The Food and Drug Administration (FDA) has accepted for review the New Drug Application for deucravacitinib, a selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate to severe plaque psoriasis.
The application is supported by data from the pivotal 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 patients 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, 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: 58.7% and 53.6% for deucravacitinib vs 12.7% and 9.4% for placebo and 35.1% and 40.2% for apremilast;
- Patients achieving PASI 75 at week 24: 69.0% and 59.3% for deucravacitinib vs 38.1% and 37.8% for apremilast;
- Among patients who achieved PASI 75 at week 24 and continued treatment with deucravacitinib, 82.5% and 81.4% maintained PASI 75 at week 52;
- Patients achieving sPGA 0/1 at week 16: 53.6% and 50.3% for deucravacitinib vs 7.2% and 8.6% for placebo and 32.1% and 34.3% for apremilast;
- Patients achieving sPGA 0/1 at week 24: 58.4% and 50.4% for deucravacitinib vs 31.0% and 29.5% for apremilast.
In both trials, treatment with deucravacitinib was also associated with significant and clinically meaningful improvements in other secondary endpoints, including symptom burden and quality of life measures.
The most common adverse events reported with deucravacitinib were nasopharyngitis and upper respiratory tract infection.
“There is a strong need for more effective and well-tolerated oral therapies for people living with moderate to severe plaque psoriasis, as many remain undertreated or even untreated,” said Jonathan Sadeh, MD, MSc, senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb. “Findings from the pivotal POETYK-PSO trials demonstrate the potential of deucravacitinib to elevate the oral standard of care for individuals who are candidates for systemic therapy.”
A Prescription Drug User Fee Act (PDUFA) target date of September 10, 2022 has been set for the application.
- Bristol Myers Squibb’s Applications for deucravacitinib for the treatment of moderate to severe plaque psoriasis accepted by US Food and Drug Administration and validated by European Medicines Agency. News release. Bristol Myers Squibb. Accessed November 29, 2021. https://www.businesswire.com/news/home/20211129005192/en/Bristol-Myers-Squibb%E2%80%99s-Applications-for-Deucravacitinib-for-the-Treatment-of-Moderate-to-Severe-Plaque-Psoriasis-Accepted-by-U.S.-Food-and-Drug-Administration-and-Validated-by-European-Medicines-Agency.
- Bristol Myers Squibb presents positive data from two pivotal phase 3 psoriasis studies demonstrating superiority of deucravacitinib compared to placebo and Otezla® (apremilast). News release. Bristol Myers Squibb. April 23, 2021. Accessed November 29, 2021. https://news.bms.com/news/corporate-financial/2021/Bristol-Myers-Squibb-Presents-Positive-Data-from-Two-Pivotal-Phase-3-Psoriasis-Studies-Demonstrating-Superiority-of-Deucravacitinib-Compared-to-Placebo-and-Otezla-apremilast/default.aspx.