From the latest Congress of the European Academy of Dermatology and Venereology (EADV) which took place recently in Berlin, good news comes for patients with psoriasis, a chronic systemic disease that can have a very heavy impact on the daily life of those who suffer from it . In fact, Bristol Myers Squibb presented the new three-year results of the POETYK PSO long-term extension (LTE) study analyzing treatment with deucravacitinib in adult patients with moderate to severe plaque psoriasis.
The clinical response
At Week 148, clinical response rates were maintained with continued treatment, with modified non-responder imputation (mNRI) responses of 73.2% and Psoriasis Area and Severity Index (PASI 75) of 48.1%. for PASI 90 and 54.1% for sPGA 0/1 (static Physician’s Global Assessment). Deucravacitinib has demonstrated a consistent safety profile over time with no increased rates of adverse events. “These new positive three-year data confirm the long-term efficacy and well-established safety profile of once-daily deucravacitinib, the first and only available TYK2 inhibitor, and strengthen our confidence in its role as a treatment oral choice for adults with moderate to severe plaque psoriasis,” says April Armstrong, MD, MPH, POETYK PSO clinical trial program investigator and Director of Dermatology at the University of California, Los Angeles.
by Dario Rubino
Safety and efficacy analysis
The safety analysis evaluated 1,519 patients treated with at least one dose of deucravacitinib in the POETYK PSO-1, POETYK PSO-2, and POETYK PSO-LTE studies. The efficacy analysis evaluated 513 patients treated continuously with deucravacitinib from Day 1 in the pivotal POETYK PSO-1 and POETYK PSO-2 studies and transitioned to the LTE study. Cumulative exposure from parental study randomization was 3,294 patient-years (PYs) for safety analyses. Clinical efficacy results were maintained in patients treated continuously with deucravacitinib from baseline to Week 148, with sustained response rates for PASI 75 (Week 16: 61.1%; Week 52: 72.6%; Week 148: 73.2%), PASI 90 (Week 16: 35.2%; Week 52: 45.6%; Week 148: 48.1%) and sPGA 0/1 (Week 16: 57.5%; Week 52: 58.1%; Week 148: 54.1%). “For my patients, more days of relief from this chronic disease means they can focus on other aspects of their lives and this long-term data from POETYK PSO adds to the evidence we had that we could offer a new standard of care to patients requiring oral treatment.”
by Letizia Gabaglio
At three years, exposure-adjusted cumulative incidence rates (EAIRs)/100 PYs were similar to or lower than those observed at two years, respectively, for AEs (144.8, 154.4), severe AEs (5, 5; 6.1), discontinuation for AEs (2.4; 2.8), herpes zoster (0.6; 0.7), malignancies (0.9; 0.9), major adverse cardiovascular events (0 .3; 0.4), venous thromboembolism (0.1; 0.1) and death (0.3; 0.4). EAIRs/100 PYs were calculated as the number of patients with an AE during the entire exposure time for all patients at risk (time to onset of an AE in patients with an AE and total exposure time for patients without an AE ).
The POETYK PSO clinical study program
The POETYK (PrOgram to Evaluate the efficacy and safety of deucravacitinib, a selective TYK2 inhibitor) PSO-1 and POETYK PSO-2 studies are global Phase 3 studies designed to evaluate the safety and efficacy of deucravacitinib, a selective TYK2 inhibitor, compared to placebo and apremilast in patients with moderate to severe plaque psoriasis. Both POETYK PSO-1, which enrolled 666 patients, and POETYK PSO-2, which enrolled 1,020, are multicenter, randomized, double-blind studies evaluating deucravacitinib (6 mg once daily) versus placebo and apremilast (30 mg twice daily). POETYK PSO-2 included a randomized withdrawal and retreatment period after week 24.
Psoriasis is a chronic, immune-mediated, widely spread systemic disease that substantially compromises patients’ health, quality of life and productivity in the workplace. Psoriasis represents a serious global problem, with at least 100 million people worldwide affected by some form of this disease, including approximately 14 million in Europe and 7.5 million in the United States. About a quarter of patients with psoriasis have moderate to severe forms. Up to 90% of patients with psoriasis have the vulgar form, or plaque psoriasis, characterized by distinct oval or round plaques typically covered with whitish scales.
Although effective systemic therapies are available, many patients with moderate to severe psoriasis are inadequately treated or even untreated and are not satisfied with current therapies. People suffering from psoriasis report an impact on emotional well-being, which affects personal and professional relationships, causing a deterioration in quality of life. Psoriasis is associated with several comorbidities that affect patients’ well-being, such as psoriatic arthritis, cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease, and depression.