Clinical response was maintained at 73.2% for Psoriasis Area and Severity Index (PASI) 75 with three years of continuous Sotyktu treatment in the POETYK PSO long-term extension trial
Sotyktu demonstrated a consistent safety profile with no increases in adverse events or serious adverse events and no emergence of any new safety signals
New data to be presented at the 2023 European Academy of Dermatology and Venereology Congress as part of 50 company-sponsored scientific presentations, demonstrating robust and growing body of dermatology research
PRINCETON, NJ, USA I October 11, 2023 IBristol Myers Squibb (NYSE:BMY) today announced new three-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. At Week 148, clinical response rates were maintained with continuous treatment with modified nonresponder imputation (mNRI) responses of 73.2% for Psoriasis Area and Severity Index (PASI) 75, 48.1% for PASI 90 and 54.1% for static Physician’s Global Assessment (sPGA) 0/1. Sotyktu demonstrated a consistent safety profile with no increases in the rates of adverse events (AEs) or serious AEs over time, and no emergence of any new safety signals.
These data (oral presentation #FC02.7) and 49 additional abstracts demonstrating Bristol Myers Squibb’s ongoing commitment to dermatology research are being presented at the European Academy of Dermatology and Venereology (EADV) Congress in Berlin, Germany taking place October 11-14, 2023.
“These new, positive, three-year results reinforce the long-term efficacy and well-established safety profile of once-daily Sotyktu, the first and only TYK2 inhibitor available, and add to our confidence in its role as an oral treatment of choice for adults with moderate-to-severe plaque psoriasis,” said April Armstrong, MD, MPH, clinical investigator in the POETYK PSO clinical trial program and professor and chief of dermatology at the University of California, Los Angeles. “For my patients, more days of relief from this chronic disease mean that they can focus on other aspects of their lives, and these POETYK PSO long-term data add to the evidence that we have the ability to offer a new standard of care to patients seeking an oral treatment option.”
The safety analysis assessed 1,519 patients who received at least one dose of Sotyktu across POETYK PSO-1, POETYK PSO-2 and POETYK PSO-LTE. The efficacy analysis assessed 513 patients who received continuous Sotyktu treatment from Day 1 in the pivotal POETYK PSO-1 and POETYK PSO-2 trials and transitioned to the LTE trial. Cumulative exposure from parent trial randomization was 3,294 patient-years (PYs) for the safety analyses.
Clinical efficacy outcomes were maintained in patients who were continuously treated with Sotyktu from baseline through 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%).
At three years, cumulative exposure-adjusted incidence rates (EAIRs)/100 PYs were similar or decreased compared with rates observed at two years, respectively, for AEs (144.8, 154.4), serious AEs (5.5, 6.1), discontinuation due to 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 deaths (0.3, 0.4). EAIRs/100 PYs were calculated as the number of patients with an AE over the total exposure time for all patients at risk (time to an initial AE occurrence for patients with AE and time of total exposure for patients without an AE).
“As the leader in TYK2 innovation, Bristol Myers Squibb continues to advance our long-term understanding of our first-in-class, oral Sotyktu treatment for plaque psoriasis and explore its full potential across serious immune-mediated diseases,” said Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience Development, Bristol Myers Squibb. “These new data validate the potential of Sotyktu to provide long-term, clinically relevant improvement for individuals living with moderate-to-severe plaque psoriasis.”
Bristol Myers Squibb thanks the patients and investigators involved in the POETYK PSO clinical trial program.
About the POETYK PSO Clinical Trial Program
PrOgram to Evaluate the efficacy and safety of Sotyktu (deucravacitinib), a selective TYK2 inhibitor (POETYK) PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) were global Phase 3 studies designed to evaluate the safety and efficacy of Sotyktu compared to placebo and Otezla® (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 patients, were multicenter, randomized, double-blind trials that evaluated Sotyktu (6 mg once daily) compared to placebo and Otezla (30 mg twice daily). POETYK PSO-2 included a randomized withdrawal and retreatment period after Week 24.
The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2 were the percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 response and those who achieved static Physician’s Global Assessment (sPGA) score of 0 or 1 (clear/almost clear) at Week 16 versus placebo. Key secondary endpoints of the trials included the percentage of patients who achieved PASI 75 and sPGA 0/1 compared to Otezla at Week 16 and other measures evaluating Sotyktu versus placebo and Otezla.
Across both clinical trials and timepoints, significantly more Sotyktu-treated patients achieved a sPGA score of 0/1, PASI 75 response and PASI 90 response. Responses persisted through Week 52, as 81% (187/230) of patients who achieved PASI 75 with Sotyktu at Week 24 maintained their response at Week 52 in POETYK PSO-1. In POETYK PSO-2, 80% (119/148) of patients who continued Sotyktu maintained PASI 75 response compared to 31% (47/150) of patients who were withdrawn from Sotyktu.
Following the 52-week POETYK PSO-1 and POETYK PSO-2 trials, patients could enroll in the ongoing POETYK PSO long-term extension (LTE) trial (NCT04036435) and receive open-label Sotyktu 6 mg once-daily. In the LTE trial, 1,221 patients were enrolled and received at least one dose of Sotyktu. Efficacy was analyzed utilizing treatment failure rules method of imputation, along with sensitivity analyses using modified non-responder imputation and as-observed analysis, which have been used in similar analyses with other agents.
In addition to POETYK PSO-1, POETYK PSO-2 and POETYK PSO-LTE, Bristol Myers Squibb has evaluated Sotyktu in two other Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462) and POETYK PSO-4 (NCT03924427).
About Psoriasis
Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity. Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease, including around 14 million people in Europe and approximately 7.5 million people in the United States. Nearly one-quarter of people with psoriasis have cases that are considered moderate-to-severe. Up to 90 percent of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, which is characterized by distinct round or oval plaques typically covered by silvery-white scales. Despite the availability of effective systemic therapy, many patients with moderate-to-severe plaque psoriasis remain undertreated or even untreated and are dissatisfied with current treatments. People with psoriasis report an impact on their emotional well-being, straining both personal and professional relationships and causing a reduced quality of life. Psoriasis is associated with multiple comorbidities that may impact patients’ well-being, including psoriatic arthritis, cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease and depression.
About Sotyktu (deucravacitinib)
Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed Sotyktu to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Sotyktu achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Sotyktu selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses, Sotyktu does not inhibit JAK1, JAK2 or JAK3.
Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives
Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and pulmonology. We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission – and perhaps even cures – in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most – the promise of living a better life.
SOTYKTU U.S. INDICATION
SOTYKTU™ (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow on LinkedIn, Twitter, YouTube, Facebook and Instagram.
SOURCE: Bristol Myers Squibb
Post Views: 354
Clinical response was maintained at 73.2% for Psoriasis Area and Severity Index (PASI) 75 with three years of continuous Sotyktu treatment in the POETYK PSO long-term extension trial
Sotyktu demonstrated a consistent safety profile with no increases in adverse events or serious adverse events and no emergence of any new safety signals
New data to be presented at the 2023 European Academy of Dermatology and Venereology Congress as part of 50 company-sponsored scientific presentations, demonstrating robust and growing body of dermatology research
PRINCETON, NJ, USA I October 11, 2023 IBristol Myers Squibb (NYSE:BMY) today announced new three-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. At Week 148, clinical response rates were maintained with continuous treatment with modified nonresponder imputation (mNRI) responses of 73.2% for Psoriasis Area and Severity Index (PASI) 75, 48.1% for PASI 90 and 54.1% for static Physician’s Global Assessment (sPGA) 0/1. Sotyktu demonstrated a consistent safety profile with no increases in the rates of adverse events (AEs) or serious AEs over time, and no emergence of any new safety signals.
These data (oral presentation #FC02.7) and 49 additional abstracts demonstrating Bristol Myers Squibb’s ongoing commitment to dermatology research are being presented at the European Academy of Dermatology and Venereology (EADV) Congress in Berlin, Germany taking place October 11-14, 2023.
“These new, positive, three-year results reinforce the long-term efficacy and well-established safety profile of once-daily Sotyktu, the first and only TYK2 inhibitor available, and add to our confidence in its role as an oral treatment of choice for adults with moderate-to-severe plaque psoriasis,” said April Armstrong, MD, MPH, clinical investigator in the POETYK PSO clinical trial program and professor and chief of dermatology at the University of California, Los Angeles. “For my patients, more days of relief from this chronic disease mean that they can focus on other aspects of their lives, and these POETYK PSO long-term data add to the evidence that we have the ability to offer a new standard of care to patients seeking an oral treatment option.”
The safety analysis assessed 1,519 patients who received at least one dose of Sotyktu across POETYK PSO-1, POETYK PSO-2 and POETYK PSO-LTE. The efficacy analysis assessed 513 patients who received continuous Sotyktu treatment from Day 1 in the pivotal POETYK PSO-1 and POETYK PSO-2 trials and transitioned to the LTE trial. Cumulative exposure from parent trial randomization was 3,294 patient-years (PYs) for the safety analyses.
Clinical efficacy outcomes were maintained in patients who were continuously treated with Sotyktu from baseline through 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%).
At three years, cumulative exposure-adjusted incidence rates (EAIRs)/100 PYs were similar or decreased compared with rates observed at two years, respectively, for AEs (144.8, 154.4), serious AEs (5.5, 6.1), discontinuation due to 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 deaths (0.3, 0.4). EAIRs/100 PYs were calculated as the number of patients with an AE over the total exposure time for all patients at risk (time to an initial AE occurrence for patients with AE and time of total exposure for patients without an AE).
“As the leader in TYK2 innovation, Bristol Myers Squibb continues to advance our long-term understanding of our first-in-class, oral Sotyktu treatment for plaque psoriasis and explore its full potential across serious immune-mediated diseases,” said Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience Development, Bristol Myers Squibb. “These new data validate the potential of Sotyktu to provide long-term, clinically relevant improvement for individuals living with moderate-to-severe plaque psoriasis.”
Bristol Myers Squibb thanks the patients and investigators involved in the POETYK PSO clinical trial program.
About the POETYK PSO Clinical Trial Program
PrOgram to Evaluate the efficacy and safety of Sotyktu (deucravacitinib), a selective TYK2 inhibitor (POETYK) PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) were global Phase 3 studies designed to evaluate the safety and efficacy of Sotyktu compared to placebo and Otezla® (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 patients, were multicenter, randomized, double-blind trials that evaluated Sotyktu (6 mg once daily) compared to placebo and Otezla (30 mg twice daily). POETYK PSO-2 included a randomized withdrawal and retreatment period after Week 24.
The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2 were the percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 response and those who achieved static Physician’s Global Assessment (sPGA) score of 0 or 1 (clear/almost clear) at Week 16 versus placebo. Key secondary endpoints of the trials included the percentage of patients who achieved PASI 75 and sPGA 0/1 compared to Otezla at Week 16 and other measures evaluating Sotyktu versus placebo and Otezla.
Across both clinical trials and timepoints, significantly more Sotyktu-treated patients achieved a sPGA score of 0/1, PASI 75 response and PASI 90 response. Responses persisted through Week 52, as 81% (187/230) of patients who achieved PASI 75 with Sotyktu at Week 24 maintained their response at Week 52 in POETYK PSO-1. In POETYK PSO-2, 80% (119/148) of patients who continued Sotyktu maintained PASI 75 response compared to 31% (47/150) of patients who were withdrawn from Sotyktu.
Following the 52-week POETYK PSO-1 and POETYK PSO-2 trials, patients could enroll in the ongoing POETYK PSO long-term extension (LTE) trial (NCT04036435) and receive open-label Sotyktu 6 mg once-daily. In the LTE trial, 1,221 patients were enrolled and received at least one dose of Sotyktu. Efficacy was analyzed utilizing treatment failure rules method of imputation, along with sensitivity analyses using modified non-responder imputation and as-observed analysis, which have been used in similar analyses with other agents.
In addition to POETYK PSO-1, POETYK PSO-2 and POETYK PSO-LTE, Bristol Myers Squibb has evaluated Sotyktu in two other Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462) and POETYK PSO-4 (NCT03924427).
About Psoriasis
Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity. Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease, including around 14 million people in Europe and approximately 7.5 million people in the United States. Nearly one-quarter of people with psoriasis have cases that are considered moderate-to-severe. Up to 90 percent of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, which is characterized by distinct round or oval plaques typically covered by silvery-white scales. Despite the availability of effective systemic therapy, many patients with moderate-to-severe plaque psoriasis remain undertreated or even untreated and are dissatisfied with current treatments. People with psoriasis report an impact on their emotional well-being, straining both personal and professional relationships and causing a reduced quality of life. Psoriasis is associated with multiple comorbidities that may impact patients’ well-being, including psoriatic arthritis, cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease and depression.
About Sotyktu (deucravacitinib)
Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed Sotyktu to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Sotyktu achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Sotyktu selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses, Sotyktu does not inhibit JAK1, JAK2 or JAK3.
Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives
Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and pulmonology. We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission – and perhaps even cures – in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most – the promise of living a better life.
SOTYKTU U.S. INDICATION
SOTYKTU™ (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow on LinkedIn, Twitter, YouTube, Facebook and Instagram.
SOURCE: Bristol Myers Squibb
Post Views: 354
