April W Armstrong, Matthias Augustin, Jennifer L Beaumont, Tan P Pham, Stacie Hudgens, Kenneth B Gordon, Joe Zhuo, Brandon Becker, Yichen Zhong, Renata M Kisa, Subhashis Banerjee, Kim A Papp
{"title":"Deucravacitinib 可改善中度至重度银屑病患者的疗效：POETYK PSO-1 和 PSO-2 3 期随机试验结果。","authors":"April W Armstrong, Matthias Augustin, Jennifer L Beaumont, Tan P Pham, Stacie Hudgens, Kenneth B Gordon, Joe Zhuo, Brandon Becker, Yichen Zhong, Renata M Kisa, Subhashis Banerjee, Kim A Papp","doi":"10.1007/s13555-024-01224-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Deucravacitinib, a novel, oral, selective allosteric tyrosine kinase 2 inhibitor, demonstrated superiority versus placebo and apremilast in the POETYK PSO-1 and PSO-2 studies. We describe patient-reported outcomes with deucravacitinib treatment versus placebo and apremilast in these studies.</p><p><strong>Methods: </strong>Two multicenter, global, double-blind, placebo- and active comparator-controlled studies randomized patients with moderate-to-severe plaque psoriasis 1:2:1 to placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. Score changes from baseline and meaningful within-patient change responses for Psoriasis Symptoms and Signs Diary (PSSD) and Dermatology Life Quality Index (DLQI) were assessed.</p><p><strong>Results: </strong>In POETYK PSO-1 (n = 666) and PSO-2 (n = 1020), respectively, improvement from baseline in PSSD total score was greater with deucravacitinib (- 27.8 and - 30.1) versus placebo (- 4.4 and - 5.9) and apremilast (- 18.9 and - 22.5) at Week 16 and versus apremilast at Week 24 (deucravacitinib: - 32.8 and - 30.7; apremilast: - 21.6 and - 22.8) (nominal p < 0.0001). Improvement from baseline in DLQI score was also greater with deucravacitinib (- 8.5 and - 7.6) versus placebo (- 3.3 and - 3.0) and apremilast (- 5.9 and - 5.8) at Week 16 and versus apremilast at Week 24 (deucravacitinib: - 8.6 and - 7.5; apremilast: - 5.6 and - 5.5) (nominal p < 0.0001). Achievement of meaningful within-patient change in PSSD total score and in DLQI score occurred more frequently with deucravacitinib than placebo and apremilast at Week 16 and versus apremilast at Week 24.</p><p><strong>Conclusions: </strong>Deucravacitinib demonstrated meaningful improvements in patient-reported outcomes in patients with moderate-to-severe plaque psoriasis compared with apremilast and placebo.</p><p><strong>Clinical trial registration: </strong>NCT03624127, NCT03611751.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2235-2248"},"PeriodicalIF":3.5000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11333388/pdf/","citationCount":"0","resultStr":"{\"title\":\"Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials.\",\"authors\":\"April W Armstrong, Matthias Augustin, Jennifer L Beaumont, Tan P Pham, Stacie Hudgens, Kenneth B Gordon, Joe Zhuo, Brandon Becker, Yichen Zhong, Renata M Kisa, Subhashis Banerjee, Kim A Papp\",\"doi\":\"10.1007/s13555-024-01224-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Deucravacitinib, a novel, oral, selective allosteric tyrosine kinase 2 inhibitor, demonstrated superiority versus placebo and apremilast in the POETYK PSO-1 and PSO-2 studies. We describe patient-reported outcomes with deucravacitinib treatment versus placebo and apremilast in these studies.</p><p><strong>Methods: </strong>Two multicenter, global, double-blind, placebo- and active comparator-controlled studies randomized patients with moderate-to-severe plaque psoriasis 1:2:1 to placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. Score changes from baseline and meaningful within-patient change responses for Psoriasis Symptoms and Signs Diary (PSSD) and Dermatology Life Quality Index (DLQI) were assessed.</p><p><strong>Results: </strong>In POETYK PSO-1 (n = 666) and PSO-2 (n = 1020), respectively, improvement from baseline in PSSD total score was greater with deucravacitinib (- 27.8 and - 30.1) versus placebo (- 4.4 and - 5.9) and apremilast (- 18.9 and - 22.5) at Week 16 and versus apremilast at Week 24 (deucravacitinib: - 32.8 and - 30.7; apremilast: - 21.6 and - 22.8) (nominal p < 0.0001). Improvement from baseline in DLQI score was also greater with deucravacitinib (- 8.5 and - 7.6) versus placebo (- 3.3 and - 3.0) and apremilast (- 5.9 and - 5.8) at Week 16 and versus apremilast at Week 24 (deucravacitinib: - 8.6 and - 7.5; apremilast: - 5.6 and - 5.5) (nominal p < 0.0001). 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Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials.
Introduction: Deucravacitinib, a novel, oral, selective allosteric tyrosine kinase 2 inhibitor, demonstrated superiority versus placebo and apremilast in the POETYK PSO-1 and PSO-2 studies. We describe patient-reported outcomes with deucravacitinib treatment versus placebo and apremilast in these studies.
Methods: Two multicenter, global, double-blind, placebo- and active comparator-controlled studies randomized patients with moderate-to-severe plaque psoriasis 1:2:1 to placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. Score changes from baseline and meaningful within-patient change responses for Psoriasis Symptoms and Signs Diary (PSSD) and Dermatology Life Quality Index (DLQI) were assessed.
Results: In POETYK PSO-1 (n = 666) and PSO-2 (n = 1020), respectively, improvement from baseline in PSSD total score was greater with deucravacitinib (- 27.8 and - 30.1) versus placebo (- 4.4 and - 5.9) and apremilast (- 18.9 and - 22.5) at Week 16 and versus apremilast at Week 24 (deucravacitinib: - 32.8 and - 30.7; apremilast: - 21.6 and - 22.8) (nominal p < 0.0001). Improvement from baseline in DLQI score was also greater with deucravacitinib (- 8.5 and - 7.6) versus placebo (- 3.3 and - 3.0) and apremilast (- 5.9 and - 5.8) at Week 16 and versus apremilast at Week 24 (deucravacitinib: - 8.6 and - 7.5; apremilast: - 5.6 and - 5.5) (nominal p < 0.0001). Achievement of meaningful within-patient change in PSSD total score and in DLQI score occurred more frequently with deucravacitinib than placebo and apremilast at Week 16 and versus apremilast at Week 24.
Conclusions: Deucravacitinib demonstrated meaningful improvements in patient-reported outcomes in patients with moderate-to-severe plaque psoriasis compared with apremilast and placebo.
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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