The goal of this N-of-1 study is to learn about treatment for individual patients who have rheumatoid arthritis (RA,) for which many treatments are available. The treatments are different in how they work, the way they are given, side- effects, and cost. While treatment guidelines are available, finding the best treatment order of treatments is often based on physician choice. The main question this study aims to answer are:
* What are the effects of different treatments on RA symptoms and condition for each individual patient
* What is the effectiveness of different treatments across all patients enrolled in the N-of-1 study
Participants will be enrolled and randomized to a sequence of three U.S. Food and Drug Administration (FDA) approved RA medications: 1. etanercept, 2. adalimumab, 3. upadacitinib 4. tocilizumab. Participants will be asked to complete questionnaires about their condition and quality of life weekly (either in clinic or remotely) and report their level of pain daily (remotely).

开始日期2025-05-15

申办/合作机构

Tufts Medical Center, Inc.

NCT06707194

/ Not yet recruiting临床4期IIT

Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis: a Multicenter Randomized Controlled Clinical Study

The purpose of the study is to verify the clinical feasibility of Benzathine penicillin (BPG) /Etanercept (ETN) combination regimen in patients with spondyloarthritis (SpA) and at the same time compare Benzathine penicillin /Etanercept combination regimen and Etanercept maintenance therapy in reducing disease activity, improving patients' clinical symptoms and body function scores, enhancing quality of life, improving imaging performance and safety.

开始日期2025-03-01

申办/合作机构

南方医科大学南方医院

NCT06585384

/ Not yet recruiting临床1期IIT

Safety of a Strategy Combining Etanercept Administration with Repeated Contrast Ultrasound in Patients with Alzheimer's Disease: Phase I Study

Alzheimer's disease (AD) is a clinico-pathological entity combining multiple and varied neuropathological lesions with characteristic abnormal accumulations (amyloid Beta (Aβ) plaques and neurofibrillary degeneration (NFD)), neuroinflammation, as well as neuronal and synaptic suffering.
To date, only symptomatic treatments are available, with no proven effect on neuropathological lesions or on the clinical course of the disease.
Anti-TNF alpha could be a therapeutic agent of choice in the treatment of central nervous sytem (CNS) diseases with an inflammatory component, such as AD. Unfortunately, their high molecular weight prevents them from passively crossing the blood brain barrier (BBB). In a pilot study published in 2006, etanercept was administered intrathecally to AD patients with encouraging clinical effects.
Transient opening of the tight junctions between the endothelial cells of the BBB by delivering High Intensity Focalised Ultrasounds (HIFU) in combination with an intravenous injection of microbubbles is a strategy that could improve bioavailability. Studies suggest that the oscillation of microbubbles in the ultrasound field generates microcurrents that induce shear forces responsible for a transient opening of the BBB. Ultrasound can be focused or unfocused and open the BBB diffusely or selectively over defined regions of the brain. This technique was first used to open the BBB in humans in 2001.
Transient opening of the BBB is also thought to modulate the immune response in the CNS, leading to a reduction in the intracerebral load of Aβ. In an Alzheimer's mouse model, several studies using ultrasound devices to open the BBB have shown a reduction in the intracerebral load of Aβ (up to 75%) and an improvement in the memory faculties and cognitive performance of the animals.
In humans, two clinical trials have assessed the safety of using ultrasound-assisted BBB disruption devices in AD patients. These were the Sonocloud® (Carthera) and ExAblate® (InSightec) devices. The Sonocloud® device is an extra-dural ultrasound emitter implanted under local anaesthetic. Enrolment was completed in October 2020, but the results of the trial are not yet available (NCT03119961). The phase I study on 5 patients evaluating the ExAblate® device coupled with the injection of gas microbubbles demonstrated reversible opening of the BBB with no serious adverse effects for the patients. No effect on intracerebral Aβ load or cognitive or behavioural improvement was demonstrated. The ExAblate® device is not implantable and is therefore less invasive than the Sonocloud® device. However, it requires MRI monitoring and the transducers used often generate high levels of heat, requiring the use of a water cooling system to avoid the risk of transducer deterioration.
In this project, our aim is to assess the safety of using a non-focused ultrasound device, the General Electric VIVID S70 clinical device (CE mark G1 023782 0112 ), to perform BBB ruptures in patients suffering from AD, combined with the administration of etanercept, whose bioavailability would thus be improved.

开始日期2025-03-01

申办/合作机构

Fondation Ophtalmologique Adolphe de Rothschild

100 项与依那西普相关的临床结果

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100 项与依那西普相关的转化医学

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100 项与依那西普相关的专利（医药）

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9,132

项与依那西普相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Successful treatment of etanercept- and adalimumab-resistant pyoderma gangrenosum with spesolimab, moderate-dose corticosteroids, and minocycline

Article

作者: Zhang, Hanlin ; Wu, Chao ; Jin, Hongzhong

PURPOSE:

Pyoderma gangrenosum (PG) is a rare, neutrophilic dermatosis characterized by rapidly developing, painful ulcers. This study explores the potential of spesolimab, an anti-IL-36R antibody, as a therapeutic option for refractory PG.

MATERIALS AND METHODS:

We report a case of a 48-year-old male with refractory PG who failed to respond to etanercept and adalimumab. Upon admission, the patient presented with extensive, painful ulcerations on the trunk and extremities. He was started on oral methylprednisolone (32 mg/day) and minocycline (50 mg twice daily). After a week, minimal improvement was observed. After reviewing the screening results and discussing treatment options, the patient received two doses of spesolimab (900 mg intravenously) administered two weeks apart.

RESULTS:

Marked clinical improvement was observed after spesolimab initiation. Complete ulcer healing was achieved within six weeks of starting spesolimab, with no adverse effects reported.

CONCLUSIONS:

This case demonstrates the potential efficacy of spesolimab for treating refractory PG, particularly in patients unresponsive to TNF-α inhibitors. Despite the added complexity of the patient's underlying HBV infection and elevated M-protein, no HBV reactivation or other hematologic complications occurred. Further studies are needed to validate its role in managing PG and other neutrophilic dermatoses.

2025-06-01·Endocrine Metabolic & Immune Disorders-Drug Targets

TNF-alpha Inhibitors Induced Eosinophilia: A Case Report of an Undervalued Side Effect of Such Biologicals

Article

作者: Pietroleonardo, Lucia ; Calogiuri, Gianfranco ; Civino, Adele ; Fiore, Massimo ; Filoni, Angela ; Sordi, Emiliano ; Congedo, Maurizio ; Diomeda, Federico ; Piscitelli, Prisco

Introduction::

We present an unusual case of a 28-year-old rheumatologic male patient who developed eosinophilia while he was on etanercept therapy previously and then on golimumab.

Case Representation::

Although eosinophilia is rarely reported in the literature as a side-effect of various Tumor Necrosis Factor-alpha (TNF-alpha) antagonists, it represents a riddle about the future treatments of these patients since the persistence of therapy might lead to the onset of dermatologic or visceral eosinophilic complications in such patients.

Conclusion::

Furthermore, the pathogenesis of eosinophilia is still unknown, and all the proposed hypotheses do not explain the eosinophilic proliferation in certain subjects.

2025-03-18·BRITISH JOURNAL OF DERMATOLOGY

Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomized placebo-controlled PROTOSTAR study

Article

作者: Wilsmann-Theis, Dagmar ; Jett, Meg ; Jiang, Gigi ; Paller, Amy S ; Prajapati, Vimal H ; Szakos, Erzsebet ; Li, Shu ; Crauwels, Herta ; van Hartingsveldt, Bart ; Sinha, Vikash ; Seyger, Marieke M B ; DeKlotz, Cynthia M C ; Kaszuba, Andrzej

Abstract:

Background:

No currently approved treatment for paediatric plaque psoriasis selectively targets interleukin (IL)-23. In adults, guselkumab (a selective IL-23 inhibitor that targets the p19 subunit) demonstrated substantial efficacy with a favourable safety profile in treating moderate-to-severe plaque psoriasis.

Objectives:

To evaluate the efficacy and safety of guselkumab in paediatric patients with moderate-to-severe plaque psoriasis (PROTOSTAR; NCT03451851).

Methods:

This phase III randomized placebo-controlled study enrolled patients aged ≥ 6 to < 18 years with moderate-to-severe plaque psoriasis. In part 1 [week (W)0–W16], patients were randomized to receive guselkumab, placebo or open-label etanercept (active reference arm). At W16, part 1 patients entered a guselkumab withdrawal/retreatment period or continued/crossed over to receive guselkumab (W16–W52). Co-primary endpoints were Investigator Global Assessment (IGA) 0/1 and ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) [or U.S. Food and Drug Administration-required ≥ 90% improvement in PASI (PASI 90) co-primary endpoint] responses at W16 of part 1. Part 2 evaluated continuous open-label guselkumab treatment (W0–W52).

Results:

Of 92 and 28 patients enrolled in parts 1 and 2, respectively, 86% and 96% continued treatment through W52. In part 1, at W16, significantly higher proportions of guselkumab-treated compared with placebo-treated patients achieved IGA 0/1 (66% vs. 16%; P < 0.001), PASI 75 (76% vs. 20%; P < 0.001) and PASI 90 (56% vs. 16%; P < 0.01). More than one-third of guselkumab-treated patients achieved clear skin [IGA 0: 39% vs. 4% placebo; 100% improvement in PASI (PASI 100): 34% vs. 0% placebo; both P < 0.01]. In part 2, at W52, 86%, 93% and 82% of guselkumab-treated patients achieved IGA 0/1, PASI 75 and PASI 90, respectively. Through W16 of part 1, 42%, 68% and 58% of guselkumab-, placebo- and etanercept-treated patients, respectively, experienced adverse events (AEs). Rates of AEs with guselkumab were similar through W52 in parts 1 and 2; common AEs included nasopharyngitis, upper respiratory tract infection and COVID-19. No serious or opportunistic infections occurred.

Conclusions:

Guselkumab demonstrated significant and clinically meaningful responses in paediatric patients with moderate-to-severe plaque psoriasis, and all co-primary and major secondary endpoints were met. Safety outcomes for guselkumab in paediatric patients were similar to placebo and consistent with the established profile in adults, with no new safety signals identified. These findings support the use of guselkumab to treat paediatric patients with moderate-to-severe plaque psoriasis.

349

项与依那西普相关的新闻（医药）

2025-03-23

·生物制品圈

药品专利悬崖有多陡？制药公司告诉你！

全球畅销药 Keytruda 宛如一位即将走下神坛的武林盟主，2028 年就要失去专利独占权这块 “免死金牌” 啦。BioSpace 如同好奇的江湖小报记者，盯上了五种已然跳下专利悬崖的药物。药企困境：重磅药专利到期的 “达摩克利斯之剑” 未来几年，大型制药公司就像被 “专利到期” 这把达摩克利斯之剑悬在头顶。默沙东的 Keytruda 那可是如今全球畅销药界的 “扛把子”，2024 年全球销售额蹭蹭蹭快到 300 亿美元了，跟印钞机似的。可谁能想到，2028 年它就要失去专利保护，一下子从特权阶层变成 “平民”。这消息一传出，整个行业都跟打了鸡血似的，纷纷投入生物类似药的研发大战，都想在 PD - 1 这个巨大市场里分一杯羹，就像一群饿狼盯着一块肥肉。默沙东的 “专利丛林” 战术：能护 Keytruda 周全？默沙东就像一位老谋深算的武林高手，面对 Keytruda 即将失去独占权、收入可能大幅缩水的危机，那是绞尽脑汁。自 2014 年 Keytruda 首次获批出道以来，默沙东一口气申请了至少 129 项专利，不过大部分都是关于药物新适应症和新配方的，药物本身倒没怎么动。这就好比给 Keytruda 打造了一片密密麻麻的 “专利丛林”，理论上能把保护期延长到 2036 年，让对手难以近身。可这一招太狠啦，引来了美国马萨诸塞州民主党参议员伊丽莎白・沃伦办公室的调查，沃伦参议员直接炮轰默沙东拥有 “垄断力量”，这默沙东可算是惹上大麻烦了。诺和诺德的 “专利网络”：Ozempic 的独家秘籍另一边，诺和诺德也不甘示弱，玩起了类似的套路。为它家的重磅糖尿病药物 Ozempic 构建了一个由近二十项专利组成的复杂网络，这就像给 Ozempic 织了一张密不透风的 “专利防护网”。Ozempic 去年在最畅销药物排行榜上可是排第二呢，销售额接近 170 亿美元，而且它还有个 “马甲” 叫 Wegovy，专门用来减肥，深受爱美人士喜爱。虽说第一批核心专利 2026 年就要到期，但第二批专利能让诺和诺德在 2033 年之前继续享受独占权，稳稳拿捏市场。历史经验：失去独占权，药物盈利能力就 “凉凉”？不过，历史告诉我们，失去独占权可不一定就意味着药物盈利能力的 “凉凉”。BioSpace 这会儿就像个侦探，开始研究近期重磅药物在失去专利保护前后的销售轨迹，试图在这混乱的药物世界里找到专利到期后的生存规律，看看这些药物巨头们到底能不能在专利悬崖下找到新的生机。 GSK的Advair 适应症：慢性阻塞性肺病和哮喘最高销售额：2013年的79亿美元专利到期年份：2010年在20世纪90年代和2000年代，新一代哮喘和慢性阻塞性肺病治疗药物问世，勃林格殷格翰和阿斯利康凭借其吸入器在全球范围内获得了数十亿美元的销售额。然而，GSK的重磅药物Advair在2000年上市后击败了所有竞争对手，成为当时最畅销的哮喘药物。该药物在2010年失去了专利保护，但此后仍保持了多年的稳定销售，2013年达到约52.7亿英镑（约合79亿美元）的峰值销售额。GSK的秘诀在于其用于给药的专利Diskus装置，该装置的单独专利一直保护其免受仿制药的冲击直至2019年。仿制药制造商不得不寻找自己的给药装置来与药物匹配，这在数年内被证明是相当困难的。因此，正如分析师保罗·迪格尔在2010年向路透社预测的那样，“这不会是一个典型的仿制药崩盘”，而是一个“相对缓慢的坍塌过程”。相关数据也确实证明了这一点。艾伯维的Humira 适应症：类风湿性关节炎、银屑病、溃疡性结肠炎及其他免疫相关疾病最高销售额：2022年的212亿美元专利到期年份：2022年在Keytruda创造令人震惊的数字之前，艾伯维的关节炎药物Humira一直是冠军。该药物在2008年获批后，在免疫学领域不断增加适应症，并在2022年达到超过210亿美元的峰值销售额。该药物的原始专利本应于2016年到期，但多年来艾伯维通过申请大量专利（总计超过250项）来抵御生物类似药，这些专利涵盖了其最初的关节炎适应症之外的各种用途。这使得该药物的独占期延长至2022年，最终在美国失去了独占权。这额外的时间使艾伯维有机会推出两款后续药物：Skyrizi（艾伯维于2016年以5.95亿美元从勃林格殷格翰收购）和Rinvoq（艾伯维自主研发）。 Skyrizi和Rinvoq在2024年的总销售额约为190亿美元，几乎弥补了Humira因失去专利保护而出现的销售下滑。艾伯维预计到2027年，Skyrizi和Rinvoq的总销售额将达到270亿美元。安进的Neulasta 适应症：化疗患者的免疫刺激最高销售额：2013年的58亿美元专利到期年份：2015年安进的重磅药物Neulasta主要用于刺激化疗患者中性粒细胞的生长，在其独占期的大部分时间里一直是全球十大畅销药物之一，并且一直是安进的畅销产品之一，与安进的关节炎治疗药物Enbrel不相上下。在2015年专利到期后，安进除了起诉潜在竞争对手Coherus（指控其挖角安进员工以获取有关Neulasta的信息）之外，并未采取任何特别的法律手段来延长该药物的生命周期。安进运气不错，因为那些竞相生产仿制药的公司难以获得FDA的批准。2018年，迈兰终于推出了一款生物类似药，抢占了安进的部分市场份额。2019年，山德士也紧随其后，进一步推动了销售额的下降。辉瑞的立普妥适应症：高胆固醇最高销售额：2006年的129亿美元专利到期年份：2011年立普妥对心脏病学领域产生了巨大影响。其所属的他汀类药物在2019年被开具给超过8亿人，其中立普妥及其仿制药占了近3亿。在2011年失去专利后，立普妥几乎完美地从专利悬崖上跌落，仿制药在一年内立即将辉瑞的药物销售额削减了三分之二。 2020年，辉瑞将立普妥和另一款传统药物万艾可分拆到一家名为晖致的新公司，该公司在过去几年中报告称该药物的总销售额每年稳定在约4亿美元。自2011年起，辉瑞开始与沃森制药合作销售自己的立普妥仿制药。强生的Remicade 适应症：克罗恩病、类风湿性关节炎最高销售额：2016年的69亿美元专利到期年份：2016年 TNFα阻断抗体Remicade是强生制药部门杨森的年年重磅药物。它是有史以来最畅销的五种药物之一，在类风湿性关节炎治疗领域，其在2016年达到峰值销售额，与Humira不相上下。强生几乎在整个药物生命周期内都在拼命维护专利独占权并保护其利润空间。2018年，Brinks Gilson & Lione的两名律师在《国家法律评论》中写道，强生在Remicade专利方面所玩的把戏未能“改写历史”。与此同时，辉瑞则押注该药物的专利将按计划于2018年到期，并于2016年推出了一款生物类似药。当一名法官暂时撤销Remicade的专利时，辉瑞于2017年起诉强生存在反竞争行为，该诉讼直至2021年才得以解决。最终，Remicade的专利于2018年如期到期，随后一系列额外的生物类似药进入该领域，导致Remicade的销售额暴跌。参考资料：https://www.biospace.com/business/just-how-steep-is-the-drug-patent-cliff-ask-these-pharmas 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

专利到期生物类似药

2025-03-18

·GlobeNewswire-Health Care

CAMP4 Appoints Multiple Industry Veterans to its Board of Directors

With decades of experience in pharmaceutical development and extensive genetic medicine expertise, Doug E. Williams, Ph.D., and Murray Stewart, DM FRCP, will provide strategic guidance for CAMP4’s multiple drug development efforts CAMBRIDGE, Mass., March 18, 2025 (GLOBE NEWSWIRE) -- CAMP4 Therapeutics Corporation (“CAMP4”) (Nasdaq: CAMP), a clinical-stage biotechnology company developing a pipeline of regRNA-targeting antisense oligonucleotide (ASO) therapies to upregulate gene expression to restore healthy protein levels, today announced the appointments of Doug E. Williams, Ph.D., and Murray Stewart, DM FRCP, to the Company’s Board of Directors. “We are delighted to welcome Drs. Williams and Stewart to our Board of Directors,” said Josh Mandel-Brehm, Chief Executive Officer of CAMP4. “With their combined expertise spanning critical aspects of R&D and clinical development, we will benefit greatly from their strategic insights as we advance our lead clinical program for urea cycle disorders and our preclinical program for SYNGAP1-related disorders, while continuing to develop additional RNA-targeting medicines designed to upregulate gene expression and meaningfully address diseases where we believe modest increases in protein levels can have a tremendous impact on the lives of patients.” Dr. Williams commented, “CAMP4’s approach is opening exciting possibilities to upregulate gene expression, a long-sought-after and challenging feat in the field of genetic medicine. I look forward to working with the team to unlock the full potential of this approach and ultimately advance novel therapeutics to the clinic.” Dr. Stewart added, “I’m thrilled to join the CAMP4 team and support its mission of advancing programmable RNA therapeutics for genetic diseases where decreased protein expression drives disease pathophysiology. By pioneering new ways to restore gene expression, CAMP4 has the potential to bring life-changing therapies to patients who currently have limited or no disease-modifying treatment options.” With over 30 years in the biopharma industry, Dr. Williams has contributed to the development of several transformative drugs, including LEUKINE®, ENBREL®, ADCETRIS®, TECFIDERA®, APROLIX®, ELOCTATE®, and SPINRAZA®. He was previously President of R&D at Sana Biotechnology and the Founding President & CEO of Codiak BioSciences. Prior to Sana, Dr. Williams served as EVP of R&D at Biogen, and earlier in his career was CEO of ZymoGenetics (acquired by BMS), and held leadership roles at Seattle Genetics, Amgen, and Immunex. Over the course of his career, he has served on the Board of Directors and Advisory Boards of more than two dozen biotech companies. Dr. Stewart currently serves as a Senior Medical Advisor to several biopharma companies, and was most recently the Chief Medical Officer at Rhythm Pharmaceuticals. Prior to this position, he served as Head of R&D at Novelion Therapeutics. Before joining Novelion, he served as corporate Chief Medical Officer at GlaxoSmithKline. With extensive clinical development experience, he has led studies across all stages, from first-in-human trials to large Phase 4 cardiovascular outcome studies. Dr. Stewart has played a key role in the successful registration and launch of multiple therapies, including AVANDIA®, ARIXTRA®, TANZEUM®, and XOLREMDI®. Before transitioning to industry, he served as a Consultant Physician and Head of Clinical Services at the Diabetes Centre in Newcastle upon Tyne, UK, where his research was focused on lipid metabolism and type 2 diabetes. About CAMP4 Therapeutics CAMP4 is developing disease-modifying treatments for a broad range of rare and prevalent genetic diseases where increasing healthy protein levels may offer meaningful therapeutic benefits. Our approach allows for targeted gene upregulation by harnessing a fundamental mechanism of how genes are controlled. To increase gene expression, our therapeutic ASO drug candidates target regRNAs, which act locally on transcription factors and are the master regulators of gene expression. CAMP4’s proprietary RAP Platform™ enables the mapping of regRNAs and generation of therapeutic candidates designed to target the regRNAs associated with genes underlying haploinsufficient and recessive partial loss-of-function disorders, of which there are more than 1,200, in which a modest increase in protein expression may have the potential to be clinically meaningful. Learn more about us at www.CAMP4tx.com and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning CAMP4’s plans, objectives, expectations and intentions. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; risks related to the operations of the Company’s suppliers; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as well as other information we file with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain and are not guarantees of future events. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, you should not unduly rely on these forward-looking statements. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contacts Investor Relations:Sandya von der WeidLifeSci Advisorssvonderweid@lifesciadvisors.com Media:Jason Braco, Ph.D.LifeSci Communicationsjbraco@lifescicomms.com

高管变更寡核苷酸

2025-03-12

·PRNewswire

Psoriatic Arthritis Market Sees Major Shift with Growing Biosimilar Adoption | DelveInsight

The arrival of biosimilars like Celltrion's STEQEYMA and Biocon's YESINTEK is shaking up the psoriatic arthritis market, challenging blockbuster biologics with cost-effective alternatives. As competition intensifies, these biosimilars are reshaping treatment choices and driving a shift in the market landscape. LAS VEGAS, March 12, 2025 /PRNewswire/ -- Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects approximately 112 per 100,000 adults worldwide. It is more prevalent in Europe and North America than in Asia and South America. In patients with psoriasis, the prevalence of psoriatic arthritis can range from 6% to 34% in Western populations. Despite its impact, many individuals with psoriatic arthritis remain undiagnosed or receive inadequate treatment, highlighting the need for increased awareness and access to specialized care. As per DelveInsight analysis, among the 7MM, the United States accounted for the highest number of prevalent cases of psoriatic arthritis in 2023, and these cases are expected to increase by the end of 2034 due to several key factors such as an increase in awareness and diagnosis, as well as the rapid prevalence of PsA. Psoriatic arthritis, occurring in approximately 20% of individuals with psoriasis, is a chronic inflammatory arthritis intricately linked to psoriatic arthritis. This aggressive condition is characterized by potential significant morbidity and compromised quality of life. Treatment approaches for psoriatic arthritis encompass a variety of strategies aimed at managing symptoms, slowing disease progression, and improving the overall quality of life. These approaches typically involve a combination of pharmacological therapies, lifestyle modifications, and, in severe cases, surgical interventions. Psoriatic arthritis treatment is highly individualized based on disease severity, response to therapy, and patient preferences, with multidisciplinary care from rheumatologists, dermatologists, and physical therapists playing a key role. Pharmacological treatment for psoriatic arthritis primarily targets inflammation and pain relief. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, are often the first line of defense, helping to reduce pain and inflammation. Disease-modifying antirheumatic drugs (DMARDs) like methotrexate, sulfasalazine, and leflunomide are commonly prescribed to prevent joint damage and suppress the inflammatory process. For individuals with mild-to-moderate psoriatic arthritis, oral small molecules (OSMs) like OTEZLA (apremilast) offer a convenient, non-injectable option by modulating inflammatory pathways. Biologic agents have revolutionized the treatment landscape for psoriatic arthritis. These medications specifically inhibit key molecules in the inflammatory cascade. TNF inhibitors like HUMIRA (adalimumab), ENBREL (etanercept), and REMICADE (infliximab) are frontline biologics that target tumor necrosis factor, a crucial driver of inflammation. Patients who do not respond to TNF inhibitors may benefit from IL-17 inhibitors like COSENTYX (secukinumab) and TALTZ (ixekizumab) or IL-12/23 inhibitors such as STELARA (ustekinumab). Learn more about the FDA-approved psoriatic arthritis drugs @ Drugs for Psoriatic Arthritis Treatment SKYRIZI (risankizumab), developed by AbbVie, is a humanized IgG1 monoclonal antibody that acts as an interleukin-23 (IL-23) antagonist. It can be used on its own or in conjunction with non-biologic DMARDs. In June 2022, the FDA approved SKYRIZI as the first and only targeted IL-23 inhibitor for adults with active psoriatic arthritis. Another biologic, TREMFYA (guselkumab by Janssen), was approved by the FDA in July 2020 as the first monoclonal antibody that selectively binds to the p19 subunit of IL-23, further expanding treatment options for psoriatic arthritis patients. BIMZELX (bimekizumab), developed by UCB Biopharma, is a humanized monoclonal antibody that targets IL-17A and IL-17F. It received European Commission approval in June 2023 for adults with active psoriatic arthritis and axial spondyloarthritis. On September 23, 2024, the FDA approved BIMZELX for treating adults with active psoriatic arthritis, non-radiographic axial spondyloarthritis (nr-axSpA) with objective inflammation, and active ankylosing spondylitis. In Phase III studies, BIMZELX showed meaningful responses in patients with inadequate TNF inhibitor responses and those new to biologics, indicating its potential as an important treatment option for psoriatic arthritis. In cases where joint damage becomes severe and unresponsive to medical therapies, surgical interventions like joint replacement surgery may be necessary to restore function and alleviate pain. Lifestyle changes, such as regular exercise, joint protection techniques, and weight management, are also critical in managing psoriatic arthritis, as excess weight can worsen symptoms and increase disease severity. The treatment landscape for psoriatic arthritis continues to evolve, offering hope to patients with more targeted therapies and improved outcomes. As companies like UCB Biopharma, AbbVie, and Janssen advance their biologic portfolios, the future looks promising for psoriatic arthritis management. The competition in the biosimilar market is intensifying as companies introduce cost-effective alternatives to blockbuster biologics. In December 2024, Celltrion announced FDA approval for STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. Simultaneously, Biocon Biologics Ltd. is strengthening its position with positive Phase III results for YESINTEK, its biosimilar to ustekinumab, in adult patients with moderate to severe chronic plaque psoriasis. The pivotal randomized, double-blind, parallel-group study demonstrated comparable efficacy and safety to the reference biologic, STELARA, and the findings are being presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida. With the approval of STEQEYMA and the promising clinical outcomes for YESINTEK, these biosimilars are poised to challenge STELARA by offering cost-effective alternatives in key immunology indications. As pricing pressures and healthcare sustainability concerns drive the demand for biosimilars, these developments mark a significant shift in the treatment landscape, providing greater accessibility and affordability for patients while increasing competition in the immunology market. To know more about psoriatic arthritis treatment options, visit @ New Treatment for Psoriatic Arthritis The psoriatic arthritis market is buzzing with numerous companies advancing treatments to cater to the growing patient base. Several therapies are expected to enter the market during the forecast period, providing new hope for patients. Some of these potential therapies include ACELYRIN Inc.'s Izokibep, Novartis Pharmaceuticals' Secukinumab, UCB Biopharma SRL's Bimekizumab, and Bristol-Myers Squibb's Deucravacitinib. Additionally, AbbVie's Upadacitinib and Risankizumab, as well as Eli Lilly and Company's Ixekizumab, are also part of the promising pipeline. Other noteworthy therapies include Sun Pharma's ILUMYA/ILUMETRI, Bristol-Myers Squibb's SOTYKTU, and Affibody's Izokibep in collaboration with Acelyrin and Inmagene. With these advancements, the psoriatic arthritis treatment landscape is set for a major shift, offering patients more tailored and effective options. The companies involved in developing biosimilars include Alvotech, Teva, Biocon Biologics, Celltrion, Fresenius Kabi, and others. Discover which therapies are expected to grab major psoriatic arthritis market share @ Psoriatic Arthritis Market Report ILUMYA/ILUMETRI by Sun Pharma is an interleukin-23 (IL-23) inhibitor classified as a humanized, anti-IL-23p19 monoclonal antibody. It works by blocking inflammatory proteins (cytokines and chemokines) in the body. By inhibiting the effects of IL-23, ILUMYA helps control the release of other inflammatory proteins, including IL-17 and TNF-α. This mechanism reduces inflammation, decreases the number of inflammatory cells in psoriatic lesions, helps prevent plaque formation, and resolves tissue damage. The drug is currently undergoing evaluation in Phase III clinical development, actively recruiting subjects with active psoriatic arthritis who have prior exposure to anti-TNF agents, as well as those who are anti-TNF naïve. SOTYKTU, developed by Bristol-Myers Squibb, is the first and only novel oral selective tyrosine kinase 2 (TYK2) inhibitor being studied across multiple immune-mediated diseases. Deucravacitinib binds to the regulatory domain of the TYK2 enzyme, inhibiting its activation. This selective inhibition reduces the release of proinflammatory cytokines and chemokines, helping to control the inflammation associated with psoriatic arthritis and alleviating its signs and symptoms. Currently, the drug is being investigated for the treatment of psoriatic arthritis in a Phase III clinical trial. Izokibep, developed by Affibody in partnership with Acelyrin and Inmagene, is a unique antibody mimetic and a novel bispecific agent that potentially targets both subunits of the IL-17A homo-dimer and serum albumin. Affibody has entered into a partnership agreement with Acelyrin for the development and commercialization of izokibep and has completed a Phase II trial. As part of this agreement, Acelyrin obtained worldwide rights to izokibep, excluding selected Asian countries, where rights have been granted to Inmagene Biopharmaceuticals. In March 2024, Acelyrin announced the release of positive top-line results from the Phase IIb/III trial, indicating that izokibep was well-tolerated with a favorable safety profile. This drug is currently in Phase III clinical trial. Discover more about drugs for psoriatic arthritis in development @ Psoriatic Arthritis Clinical Trials The anticipated launch of these emerging therapies for psoriatic arthritis is poised to transform the market landscape in the coming years. As these cutting-edge treatments continue to mature and gain regulatory approval, they are expected to reshape the psoriatic arthritis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the psoriatic arthritis market size was USD 9 billion in 2021 and is expected to grow significantly in the coming years. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the condition. The anticipated launch of these therapies is also expected to attract new entrants to the psoriatic arthritis market, resulting in increased competition and innovation. DelveInsight's latest published market report titled " Psoriatic Arthritis Market Insight, Epidemiology, and Market Forecast – 2034" will help you discover which market leader is set to capture the largest market share. The report provides comprehensive insights into country-specific treatment guidelines, patient pool analysis, and epidemiology forecasts to help understand key opportunities and assess the market's underlying potential. The psoriatic arthritis market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Prevalent Cases of Psoriatic Arthritis Total Diagnosed Prevalent Cases of Psoriatic Arthritis Gender-specific Diagnosed Prevalent Cases of Psoriatic Arthritis Severity-specific Diagnosed Prevalent Cases of Psoriatic Arthritis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM Psoriatic Arthritis market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this psoriatic arthritis market report to assess the epidemiology forecasts, understand patient journeys, gain insights into KOLs' opinions about upcoming treatment paradigms, and identify the factors contributing to changes in the psoriatic arthritis market. Additionally, stay informed about the mitigating factors that can enhance your market position in the psoriatic arthritis therapeutic space. Related Reports Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Affibody, Kymera, Selection Therapeutics GmbH, Jiangsu HengRui Medicine Co., Ltd., Nimbus Lakshmi, Inc., Hansoh BioMedical R&D Company, Bio-Thera Solutions, ACELYRIN Inc., among others. Psoriatic Arthritis Epidemiology Forecast Psoriatic Arthritis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and Psoriatic Arthritis epidemiology trends. Ankylosing Spondylitis Market Ankylosing Spondylitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Ankylosing Spondylitis companies, including UCB, AbbVie, Pfizer, Astella, Amgen, Janssen Biotech, Pozen, Novartis, Iroko Pharmaceuticals, Syntex Pharmaceuticals, Horizon Pharma, Eli Lilly and Company, among others. Psoriasis Market Psoriasis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Psoriasis companies, including Amgen, Janssen, Abbvie, Novartis, AstraZeneca, Bausch Health, Eli Lilly, Sun Pharmaceutical, Janssen Biotech, UCB Inc., LEO Pharma, Promius Pharma, Mayne Pharma, Bausch Health Companies, MC2 Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期上市批准临床结果临床2期

100 项与依那西普相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00742	依那西普	L04AB01	DB00005

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
银屑病	中国	C.H. Boehringer Sohn AG & Co. KG	2010-02-26
非放射性轴性脊柱关节炎	澳大利亚	Pfizer Australia Pty Ltd.	2003-03-18
多关节型幼年特发性关节炎	美国	Immunex Corp.	2002-01-15
强直性脊柱炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
强直性脊柱炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
强直性脊柱炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
强直性脊柱炎	挪威	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
银屑病关节炎	挪威	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
中轴性脊柱关节炎	挪威	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	冰岛	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	列支敦士登	Pfizer Europe MA EEIG	2000-02-02
附着点炎相关关节炎	挪威	Pfizer Europe MA EEIG	2000-02-02
幼年特发性关节炎	欧盟	Pfizer Europe MA EEIG	2000-02-02

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适应症	最高研发状态	国家/地区	公司	日期
疼痛	临床3期	美国	Amgen, Inc.	2016-11-29
疼痛	临床3期	波多黎各	Amgen, Inc.	2016-11-29
青少年少关节慢性关节炎	临床3期	澳大利亚	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	比利时	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	哥伦比亚	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	捷克	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	法国	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	德国	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	匈牙利	Pfizer Inc.	2009-09-01
青少年少关节慢性关节炎	临床3期	意大利	Pfizer Inc.	2009-09-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EULAR2024	N/A	幼年特发性关节炎一线	118	Etanercept (ETN)	築夢窪鏇蓋鹽憲艱觸醖(積糧膚夢蓋遞遞餘蓋築) = 淵餘願選範選鬱選壓願築範廠淵糧壓鬱廠鹽糧 (鏇網膚餘醖網鬱憲膚廠 )	积极	2024-06-05
				Adalimumab (ADA)	築夢窪鏇蓋鹽憲艱觸醖(積糧膚夢蓋遞遞餘蓋築) = 構衊鑰網淵願壓獵窪鹹築範廠淵糧壓鬱廠鹽糧 (鏇網膚餘醖網鬱憲膚廠 )
EULAR2024	N/A	-	-	Etanercept bio-originator	網遞願壓廠鑰選觸選夢(膚膚膚淵製遞網糧膚廠) = 28% vs 22%, mostly injection site reactions 遞範衊鹹選鹹遞鹹簾窪 (淵餘衊衊廠築膚鹽鏇襯 ) 更多	-	2024-06-05
				Etanercept biosimilar SB4
EULAR2024	N/A	类风湿关节炎	-	biologic drugs (Obese patients)	顧蓋鏇繭餘齋夢壓壓獵(夢繭鑰醖鏇網夢簾鹹獵) = 醖憲艱顧夢願膚選衊夢範選構繭糧餘範憲憲遞 (構餘窪憲願醖衊顧廠窪 ) 更多	不佳	2024-06-05
				biologic drugs (Non-obese patients)	顧蓋鏇繭餘齋夢壓壓獵(夢繭鑰醖鏇網夢簾鹹獵) = 窪遞餘醖夢構製廠膚衊範選構繭糧餘範憲憲遞 (構餘窪憲願醖衊顧廠窪 ) 更多
EULAR2024	N/A	类风湿关节炎	-	Rituximab	範齋窪憲獵鑰範鹹製廠(簾簾夢廠壓醖壓構繭範) = 窪蓋鏇選觸淵鏇衊簾蓋夢觸顧簾膚獵衊遞淵遞 (夢顧簾艱襯構醖繭鹽築 ) 更多	-	2024-06-05
				Tocilizumab	範齋窪憲獵鑰範鹹製廠(簾簾夢廠壓醖壓構繭範) = 齋網選襯範獵獵夢遞製夢觸顧簾膚獵衊遞淵遞 (夢顧簾艱襯構醖繭鹽築 ) 更多
EULAR2024	N/A	IL-17A	135	Adalimumab (ADA)	觸鹹築製繭齋鹽獵鏇淵(鏇齋糧鹹鏇選鹽觸顧觸) = 顧觸鹽糧繭醖餘襯構淵鹽衊鬱夢繭製簾蓋觸簾 (憲糧網網範齋齋鑰鬱蓋 )	积极	2024-06-05
				Infliximab (IFX)	觸鹹築製繭齋鹽獵鏇淵(鏇齋糧鹹鏇選鹽觸顧觸) = 襯憲願壓網蓋艱遞衊範鹽衊鬱夢繭製簾蓋觸簾 (憲糧網網範齋齋鑰鬱蓋 )
EULAR2024	N/A	类风湿关节炎	-	Biologic and targeted synthetic DMARDs	膚衊觸構構範淵鹽膚選(夢衊醖網製鹹夢糧鹽網) = 觸鬱獵衊鏇蓋鹹糧簾壓獵鏇糧憲餘艱夢醖艱觸 (壓顧鑰餘範構鹽夢鑰襯 ) 更多	-	2024-06-05
NCT02464878 (CTgov)	临床2期	1型糖尿病	2	Islet Transplantation+Thymoglobulin+Basiliximab+Alpha 1-Antitrypsin+Etanercept	糧網淵網顧鹽構獵壓選 = 遞繭構製膚鑰憲構鑰鹽襯憲鏇襯鹹獵襯築蓋窪 (衊選膚鑰壓窪鏇襯鹹遞, 糧齋夢鹹觸觸獵鹽網構 ~ 餘蓋觸醖襯選遞願網製) 更多	-	2023-12-22
ACR2023	N/A	脊椎关节炎	-	Etanercept	願鬱選遞鑰壓鹹網壓遞(膚醖壓觸廠鬱願壓鬱簾) = 鹹艱糧積網網鑰觸鏇餘鏇遞淵糧築壓齋鏇積鬱 (糧簾選衊網鹽構築鑰淵, 1.2 ~ 7.0)	积极	2023-11-14
				Anti-TNF	願鬱選遞鑰壓鹹網壓遞(膚醖壓觸廠鬱願壓鬱簾) = 鬱鏇鹽願餘積膚鹽顧鏇鏇遞淵糧築壓齋鏇積鬱 (糧簾選衊網鹽構築鑰淵, 0.4 ~ 1.8)
NCT03636373 (CTgov)	临床4期	原发性痛风	5	Etanercept (Etanercept)	選襯遞壓遞窪夢憲獵鹹(構製糧艱選衊蓋鑰繭製) = 築膚範顧蓋築齋憲窪廠選選鹹遞蓋築壓襯鬱糧 (廠餘鹹簾鑰顧網獵築選, 鹽齋襯鏇範願鏇願膚餘 ~ 獵鹽艱積艱餘遞糧築醖) 更多	-	2023-10-27
				Triamcinolone Acetonide (Triamcinolone Acetonide)	選襯遞壓遞窪夢憲獵鹹(構製糧艱選衊蓋鑰繭製) = 鹹鑰壓積襯壓積衊窪衊選選鹹遞蓋築壓襯鬱糧 (廠餘鹹簾鑰顧網獵築選, 鹽餘膚觸鹹構鏇構衊鏇 ~ 鹽齋鹹構齋鹹顧襯衊鑰) 更多
FDA 人工标引	N/A	斑块状银屑病	211	Placebo	築願選壓選壓網齋製衊(積鏇夢膚繭醖膚積鬱繭) = 齋淵簾壓遞齋衊獵鑰製餘選積繭觸糧積襯淵選 (選夢夢範蓋顧夢艱窪餘 ) 更多	积极	2023-10-18
				Enbrel 0.8 mg/kg	築願選壓選壓網齋製衊(積鏇夢膚繭醖膚積鬱繭) = 齋衊襯範築鹽願遞糧憲餘選積繭觸糧積襯淵選 (選夢夢範蓋顧夢艱窪餘 ) 更多