New 4-Year Extension Trial Results Announced for Deucravacitinib Treatment of Psoriasis

April W. Armstrong, MD, MPH

Credit: UCLA Health

Biopharmaceutical company Bristol Myers Squibb announced new 4-year results from their POETYK PSO long-term extension (LTE) trial evaluating deucravacitinib (Sotyktu) as a treatment for adults with moderate-to-severe plaque psoriasis, noting major improvements in patients’ Psoriasis Area and Severity Index (PASI) and static Physician’s Global Assessment (sPGA) scores.¹

These conclusions were presented at the 2024 European Academy of Dermatology and Venereology (EADV) Spring Symposium. Deucravacitinib is a selective, oral, allosteric tyrosine kinase 2 (TYK2) inhibitor of the key cytokines connected to the pathogenesis of immune-mediated diseases, functioning as the first selective TYK2 inhibitor used in clinical studies over various types of immune-mediated conditions.

“These four-year results further validate the safety profile, efficacy and key role of once-daily Sotyktu, the first and only TYK2 inhibitor available, for adults with moderate-to-severe plaque psoriasis,” April Armstrong, MD, MPH, POETYK PSO clinical investigator and chief of dermatology at the University of California, Los Angeles, said in a statement.

Armstrong and colleagues’ efficacy analysis included 513 individuals who were treated continuously with deucravacitinib from the first day of the pivotal POETYK PSO-1 and POETYK PSO-2 trials. These subjects were transitioned to the POETYK PSO-LTE trial. POETYK PSO-1 and POETYK PSO-2, which enrolled 666 and 1020 people, respectively, were multicenter, randomized, double-blind studies and had compared once-daily deucravacitinib to placebo and apremilast.²

Additionally, the POETYK PSO-2 trial had involved a randomized withdrawal and retreatment period following the 24-week mark.

The co-primary endpoints used in both POETYK PSO-1 and POETYK PSO-2 were specifically the percentage of subjects who were able to achieve Psoriasis Area and Severity Index (PASI) 75 response and static Physician's Global Assessment (sPGA) scores of 0 or 1 (clear/almost clear) at the 16-week mark compared to placebo.

Among their key secondary endpoints, the trial investigators also looked at the percentage of subjects who reported achieving PASI 75 and sPGA 0/1 compared to apremilast at the 16-week mark and other measures evaluating Sotyktu versus placebo and Otezla.

Following the 4-year course of continuous treatment, the extension trial investigators noted that subjects at the the 208-week mark had achieved PASI 75 and 90 among 71.7% and 47.5% of study participants, respectively. Additionally, the team found that 57.2% had an sPGA 0/1 (clear/almost clear) with the use of a modified nonresponder imputation (mNRI) noted.

The subjects’ responses had persisted through to the 52-week mark, with 82% of those who were shown to have gotten PASI 75 with deucravacitinib at Week 24 continuing to maintain their response at the 52-week mark in POETYK PSO-1. Within the POETYK PSO-2 study, the team found that 80% of those who continued treatment maintained their PASI 75 response versus 31% of those who were withdrawn from the drug.

Additionally, the safety profile of deucravacitinib at the 4 year-mark was shown by the research team to have remained consistent with the established safety profile, with no new safety signals identified.

Bristol Myers Squibb, in addition to working on POETYK PSO-1, POETYK PSO-2 and POETYK PSO-LTE, is assessing deucravacitinib for psoriasis in 2 other phase 3 studies, titled POETYK PSO-3 and POETYK PSO-4.

“Many patients and their healthcare providers are looking for an efficacious, convenient oral treatment option that provides sustained relief from this chronic disease, allowing patients to prioritize other aspects of their daily lives,” Armstrong noted in her statement. “These findings further reinforce that we are able to offer a potential oral standard of care to meet patients’ needs.”

References

1. ^{New Four-Year Sotyktu (deucravacitinib) Data Demonstrate Durable Response Rates and Consistent Safety in Moderate-to-Severe Plaque Psoriasis. Bristol Myers Squibb. May 16, 2024. https://news.bms.com/news/details/2024/New-Four-Year-Sotyktu-deucravacitinib-Data-Demonstrate-Durable-Response-Rates-and-Consistent-Safety-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx. Date accessed: May 16, 2024.}
2. ^{Armstrong A. POETYK PSO-1 and POETYK PSO-2 Trials for Plaque Psoriasis. HCPLive. March 13, 2024. https://www.hcplive.com/view/poetyk-pso-1-and-poetyk-pso-2-trials-for-plaque-psoriasis. Date accessed: May 16, 2024.}