque psoriasis that can be taken just once daily and the first oral medication approved for the disease in a decade.

FDA approved the drug based on two clinical trials comparing Sotyktu to Otezla in nearly 1,700 adults with a mean age of 46 years. Participants all had moderate to severe plaque psoriasis and, on average, they experienced psoriasis for 17 years on a quarter of their bodies. More than one-fifth had clinically severe psoriasis, and nearly 40 percent had used biological therapies to control their condition.

In the trials, one group of participants took a six milligram tablet of Sotyktu once per day, while other participants took 30 milligrams of Otezla twice daily or received a placebo. By month four, nearly 60 percent of patients achieved a meaningful benchmark: Psoriasis Area and Severity Index (PASI) 75, a measurement indicating 75 percent improvement in the amount of skin surface area covered by plaques. In comparison, fewer than 13 percent in the placebo group and 35 percent in the Otezla group reached PASI 75. Additionally, plaques cleared or nearly cleared in more than half of the people treated with Sotyktu, in contrast to only about seven percent of those in the control group. And, patients who took Sotyktu continued to improve over time. After six months of treatment, 69 percent reached PASI 75 compared with 38 percent of those who took Otezla.

Unlike existing treatment for this population, Sotyktu doesn’t require laboratory follow-up and seems to be well-tolerated, said April Armstrong, MD, MPH, professor of dermatology and associate dean of clinical research at the University of Southern California, who led the clinical trials. “This is a breakthrough medication and, in my opinion, this drug will be the leading oral agent for our patients with psoriasis because of its robust efficacy and good safety profile. I’m very excited to talk to my patients about this drug.”

Sotyktu is the first to target tyrosine kinase 2 (TYK2), an enzyme that is linked to susceptibility for psoriasis. TYK2 is a member of the Janus kinase (JAK) family. Many treatments for autoimmune disorders target JAKs, but most JAK inhibitors don’t do much to affect TYK2. By blocking this specific enzyme, the drug interrupts some of the cellular processes that are key for forming psoriatic lesions. Plus, a TYK2 inhibitor drug could be safer because it has a narrow target compared to other JAK inhibitors, which can have a broad effect on the immune system. “By having more specific targeting of the pathways that are involved in psoriasis, we avoid essentially hitting the other pathways that are important for our normal human functions,” Dr. Armstrong said. These include the effects on blood cell counts, lipid and other types of metabolism, and other types of immunity.

Sotyktu works similarly to the widely-used psoriasis biologic agent Stelara (ustekinumab), but that drug is a monoclonal antibody that needs to be injected in a hospital setting. Sotyktu, on the other hand, comes as an oral pill that patients can easily take at home or while traveling.