A Phase 3, Randomised, Double-blind, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Brodalumab Treatment Compared to Placebo and Ustekinumab in Adolescent Subjects With Moderate-to-severe Plaque Psoriasis

The study will investigate the efficacy and safety compared to placebo and the safety compared to ustekinumab of brodalumab in adolescents with moderate to severe plaque psoriasis. The study will also investigate if brodalumab affects development of vaccination-induced immune responses.
The study will run over 62-64 weeks (including screening, treatment, and safety follow-up) for each participant, but with the primary endpoint measured at Week 12.

开始日期2022-12-07

申办/合作机构

Leo Pharma, Inc.

NCT04306315 / Recruiting临床4期

Adjustable Brodalumab Dosage Regimen Compared With Standard Brodalumab Treatment for 52 Weeks in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight

This study investigates if an adjusted brodalumab dosage regimen will give improved efficacy in psoriasis in patients with a body weight of over 120 kg. The increased dosage regimen will be compared to the standard brodalumab treatment plus placebo.

开始日期2022-07-18

申办/合作机构

Leo Pharma, Inc.

100 项与布罗利尤单抗相关的临床结果

登录后查看更多信息

100 项与布罗利尤单抗相关的转化医学

登录后查看更多信息

100 项与布罗利尤单抗相关的专利（医药）

登录后查看更多信息

416

项与布罗利尤单抗相关的文献（医药）

2024-02-03·Journal of the European Academy of Dermatology and Venereology : JEADV

Real-world data on the effectiveness of brodalumab in patients with moderate-to severe plaque psoriasis in the Greek clinical setting (the BrIDGE study).

Article

作者: Dimitrios Rigopoulos ; Eleftheria Tampouratzi ; Charalampos Angelakopoulos ; Zoe Apalla ; Ioannis Barkis ; Sophia Georgiou ; Florentina Delli ; Alexandros Drosos ; Efterpi Zafiriou ; John Katsantonis ; Elisavet Lazaridou ; Pantelis Panagakis ; Evangelia Papadavid ; Markos Papakonstantis ; Angeliki-Viktoria Roussaki-Schulze ; Elena Sotiriou ; Georgios Anastasiadis ; Vasiliki Chasapi ; Konstantinos Sfaelos ; Dimitrios Ioannides ; BrIDGE Study Group

BACKGROUND:

Despite that brodalumab's efficacy and safety have been assessed in randomized clinical trials, real-life data remain scarce. BrIDGE was an observational, prospective, single-cohort, multicentre study that recruited patients with moderate-to severe plaque psoriasis in Greece.

OBJECTIVES:

The primary objective was to assess the proportion of patients who achieved Psoriasis Area and Severity Index (PASI)100 after 24 weeks. Other endpoints included: the maintenance of PASI90/100 through to 104 weeks, the short-term response [PASI75/90/100 and static Physician's Global Assessment (sPGA) 0/1] to brodalumab at 12-16 weeks and time to complete clearance. Moreover, we explored the change in quality of life [Dermatology Life Quality Index (DLQI) 0/1] and adherence to brodalumab.

METHODS:

Two hundred patients who were initiating treatment with or switching to brodalumab, were recruited. Analyses were conducted using the as observed data and three imputation approaches were also applied for the missing data (last observation carried forward, 'worst case' and 'best case' scenario). Continuous variables were reported using summary statistics, whereas categorical variables were reported in frequency tables.

RESULTS:

Based on the 'as observed data', 42.0% of patients achieved PASI100 at Week 24 after 25.9 ± 3.5 weeks and 65% of patients attained PASI100 at Week 104. In total, 70.2%, 47.5% and 32.0% achieved PASI75/90/100, respectively, whereas 72.6% of patients achieved sPGA 0/1, at Weeks 12-16. With respect to sPGA status 82.8%, 89.2% and 92.5% of patients achieved sPGA 0/1 at Weeks 24, 52 and 104, respectively. The time to achieve PASI100 at Weeks 12-16 was 13.7 ± 1.3, 52.1 ± 3.4 weeks at Week 52 and 105.5 ± 4.8 weeks at Week 104. Mean DLQI and Psoriasis Symptom Inventory (PSI) scores decreased by 11.4 ± 7.0 and 15.4 ± 6.5 points from baseline to Week 104, respectively. Adherence to treatment was equal to 98.9%.

CONCLUSIONS:

Brodalumab confers rapid and durable responses, as well as improvements in the quality of life of moderate-to-severe psoriasis patients.

2024-02-01·Dermatology and therapy

Brodalumab Versus Guselkumab in Patients with Moderate-to-Severe Psoriasis with an Inadequate Response to Ustekinumab: A Randomized, Multicenter, Double-Blind Phase 4 Trial (COBRA).

Article

作者: Kristian Reich ; Luca Bianchi ; Abdallah Khemis ; Julia-Tatjana Maul ; Athanasios Tsianakas ; Christoph M Schempp ; Kim Petersen ; Mia M Noergaard ; Lluis Puig

INTRODUCTION:

Despite improved treatment options for plaque psoriasis within the last decades, some patients still have an inadequate response to treatment. Direct clinical evaluation between therapies used after biologic failure could facilitate physicians' choice of treatment.

METHODS:

COBRA (NCT04533737) was a randomized (1:1), blinded (patient and assessor), 28-week, active-comparator trial conducted in Europe from December 2020 to December 2022. The objective was to compare the efficacy and safety of brodalumab versus guselkumab in adults with moderate-to-severe plaque psoriasis and inadequate response to ustekinumab. Patients received either brodalumab 210 mg or guselkumab 100 mg. The primary [having Psoriasis Area and Severity Index (PASI)-100 response at week 16] and key secondary (time to PASI-100 response) endpoints were tested in a fixed sequence.

RESULTS:

Due to delays and enrollment challenges, recruitment was terminated with 113 patients enrolled of 240 planned. The proportion of patients having PASI-100 at week 16 for brodalumab was 53.4% compared with 35.9% for guselkumab [odds ratio (OR) 2.05; 95% confidence interval (CI) 0.95, 4.44; p = 0.069]. As this was not statistically significant, the hierarchical testing procedure was stopped. All other secondary PASI endpoints had nominal p-values below 0.05 in favor of brodalumab. In the time to PASI response analyses, brodalumab separated from guselkumab in estimated cumulative incidence of patients achieving a response from week 2 onward, suggesting fast onset of action with brodalumab. Quality of life measures improved in both treatment groups. The safety findings were consistent with the known safety profiles.

CONCLUSIONS:

Brodalumab showed a tendency toward better and earlier effect than guselkumab in patients who had failed ustekinumab. Thus, this trial provides important information in assisting physicians in their choice of therapy for patients who have failed their prior anti-interleukin (IL)-12/23 treatment.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier NCT04533737.

2024-01-31·Actas dermo-sifiliograficas

Comparing the use of topical therapy along with anti-IL17 and anti-IL23 to treat moderate-to-severe psoriasis in the routine clinical practice.

Article

作者: S Berenguer-Ruiz ; M Romero-Dávila ; M Aparicio-Domínguez ; E Daudén ; M Llamas-Velasco

BACKGROUND:

Combinations of topical (TT) and biological therapies (BT) are a common thing in the routine clinical practice. However, the scientific medical literature on how TT is, actually, used after the initiation of BT is scarce, particularly in combination with anti-IL17, or anti-IL23.

OBJECTIVES:

To describe the frequency of the concomitant use of TT + BT at baseline and after a 6-month course of several drugs (anti-IL17, ustekinumab, and anti-IL23). Our secondary endpoints are to describe the type of topical therapy used, compare the frequency of use of TT among the different groups of BT, describe the survival of topical therapy in these patients, and identify the factors that can impact the use or discontinuation of topical therapy in these patients (clinical response, quality of life, type of drug, etc.).

MATERIALS AND METHODS:

This was a retrospective, observational, and single-center study of patients with moderate-to-severe psoriasis treated with anti-IL17 (secukinumab, ixekizumab), anti-IL17R (brodalumab), ustekinumab, and guselkumab from January 2015 through December 2020.

RESULTS:

We included a total of 138 patients. When treatment started, 82.7% were on TT (55% daily), and after 6 months, 86.6% had discontinued TT. Regarding the analysis by type of drug, at 6 months, we found that 100% of the patients with BRO had discontinued topical treatment. We did not find any significant differences in the frequency of use of TT based on the BT used during the 6-month course of treatment. The estimated mean course of TT was 4.3 months (SD, 6.7). Also, the estimated mean course of TT was significantly shorter in the group of patients who achieved PASI100 (2.8 months vs 8.1 months).

CONCLUSIONS:

In our cohort, we saw a significant decrease in the frequency of use of TT at 6 months after starting BT in the routine clinical practice. This reduction occurred earlier in patients who improved their objective clinical response and quality of life.

项与布罗利尤单抗相关的新闻（医药）

2024-03-19

·药渡Daily

今日，荃信生物正式在港交所上市

今日，荃信生物在港交所上市，共发行1204.64万股，由中金公司、安信国际联席保荐。在自免药物国产化替代的浪潮下，加之此前与国际市场存在较大的市场落差的局面下，自免赛道正值爆发的前夕。荃信生物虽是初登资本市场，但江湖上早有它的传说。在国内专注自免赛道的Biotech并不算多，荃信生物凭借丰富的管线占有着极大的份量。来源：招股书最丰富的管线江苏荃信生物医药股份有限公司（“荃信生物”）是一家完全专注于针对自身免疫及过敏性疾病生物疗法的Biotech，是目前国内在自身免疫性疾病及过敏性疾病方面获最多临床试验申请（IND）批准的药企之一。荃信生物的在研管线中包含两个核心产品QX002N及QX005N，以及七个其他候选药物；涉及的靶点包括IL-17A、IL-33、TSLP、IFNAR1等，涵盖了自身免疫和过敏性疾病的四个主要领域，即皮肤、风湿、呼吸道及消化道疾病；适应症包括银屑病、特应性皮炎、系统性红斑狼疮、中重度哮喘等等。荃信生物在研管线来源：招股书核心产品QX002N（IL-17A单抗）QX002N是一种人源化IgG1单克隆抗体，旨在用于特异性结合IL-17A，包括IL-17AA和IL-17AF，从而阻断其与预期受体复合物的结合，包括白细胞介素17受体A（IL-17RA）及白细胞介素17受体C（IL-17RC），并阻止若干促炎信号通路的后续激活。在II期临床试验中，每4周一次接受QX002N（160mg）的受试者在第16周时的ASAS20及ASAS40应答率分别达到60.0%及40.0%。目前QX002N治疗强直性脊柱炎（AS）的III期临床试验已启动，预计在2025年下半年完成。QX002N的作用机制来源：招股书核心产品QX005N（IL-4Rα单抗）QX005N是一种针对白介素4受体α亚基（IL-4Rα）的重组人源化IgG4单克隆抗体。IL-4Rα是一种经充分验证的广泛作用靶点，可控制IL-4及IL-13的信号传导，这对于2型炎症（一种支持多种慢性过敏性疾病的病理生理学的免疫应答模式）的发生至关重要。通过与IL-4Rα结合，QX005N被设计用于阻断驱动2型炎症反应的IL-4和IL-13信号通路，可望成为2型过敏性疾病的有效治疗方案。目前，QX005N正在开发用于七种适应症，包括成人中重度特应性皮炎、青少年特应性皮炎、结节性痒疹、慢性鼻窦炎合并鼻息肉、慢性自发性荨麻疹、中重度哮喘及慢性阻塞性肺病。其中，成人中重度特应性皮炎、结节性痒疹、慢性鼻窦炎合并鼻息肉患者正在进行II期临床试验评估，青少年特应性皮炎、慢性自发性荨麻疹、中重度哮喘及慢性阻塞性肺病的IND已获批准。QX005N的作用机制来源：招股书QX001S（乌司奴单抗生物类似药）QX001S是首个在中国提交上市申请的国产乌司奴单抗生物类似药，且可能成为首个获批的乌司奴单抗生物类似药。乌司奴单抗于2009年获得美国FDA批准，是针对性抑制IL-23及IL-12路径的首款生物疗法，是治疗银屑病的主要疗法之一。在针对银屑病的III期临床试验中，QX001S显示出与乌司奴单抗相当的临床疗效、安全性、免疫原性及PK特性。QX001S已于2023年7月在中国提交上市申请，预计2024年第四季度获批，中美华东拥有QX001S在中国的独家商业化权利。QX004NQX004N是一款IL-23p19抑制剂，IL-23p19已成为对症状更严重或对现有治疗反应欠佳的银屑病患者具有卓越疗效的关键靶点。目前QX004N在中国启动治疗银屑病的Ib期临床试验及II期临床试验，正在开展治疗克罗恩病的Ia期临床试验。QX006NQX006N是一种IFNAR1靶向单抗，开发用于治疗系统性红斑狼疮。首创的IFNAR1抑制剂SAPHNELO（阿尼鲁单抗）于2021年获FDA批准，成为10多年来唯一的SLE新疗法。但在中国，仍未有获批的治疗系统性红斑狼疮的IFNAR1抑制剂，QX006N是中国仅有两款国产IFNAR1抑制剂之一，目前正在开展Ib期临床试验。QX008NQX008N是一种靶向TSLP的人源化IgG1单克隆抗体，为治疗中重度哮喘和中重度慢性阻塞性肺病而设。TSLP靶向治疗是全球唯一一类被批准用于哮喘的生物药物，可以减缓2型生物标志物表达水平低或无表达的哮喘患者的疾病进展。目前QX008N正在开展对中重度哮喘的成年患者开始Ib期临床试验，并且已经License-out给了健康元。从上述自免领域管线来看，荃信生物布局的都是近年来自免靶点的大热门，国内也不乏大力布局的Biotech。那么，在自免赛道全面爆发之前，荃信生物处于什么样的梯队状态，能否夺取较大的优势呢？暴风雨来临的前夜自免赛道历来不缺乏大单品，在2023年全球最畅销药物TOP10中，自免药物就占了三席，分别是修美乐（144.04亿美元）、度普利尤单抗（115.88亿美元）和乌司奴单抗（108.58亿美元）。自免药物之所以能出“爆款”，主要在于自免疾病的特性。全球自免患病人群总数预计5亿以上，根据对于常见的自免疾病的统计，全球自免疾病的患病率约5-8%，是继癌症和心血管疾病外第三大慢性病。自免疾病目前难以完全根治，患者需要长期甚至终身用药，这造就了自免药物超千亿美元的大市场。主要自身免疫疾病分类及其全球发病率来源：东方证券研报但在中国，自免市场却是另一种模样。尽管中国主要自免疾病患者近4000万人，但市场开发仍显著落后。2022年，自身免疫及过敏性药物的全球市场规模为1875亿美元，而中国的该市场规模仅为90亿美元，生物药的渗透率也仅为10%。因此中国自免药物市场的增长潜力巨大，有望从2018年的20亿美元增长至2025年的61亿美元，并于2030年达到199亿美元。中国自免药物市场预测走势图来源：招股书白介素是免疫调节的靶点大家族，在机体免疫和炎症相关的信号通路中，白介素家族协同刺激naiveＴ细胞分化成不同功能的辅助型Ｔ细胞，包括Th1、Th2等。可用于自免行业的白介素靶点主要包括IL-17、IL-23和IL-6等。在某些自免疾病，如银屑病，IL-17A抑制剂和IL-12/23抑制剂的安全性优于TNF-α抑制剂。2019年以来，国内共上市了3款IL-17靶点抗体药物：司库奇尤单抗、依奇珠单抗和布罗利尤单抗。司库奇尤单抗作为首个获批上市的IL-17药物，凭借其先发优势和不断拓宽的适应症，2023年实现全球49.80亿美元的销售额。根据药渡数据，2023年前三季度，该药在中国的销售额为18亿元。在中国，IL-17靶点药物适应症以银屑病、强直性脊柱炎和中轴型脊柱关节炎为主，进度居前的为智翔金泰的GR1501和恒瑞医药的夫那奇珠单抗，二者分别于2023年年3月和4月提交上市申请；三生国健、百奥泰、康方生物的IL-17在研与荃信生物的QX002N同处于临床III期，为第二梯队。IL-17靶点国内研发情况来源：东方证券研报IL-23靶点方面，目前全球有四种IL-23抗体药物获批，分别为乌司奴单抗、古塞奇尤单抗、替拉珠单抗及瑞莎珠单抗。乌司奴单抗（Stelara）是强生的核心单品，2023年的营收让人意外，全年收入达到了108.58亿美元，正式迈入百亿美元畅销单品俱乐部。根据药渡数据，2023年前三季度，Stelara在中国的销售额达2.78亿元，已超2022年总销售额，劲头迅猛。但2023年或许将是Stelara最后的辉煌，因其专利期已到，目前全球已有两款乌司奴单抗生物类似药获批上市。国内的乌司奴单抗生物类似物研发除了荃信生物的QX001S外，还有百奥泰的BAT2206；而同为IL-12/IL-23靶点的创新药有康方生物的AK101（NDA）、信达生物的IBI112（II期）、新石生物的NBL-012（I期），以及荃信生物的另一款QX004N（I期）。国内IL-12/23靶点药物研发情况来源：东方证券研报IL-4R靶点方面，目前中国仅有一款IL-4R单抗获批上市，为赛诺菲制药的度普利尤单抗，其于2020年6月在中国首次获批上市，目前已获批用于治疗特应性皮炎、结节性痒疹和哮喘，还有多项适应症处于临床研发阶段。康诺亚的IL-4R单抗Stapokebart（CM310）目前已有多项适应症处于临床III期，包括特应性皮炎、过敏性鼻炎、哮喘、慢性鼻窦炎伴鼻息肉；康乃德的Rademikibart（CBP-201）、三生国健的SSGJ-611、智翔金泰的GR1802、康方生物的曼多奇单抗、麦济生物的Comekibart、荃信生物的QX005N、恒瑞医药的SHR-1819、正大天晴的TQH2722等IL-4R单抗也先后进入临床II期。国内IL-4R靶点药物研发进展梳理来源：民生证券研报从往年国际自免大单品在国内的销售表现看，十分不尽人意。如“药王”修美乐在中国的年销售额很长的一段时间里都不超过1亿元人民币。这里面固然有价格和政策的因素，但同时也说明了中国自免药物的市场教育太落后。近两年越来越多专注自免领域的Biotech陆续登陆资本市场后，这一现状或将得到较大的改善，市场或许也将就此打开。结语从荃信生物的股权结构中，我们发现了一个熟悉的身影----华东医药。华东医药对荃信生物来说，不仅仅只是BD的合作对象，更是占比达16.17%的股东。原来华东医药的创新资产押注在这里，这也就难怪华东医药自己主营业务一心在医美和减重领域摸爬滚打。从质地上看，荃信生物确实非常不错，不仅自免靶点种类齐全，而且进度也基本处于前列梯队，前景十分乐观。后续发展如何，药渡还将持续关注。参考资料荃信生物招股书、官网等东方证券、民生证券研报等

临床申请临床2期

2024-03-18

·动脉网

国产自免，即将深陷百药大战

自免药物市场重新变得充满不确定性。自从修美乐全球销量出现拐点，K药取代修美乐，坐上“药王”宝座，自免药物的开发者们又有了新奔头。在一个非共识的市场里，建立新的秩序，无疑将带来巨大的商业价值。可以看到，全球自免药物市场加速变得拥挤。原本的自免药物巨头没有功成离场，新的跨国药企手持重金加入战局。2023年6月，诺华35亿美元收购IgA肾病药物领先公司Chinook Therapeutics，礼来24亿美元收购DICE Therapeutics，获得其口服IL-17抑制剂等自免用药。在国内，自免新药的开发，相对肿瘤新药，并不算十分热门的领域，但随着越来越多的新靶点被验证，不少企业开始加码布局自免管线。数据显示，国内有数十家新药研发企业，布局了上百条自免新药管线。其中，TNFα和IL-12/IL-23两个自免领域老靶点引发的国产生物类似药竞逐，依然激烈，而JAK、IL-17A等新靶点，则吸引大量创新药企深耕，在研产品数量最多。国产自免药无战事在国内，自免药物市场一直充满不确定性。在生物制剂取代传统抗炎药物，成为自免疾病主流治疗方案的很长一段时间里，这个领域的进口药是干不过国产的。2002年，三生国健的前身中信国健成立。3年后，三生国健推出了靶向TNF-α的重磅产品益赛普，用于治疗类风湿关节炎，2年后新增强直性脊柱炎、银屑病适应症。后来，这款药主导国内自免药市场近15年之久。根据三生国健招股书，2018年至2020年间，益赛普的销售收入是公司营收的主要来源，占比超过99%。2017年9月，益赛普纳入国家医保，进一步推高了销售额。财报显示，2018年，益赛普的销售额达到 11.1 亿元，同比增长 9.7%，占国内TNF-α药物市场份额达到64%。在这个过程中，依那西普的原研药恩利，和在海外卖翻了的TNF-α重磅药物修美乐，一直在国内被益赛普压着打。2010年，恩利和修美乐在国内上市。失去了先发优势的原研明星药，加上高出至少一倍的用药费用，在国内销售十分低迷。2018年，修美乐在样本医院的销售额才刚刚接近2000万元，是益赛普同期销量的1/20。早期国内销售的自免生物制剂数据来源：动脉网根据公开信息整理不过，建立在外部因素之上的市场独占地位，很容易被撼动。转折发生在2019年。2019年，修美乐和类克进入医保，百奥泰的格乐立、海正药业的安健宁获批上市。当年，修美乐、格乐立、安健宁的年治疗费用分别降低到3.35万元、3.01万元和2.99万元，远低于益赛普彼时的6.69万元。2020年，修美乐在样本医院销售额达7008万元，较2019年增长270.76%。2022年，益赛普在TNF-α类药品的市场份额为27%，益赛普的市场份额较去年同期略有下降。2018年至2022年间，国内TNF-α药物市场变化数据来源：三生国健财报实际上，益赛普独占市场背后的另一重原因，在于国内自免药物市场的整体规模一直没有起量。据Frost & Sullivan统计，尽管一直保持着上升趋势，到2022年，国内的自免药物市场规模仍没有突破50亿美元，而同期的全球自免药物市场已经接近1500亿美元。与之形成对比的是，2022年，全球肿瘤药物市场规模约1500亿美元，而国内的这一市场规模已经达到354亿美元。当然，自免药物自有其独特性。自免疾病的患者基数大，治疗周期长，加上药物在适应症之间的拓展性强，本身就很容易出现重磅药物。近年来，随着人们对自免疾病机理研究走向深入，新靶点自免药物逐步改变国内的临床实践和患者习惯，拓宽了自免药物的市场边界。益赛普被迫走下神坛之初，三生国健曾经尝试走出舒适区，去拓展新的疾病领域。但多番尝试后，三生国健又再聚焦自免新药。2023年末，三生国健在财报中表示，将集中全力在自免领域深耕。动脉网注意到，自2023年开始，三生国健陆续减少在其他领域的研发费用，甚至交易其他领域的在研管线。2023年4月，三生国健将公司在研抗肿瘤项目602、609、705、707以及眼科在研药物601A项目独家授予沈阳三生，允许其在中国大陆以及美国开发以上药物。此外，三生国健还将304R项目所产生的所有化合物及其成为药物后的其他在全球范围内的一切权利转让给沈阳三生。白介素闯入者充分挖掘过TNF-α靶向药的潜力之后，扩大自免药物市场规模的希望，落到这个行业的闯入者之上。在国内，IL-17A无疑是最热门的自免新药靶点。除了已经上市的司库奇尤单抗、依奇珠单抗等进口药，从研发进度看，公开信息可以查询的在研IL-17A新药，形成了三个梯队，即以赛立奇单抗和夫那奇珠单抗为代表的NDA药物梯队，由国内的创新药企开发，以QX002N、古莫奇单抗等为代表的已经进入III期临床阶段的管线，和尚处于研发中早期阶段的大量管线。现阶段，全球共上市5款靶向IL-17A/IL-17RA药物，即司库奇尤单抗、依奇珠单抗、尼塔奇单抗、比吉利珠单抗和布罗利尤单抗。其中，司库奇尤单抗、依奇珠单抗和布罗利尤单抗已在国内获批，比吉利珠单抗也已在国内申报上市。作为自免新药，IL-17A/IL-17RA药物极大减少了自免患者的治疗支出，但花费仍然不低。以诺华制药的司库奇尤单抗为例，初始定价每支单价2998元，年治疗费用达4.04万元，而礼来的依奇珠单抗，单支定价4318元，年治疗费用为2.59万元。当然，纳入医保后的治疗价格大幅下降，这是后话。属于国产第一梯队的赛立奇单抗和夫那奇珠单抗，分别由智翔金泰和恒瑞开发，2023年3月和4月，赛立奇单抗和夫那奇珠单抗相继申请在国内上市，成为替代进口IL-17A/IL-17RA药物最有力的竞争者。目前，赛立奇单抗和夫那奇珠单抗都在大人群的临床研究中，表现出了优秀的安全性和有效性。数月前，恒瑞曾公布了夫那奇珠单抗的一项研究结果，评估其在中至重度斑块状银屑病患者中的多中心双盲2期研究（NCT03463187）取得积极结果。数据显示，在第12周，与安慰剂组相比，所有夫那奇珠单抗组的银屑病PASI 75都有所改善，40、80、160和240mg组PASI 75分别为56.8%、65.8%、81.6%和86.5%，而安慰剂组为5.4%；使用夫那奇珠单抗时，达到0或1的医师整体评估反应的患者也更高，40、80、160和240mg组分别为45.9%、47.4%、60.5%和73.0%，而安慰剂组为8.1%。未观察到意想不到的不良反应。本月初，智翔金泰也公布了赛立奇单抗的最新研究数据。数据显示，第12周，200mg赛立奇单抗试验组达到PASI 75的受试者比例为90.7%（安慰剂对照组为8.6%），达到皮损清除/几乎清除（PGA 0/1）的受试者比例为74.4%（安慰剂对照组为3.6%），达到主要临床终点。与此同时，PASI90应答率为74.4%，第52周PASI75应答率96.5%，PASI90应答率为84.1%，PGA0/1应答率为83.7%，保持了高水平的皮损改善，获得持续性的治疗应答。智翔金泰的强势入局，让国产自免一哥之争充满变数。相比之下，国产IL-17A/IL-17RA药物第二梯队的企业颇为庞大，既有国产自免的老大哥三生国健，也有跨界而来的肿瘤新药明星企业君实生物、康方生物。主要的国产IL-17A药物研发进展数据来源：动脉网根据公开信息整理至少7家企业挤在IL-17A药物的III期临床之上，适应症选择高度重叠，破局之争不可谓不激烈。更重要的是，目前冲在研发最前线的创新药企，医学临床和商业渠道能力都不容置疑，也不相上下。作为曾经国内自免生物制剂市场的霸主，三生国健没能跑进IL-17A药物第一梯队，已是遗憾，但基于益赛普建立的，对国内自免疾病治疗特点的理解，和品牌认知，无疑会增加一些胜算。而君实生物和康方生物，作为肿瘤新药领域拓荒者，荃信生物的创始团队也并非新药新兵，他们对新药研发到上市的认知，复制到IL-17A的开发之上，也能减少这个过程的不确定性。从某种意义上讲，或许IL-17A/IL-17RA药物的上市之争，才是国内创新药企业之间，开发能力的第一次真正拼刺刀。弯道超车的JAK抑制剂？以往谈及JAK抑制剂，人们第一反应可能是做肿瘤新药。但从在研项目数量看，JAK是吸引药企数量仅次于TNFα的靶点，热度甚至比IL-17A更高。JAK-STAT信号通路由酪氨酸激酶相关受体、酪氨酸激酶JAK和转录因子STAT组成，由细胞因子刺激的信号转导，参与细胞的增殖、分化、凋亡以及免疫调节等许多重要的生物学过程，是人体内重要的信号通路之一。作为细胞质酪氨酸激酶家族的一员，JAKs共有JAK1、JAK2、JAK3、TYK2四种亚型，亚型之间有重叠的结合对象。其中JAK1、JAK3更多负责免疫调节，而JAK2主要与红细胞和血小板的生成相关。JAK－STAT信号通路与多种自身免疫性疾病的发病机制相关，包括类风湿关节炎、银屑病和炎症性肠病等。从上个世纪90年代全球首个JAK抑制剂被发现以来，全球范围内已经有11款JAK抑制剂原研药获批上市。不同代际的JAK抑制剂数据来源：动脉网根据公开信息整理不同代际 JAK 抑制剂之间的差异，主要体现在对体内信号通路的选择性强弱。第一代JAK抑制剂为非选择性JAK抑制剂，同时阻断多条相关信号通路，缺乏选择性。第二代JAK抑制剂减少了第一代的严重不良反应，选择性地抑制JAK家族成员。到了第三代JAK抑制剂，可高度选择性地结合细胞上的相应结构域，特异性地抑制剂细胞活性。2017年，首款JAK抑制剂登陆国内市场，快速得到临床端认可，JAK抑制剂的市场规模也迅速扩容。数据显示，2022年，国内JAK抑制剂市场规模达到9.43亿元，同比增长222.95%。据弗若斯特沙利文预测，国内JAK抑制剂的销售还将持续增长，到2024年和2030年，市场规模将分别达到100亿、481亿元人民币，2019年至2024年间的复合增长率可以达到92.2%。不过，总体来看，国产JAK抑制剂的自免适应症开发，进展稍逊于IL-17A。动脉网查询发现，现阶段，国内注册申报JAK抑制剂涉及60个品种，313个受理号。其中，在国内JAK抑制剂研发数量TOP10企业中，恒瑞、凌科药业、泽璟生物等，开发进度最靠前。恒瑞开发的SHR0302是一种高选择性的JAK1抑制剂，已在中国获批开展类风湿关节炎、白癜风、溃疡性结肠炎等多种自免疾病的临床试验。其中，SHR0302的斑秃、特应性皮炎、溃疡性结肠炎、类风湿性关节炎、强直性脊柱炎等适应症进展最快，已经进入III期临床试验。泽璟制药开发的盐酸杰克替尼，也已经在进行中高危骨髓纤维化、重症斑秃、中重度特应性皮炎等自免疾病适应症的III期临床试验。除此之外，大多数国产自免JAK抑制剂还出去II期临床试验，或者更早的开发阶段。其中，凌科药业开发的LNK01003，对肠道具有限制性，将用于治疗溃疡性肠炎等疾病的治疗，颇受行业关注，目前，这款药物正在进行II期临床试验。相比IL-17A药物竞争的短兵相接，国产自免JAK抑制剂之争相对温和，但是在定价更低的JAK抑制剂市场，丢了先发优势的国产药物，能否在与进口原研药的竞争中立足，甚至凭借更强的本土化能力弯道超车，答案还不算清晰。无论是在全球还是国内，自免疾病都是第二大的临床用药市场。但与之相对应，药物供给侧的产品体系，尚不算完善。在国内，自免药物体系的缺失则更为明显。自免药物市场规模扩容之下，我们看到，越来越多的国内药企加入、加码这个并不算炙手可热的领域，而谁能笑到最后，我们拭目以待。*封面图片来源：pexels文|王世薇微信|no_th_ing添加时请注明：姓名-公司-职位网站、公众号等转载请联系授权：Rekkiiie近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

财报并购免疫疗法上市批准生物类似药

2024-03-14

·PRNewswire

Psoriasis in America - Insights into Psoriasis Patient Demographics, Quality of Life, Information-seeking Behaviors, HCP Engagement and Treatment Experiences

DUBLIN, March 14, 2024 /PRNewswire/ -- The "Psoriasis in America 2023: Understanding the Psoriasis Patient Experience" report has been added to ResearchAndMarkets.com's offering. Approximately 7.5 million people in the United States have psoriasis. This Psoriasis in America report provides a comprehensive look at life for those living with psoriasis. Using detailed quantitative data, it gives a full picture of the psoriasis patient experience - from symptoms to treatment to HCP relationships to quality of life - so you can make informed, strategic decisions, identify opportunities, and understand potential challenges. The report offers an in-depth look at the psoriasis patient experience. This large-scale, patient-reported data leverages vital quantitative insights essential to understanding key touchpoints in the psoriasis patient journey, including condition management, HCP engagement, quality of life, treatment experience and satisfaction, and much more. This report lifts the curtain on life with psoriasis, giving stakeholders an actionable look at the behaviors, attitudes, perceptions, needs, and experiences of people living with the condition. Data can be used to inform strategic decisions, including product communications, competitive assessments, concept development, landscape analyses, patient journey overlays, and forecasting inputs. This report also addresses important questions that stakeholders may not even know to ask while offering valuable insights into must-have patient-reported data points not available anywhere else. Add-on custom data analysis opportunities are also available for an additional cost - please see the report following purchase for more information. The analyst reaches millions of people through its portfolio of 45+ condition-specific online health communities - including PlaquePsoriasis.com - to provide information, connection, and support to patients and caregivers in the U.S. This report includes a deep-dive into: Psoriasis patient demographics Age, gender, ethnicity, marital status, children, employment status, income, location, insurance, and other health conditions Impact of psoriasis on quality of life Severity, impact on quality of life, symptoms experienced, and what patients wish others better understood Information-seeking behaviors Information sources used, plus topics of interest HCP engagement Primary HCP seen for condition, satisfaction with HCP, and discussion about brands aware of/not used Psoriasis treatment awareness and experiences Aided awareness of specific treatments, treatment experience, satisfaction with current treatments, perceived control with current treatment plan, and interest/participation in clinical trials Key questions answered in this report: To what extent do people say psoriasis impacts their overall quality of life? What's the average number of flares in the past year? What do patients wish others understood about psoriasis? What percentage of patients see a specialist for psoriasis treatment? What treatments have the highest aided brand awareness among patients? What percentage of patients use a biologic? How many patients feel their psoriasis is well-controlled on their current treatment plan? What percentage of patients are likely to switch or add new treatments in the next six months? What medications have patients discussed with their HCP? What are the top online resources people with psoriasis use to find information? What kinds of content and information do patients search for? What percentage of patients search for information on treatment options? Methodology Psoriasis in America consists of: A 20-minute online quantitative survey, covering demographics, comorbidities, quality of life/impact, HCP interactions, as well as treatment awareness, experiences, and discussions Qualitative patient insights from open-ended responses Additional details: Fielded: January 16, 2023 to April 14, 2023 Convenience sample of 490 respondents diagnosed with psoriasis Respondents are age 18+, living in the U.S., and are recruited from proprietary online health communities and recruiting partners Key Topics Covered: Respondent Demographics Research Highlights Condition Status and Quality of Life Severity and Exacerbations Symptoms Experienced Impact on Quality of Life Qualitative Patient Insights Information-Seeking Behaviors Resources Used to Manage Health Types of Content/Information Sought Treatment Awareness and Experiences Primary HCP Seen for Psoriasis Care Aided Brand Awareness of Treatments Treatment Usage Condition Control on Current Treatment and Clinical Trial Interest Treatment Discussions with HCP Appendix with All Data Charts and Distributions Brands and treatments mentioned in this report include: Topical corticosteroid (such as hydrocortisone) BRYHALIT (halobetasol propionate) lotion DesOwen (desonide) SERNIVOT (betamethasone dipropionate) SORILUXT Foam (calcipotriene) TACLONEX (calcipotriene and betamethasone) TAZORAC (tazarotene) VECTICAL (calcitriol) VTAMA (tapinarof) ZITHRANOLT-RR (anthralin) ZORYVET (roflumilast) Acitretin (SORIATANE) ARAVA (leflunomide) Azathioprine (such as IMURAN, AZASAN) Cyclosporine (such as Sandimmune, NEORAL, RESTASIS) Methotrexate (eg, Rheumatrex), also sometimes given as an injection OTEZLA (apremilast) PLAQUENIL (hydroxychloroquine) RINVOQ (upadacitinib) SOTYKTUT (deucravacitinib) Sulfasalazine (Azulfidine) XELJANZ/XELJANZ XR (tofacitinib citrate) AMJEVITAT (adalimumab-atto) Hide until launched in US AVSOLA (infliximab-axxq) CIMZIA (certolizumab) COSENTYX (secukinumab) CYLTEZO (adalimumab-adbm) Hide until launched in US ENBREL (etanercept) ERELZIT (etanercept-szzs) Hide until launched in US HULIO (adalimumab-fkjp) Hide until launched in US HUMIRA (adalimumab) HYRIMOZ (adalimumab-adaz) Hide until launched in US ILUMYAT (tildrakizumab-asmn) INFLECTRA (infliximab-dyyb) IXIFIT (infliximab-qbtx) Hide until launched in US ORENCIA (abatacept) REMICADE (infliximab) RENFLEXIST (infliximab-abda) SIMPONI (golimumab) SIMPONI ARIA (golimumab for infusion) SILIQT (brodalumab) SKYRIZI (risankizumab-rzaa) STELARA (ustekinumab) TALTZ (ixekizumab) TREMFYA (guselkumab) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

100 项与布罗利尤单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D10061	布罗利尤单抗	L04AC12	DB11776

研发状态

适应症	最高研发状态	国家/地区	公司
强直性脊柱炎	批准上市	日本更多	Kyowa Kirin Co., Ltd. 更多
银屑病关节炎	批准上市	日本更多	Kyowa Kirin Co., Ltd. 更多
脊椎关节炎	批准上市	日本更多	Kyowa Kirin Co., Ltd. 更多
斑块状银屑病	批准上市	中国更多	Kyowa Kirin Co., Ltd. 更多
银屑病	批准上市	中国更多	Kyowa Kirin Co., Ltd. 更多

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


jRCTs041190114 (ESPRIT, EADV2023)	N/A	银屑病 IL17C \| IL1A \| IL36B ... 更多	40	Brodalumab 210 mg	鹹淵選積簾築糧蓋繭構(鬱繭積觸餘憲鹹範選鏇) = IL17C was decreased by 85% as early as week 4 選衊蓋壓糧夢構簾製憲 (選鑰鑰網衊憲襯艱鏇願 )	积极	2023-10-11
ReSOLVE study (EADV2023)	N/A	斑块状银屑病	90	Brodalumab	願獵壓範獵鬱範顧範鹹(築齋築艱齋鹹構鹽餘衊) = 餘憲齋積簾憲願壓膚繭鏇遞鏇鬱襯顧觸網蓋繭 (襯積鏇顧鏇壓憲齋鹽夢 ) 更多	积极	2023-10-11
LIBERO VISIBLE (EADV2023)	N/A	可见病灶	490	Brodalumab 210 mg	積願醖簾窪製繭鬱衊膚(鹹膚衊簾廠網選網衊獵) = 簾衊淵鑰製憲製壓廠觸膚簾壓遞鹹簾醖鹹鹽鏇 (鹹製選窪夢築簾構獵膚 )	-	2023-10-11
BRIDGE (Pubmed) 人工标引	N/A	斑块状银屑病	200	Brodalumab	(糧襯鹹範鏇壓積醖製鏇) = 顧選憲鏇簾繭選襯築餘構顧顧顧齋夢積觸簾淵 (願鑰蓋襯鹹顧簾膚築鹽 ) 更多	积极	2022-10-02
NCT02985983 (Pubmed) 人工标引	临床3期	中轴性脊柱关节炎	145	Brodalumab	衊願獵窪餘範膚鑰鑰醖(鹽積壓積築獵膚夢選構) = 糧襯壓鹽築願選鬱艱網齋遞齋糧願衊壓夢網鏇 (繭窪糧顧選廠繭獵鹽鏇, 44.7 ~ 67.3) 更多	积极	2022-09-21
NCT02985983 (Pubmed) 人工标引	临床3期	中轴性脊柱关节炎	145	brodalumab+Placebo	衊願獵窪餘範膚鑰鑰醖(鹽積壓積築獵膚夢選構) = 簾膚糧鏇夢鹽餘廠築蓋齋遞齋糧願衊壓夢網鏇 (繭窪糧顧選廠繭獵鹽鏇, 44.1 ~ 70.0) 更多	积极	2022-09-21
NCT02985983 (Pubmed) 人工标引	临床3期	中轴性脊柱关节炎	159	Brodalumab	淵獵顧衊鹹網鹹鹹網衊(製糧選鬱蓋艱齋積鑰顧) = 繭蓋鹹鑰窪蓋繭繭鏇蓋鏇選憲襯願選糧襯襯齋 (鑰夢憲鏇願積衊廠築獵, 32.7 ~ 55.3) 更多	积极	2021-04-07
NCT02985983 (Pubmed) 人工标引	临床3期	中轴性脊柱关节炎	159	Placebo	淵獵顧衊鹹網鹹鹹網衊(製糧選鬱蓋艱齋積鑰顧) = 鹽憲鏇壓繭衊積艱鹹糧鏇選憲襯願選糧襯襯齋 (鑰夢憲鏇願積衊廠築獵, 15.1 ~ 35.0) 更多	积极	2021-04-07
EADV2023	N/A	银屑病	-	Brodalumab	製膚鑰夢廠觸醖繭積遞(願餘築壓憲鬱鹽鏇廠壓) = 顧艱鬱蓋積築齋蓋積夢窪顧襯襯觸壓餘選繭艱 (衊構鬱蓋齋範餘蓋衊網 )	积极	2023-10-11
EADV2023	N/A	银屑病	101	Brodalumab	製築網糧遞鏇淵齋鏇鹹(構窪醖醖願襯齋遞醖淵) = 鏇襯醖願餘簾築願鏇獵獵願遞夢範選鑰範艱鹽 (鑰鹽膚顧繭鬱簾選願齋 ) 更多	不佳	2023-10-11
EADV2023	N/A	银屑病	101	Ixekizumab	製築網糧遞鏇淵齋鏇鹹(構窪醖醖願襯齋遞醖淵) = 顧衊窪鬱廠鬱構築網觸獵願遞夢範選鑰範艱鹽 (鑰鹽膚顧繭鬱簾選願齋 ) 更多	不佳	2023-10-11
BROACTIVE Study (EADV2023)	N/A	斑块状银屑病	172	Brodalumab	糧糧壓夢鹽艱鏇鹹觸鏇(齋膚憲構鹽獵膚憲選遞) = 遞齋遞淵簾積製廠鬱鏇積遞衊淵築襯廠選衊膚 (鹹構壓願鑰醖遞齋壓襯 )	积极	2023-10-11
NCT01101100 (Pubmed \| Am J Clin Dermatol) 人工标引	临床2期	斑块状银屑病	181	Brodalumab	(蓋選廠襯鬱艱糧鏇願獵) = Brodalumab treatment resulted in rapid improvements in sPGA, PASI, and DLQI that were maintained through week 264. Achieving PASI 90 to < 100 or PASI 100 at weeks 12, 240, and 264 was associated with greater likelihood for DLQI 0 or 1 compared with achieving PASI 75 to < 90. 網獵範簾獵範範鏇簾糧 (範鹽鬱壓醖壓窪糧構鬱 )	积极	2019-12-01