Bristol Myers Squibb announces new four-year results from the Poetyk PSO long-term extension (LTE) study with deucravacitinib for the treatment of adult patients with moderate to severe plaque psoriasis. After four years of continuous treatment, at week 208 the Pasi (Psoriasis area and severity index) 75 and 90 responses were 71.7% and 47.5%, respectively, and 57.2% according to the sPGA (Physician’s global assessment) 0/1 (clear/ almost clear), using the “modified non-responder imputation” (mNRI). The four-year safety profile of deucravacitinib remained consistent with the established profile and no new safety signals were identified. The data were presented at the Spring Symposium of the European Academy of Dermatology and Venereology (EADV) which took place from 16 to 18 May 2024 in St. Julian’s, Malta.
“These four-year results confirm the safety profile, efficacy and critical role of once-daily administration of deucravacitinib, the first and only Tyk2 inhibitor available for the treatment of adult patients with moderate to severe plaque psoriasis – says April Armstrong, Md, Mph, Poetyk Pso clinical trial program investigator, professor and director of Dermatology at the University of California, Los Angeles – Many patients and healthcare professionals are looking for an effective and convenient oral treatment option that offers long-lasting relief from this chronic disease, allowing patients to prioritize other aspects of their lives. These results further confirm that we can offer a potential standard of oral care that meets the needs of these patients.”
The efficacy analysis – reports a note – evaluated 513 patients treated continuously with deucravacitinib from day 1 in the registration studies Poetyk Pso-1 and Poetyk Pso-2 then moved on to the Poetyk Pso-Lte study. Clinical efficacy results were maintained in patients treated continuously with deucravacitinib from baseline to four years, with sustained Pasi 75 response rates of 71.7% (72.0% at 1 year; 73.8% at 3 years ), Pasi 90 by 47.5% (45.6% at 1 year; 49.0% at 3 years) and sPGA 0/1 by 57.2% (57.7% at 1 year; 55.2% at 3 years).
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 note details – Cumulative exposure, starting from randomization in the original studies (Poetyk Pso-1, Poetyk Pso-2), was 4,392.8 patient-years (PYs) for safety analyses. With increasing exposure to deucravacitinib, 4-year exposure-adjusted cumulative incidence rates (EAIRs)/100 PYs decreased or remained similar to those at 1 year for adverse events (AEs) ( 229.2 at 1 year; 131.7 at 4 years), severe AEs (5.7 at 1 year; 5.0 at 4 years), interruption for AEs (4.4 at 1 year; 2.2 at 4 years), herpes zoster (0.8 at 1 year; 0.6 at 4 years), malignant tumors (1.0 at 1 year; 0.9 at 4 years), major adverse cardiovascular events ( 0.3 at 1 year; 0.3 at 4 years), venous thromboembolism (0.2 at 1 year; 0.1 at 4 years) and death (0.2 at 1 year; 0.3 at 4 years ). EAIRs/100 PYs were calculated as the ratio of patients with an Ae throughout the exposure time to all patients at risk (time to onset of an Ae in patients with an Ae and total exposure time for patients without an Ae).
“Data from our robust Poetyk Pso clinical program continues to support the potential of first-in-class deucravacitinib as a standard of oral care for patients with moderate to severe plaque psoriasis,” says Alyssa Johnsen, Md, Phd, Senior Vice President and Director of Clinical Development in Immunology, Cardiovascular and Neurosciences at Bristol Myers Squibb – Our innovation leadership with Tyk2 highlights how our transformative science is driving advances in the treatment of immune-mediated diseases.”
The Poetyk Pso 1 and 2 studies – we read in the note – are global phase 3 studies, designed to evaluate the efficacy of deucravacitinib 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 resumption of treatment after week 24.
The co-primary endpoints of both the Poetyk Pso-1 and Poetik Pso-2 studies were the percentage of patients achieving Psoriasis area and severity index (Pasi) 75 and the percentage of patients achieving a static Physician’s Global Assessment (sPGA) of 0 or 1 (clear/ almost clear) at week 16 compared to placebo. Key secondary endpoints of the studies included the percentage of patients achieving Pasi 75 and sPGA score 0/1 compared to apremilast at week 16 and other parameters evaluating deucravacitinib compared to placebo and apremilast.
Psoriasis is a chronic, immune-mediated, widely spread systemic disease that significantly 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.
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