A treatment for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy has been approved by the U.S. Food and Drug Administration (FDA).
Bristol Myers Squibb made the announcement today (September 12) that its allosteric tyrosine kinase 2 (TYK2) inhibitor, Sotyku (deucravacitinib) had been approved based on results from a phase 3 clinical trial. Sotyktu is not recommended for use in combination with other potent immunosuppressants.
Sotyktu for plaque psoriasis
The phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials demonstrated superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Otezla (apremilast) in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis.
The efficacy of Sotyktu compared to placebo and Otezla was demonstrated at both 16 and 24 weeks, and responses with Sotyktu persisted through 52 weeks.
April Armstrong, clinical investigator in th POETYK PSO-1 trial, said: “Sotyktu has the potential to become the new standard of care oral treatment for people with moderate-to-severe plaque psoriasis, given its profile in helping patients achieve clearer skin as demonstrated in the POETYK PSO clinical program.
“People living with moderate-to-severe plaque psoriasis face significant burdens, and Sotyktu is a welcome first-line systemic treatment option.”
Widely prevalent disease
The company explained that psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that affects approximately 7.5 million people in the U.S.
They added that up to 90% of patients with psoriasis have plaque psoriasis, which is characterized by distinct, round or oval plaques typically covered by silvery white scales. Nearly one-quarter of people with psoriasis, or around two million in the U.S., have cases that are considered moderate-to-severe.
Samit Hirawat, chief medical officer at Bristol Myers Squibb, said: “The approval of Sotyktu represents an exciting day for patients suffering from moderate-to-severe plaque psoriasis who are not satisfied with topical and conventional treatments.
“This is another extraordinary achievement for Bristol Myers Squibb, as we bring forward a new mechanism of action, the first oral treatment approved in nearly 10 years, and the first orally dosed once-daily treatment for moderate-to-severe plaque psoriasis.
“We believe Sotyktu is a breakthrough in the treatment of patients with this condition, and we’re excited about its potential in other immune-mediated diseases.”
Sotyktu’s common adverse reactions
During the POETYK PSO trials, at week 16, the most common adverse reactions (less than one percent and higher than placebo) in patients on Sotyktu were upper respiratory infections (19.2%), blood creatine phosphokinase increase (2.7%), herpes simplex (2.0%), mouth ulcers (1.9 percent), folliculitis (1.7%) and acne (1.4%).
In addition, 2.4% of patients on Sotyktu, 3.8% of patients on placebo, and 5.2% of patients on Otezla experienced adverse reactions leading to discontinuation.
Leah Howard, president and CEO of the National Psoriasis Foundation, said: “Despite the availability of therapies, many people living with plaque psoriasis in the United States are untreated or undertreated.
“The FDA approval of a new oral treatment is exciting news for the psoriasis community. We welcome this new treatment option.”
Sotyktu is expected to be available to patients in the U.S. in September 2022.