Four-Year Sotyktu Data Shows Durable Response and Safety in Moderate-to-Severe Plaque Psoriasis

Bristol Myers Squibb recently unveiled four-year data from the POETYK PSO long-term extension trial evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adult patients with moderate-to-severe plaque psoriasis. The results showed that sustained clinical response was maintained for the majority of patients over the four-year period.

In the trial, clinical responses for Psoriasis Area and Severity Index (PASI) 75 and 90 scores were 71.7% and 47.5%, respectively, while 57.2% of patients achieved a static Physician’s Global Assessment (sPGA) score of 0/1 (clear/almost clear). These findings were presented at the European Academy of Dermatology and Venereology (EADV) Spring Symposium.

Dr. April Armstrong, a clinical investigator in the POETYK PSO trial and a professor at UCLA, highlighted the significance of these results. She emphasized the efficacy and safety of Sotyktu as an oral treatment option, providing sustained relief for patients with this chronic condition.

The efficacy analysis involved 513 patients who were treated continuously with Sotyktu from the start of the pivotal POETYK PSO-1 and POETYK PSO-2 trials and transitioned to the POETYK PSO-LTE trial. The trial's outcomes showed that clinical responses were consistent over the years, with PASI 75 scores remaining above 71% and PASI 90 scores and sPGA scores also demonstrating sustained efficacy throughout the four years.

The safety analysis included 1,519 patients who received at least one dose of Sotyktu. The cumulative exposure was approximately 4,392.8 patient-years. Over four years, the adjusted incidence rates for adverse events either remained stable or decreased compared to the first year. This included serious adverse events, discontinuations due to adverse events, incidences of herpes zoster, malignancies, major cardiovascular events, venous thromboembolism, and deaths.

Dr. Alyssa Johnsen, a senior vice president at Bristol Myers Squibb, underscored the significance of the POETYK PSO clinical program. She pointed out that Sotyktu represents a potential oral standard of care for patients with moderate-to-severe plaque psoriasis, emphasizing the company's commitment to advancing therapies for immune-mediated diseases.

The POETYK PSO clinical trial program includes several Phase 3 studies, including POETYK PSO-1, POETYK PSO-2, POETYK PSO-3, and POETYK PSO-4. These trials were designed to evaluate the efficacy and safety of Sotyktu compared to placebo and the drug Otezla. The trials demonstrated that patients treated with Sotyktu consistently achieved higher rates of PASI 75 and sPGA 0/1 responses compared to those treated with placebo or Otezla.

Psoriasis is a chronic and systemic immune-mediated disease affecting millions globally, with significant physical, emotional, and social impacts. Despite the availability of effective treatments, many patients with moderate-to-severe plaque psoriasis remain dissatisfied with their current options.

Sotyktu, an oral selective TYK2 inhibitor, represents a new class of small molecules designed to selectively target TYK2, thereby inhibiting key cytokines involved in immune-mediated diseases' pathogenesis. The drug achieves a high degree of selectivity by binding to TYK2's regulatory domain, thus inhibiting its downstream functions without affecting other similar enzymes at therapeutic doses.

Bristol Myers Squibb remains dedicated to pioneering advancements in immunology to transform patients' lives. With over two decades of experience in understanding the immune system, the company continues to pursue innovative solutions to address unmet needs in dermatology and other related fields. Through extensive partnerships and research, Bristol Myers Squibb aims to improve patient outcomes and expand treatment options for chronic diseases.