Kim A. Papp, Janusz Jaworski, Bartlomiej Kwiek, Jakub Trefler, Anna Dudek, Jacek C. Szepietowski, Nataliya Reznichenko, Joanna Narbutt, Wojciech Baran, Joanna Kolinek, Stefan Daniluk, Katarzyna Bartnicka-Maslowska, Adam Reich, Yuriy Andrashko, Sunghyun Kim, Yunju Bae, Dabee Jeon, Jinsun Jung, Hyunseung Lee, Woori Ko, YeJin Kim, Diamant Thaçi
Equivalent efficacy—mean per cent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at Week (W) 12 (primary endpoint)—was demonstrated between CT-P43, a candidate ustekinumab biosimilar, and reference ustekinumab. This study further evaluated the efficacy, pharmacokinetics, safety and immunogenicity of CT-P43 vs. reference ustekinumab, including after switching to CT-P43 from reference ustekinumab, in patients with moderate-to-severe plaque psoriasis. In this double-blind Phase III trial, patients were randomised (1:1) to treatment with subcutaneous CT-P43 or reference ustekinumab (45/90 mg [baseline body weight ≤ 100/> 100 kg]). At W16, patients receiving reference ustekinumab were re-randomised (1:1) to either continue this treatment or switch to CT-P43; CT-P43-treated patients continued CT-P43. Study medication was administered at W16 (after re-randomisation), W28 and W40. Secondary efficacy endpoints, pharmacokinetics, safety and immunogenicity were evaluated until W52. At W16, 502 patients were re-randomised (n = 253 continued receiving CT-P43; n = 125 continued receiving reference ustekinumab; n = 124 switched to CT-P43). Mean (standard deviation) PASI scores at W52 were similar across groups (continuing CT-P43: 1.44 [2.921]; continuing reference ustekinumab: 1.33 [3.070]; switched: 1.93 [2.966]). At W52, similar proportions of patients continuing CT-P43, continuing reference ustekinumab and switching achieved ≥ 75% improvement in PASI score (n = 226 [89.3%], 116 [92.8%] and 111 [89.5%]), static Physician’s Global Assessment score of 0/1 (n = 215 [85.0%], 110 [88.0%] and 96 [77.4%]) and Dermatology Life Quality Index score of 0/1 (n = 150 [59.3%], 67 [53.6%] and 78 [62.9%]). Serum ustekinumab concentrations were comparable across groups. Proportions of patients experiencing treatment-emergent adverse events (TEAEs) were similar across groups; study medication–related TEAEs occurred in 14 (5.5%), 8 (6.4%) and 12 (9.7%) patients continuing CT-P43, continuing reference ustekinumab and switching, respectively. Switching did not increase antidrug antibody positivity. Results support the comparability of CT-P43 to reference ustekinumab. Efficacy was maintained after switching to CT-P43 from reference ustekinumab, without notable safety or immunogenicity findings.
{"title":"Efficacy and Safety of CT-P43, a Candidate Ustekinumab Biosimilar, in Moderate-to-Severe Plaque Psoriasis: 52-Week Results From a Randomised, Active-Controlled, Double-Blind, Phase III Study","authors":"Kim A. Papp, Janusz Jaworski, Bartlomiej Kwiek, Jakub Trefler, Anna Dudek, Jacek C. Szepietowski, Nataliya Reznichenko, Joanna Narbutt, Wojciech Baran, Joanna Kolinek, Stefan Daniluk, Katarzyna Bartnicka-Maslowska, Adam Reich, Yuriy Andrashko, Sunghyun Kim, Yunju Bae, Dabee Jeon, Jinsun Jung, Hyunseung Lee, Woori Ko, YeJin Kim, Diamant Thaçi","doi":"10.1155/dth/8811546","DOIUrl":"https://doi.org/10.1155/dth/8811546","url":null,"abstract":"<p>Equivalent efficacy—mean per cent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at Week (W) 12 (primary endpoint)—was demonstrated between CT-P43, a candidate ustekinumab biosimilar, and reference ustekinumab. This study further evaluated the efficacy, pharmacokinetics, safety and immunogenicity of CT-P43 vs. reference ustekinumab, including after switching to CT-P43 from reference ustekinumab, in patients with moderate-to-severe plaque psoriasis. In this double-blind Phase III trial, patients were randomised (1:1) to treatment with subcutaneous CT-P43 or reference ustekinumab (45/90 mg [baseline body weight ≤ 100/> 100 kg]). At W16, patients receiving reference ustekinumab were re-randomised (1:1) to either continue this treatment or switch to CT-P43; CT-P43-treated patients continued CT-P43. Study medication was administered at W16 (after re-randomisation), W28 and W40. Secondary efficacy endpoints, pharmacokinetics, safety and immunogenicity were evaluated until W52. At W16, 502 patients were re-randomised (<i>n</i> = 253 continued receiving CT-P43; <i>n</i> = 125 continued receiving reference ustekinumab; <i>n</i> = 124 switched to CT-P43). Mean (standard deviation) PASI scores at W52 were similar across groups (continuing CT-P43: 1.44 [2.921]; continuing reference ustekinumab: 1.33 [3.070]; switched: 1.93 [2.966]). At W52, similar proportions of patients continuing CT-P43, continuing reference ustekinumab and switching achieved ≥ 75% improvement in PASI score (<i>n</i> = 226 [89.3%], 116 [92.8%] and 111 [89.5%]), static Physician’s Global Assessment score of 0/1 (<i>n</i> = 215 [85.0%], 110 [88.0%] and 96 [77.4%]) and Dermatology Life Quality Index score of 0/1 (<i>n</i> = 150 [59.3%], 67 [53.6%] and 78 [62.9%]). Serum ustekinumab concentrations were comparable across groups. Proportions of patients experiencing treatment-emergent adverse events (TEAEs) were similar across groups; study medication–related TEAEs occurred in 14 (5.5%), 8 (6.4%) and 12 (9.7%) patients continuing CT-P43, continuing reference ustekinumab and switching, respectively. Switching did not increase antidrug antibody positivity. Results support the comparability of CT-P43 to reference ustekinumab. Efficacy was maintained after switching to CT-P43 from reference ustekinumab, without notable safety or immunogenicity findings.</p><p><b>Trial Registration:</b> ClinicalTrials.gov identifier: NCT04673786</p>","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"2026 1","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/dth/8811546","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147299963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
J. Y. Hong and K. Y. Park, “Pilot Study on the Efficacy of a Dual-Length Microneedle Radiofrequency Device With Microblade Design for Neck Rejuvenation,” Dermatologic Therapy, https://doi.org/10.1155/dth/8855222.
In the Funding section of the article, the statement “No funding was received for this research.” was incorrect.
This should have read:
“This work was supported by the Technology Innovation Program (or Industrial Strategic Technology Development Program-Material and Component Technology Development Project [Heterogeneous Technology Convergence Type] [20024946, Development of Tissue Regenerative Biosurgery Convergence Medical Products Using High-Functional Implantable Biomaterials]) funded by the Ministry of Trade, Industry & Energy (MOTIE, Korea).”
We apologize for this error.
J. Y. Hong和K. Y. Park,“双长度微针射频装置与微刀设计用于颈部年轻化的有效性的试点研究”,《皮肤疗法》,https://doi.org/10.1155/dth/8855222.In文章的资助部分,“没有收到这项研究的资助”的声明是不正确的。这应该是:“这项工作得到了技术创新计划(或工业战略技术开发计划-材料和组件技术开发项目[异质技术融合型][20024946,使用高功能可植入生物材料的组织再生生物外科融合医疗产品的开发]的支持,由贸易,工业和能源部(MOTIE,韩国)资助。”我们为这个错误道歉。
{"title":"Correction to “Pilot Study on the Efficacy of a Dual-Length Microneedle Radiofrequency Device With Microblade Design for Neck Rejuvenation”","authors":"","doi":"10.1155/dth/9813767","DOIUrl":"https://doi.org/10.1155/dth/9813767","url":null,"abstract":"<p>J. Y. Hong and K. Y. Park, “Pilot Study on the Efficacy of a Dual-Length Microneedle Radiofrequency Device With Microblade Design for Neck Rejuvenation,” <i>Dermatologic Therapy</i>, https://doi.org/10.1155/dth/8855222.</p><p>In the Funding section of the article, the statement “No funding was received for this research.” was incorrect.</p><p>This should have read:</p><p>“This work was supported by the Technology Innovation Program (or Industrial Strategic Technology Development Program-Material and Component Technology Development Project [Heterogeneous Technology Convergence Type] [20024946, Development of Tissue Regenerative Biosurgery Convergence Medical Products Using High-Functional Implantable Biomaterials]) funded by the Ministry of Trade, Industry & Energy (MOTIE, Korea).”</p><p>We apologize for this error.</p>","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"2026 1","pages":""},"PeriodicalIF":3.4,"publicationDate":"2026-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/dth/9813767","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147320938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}