The Food and Drug Administration (FDA) has approved Sotyktu™ (deucravacitinib) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for a systemic therapy or phototherapy.
Sotyktu is an inhibitor of tyrosine kinase 2, a member of the Janus kinase family. The approval was based on data from the phase 3 POETYK PSO-1 (ClinicalTrials.gov Identifier: NCT03624127) and POETYK PSO-2 (ClinicalTrials.gov Identifier: NCT03611751) trials, which evaluated the efficacy and safety of deucravacitinib in 1684 adults with moderate to severe plaque psoriasis. Patients were randomly assigned to receive deucravacitinib 6mg orally once daily, apremilast 30mg orally twice daily, or placebo.
The coprimary endpoints for both trials were the percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 and the percentage of patients who achieved static Physician’s Global Assessment (sPGA) score of 0 to 1 with at least a 2-grade improvement from baseline, compared with placebo, at week 16. Key secondary end points included the percentage of patients who achieved PASI 75 and sPGA 0/1 compared with apremilast at weeks 16 and 24.
Findings from the POETYK PSO-1 and POETYK PSO-2 trials, respectively, included the following:
- Patients achieving PASI 75 response at week 16: 58% and 53% for deucravacitinib vs 13% and 9% for placebo (both P <.0001) and 35% (P <.0001) and 40% (P =.0004) for apremilast;
- Patients achieving PASI 75 at week 24: 69% and 58% for deucravacitinib vs 38% and 38% for apremilast (both P <.0001);
- Patients achieving PASI 90 response at week 16: 36% and 27% for deucravacitinib vs 4% and 3% for placebo (both P <.0001) and 20% (P =.0002) and 18% (P =.0046) for apremilast;
- Patients achieving PASI 90 response at week 24: 42% and 32% for deucravacitinib vs 22% (P <.0001) and 20% (P =.0002) for apremilast;
- Patients achieving sPGA 0/1 at week 16: 54% and 50% for deucravacitinib vs 7% and 9% for placebo (both P <.0001) and 32% and 34% for apremilast (both P <.0001);
- Patients achieving sPGA 0/1 at week 24: 59% and 49% for deucravacitinib vs 31% and 30% for apremilast (both P <.0001).
In POETYK PSO-1, 82% (n=187/228) of patients who achieved PASI 75 with deucravacitinib at week 24 maintained their response at week 52. In POETYK PSO-2, 80% (n=119/148) of patients who continued deucravacitinib maintained PASI 75 vs 31% (n=47/150) of those who were withdrawn from deucravacitinib.
In both trials, a greater proportion of patients treated with deucravacitinib achieved a Psoriasis Symptoms and Signs Diary symptom score of 0 (absence of itch, pain, burning, stinging, and skin tightness) at week 16 compared with placebo (8% vs 1%, respectively).
The most common adverse events reported with deucravacitinib were upper respiratory infections, increased blood creatine phosphokinase, herpes simplex, mouth ulcers, folliculitis, and acne.
“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.”
Sotyktu is supplied as 6mg film-coated tablets in 30-count bottles. The product is expected to be available in September 2022.
- U.S. Food and Drug Administration approves Sotyktu™ (deucravacitinib), oral treatment for adults with moderate-to-severe plaque psoriasis. News release. Bristol Myers Squibb. September 9, 2022. Accessed September 12, 2022. https://news.bms.com/news/corporate-financial/2022/U.S.-Food-and-Drug-Administration-Approves-Sotyktu-deucravacitinib-Oral-Treatment-for-Adults-with-Moderate-to-Severe-Plaque-Psoriasis/default.aspx
- Sotyktu. Package insert. Bristol Myers Squibb; 2022. Accessed September 12, 2022. https://packageinserts.bms.com/pi/pi_sotyktu.pdf