Deucravacitinib Demonstrates Sustained Efficacy and Safety in 4-Year Psoriasis Trial

Image Credit: © Игорь Головнёв - stock.adobe.com

Today, Bristol Myers Squibb announced 4-year results from the POETYK PSO long-term extension (LTE) (NCT04036435)trial for their drug deucravacitinib (Sotyktu), aimed at treating moderate to severe plaque psoriasis in adults. The data, which were presented at the European Academy of Dermatology and Venereology (EADV) Spring Symposium in St. Julian’s, Malta, revealed that more than 70% of patients maintained significant clinical responses over the 4-year period, with no new safety concerns.¹

The POETYK PSO program includes several phase 3 studies aimed at evaluating the efficacy and safety of deucravacitinib. The pivotal trials, POETYK PSO-1 (NCT03624127)and POETYK PSO-2 (NCT03611751), compared deucravacitinib to placebo and apremilast (Otezla) in patients with moderate to severe plaque psoriasis. Both trials achieved their co-primary endpoints, showing significant improvements in PASI 75 and sPGA 0/1 responses at week 16 compared to placebo. Additionally, the LTE trial allowed for ongoing assessment of long-term efficacy and safety.² 

4-Year Efficacy Results

The efficacy of deucravacitinib was assessed using the Psoriasis Area and Severity Index (PASI) and the static Physician’s Global Assessment (sPGA). At the 208-week mark, 71.7% of patients achieved a PASI 75 response, meaning a 75% reduction in psoriasis severity, while 47.5% achieved a PASI 90 response, indicating a 90% reduction. Additionally, 57.2% of patients reached an sPGA score of 0/1, denoting clear or almost clear skin. These results were consistent with earlier findings, demonstrating the long-term efficacy of deucravacitinib.

The analysis included 513 patients who received continuous treatment from the initial POETYK PSO-1 and PSO-2 trials, transitioning into the LTE phase. The sustained response rates were significant: PASI 75 responses were 71.7% at year 4, compared to 72.0% at year 1 and 73.8% at year 3. Similarly, PASI 90 responses were 47.5% at year 4, compared to 45.6% at year 1 and 49.0% at year 3. For sPGA 0/1, the rates were 57.2% at year 4, close to the 57.7% at year 1 and 55.2% at year 3.

4-Year Safety Profile

The safety analysis encompassed 1519 patients who received at least 1 dose of deucravacitinib across the POETYK PSO-1, POETYK PSO-2, and POETYK PSO-LTE trials, with a cumulative exposure of 4392.8 patient-years. Importantly, no new safety signals were observed, and the safety profile remained consistent over the 4 years. The exposure-adjusted incidence rates (EAIRs) for adverse events (AEs) decreased or remained stable compared to year 1. Specifically, the EAIRs for AEs were 131.7 per 100 patient-years at year 4, down from 229.2 at year 1. Serious AEs decreased from 5.7 to 5.0, and discontinuations due to AEs dropped from 4.4 to 2.2. Incidence rates for herpes zoster, malignancies, major adverse cardiovascular events, venous thromboembolism, and deaths also either decreased or remained stable.

Clinical Implications

April Armstrong, MD, MPH, chief of the division of dermatology at the UCLA Health David Geffen School of Medicine, and a clinical investigator in the POETYK PSO clinical trial program, emphasized the significance of these results. She said in a press release, “These 4-year results further validate the safety profile, efficacy and key role of once-daily Sotyktu [deucravacitinib], the first and only TYK2 inhibitor available, for adults with moderate to severe plaque psoriasis. Many patients and their health care 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. These findings further reinforce that we are able to offer a potential oral standard of care to meet patients’ needs.”

Alyssa Johnsen, MD, PhD, senior vice president and head of clinical development for immunology, cardiovascular, and neuroscience at Bristol Myers Squibb, echoed these sentiments. She concluded in a press release, “Our leadership in TYK2 innovation highlights our transformational science that is advancing care for immune-mediated diseases.”

References

1. New four-year Sotyktu (deucravacitinib) data demonstrate durable response rates and consistent safety in moderate-to-severe plaque psoriasis. News Release. Bristol Myers Squibb. May 16, 2024. Accessed 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
2. Armstrong AW, Gooderham M, Warren RB, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. J Am Acad Dermatol. 2023;88(1):29-39. doi:10.1016/j.jaad.2022.07.002