Deucravacitinib Shown More Effective Than Apremilast in Treating Moderate to Severe Plaque Psoriasis in Phase 3 Trials

Two phase 3 trials evaluating deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis have announced positive results, according to a press release from Bristol Myers Squibb. The POETYK PSO-1 and POETYK PSO-2 trials, which evaluated deucravacitinib 6 mg once daily, met both co-primary endpoints versus placebo, with significantly more patients achieving Psoriasis Area and Severity Index (PASI) 75 response and a static Physician's Global Assessment score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment with deucravacitinib.

In terms of PASI 75 response in the POETYK PSO-1 and POETYK PSO-2 trials, 69.0% and 59.3% of patients receiving deucravacitinib achieved PASI 75 response in week 24, respectively, compared to 38.1% and 37.8% receiving apremilast (Otezla, Amgen), respectively. Additionally, among patients who achieved PASI 75 response at week 24 with deucravacitinib and continued treatment with deucravacitinib, 82.5% and 81.4% maintained PASI 75 response at Week 52, respectively. When examining sPGA 0/1 response, 58.4% and 50.4% of patients receiving deucravacitinib in POETYK PSO-1 and POETYK PSO-2, respectively, achieved sPGA 0/1 response by week 24, compared to 31.0% and 29.5% receiving apremilast.

Deucravacitinib was also found to be superior to placebo, with 58.7% and 53.6% of patients in POETYK PSO-1 and POETYK PSO-2, respectively, achieving PASI 75 response by week 16, compared to 12.7% and 9.4% receiving placebo respectively. Further, 53.6% and 50.3% of patients had achieved sPGA 0/1 response, respectively, in week 16, versus 7.2% and 8.6% receiving placebo.

“In both pivotal studies, deucravacitinib was superior to Otezla across multiple endpoints, including measures of durability and maintenance of response, suggesting that deucravacitinib has the potential to become a new oral standard of care for patients who require systemic therapy and need a better oral option for their moderate to severe plaque psoriasis,” said April Armstrong, MD, MPH, associate dean and professor of dermatology at the University of Southern California, in the release. “As many patients with moderate to severe plaque psoriasis remain undertreated or even untreated, it is also highly encouraging to see that deucravacitinib improved patient symptoms and outcomes to a greater extent than Otezla.”

In both trials, deucravacitinib was well-tolerated, with 1.8% of 842 patients on deucravacitinib, 2.9% of 419 patients on placebo, and 1.2% of 422 patients on apremilast experiencing serious adverse effects (AEs) across both studies at week 16. The most common AEs (≥5%) with deucravacitinib treatment at week 16 were nasopharyngitis and upper respiratory tract infection with low rates of headache, diarrhea, and nausea. At week 16, 2.4% of patients on deucravacitinib, 3.8% of patients on placebo, and 5.2% of patients on apremilast experienced AEs leading to discontinuation. No new safety signals were observed during weeks 16 to 52.

“The findings from both studies affirm that deucravacitinib—a first-in-class, oral, selective TYK2 inhibitor with a unique mechanism of action that inhibits the IL-12, IL-23 and Type 1 IFN pathways—may become an oral treatment of choice for people living with psoriasis,” said Mary Beth Harler, MD, head of Immunology and Fibrosis Development, Bristol Myers Squibb, in the release. “We believe deucravacitinib has significant potential across a broad range of immune-mediated diseases, and we are committed to further advancing our expansive clinical program with this agent. We are in discussions with health authorities with the goal of bringing this new therapy to appropriate patients as soon as possible.”

REFERENCE

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 April 23, 2021. https://news.bms.com/news/details/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