Long-Term Data Show Efficacy of Deucravacitinib Maintained Up to 2 Years in Moderate-to-Severe Plaque Psoriasis

Continuous treatment with deucravacitinib (Sotyktu, Bristol Myers Squibb) was found to maintain clinical efficacy in adult patients with moderate-to-severe plaque psoriasis after 2 years, according to results from the POETYK PSO long-term extension trial. Based on these trial results, the FDA approved the treatment earlier this week for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Deucravacitinib is a selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, which is a member of the Janus kinase (JAK) family. Deucravatinib binds to the regulatory domain of TYK2, stabilizing an inhibitory interaction between the regulatory and the catalytic domains of the enzyme.

The investigators evaluated patients from the POETYK PSO-1 trial who transitioned into the LTE trial. At week 112 of deucravacitinib treatment, modified non-responder imputation (mNRI) response rates were 82.4% for Psoriasis Area and Severity Index (PASI) 75, 55.2% for PASI 90, and 66.5% for static Physician’s Global Assessment (sPGA) 0/1.

“The reality we are facing is that dermatologists and individuals with psoriasis alike have identified the need for more effective and tolerable oral therapies, as psoriasis is a chronic, systemic, immune-mediated disease that is associated with serious comorbidities,” said Mark Lebwohl, MD, dean of Clinical Therapeutics at the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine, Mount Sinai, in a press release. “These new long-term results showing durable efficacy through up to 2 years of continuous treatment further support the use of once-daily Sotyktu for people with moderate-to-severe plaque psoriasis and address the need for more effective oral treatment options.”

Of 262 patients administered deucravacitinib in the analysis, 171 achieved PASI 75 at week 16 of the POETYK PSO-1 trial and efficacy was maintained for up to 112 weeks, including response rates for PASI 75, PASI 90, and sPGA 0/1.

“These 2-year follow-up data demonstrate the durable efficacy offered by Sotyktu and its potential to provide long-term, clinically relevant improvement for individuals with moderate-to-severe plaque psoriasis,” said Jonathan Sadeh, MD, MSc, senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb, in a press release. “At Bristol Myers Squibb, we are committed to exploring pathbreaking science to elevate care for people burdened by serious immune-mediated diseases and are focused on continuing our research with Sotyktu and other novel molecules in our deep and differentiated portfolio.”

REFERENCE

Bristol Myers Squibb Announces New Sotyktu™ (deucravacitinib) Long-Term Data Showing Clinical Efficacy Maintained for Up to Two Years with Continuous Treatment in Moderate-to-Severe Plaque Psoriasis. Bristol Myers Squibb. September 10, 2022. Accessed September 13, 2022. https://news.bms.com/news/corporate-financial/2022/Bristol-Myers-Squibb-Announces-New-Sotyktu-deucravacitinib-Long-Term-Data-Showing-Clinical-Efficacy-Maintained-for-Up-to-Two-Years-with-Continuous-Treatment-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx