Deucravacitinib phase 2 psoriasis. 2022;12(2):495–510.

Deucravacitinib phase 2 psoriasis gov identifier: NCT03881059) randomly assigned Tyrosine kinase 2 (TYK2) mediates cytokine signaling involved in adaptive [interleukin (IL)-12, IL-23] and innate (type-I interferons) immune responses; IL-23–driven T-helper (Th)17 pathways play a key role in chronic inflammation in psoriasis. The POETYK PSO-1 and POETYK PSO-2 trials, which evaluated Objective: To evaluate the efficacy and safety of deucravacitinib (DEUC) in scalp psoriasis. Based on the positive results of two phase III randomized, double-blind clinical trials POETYK PSO-1 and POETYK PSO-2, the tyrosine kinase 2 (TYK2) allosteric inhibitor deucravacitinib was approved by the U. The study met the primary endpoint AbstractBackground: Psoriasis is a chronic, inflammatory disease associated with numerous negative physical and psychosocial impacts. Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. 2022;12(2):495–510. Tyrosine kinase (TYK) 2 is an intracellular enzyme that mediates signalling of cytokines (e. In a phase 2 Methods: In the 52-week blinded phase III POETYK PSO-3 trial (NCT04167462), patients were randomized 1 : 2 to placebo (n = 74) or deucravacitinib 6 mg once daily (n = 146) for 16 weeks followed by deucravacitinib alone. 24 The two main aims of the study were the achievement of PASI75 response and The efficacy and safety of deucravacitinib was evaluated in two phase 3 trials, POETYK PSO-1 (n=666) 5 and PSO-2 (n=1020). Food and Drug Administration (FDA) in September 2022 for the treatment of adults with moderate to severe plaque psoriasis . Patients were randomized 1:2:1 to oral placebo, DEUC 6 mg once daily, or apremilast 30 mg twice daily. The study designs for POETYK PSO-1 and PSO-2 were previously described (Fig. [1] Deucravacitinib is . Papp,11 Matthew J. This analysis evaluated onset of action and maintenance of response in patients randomized to deucravacitinib and placebo only. Gottlieb, 2 Diamant Thaçi, 3 Luis Puig, 4 Matthew J. Deucravacitinib, formally known as BMS-986165, is an oral, selective TYK2 inhibitor that is currently in phase III of development for the treatment of psoriasis and psoriatic arthritis []. • Deucravacitinib has demonstrated efficacy and tolerability in phase 2 trials in patients with moderate to severe plaque psoriasis3 and with active psoriatic arthritis4 compared with placebo, and in 2 pivotal phase 3 trials in patients with moderate to severe Based on the mechanism of action of deucravacitinib, this phase II trial (PAISLEY) was designed to evaluate the efficacy and safety of deucravacitinib in adult patients with active SLE. 1 Phase 2 results showed deucravacitinib was efficacious and well tolerated versus placebo in patients with moderate to Objective: To evaluate the efficacy and safety of an oral selective tyrosine kinase 2 (TYK2) inhibitor, deucravacitinib, in patients with active psoriatic arthritis (PsA). S1) [8, 11]. 9 Outcomes are also consistent with those By week 16, deucravacitinib significantly outperformed placebo for all primary and secondary efficacy outcomes. 28 POETYK PSO-1 and POETYK PSO-2 ≥75% reduction from baseline PASI [PASI 75] in PSO-2) switched to deucravacitinib at Week 24 • PSO-2 included a randomized withdrawal phase starting at Week 24; those results will be presented at a future date — All patients were eligible for a long-term extension study after 52 weeks of treatment Figure 2. It has proven efficacy superior to apremilast in psoriasis, promising early phase results in Based on the positive results of two phase III randomized, double-blind clinical trials POETYK PSO-1 and POETYK PSO-2, the tyrosine kinase 2 (TYK2) allosteric inhibitor deucravacitinib was approved by the U. Efficacy of Deucravacitinib Phase 3 Trials. Deucravacitinib is being Deucravacitinib demonstrated a favourable safety profile in phase 2 and 3 clinical trials in 1723 patients with moderate-to-severe plaque psoriasis and psoriatic arthritis (Table 1). Deucravacitinib is a novel, oral, selective, allosteric inhibitor of TYK2 that achieves high selectivity by uniquely sponses. 4,5 In phase 2 trials in plaque psoriasis7 and psoriatic arthritis,8 deucravacitinib was signifi-cantly more efficacious than placebo and was well tolerated. Methods: Participants were randomized 2:1:1 to deucravacitinib 6 mg every day (n = 332), placebo (n = 166), or apremilast 30 mg twice a day (n = 168) in the 52-week, double-blinded, phase 3 POETYK Deucravacitinib is a safe and efficacious once daily, oral, long-term treatment for plaque psoriasis, according to a study published in the British Journal of Dermatology. Deucravacitinib, an oral selective allosteric TYK2 inhibitor, was efficacious and well tolerated over 52 weeks in two pivotal phase III clinical trials in patients with The safety and efficacy of deucravacitinib was also studied in a 52-week, randomized, double-blinded, placebo-controlled phase III trial (POETYK PSO-1) enrolling 666 patients randomized to receive deucravacitinib 6mg every day (n = 332), placebo BID (n = 166), or apremilast 30mg BID (n = 168). Deucravacitinib is being investigated as a treatment for psoriasis. 6 Both included adults with moderate to severe plaque psoriasis with ≥10% body surface area involvement (mean at baseline 26. Objectives: To evaluate the safety and efficacy of deucravacitinib through 4 years in the Phase 3 POETYK PSO-1, PSO-2 and long-term This approval is based on results from the global phase 3 POETYK PSO-1 and PSO-2 trials in which deucravacitinib was associated with significantly improved efficacy outcomes compared with placebo in adults with moderate to severe plaque psoriasis, and results described here from POETYK PSO-4, an open-label, single-arm, phase 3 trial (NCT03924427), which evaluated Background: Scalp involvement in plaque psoriasis is challenging to treat. Efficacy and safety outcomes in PSO-2 are consistent with those in the companion phase 3 PSO-1 trial. 7 Deucravacitinib (DEUC), an oral, selective, allosteric TYK2 Since the pathogenesis of psoriasis is associated with the cytokine signal transduction pathway, deleting the TYK2 gene is associated with susceptibility to psoriasis. gov up to December 2022 using the terms "deucravacitinib" and "BMS-986165. Colombo, 5 Sudeep Kundu, 5 Renata Kisa, 5 Subhashis Banerjee 5 kinase 2 inhibitor, versus placebo and apremilast in adults with moderate to severe plaque psoriasis. Colombo,12 John Vaile,12 Background In the phase 3 POETYK PSO-1 and PSO-2 trials, deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, was well-tolerated and efficacious over 1 year in patients with plaque psoriasis include rapid onset of action and symptom relief, as well as long-term maintenance of treatment response (24–27). Objective: To compare the efficacy and safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, versus placebo and apremilast in adults with moderate to severe plaque psoriasis. Data sources: Literature was reviewed from MEDLINE and Clinicaltrials. Deucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis. doi: 10. Psoriasis is a chronic inflammatory skin disease with enhanced immune axis of interleukin (IL)-23/IL-17 (Citation 1, Citation 2). J. Dermatol Ther (Heidelb). Table 1. 0–21. In a phase 2 trial, deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, reduced IL-23/Th17 and type-I interferon pathway expression in the skin of patients with moderate to severe plaque psoria-sis, reductions that were accompanied by clini-cal improvement of psoriatic lesions. 2 Objectives To assess the long-term efficacy and safety of deucravacitinib Background: Deucravacitinib, a first-in-class, oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in multiple countries for the treatment of adults with plaque psoriasis. The primary endpoint was American College of Background: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, inhibits cytokine signaling in psoriasis pathogenesis. At week 16, over 50% of patients treated with deucravacitinib reached PASI75, significantly superior to placebo and apremilast. POETYK PSO-1 and PSO-2 involved 1688 In the phase 2 trial, the use of deucravacitinib at doses of 3 mg daily and higher Deucravacitinib has been shown to improve psoriatic patches and symptoms The efficacy and safety of deucravacitinib, 6 mg once daily, were demonstrated Deucravacitinib is a novel, oral, selective inhibitor of TYK2 acting via binding to the TYK2 regulatory domain. 5%), PASI score ≥12 (mean 21. Tyrosine kinase 2 (TYK2) mediates cytokine signaling involved in adaptive [interleukin (IL)-12, IL-23] and innate (type-I interferons) immune responses; IL-23–driven T-helper (Th)17 pathways play a key role in chronic inflammation in psoriasis. Methods: The phase 2 trial (ClinicalTrials. 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. The mean change from baseline in Background: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is approved in multiple countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was superior to placebo and apremilast in the global, 52-week, phase 3 POETYK PSO-1 ([NCT03624127][1]) and PSO-2 ([NCT03611751][2]) trials in psoriasis. 12 The study included 267 adults Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, Reduced Absolute Psoriasis Area and Severity Index in a Phase 2 Trial in Moderate to Severe Plaque Psoriasis Bruce Strober, 1 Alice B. Deucravacitinib showed a similar number of adverse events (AEs) and serious AEs (SAEs) across treatment groups. Deucravacitinib is a novel, oral, selective inhibitor of TYK2 acting via binding to the TYK2 regulatory domain. Both trials achieved their co In the 52-week blinded phase III POETYK PSO-3 trial (NCT04167462), patients were randomized 1 : 2 to placebo (n = 74) or deucravacitinib 6 mg once daily (n = 146) for 16 weeks followed by deucravacitinib alone. 3,13,14 Safety AEIs included serious infections, select infections (ie, herpes zoster [HZ], COVID-19 [the LTE trial was conducted during the Background: Effective, well-tolerated oral psoriasis treatments are needed. Deucravacitinib is a novel, selective TYK2 inhibitor approved by the FDA for the treatment of moderate-to-severe plaque psoriasis in adults. 9 Both PSO-1 and PSO-2 demonstrated that deucravacitinib was superior to placebo based on the coprimary end points of PASI 75 and sPGA 0/1 at week 16 and was superior to apremilast at weeks 16 and 24. Patients were randomized 1:2:1 to oral placebo, DEUC 6 mg once daily, or Participants were randomized 2:1:1 to deucravacitinib 6 mg every day (n = 332), placebo (n = 166), or apremilast 30 mg twice a day (n = 168) in the 52-week, double-blinded, phase 3 POETYK PSO-1 trial (NCT03624127). 15 This analysis of the phase 2 trial of deucravacitinib in PsA 11 evaluated the association of serum biomarkers with baseline The POETYK PSO-2 phase III study found that 53% of patients with moderate to severe plaque psoriasis using deucravacitinib had a reduction of 75% or more in their et al. Methods: Participants were randomized 2:1:1 to deucravacitinib 6 mg every day (n = 332), placebo (n = In the recent phase 3 POETYK PSO-1 and PSO-2 trials, deucravacitinib was significantly more efficacious than placebo or apremilast and well-tolerated over 52 weeks in patients with moderate-to-severe plaque psoriasis. This report presents primary results from the phase 3 POETYK psoriasis (PSO)-second (2) trial, which compared the efficacy and safety of deucravacitinib versus placebo and an active Deucravacitinib is a novel, selective TYK2 inhibitor approved by the FDA for the treatment of moderate-to-severe plaque psoriasis in adults. 9, 10 Deucravacitinib is approved in the United States, European Union, Japan and other countries for the treatment of adults with moderate Two global Phase 3 trials, POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751), demonstrated the efficacy and safety of deucravacitinib versus placebo at Week 16 and apremilast at Weeks 16 and 24 in patients with moderate to severe plaque psoriasis based on the co-primary endpoints of a ≥ 75% reduction from baseline in the Psoriasis Area and PRINCETON, N. In a phase 2 trial, deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, reduced IL-23 The POETYK PSO program includes several phase 3 studies aimed at evaluating the efficacy and safety of deucravacitinib. 9 Outcomes are also consistent with those previously reported for Deucravacitinib showed superior efficacy compared with placebo at 16 weeks in a phase 2 trial in patients with PsA. 3–26. Background: Two phase 3 trials, POETYK PSO-1 and PSO-2, previously established the efficacy and overall safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, in plaque psoriasis. 1 The efficacy and tolerability of deucravacitinib in patients with moderate to severe psoriasis were previously demonstrated in 2 pivotal, Phase 3, double-blind trials, POETYK PSO-1 and PSO-2. " Study selection: Relevant articles in English Efficacy and safety outcomes in PSO-2 are consistent with those in the companion phase 3 PSO-1 trial. As described previously, POETYK PSO-1 and PSO-2 were 52-week, phase 3, double-blinded trials that randomized adults with moderate to severe plaque psoriasis 1:2:1 to placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily []. The mean change from baseline in ATP, adenosine triphosphate; TYK2, tyrosine kinase 2. Deucravacitinib has established efficacy and safety through several clinical trials, but many Superiority of deucravacitinib was demonstrated on both co-primary endpoints and multiple key secondary endpoints in the POETYK PSO-2 trial The overall safety profile remains consistent with previously reported results and consistent with the mechanism of action of deucravacitinib, an oral selective tyrosine kinase 2 (TYK2) inhibitor Bristol Myers Squibb (interleukin [IL]-23, IL-12, and Type I interferons) involved in psoriasis pathogenesis1,2 • SDeucravacitinib is a novel oral agent that selectively inhibits TYK2 via an allosteric mechanism by uniquely binding to the regulatory domain2 • In the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials, deucravacitinib was significantly more Introduction Deucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis. 4) and a Physician's Global Assessment (PGA) score of ≥3 In a phase 2 trial, deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, reduced IL-23/Th17 and type-I interferon pathway expression in the skin of patients with moderate to severe plaque psoriasis, reductions that were accompanied by clinical improvement of psoriatic lesions. Co-primary endpoints were the achievement of a ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Findings from the global, phase 3, double-blind POETYK PSO-1 and PSO-2 trials in patients with moderate to severe PP showed that deucravacitinib was significantly more effective than placebo and apremilast based on the coprimary endpoints of a ≥75% reduction in the Psoriasis Area and Severity Index (PASI 75) and a static Physician's Global Assessment Deucravacitinib (SOTYKTU™) is a tyrosine kinase 2 (TYK2) inhibitor that expands the availability of effective oral treatments for the management of moderate to severe plaque psoriasis in adults. The most frequent AEs were nasopharyngitis and URTI, and the frequency of discontinuations due to AEs was lower in the Deucravacitinib was well tolerated and had a similar safety profile in the phase 3 trials to previously published phase 2 results. The data, showcased in a poster, highlighted the efficacy and safety of deucravacitinib (Sotyktu) in patients with moderate to severe scalp psoriasis, demonstrating significant improvements in clinical outcomes compared to In a 52-week phase 3 trial (POETYK PSO-1), 5 which compared the efficacy and safety of deucravacitinib with apremilast and placebo in patients with psoriasis, the types and rates of AEs and SAEs were similar across the groups. This mechanism may allow more specific targeting of Aim: In the global phase 3 POETYK PSO-1 and PSO-2 trials, significantly greater proportions of deucravacitinib-treated patients met the coprimary endpoints (PASI 75, sPGA 0/1) at Week 16 versus placebo or apremilast-treated patients. 2 The long-term efficacy and safety of deucravacitinib were assessed in Objective: Our objective was to evaluate the association of serum biomarkers with baseline psoriatic arthritis (PsA) disease activity, pharmacodynamic effects of deucravacitinib on biomarker levels, and the relationship between biomarkers and clinical responses to deucravacitinib. Armstrong,1 Mark Lebwohl,2 Richard B. S. interleukin-23, type I interferons) involved in the pathogenesis of psoriasis. . Objectives: To further assess the safety of deucravacitinib over 52 weeks in the pooled population from these two trials. Objective: The objective of this study was to demonstrate deucravacitinib superiority versus placebo and apremilast in moderate to severe plaque psoriasis based on ≥75% reduction from baseline in Psoriasis Area and Severity Index Deucravacitinib demonstrated efficacy in a phase 2 trial in patients with active PsA, 11 four phase 3 trials in patients with moderate to severe plaque PsO, 2, 3, 12-14 and a phase 2 trial in patients with active systemic lupus erythematosus. Methods: In this double-blind, phase II trial, 203 patients with PsA were randomised 1:1:1 to placebo, deucravacitinib 6 mg once a day or 12 mg once a day. Efficacy and adverse events with deucravacitinib in phase 2 and 3 clinical trials. Patients and Study Design. g. Deucravacitinib has established efficacy and safety through several clinical trials, but many clinicians are unfamiliar with its safety profile given the lack of formal guidelines. POETYK PSO-1 and PSO-2 involved 1688 patients with moderate-to-severe psoriasis. Deucravacitinib was superior to placebo and apremilast in the global, 52-week, phase 3 POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) trials in psoriasis. POETYK PSO-1 and POETYK PSO-2 In a phase 2 trial in patients with active PsA, deucravacitinib was significantly more efficacious than placebo after 16 weeks of treatment, including demonstrating significant improvements in musculoskeletal manifestations, psoriasis and overall physical/mental health, with around 24% of patients achieving minimal disease activity (MDA) by week 16 . Co-primary endpoints were the achievement of a ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Physician Deucravacitinib was evaluated in a randomized, placebo-controlled, dose-ranging 12-week phase 2 trial (NCT02931838) in patients with moderate to severe plaque psoriasis as defined by a Psoriasis Area and Severity Index (PASI) score of ≥12, affected body surface area of ≥10%, and static Physicians Global Assessment score of ≥3. Food and Drug Administration (FDA) in September 2022 for the treatment of adults with moderate to severe plaque psoriasis (14–16). 0001). Here, onset of action and maintenance of response were evaluated in deucravacitinib-treated patients with moderate to severe plaque psoriasis enrolled in the global phase 3 POETYK PSO-1 and PSO-2 trials. This analysis was designed to evaluate the effect of deucravacitinib on additional clinical and quality-of-life (QoL) outcomes and assess the relationship between Bristol Myers Squibb presented the results of the phase 3b/4 PSORIATYK SCALP trial at the 2024 Fall Clinical Dermatology Conference. In brief, both multicenter, global, randomized, double-blind, placebo- and active comparator-controlled studies evaluated the efficacy and safety of deucravacitinib versus placebo and apremilast in patients with moderate-to-severe plaque After completing 52 weeks in the 2 parent trials, patients transitioned to open-label deucravacitinib in the LTE trial, where safety and efficacy (including Psoriasis Area and Severity Index (PASI) scores and adverse event rates) were assessed over 3 years. Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor that demonstrated superior efficacy versus placebo and apremilast in a global phase 3 trial (POETYK PSO-1; NCT03624127) in patients with moderate to severe plaque psoriasis Psoriasis is an immune-mediated disease, with the interleukin (IL)-23/IL-17 axis currently considered its main pathogenic pathway. 5% of patients from the deucravacitinib group achieved an ss-PGA score of 0/1 compared with 13. In the analysis of 1519 patients, sustained results were evident. Deucravacitinib demonstrated robust efficacy over 52 weeks in 2 phase 3 clinical trials of moderate to severe plaque psoriasis (POETYK PSO-1 and PSO-2). We performed a Phase 2 dose-ranging, placebo-controlled, 12-week study of deucravacitinib in adults with moderate to severe psoriasis. Psoriasis impacts not only physical and mental health but also quality of life (QoL). • Findings from the phase 3 POETYK PSO-1 and PSO-2 trials in patients with moderate to severe plaque psoriasis showed that deucravacitinib was significantly more efficacious than placebo and apremilast based on the coprimary endpoints of ≥75% reduction from baseline in Psoriasis Area Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 POETYK PSO-2 trial Deucravacitinib has demonstrated safety and efficacy in moderate to severe plaque psoriasis in clinical trial development, with >50% of patients on deucravacitinib 6 mg daily achieving ≥75% reduction in Psoriasis Area and Severity Index score from baseline at 16 weeks versus 9-13% on placebo and 35-41% on apremilast 30 mg twice daily in phase Deucravacitinib showed superior efficacy compared with placebo at 16 weeks in a Phase 2 trial in patients with PsA. Three phase 3 clinical trials have examined the efficacy of deucravacitinib in adults with moderate-to-severe plaque psoriasis: two pivotal trials (POETYK PSO-1 and POETYK PSO-2) 26,27 and one long-term extension trial (POETYK PSO-LTE). What makes deucravacitinib unique from other kinase inhibitors is that it Deucravacitinib was evaluated in a randomized, placebo-controlled, dose-ranging 12-week phase 2 trial (NCT02931838) in patients with moderate to severe plaque psoriasis as defined by a Psoriasis Area and Severity Index (PASI) score of ≥12, affected body surface area of ≥10%, and static Physicians Global Assessment score of ≥3. 7% from the placebo group (P <. Deucravacitinib selectively Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor that demonstrated superior efficacy versus placebo and apremilast in a global phase 3 trial (POETYK PSO-1; NCT03624127) in patients with moderate to severe plaque psoriasis (N = 666). 0001), while 38. Researchers previously demonstrated the efficacy and safety of deucravacitinib in the treatment of plaque psoriasis in 2 phase 3, double-blinded, randomized clinical trials: POETYK PSO-1 Background Tyrosine kinase 2 (TYK2) is an intracellular kinase that mediates signaling of key cytokines (eg, interleukin [IL]-23 and Type I interferons) involved in the pathogenesis of immune-mediated diseases including plaque psoriasis and psoriatic arthritis (PsA). Background In the phase 3 POETYK PSO-1 and PSO-2 trials, deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, was well-tolerated and efficacious over 1 year in patients PRINCETON, N. Patients (n = 363) were randomized 1:1:1:1 to receive deucravacitinib 3 mg twice daily, 6 mg twice daily, 12 chronic inammation in psoriasis. 0% reached PSSI 90, respectively (P <. Safety and tolerability of Background/Purpose: Deucravacitinib, a first-in-class, oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in multiple countries for the treatment of adults with plaque psoriasis. Background Psoriasis, a chronic, immune-mediated, inflammatory disease, affects 2‒3% of the population. 12 The study included 267 adults Results: Two phase 3, 52-week trials evaluated deucravacitinib 6 mg against placebo and apremilast - POETYK PSO-1 and PSO-2, enrolling 1688 patients with moderate-to-severe psoriasis. This article aims to review the current Objective: To assess the efficacy and safety of deucravacitinib, an oral, selective, allosteric inhibitor of TYK2, in a phase II trial in adult patients with active systemic lupus erythematosus (SLE). It is being developed by Bristol-Myers Squibb and is expected in late 2022 assuming further trials proceed smoothly []. --(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) announced positive results from the Phase 2 PAISLEY study evaluating deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, compared to placebo in patients with moderate to severe systemic lupus erythematosus (SLE). Objective: To evaluate the efficacy and safety of deucravacitinib (DEUC) in scalp psoriasis. 1007 Safety AEIs were identified based on comorbidities associated with psoriasis (eg, cardiovascular disease), the tolerability profile of deucravacitinib in phase 1 to 2 trials, and AEs reported with other approved psoriasis therapies. Methods: POETYK PSO-1 and PSO-2 were global phase 3, 52-week, double-blinded trials in adults with moderate to severe psoriasis. Coprimary end points included response rates for ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static (A-B): Mechanism of action of deucravacitinib. This report describes efficacy and safety in Japanese patients from this study (N = 66) who were The results of this analysis are consistent with those of two recently completed phase 3 trials in patients with moderate-to-severe plaque psoriasis (POETYK PSO-1 and PSO-2), as well as a phase 2 trial in psoriasis, in which deucravacitinib was efficacious and well tolerated, without clinical or laboratory abnormalities suggestive of JAK 1/2/3 inhibition being observed. Objective: The objective of this study was to review the safety and efficacy of deucravacitinib, a tyrosine kinase 2 (TYK2) inhibitor for moderate to severe plaque psoriasis. 1 Phase 2 results showed In a phase 2 trial, deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, reduced IL After good efficacy and safety results in a phase II, placebo-controlled trial, two phase III, 52-week trials evaluated deucravacitinib 6 mg against placebo and apremilast—an active comparator. Warren,3,4 Howard Sofen,1,5 Akimichi Morita,6 Shinichi Imafuku,7 Mamitaro Ohtsuki,8 Lynda Spelman,9 Thierry Passeron,10 Kim A. By week 16, deucravacitinib significantly outperformed placebo for all primary and secondary efficacy outcomes. 1 The efficacy and tolerability of deucravacitinib in patients with moderate to severe psoriasis were previously demonstrated in 2 pivotal, phase 3, double-blind trials, POETYK PSO-1 and PSO-2. Deucravacitinib specifically targets TYK2 Deucravacitinib in plaque psoriasis: 4-year safety and efficacy results from the phase 3 POETYK PSO-1, PSO-2, and LTE trials April W. Thus, this expert Superiority of deucravacitinib was demonstrated on both co-primary endpoints and multiple key secondary endpoints in the POETYK PSO-1 trial The overall safety profile of deucravacitinib in this study was consistent with previously reported Phase 2 results POETYK PSO-1 is the first Phase 3 trial evaluating the efficacy and safety of deucravacitinib, the first After good efficacy and safety results in a phase II, placebo-controlled trial, two phase III, 52-week trials evaluated deucravacitinib 6 mg against placebo and apremilast-an active comparator. Specifically, 48. Deucravacitinib is a selective oral tyrosine kinase 2 inhibitor for the systemic treatment of moderate to severe plaque psoriasis and other immune-mediated diseases. Tyrosine kinase 2 (TYK2) is responsible for mediating immune signalling of IL-12, IL-23 and type I interferons, without interfering with other critical systemic functions as other JAK proteins do. 16 Different from traditional JAK inhibitors, Deucravacitinib has a unique mechanism of action and is a selective TYK2 allosteric inhibitor, with high affinity to TYK2 pseudokinase domain Janus immune response. Patients receiving placebo crossed over to deucravacitinib at week 16, and some patients receiving In the present analyses of the phase 3 POETYK PSO-1 and PSO-2 trials, oral deucravacitinib demonstrated rapid onset of efficacy using a number of different measures in patients with moderate to severe plaque psoriasis, with some measures demonstrating a statistically significant difference from placebo as early as Weeks 1–2. (TYK2), an intracellular kinase, mediates cytokine signaling (eg interleukin-23, type I interferons) in psoriasis pathogenesis. --(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced positive results from two pivotal Phase 3 trials evaluating deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. Patients in the Niamh Kearney, Andrew Pink, Kim Hoyt, Renata M Kisa, Subhashis Banerjee, Alexandra Rogers, Jill Mullan, Richard B Warren, P096 Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, in moderate-to-severe plaque psoriasis: safety profile in older (≥ 65 years) and younger (< 65 years) patients in the phase III POETYK PSO-1, PSO Introduction. In contrast to Janus kinase inhibitors that target Janus kinase 1–3, deucravacitinib selectively inhibits TYK2. Tyrosine kinase 2 (TYK2) is a member of the Janus kinase (JAK) family, and mediates intracellular signalings from cytokines, type I interferons (IFNs) (IFN-α, β), IL-12, and IL-23 (Citation 3). 8% vs 2. Methods: Adults with active SLE were enrolled from 162 sites in 17 countries. tpor qqgi fgxz mmohjzsp rvz wihn xlnlnf fykn nteov edbgafc togzz ebsdz jjnz cvpebyx ajla