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Bristol Myers Squibb today announced that the U.S. Food and Drug Administration (FDA) approved Sotyktu™(deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sotyktu is not recommended for use in combination with other potent immunosuppressants.

The approval is based on results from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which 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 superior efficacy of Sotyktu compared to placebo and Otezla was demonstrated at both 16 and 24 weeks, and responses with Sotyktu persisted through 52 weeks. See below for more information.

“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,” said April Armstrong, MD, MPH, clinical investigator in the POETYK PSO-1 trial and Associate Dean and Professor of Dermatology at the University of Southern California. “People living with moderate-to-severe plaque psoriasis face significant burdens, and Sotyktu is a welcome first-line systemic treatment option.”

“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,” said Samit Hirawat, MD, Chief Medical Officer, Bristol Myers Squibb. “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.”

In the POETYK PSO trials, at Week 16, the most common adverse reactions (≥1 percent and higher than placebo) in patients on Sotyktu were upper respiratory infections (19.2 percent), blood creatine phosphokinase increase (2.7 percent), herpes simplex (2.0 percent), mouth ulcers (1.9 percent), folliculitis (1.7 percent) and acne (1.4 percent). In addition, 2.4 percent of patients on Sotyktu, 3.8 percent of patients on placebo, and 5.2 percent of patients on Otezla experienced adverse reactions leading to discontinuation.

(Mon-27-02-2023, 14:36 PM)BobD Wrote:

(Sat-10-09-2022, 21:12 PM)Caroline Wrote: Seems positive .
I am curious about the side effects.

A web search for sotyktu will turn up web sites that list side effects.
I found these:
  body aches or pain
  chest tightness
  chills
  cough
  dryness or soreness of the throat
  ear congestion
  fever
  headache
  loss of voice
  muscle aches
  pain or tenderness around eyes and cheekbones
  sneezing
  sore throat
  stuffy or runny nose
  swollen glands
  trouble breathing
  trouble in swallowing
  unusual tiredness or weakness
  voice changes

(Mon-27-02-2023, 14:45 PM)BobD Wrote: Has anyone found the prices for Sotyktu (generic deucravacitinib) outside the USA, e.g. Canada, Europe)?

(Wed-01-03-2023, 01:53 AM)mataribot Wrote:

(Mon-27-02-2023, 14:45 PM)BobD Wrote: Has anyone found the prices for Sotyktu (generic deucravacitinib) outside the USA, e.g. Canada, Europe)?

Nope, The only thing I saw was for the US with the ridiculous price tag (that no one pays) of $72,000.00 USD.

(Thu-09-03-2023, 23:34 PM)BobD Wrote: Bristol Myers is enthusiastically promoting Sotyktu. 

They have a "Co-Pay Assistance Program" under which patients might pay as little as $0 for a 30-day supply.
From their Terms and Conditions: "Patients must have commercial (private) insurance...".  "Patients are not eligible if they have prescription insurance coverage through a state or federal healthcare program...".

By telephone, they verified that Medicare Part D is excluded.  Only "private".

(Fri-10-03-2023, 04:59 AM)mataribot Wrote:

(Thu-09-03-2023, 23:34 PM)BobD Wrote: Bristol Myers is enthusiastically promoting Sotyktu. 

They have a "Co-Pay Assistance Program" under which patients might pay as little as $0 for a 30-day supply.
From their Terms and Conditions: "Patients must have commercial (private) insurance...".  "Patients are not eligible if they have prescription insurance coverage through a state or federal healthcare program...".

By telephone, they verified that Medicare Part D is excluded.  Only "private".

The government sees copay cards as way to promote the sale prescriptions - they have been determine to be illegal.  We all know it's a bunch of poo, but none of the co-pay cards can be accepted for government sponsored health insurance.