FDA approves new drug for plaque psoriasis

A novel TYK2 inhibitor showing promise for conditions like lupus and psoriatic arthritis has received a green light.

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The US FDA has approved the novel TYK2 inhibitor deucravacitinib to treat patients with moderate to severe plaque psoriasis.

The announcement comes just weeks out from the November Pharmaceutical Benefits Advisory Committee (PBAC) meeting, at which an application to make deucravacitinib available on the PBS in Australia is expected to be considered.

Patient advocacy group CreakyJoints has been lobbying patients, carers and health professionals to make submissions to PBAC in support of the application. Submissions closed on 18 September.

While a successful application is unlikely to change current clinical management pathways in Australia, it will provide patients currently eligible for apremilast with another oral treatment option.

The decision is also being watched closely by Australian researchers who believe deucravacitinib has promise in treating other immune-mediated inflammatory diseases, including psoriatic arthritis and systemic lupus erythematosus.

Deucravacitinib is the first TYK2 inhibitor approved for treatment of plaque psoriasis in the US and has so far avoided an FDA Black Box warning attached to other JAK inhibitors that treat arthritis and ulcerative colitis.

This requires the boxes containing the drugs to display warnings about increased risk of serious cardiac events, cancer, blood clots and death.

Research published this year has reported deucravacitinib is both effective and well-tolerated in treating moderate to severe plaque psoriasis.

In July the Journal of the American Academy of Dermatology published results of a year-long, randomised, double-blinded, placebo-controlled phase 3 trial that examined deucravacitinib versus placebo and apremilast in patients with moderate to severe plaque psoriasis.

The trial was sponsored by Bristol Myers Squibb, which developed deucravacitinib under the brand name Sotyktu. Researchers found deucravacitinib was superior to placebo and apremilast across multiple 169 efficacy endpoints and was well tolerated in patients with moderate to severe psoriasis.

The trial was conducted at 154 sites in Canada, China, Germany, Japan, Poland, Russia, South Korea, Spain, Taiwan, the UK and the US.

Between August 7, 2018, and July 5, 2019, 666 patients were randomly assigned to treatment with deucravacitinib 6 mg QD (332), placebo BID (166), or apremilast 30 mg BID (168).

Adverse event rates overall were similar across all three treatment groups. In deucravacitinib-treated patients the main issues were nasopharyngitis and upper respiratory tract infection, whereas headache, diarrhea, and nausea were more common with apremilast than in other treatment groups. The incidence rates of severe adverse events during the trial were 7.5/100 PY with deucravacitinib and 5.2/100 PY with apremilast.

The researchers concluded that deucravacitinib was well tolerated and demonstrated efficacy that was superior to placebo and apremilast.

“As expected, based on its TYK2 selectivity, deucravacitinib did not elicit any laboratory changes characteristic of JAK 1/2/3 inhibitors,” the authors wrote.

“These data highlight the potential for deucravacitinib, a once-daily oral drug, to reduce disease activity and improve symptoms and QoL (quality of life) among patients who require systemic therapy for psoriasis.”

This followed another paper published in the journal Dermatology and Therapy in January this year, which looked at the effect of deucravacitinib on clinical and quality of life outcomes in adults with psoriasis.

Researchers performed a phase 2 dose-ranging, placebo-controlled, 12-week study of deucravacitinib in adults with moderate to severe psoriasis. Patients in Australia, the US, Canada, Germany, Japan, Latvia, Mexico, and Poland participated.

They found that oral treatment with deucravacitinib was effective using a disease severity score (percentage of patients with ? 75% reduction from baseline in Psoriasis Area and Severity Index score) at week 12—placebo 7% and deucravacitinib 67%–75% for the three highest dosages—and was generally well tolerated.

They reported that deucravacitinib treatment produced early response and similar trends in improvements across multiple efficacy assessments and quality of life measures in patients with moderate to severe plaque psoriasis.

“Deucravacitinib has the potential to become a promising new oral therapy for this condition,” the authors said.