A Continuation Protocol for Deucravacitinib in Patients With Patients With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

The purpose of this study is to allow the continued administration of Deucravacitinib in participants with Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) who have completed study IM011074 or Study IM011132

开始日期2025-03-17

申办/合作机构

Bristol Myers Squibb Co.

NCT06869551

/ Recruiting临床3期

A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Children and Adolescents From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis

The purpose of this study is to evaluate the drug levels, efficacy, and safety of Deucravacitinib (BMS-986165) in pediatric participants with juvenile psoriatic arthritis.

开始日期2025-03-10

申办/合作机构

Bristol Myers Squibb Co.

NCT05821374

/ Not yet recruiting早期临床1期IIT

Novel Treatment of Pyoderma Gangrenosum With Deucravacitinib

The main goal of this study is to see if the study drug called "Deucravacitinib" is safe and effective in treating people with pyoderma gangrenosum (PG).

开始日期2025-03-01

申办/合作机构

Dartmouth-Hitchcock Medical Center

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100 项与氘可来昔替尼相关的临床结果

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100 项与氘可来昔替尼相关的转化医学

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100 项与氘可来昔替尼相关的专利（医药）

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263

项与氘可来昔替尼相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Cardiovascular safety of Janus kinase inhibitors in inflammatory bowel disease: a systematic review and network meta-analysis

Review

作者: Wang, Bangmao ; Yang, Huibin ; Zhang, Qingyu ; Zhao, Yuxuan ; An, Ting ; Shi, Xiaojing

BACKGROUND AND OBJECTIVE:

Janus kinase (JAK) inhibitors (JAKinibs) are effective for inflammatory bowel disease (IBD), but their cardiovascular safety is inconclusive. We aim to assess the cardiovascular risks associated with JAKinibs in IBD patients.

PATIENTS AND METHODS:

Systematic searches of seven databases and ClinicalTrials.gov from inception to February 2024 were conducted. Outcomes included major adverse cardiovascular events (MACE), venous thromboembolism events (VTE) and cardiovascular events (CVE), which were separately evaluated based on whether or not the dose was considered. P-score was applied to rank interventions.

RESULTS:

A total of 26 trials involving 10,537 IBD patients were included, and results showed no significantly increased risk of MACE, VTE and CVE was associated with JAKinibs. However, when the dose was considered, Tofacitinib 5 mg BID (versus placebo) showed a trend towards an increased risk of MACE [odds ratio (OR)=1.05, 95% confidence interval (CI): 0.23-4.82], as well as Upadacitinib 30 mg QD (versus placebo) showed a trend towards increased risks of VTE (OR=1.36, 95% CI: 0.23-8.03) and CVE (OR=1.08, 95% CI: 0.24-4.85), and ranked higher than placebo for the risk of VTE [P-score=0.766 (versus 0.722)]. Notably, Deucravacitinib ranked lowest for all cardiovascular risks, and significantly decreased the risks of VTE (OR=0.03, 95% CI: 0.00-0.87) and CVE (OR=0.03, 95% CI: 0.00-0.87) compared with placebo.

CONCLUSIONS:

Although a trend of increased cardiovascular risks was found considering dose, no significantly increased cardiovascular risk was associated with JAKinibs in IBD patients, and Deucravacitinib significantly decreased the risks of VTE and CVE.

2025-04-01·ANTI-CANCER DRUGS

Dual inhibition of TYK2 and PD-L1 boosts immune response in triple negative breast cancer

Article

作者: Xiang, Huali ; Tu, Binfeng ; Feng, Xin ; Huang, Yajuan ; Chen, Linjing

Recent studies have shown that Janus Kinase inhibitors can enhance the tumor therapeutic effect of immune checkpoint inhibitors. However, it remains to be studied whether TYK2 selective inhibitors can enhance the therapeutic effect of small molecule PD-L1 inhibitors in triple-negative breast cancer (TNBC). We verified the efficacy of the combination of the selective TYK2 inhibitor Deucravacitinib and the small molecule inhibitor of PD-L1, INCB086550, in two TNBC animal models: a syngeneic mouse model (4T1 with humanized PD-L1) and a peripheral blood mononuclear cell (PBMC)-humanized model (MDA-MB-231). Following that, we explored the regulation of immune cell activity in tumors by the combined treatment using flow cytometry. Finally, we validated the expression of genes related to the regulated immune cells through reverse transcription-PCR. Both animal models demonstrated that the addition of a TYK2 inhibitor to a PD-L1 inhibitor significantly enhanced the antitumor capabilities of mice with good safety profiles. The combined therapy significantly elevated the counts of T, B, and natural killer cells while concurrently diminishing myeloid-derived suppressor cells in the syngeneic model. Similarly, in the PBMC-humanized model, this therapy markedly augmented progenitor-like and proliferative precursor-like CD8 T cells, while effectively diminishing exhausted and terminally differentiated CD8 T cell populations. This enhanced antitumor effect is associated with the modulation of antitumor immune-related gene expression by the combined therapy. The combination of TYK2 inhibitors and immune checkpoint inhibitors is a potentially effective strategy for treating TNBC.

2025-03-04·EXPERT OPINION ON INVESTIGATIONAL DRUGS

A focused report on IFN-1 targeted therapies for lupus erythematosus

Review

作者: Furie, Richard ; Vashistha, Himanshu ; Bhatt, Anushka ; Gupta, Pramiti

INTRODUCTION:

Patients with Systemic Lupus Erythematosus (SLE) experience varied manifestations and unpredictable flares, complicating treatment and drug development. Despite these challenges, anifrolumab, voclosporin, and belimumab were approved by FDA. These treatments complement, but don't replace, traditional therapies like NSAIDs, corticosteroids, antimalarials, and immunosuppressives. Therefore, there remains an unmet need for more effective medications targeting excessive proinflammatory cytokines in SLE patients.

AREAS COVERED:

This review summarizes the clinical trial outcomes of four upcoming medications targeting cytokine activity: Litifilimab showed a 7-point reduction in CLASI-A in its phase II trial. Daxdilimab was unsuccessful in its phase II trial. Anifrolumab reduced SLE activity in both phase II and III trials. Deucravacitinib decreased disease activity by multiple measures in its phase II trial.

EXPERT OPINION:

High levels of IFN-I (type 1 interferon) are present in most SLE patients, making this pathway an attractive target for drug development. Litifilimab downregulates IFN-I by targeting BDCA2, while dexadilimab targets ILT7 to recruit effector cells, reducing IFN-I production by killing PDCs. Anifrolumab binds to the IFN-I receptor, blocking the activity of all IFN-Is, and deucravacitinib reduces IFN-I by inhibiting TYK2, thereby interfering with downstream signaling. Therapies that target IFN-I represents a promising class of medications for SLE patients.

410

项与氘可来昔替尼相关的新闻（医药）

2025-03-21

·BioSpace

J&J Wins Crohn’s Expansion for Tremfya as Stelara Biosimilars Enter US Market

iStock, Sundry Photography The label expansion couls help J&J establish Tremfya as a successor to Stelara, which is now facing a growing biosimilar challenge. The FDA signed off on the use of Johnson & Johnson ’s Tremfya Thursday to treat adults with moderately to severely active Crohn’s disease. As per the pharma’s news release, Tremfya is the “first and only” IL-23 blocker that can be used intravenously and subcutaneously for this indication. The label expansion should help J&J to better position Tremfya as a successor to its blockbuster drug Stelara. Earlier this year, the first four Stelara biosimilars hit the U.S. market, led by Amgen’s Wezlana in January . Teva and Alvotech’s Selarsdi , Sandoz’s Pyzchiva and Biocon Biologics’ Yesintek followed suit in the subsequent weeks. Adding to J&J’s challenges in trying to market Stelara is a September 2024 announcement from Cigna Evernorth Health Services, one of the biggest insurance providers in the U.S., that it would offer a Stelara copycat this year at $0 out-of-pocket cost. First approved in 2017 for moderate to severe plaque psoriasis, Tremfya is a human IgG1 monoclonal antibody that targets the IL-23 cytokine, blocking its interaction with its corresponding receptor. Through this mechanism of action, Tremfya suppresses the release of proinflammatory factors, in turn dampening inflammation that underlies several immune-mediated diseases. The biologic has also been approved for psoriatic arthritis and, most recently, ulcerative colitis . Thursday’s label expansion for Tremfya is backed by data from several Phase III trials evaluating the biologic in more than 1,300 patients with Crohn’s disease who had failed or were otherwise intolerant to corticosteroids, immunomodulators or other biologics. In its GRAVITI study, subcutaneous Tremfya led to significantly better clinical remission and endoscopic response than placebo. Tremfya beat out Stelara in terms of all pooled endoscopic endpoints in GALAXI, making it the only IL-23 blocker to best the blockbuster in a double-blinded pivotal program, according to Thursday’s release. Chris Gasink, J&J’s vice president for Medical Affairs, Gastroenterolgy & Autoantibody said Thursday’s approval not only provides patients with a new effective treatment option but also gives them “the flexibility of self-administration from the start.” The pharma is also seeking approval for a subcutaneous formulation of Tremfya for ulcerative colitis. Elsewhere in its immunology business, J&J earlier this month released Phase III findings for investigational oral IL-23 receptor blocker icotrokinra, touting its superiority over Bristol Myers Squibb’s Sotyktu in plaque psoriasis. J&J believes that icotrokinra could become the “new standard of treatment” in this indication.

临床3期上市批准临床结果生物类似药免疫疗法

2025-03-13

·九洲药业

【速递】3期临床银屑病：口服IL-23R多肽打败TYK2抑制剂

●每日一次的药丸具有完全皮肤清除和良好安全性的出色表现，可能会改变治疗模式； ●在ICONIC-LEAD Ⅲ期临床试验的第24周，接受JNJ-2113治疗的中度至重度斑块状银屑病（PsO）患者中，近一半的患者皮肤完全恢复（IGA 0）； ●CONIC-ADVANCE 1&2 Ⅲ临床研究的顶线结果显示，JNJ-2113达到了共同主要终点，并且在治疗中度至重度斑块性PsO方面优于deucravacitinib； ●这些结果为首次头对头研究奠定了基础，旨在证明药丸相对于注射生物制剂在治疗中度至重度斑块性PsO方面的优势。 Jiuzhou News 近日，强生公司公布了其综合3期临床计划中icotrokinra(JNJ-2113）新的数据，并启动了首项针对PsO的头对头研究，旨在证明口服药icotrokinra相对于注射生物制剂ustekinumab的优越性。Icotrokinra是一种首创的在研靶向口服肽，可选择性阻断IL-23受体，目前正在对患有中度至重度斑块状银屑病的12岁及以上成人和青少年进行研究。 ICONIC-LEAD 3期研究的数据作为最新摘要在2025年美国皮肤病学会（AAD）年会上公布，结果显示每日一次的icotrokinra对患有PsO的成人和12岁及以上青少年表现出显著的皮肤清除效果和良好的安全性。在ICONIC-LEAD研究中，第16周时，近三分之二（65%）每日一次接受 icotrokinra治疗的患者研究者总体评估（IGA）评分达到0/1（皮肤透明或几乎透明），50%的患者达到银屑病面积和严重程度指数（PASI）90反应，而接受安慰剂治疗的患者分别为8%和4%（两个终点的p值均小于0.001）。第24周报告皮肤清除情况持续改善，74%接受 icotrokinra治疗的患者达到IGA 0/1，65%达到PASI 90。在第24周，近一半接受icotrokinra治疗的患者皮肤完全透明——46%达到IGA 0，40%达到PASI 100。Icotrokinra组（49%）和安慰剂组（49%）出现不良事件（AE）的患者比例相似，未识别出新的安全信号。 ▲ICONIC-LEAD研究的研究设计 ▲ICONIC-LEAD研究的基线情况 ▲ICONIC-LEAD研究的16周时的共同主要终点 ▲ICONIC-LEAD研究的24周时的结果 ▲ICONIC-LEAD研究的24周时的结果 ▲ICONIC-LEAD研究的24周时的结果 ▲ICONIC-LEAD研究的24周时的结果 ▲ICONIC-LEAD研究的安全性概况加拿大蒙特利尔Innovaderm Research主席、ICONIC-LEAD研究员Robert Bissonnette医学博士表示：“中度至重度斑块状银屑病患者正在寻求能够平衡疗效、安全性和易用性的治疗方案。这些研究结果令人鼓舞，并显示了使用icotrokinra治疗的潜力，每天服用一次的药丸即可为患者提供完全皮肤清除和良好安全性的独特组合。” 此外，顶线结果显示，第3阶段 ICONIC-ADVANCE 1&2研究在第16周达到了其共同主要终点，即与deucravacitinib相比，IGA 0/1和PASI 90的改善情况。Icotrokinra还在第16周和第24周达到了所有关键次要终点。基于 ADVANCE研究的积极结果，强生公司正在启动第3阶段ICONIC-ASCEND研究，这是有史以来第一次头对头研究，旨在证明口服药icotrokinra相对于注射生物制剂ustekinumab的优越性，代表了牛皮癣研究向前迈出的重要一步。关于PsO PsO是一种慢性免疫介导疾病，会导致皮肤细胞过量生成，从而引起发炎、鳞状斑块，并可能伴有瘙痒或疼痛。据估计，800万美国人和全球超过1.25亿人患有这种疾病。近四分之一的PsO患者病情被认为是中度到重度。在白种人的皮肤上，斑块通常表现为凸起的红色斑块，上面覆盖着银白色的死皮细胞或鳞屑。在有色人种的皮肤上，斑块可能看起来更深更厚，颜色更偏向紫色、灰色或深棕色。斑块可以出现在身体的任何部位，但最常出现在头皮、膝盖、肘部和躯干上。患有PsO是一种挑战，它不仅会影响一个人的身体健康，还会影响他的情绪健康、人际关系以及应对生活中的压力。身体上明显可见的部位或敏感皮肤（如头皮、手、脚和生殖器）上的银屑病会对生活质量产生更大的负面影响。关于Icotrokinra(JNJ-77242113, JNJ-2113) 研究性icotrokinra是首个旨在选择性阻断IL-23受体的靶向口服肽，IL-23受体是PsO、溃疡性结肠炎（UC）炎症反应的基础，并有望用于治疗其他IL-23介导的疾病。Icotrokinra以个位数皮摩尔亲和力与IL-23受体结合，并显示出对人类T细胞中IL-23信号传导的强效选择性抑制。小结在2024年11月份的时候，强生公布了ICONIC-LEAD试验的顶线结果，如今进一步在AAD 2025会议上披露更多ICONIC-LEAD试验的数据。同时宣布了ICONIC-ADVANCE 1&2试验达到了主要终点，这项试验的对照组是TYK2抑制剂deucravacitinib，icotrokinra头对头打败了获批仅有3年的deucravacitinib。基于这样优异的结果表现下，强生顺带启动了一项和IL-12/IL-23单抗ustekinumab头对头的3期临床试验，IL-23受体口服肽icotrokinra一时风光无两。长期以来治疗银屑病的畅销药物都是需要注射的抗体药物，直到前些年推出了口服小分子TYK2抑制剂的药物，才慢慢打破了这一局面。如今icotrokinra不仅在3期头对头试验中打败了安慰剂，还打败了TYK2抑制剂deucravacitinib，并且下一步还打算与大分子药物IL-12/IL-23单抗ustekinumab在3期临床试验中正面交锋，这并不是盲目激进的举动，而是基于现有的优异数据，通过间接比较，icotrokinra在未来获胜的概率还是挺大的。 ▲不同银屑病药物的数据间接比较说起icotrokinra，就不得不提起2017年Protagonist公司与强生公司达成的一笔交易了，当年强生花了5000万美元首付款和9.4亿美元的里程碑付款获得了第一代IL-23受体口服肽PTG-200，当时PTG-200正处于IND阶段，尚未进入临床阶段。 Protagonist公司花了大约2～3年时间，综合考虑口服稳定性和效力等方面，才筛选出PTG-200分子。然而先驱往往难以躲避成为先烈的命运，在2021年的时候，PTG-200由于在2期临床试验用于治疗炎症性肠炎中效果不达预期而终止开发了。 ▲口服IL-23受体肽的发现过程 ▲PTG-200理化特征第一代IL-23受体口服肽PTG-200的终止开发其实早有征兆，在2019年，强生扩大与Protagonist公司的合作，将第二代IL-23受体口服肽也纳入合作范围中，而本文的主角icotrokinra/PN-235也在2020年被正式提名，推进到临床阶段。同期一同进入到临床阶段的第二代IL-23受体口服肽PN-232，也在2021年由于PK/PD不够PN-235优秀，被终止开发了。第二代IL-23受体口服肽与第一代相比，其实也是主要围绕口服稳定性和效力方面进一步优化。如口服稳定性方面，第一代仅仅做到胃肠道暴露，而几乎没有进入到系统循环当中，而第二代药物在经过胃肠道的洗礼之后，可以在粪便中做到＞20%的药物回收，也有不错的系统暴露活性。 ▲PTG-200的暴露情况 ▲PN-235的理化特征而在效力方面，第一代仅在nM级别，而第二代则做到pM级别，提高了3个数量级。 ▲PN-235的理化特征下面则是PN-235的化学结构，通过化学合成得来的大环肽，分子量在1898.19g/mol。 ▲PN-235的化学结构参考资料 1.https://www.investor.jnj.com/news/news-details/2025/Icotrokinra-results-show-potential-to-set-a-new-standard-of-treatment-in-plaque-psoriasis/default.aspx 2.https://www.prnewswire.com/news-releases/protagonist-therapeutics-enters-into-worldwide-agreement-with-janssen-to-co-develop-and-commercialize-ptg-200-for-inflammatory-bowel-disease-300465102.html 3.https://www.prnewswire.com/news-releases/protagonist-therapeutics-initiates-phase-1-trial-of-oral-peptide-il-23-receptor-antagonist-ptg-200-300552645.html 4.https://www.prnewswire.com/news-releases/protagonist-therapeutics-expands-ptg-200-collaboration-agreement-with-janssen-to-include-second-generation-oral-il-23-receptor-antagonists-300845931.html 5.https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-advancement-of-oral-il-23-receptor-antagonists-program-in-collaboration-with-janssen-301163376.html 6.https://www.prnewswire.com/news-releases/protagonist-therapeutics-reports-third-quarter-2021-financial-results-and-provides-corporate-update-301415722.html 7.https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-the-selection-of-oral-peptide-pn-235-into-phase-2-clinical-development-program-for-multiple-indications-301436694.html 8.https://www.nature.com/articles/s41598-024-67371-5 9.https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/protagonist-announces-positive-topline-results-from-phase-3-iconic-stu-944100 10.Protagonist公司推介材料免责申明本公众号注明原创的内容权利均属九洲药业所有，未经授权，不得擅自使用或许可他人使用。如需获得授权，请和九洲药业提前联系。已获得授权的，应在授权范围内使用，并注明来源且不得再全部或部分转授权他人。本公众号对转载、分享的内容、陈述、观点判断保持中立，不对所包含内容的合法性、准确性、可靠性或完善性提供任何明示或暗示的保证，该等内容版权归原作者所有，仅供学习参考之用，若对转载、分享的内容有任何权利疑问，烦请联系九洲药业。

临床3期临床结果临床失败

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 项与氘可来昔替尼相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11817	-	-	-

研发状态

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适应症	国家/地区	公司	日期
红皮病性银屑病	日本	Bristol-Myers Squibb KK	2022-09-26
寻常性银屑病	日本	Bristol-Myers Squibb KK	2022-09-26
脓疱型银屑病	日本	Bristol-Myers Squibb KK	2022-09-26
斑块状银屑病	美国	Bristol Myers Squibb Co.	2022-09-09

未上市

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适应症	最高研发状态	国家/地区	公司	日期
干燥综合征	临床3期	美国	Bristol Myers Squibb Co.	2023-09-11
干燥综合征	临床3期	中国	Bristol Myers Squibb Co.	2023-09-11
干燥综合征	临床3期	日本	Bristol Myers Squibb Co.	2023-09-11
干燥综合征	临床3期	阿根廷	Bristol Myers Squibb Co.	2023-09-11
干燥综合征	临床3期	澳大利亚	Bristol Myers Squibb Co.	2023-09-11
干燥综合征	临床3期	奥地利	Bristol Myers Squibb Co.	2023-09-11
干燥综合征	临床3期	比利时	Bristol Myers Squibb Co.	2023-09-11
干燥综合征	临床3期	巴西	Bristol Myers Squibb Co.	2023-09-11
干燥综合征	临床3期	保加利亚	Bristol Myers Squibb Co.	2023-09-11
干燥综合征	临床3期	加拿大	Bristol Myers Squibb Co.	2023-09-11

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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


NCT05478499 (CTgov)	临床4期	头皮银屑病	154	Deucravacitinib	選艱鏇網觸選簾衊醖鏇 = 廠廠願遞鹽糧醖鹹網蓋積鏇齋淵糧窪繭繭齋範 (鏇範蓋鹹繭夢淵衊襯膚, 繭蓋窪選簾糧襯築範窪 ~ 遞憲繭製蓋鑰廠餘窪鏇) 更多	-	2025-03-13
NCT04908189 (POETYK PsA-2 \| IM011-055, NEWS) 人工标引	临床3期	银屑病关节炎	730	氘可来昔替尼	製襯製壓糧醖製憲製繭(顧壓觸鏇壓獵鏇積願夢) = 膚廠艱範鹽襯壓窪構鏇艱鹹夢糧製範網構鹽構 (壓衊繭壓蓋齋蓋淵繭蓋 ) 达到更多	积极	2025-03-10
				安慰剂	製襯製壓糧醖製憲製繭(顧壓觸鏇壓獵鏇積願夢) = 壓鹽積夢鹽願製壓鑰廠艱鹹夢糧製範網構鹽構 (壓衊繭壓蓋齋蓋淵繭蓋 ) 达到更多
NCT03624127 \| NCT03611751 \| NCT04036435 (POETYK PSO-LTE, PipelineReview) 人工标引	临床3期	斑块状银屑病	-	deucravacitinib (1-year)	網積築壓鹹餘窪襯鹽憲(簾鬱顧憲簾夢衊憲蓋糧) = 壓艱鏇鹽製獵選餘製齋餘鏇醖淵壓積憲製衊鬱 (觸製築範獵壓艱壓糧艱 ) 更多	积极	2025-02-17
				deucravacitinib (5-year)	網積築壓鹹餘窪襯鹽憲(簾鬱顧憲簾夢衊憲蓋糧) = 壓衊窪顧製衊窪壓獵襯餘鏇醖淵壓積憲製衊鬱 (觸製築範獵壓艱壓糧艱 ) 更多
NCT04908189 (POETYK PsA-2, Company_Website) 人工标引	临床3期	银屑病关节炎	730	deucravacitinib	網壓壓壓鏇網觸糧鑰衊(壓築網願艱鏇繭廠淵淵) = significantly greater proportion of Sotyktu -treated patients achieving ACR20 response. 糧鹹觸襯夢網鹹選繭鏇 (構夢夢顧簾築構鑰選淵 ) 达到更多	积极	2024-12-23
				Placebo
NCT04908202 (POETYK PsA-1, Company_Website) 人工标引	临床3期	银屑病关节炎	670	deucravacitinib	簾觸夢醖選繭鑰顧餘鹽(鏇鑰壓夢簾範顧獵構壓) = significantly greater proportion of Sotyktu -treated patients achieving ACR20 response. 鑰艱繭醖憲鏇網廠繭選 (廠觸齋襯選積選鹹齋衊 ) 达到更多	积极	2024-12-23
				Placebo
NCT03624127 \| NCT03611751 \| NCT04036435 (POETYK PSO-1, PSO-2, and LTE trials, Pubmed \| JAMA Dermatol)	临床3期	斑块状银屑病	1,519	Deucravacitinib 6 mg once daily	顧積觸鹽鏇獵齋觸壓齋(積遞獵獵顧糧齋繭鑰顧) = 糧憲顧廠艱鏇積醖淵簾醖網願淵製選鬱廠簾齋 (繭夢醖鹹壓獵夢觸構鏇, 215.4 ~ 243.9) 更多	积极	2024-11-27
				Apremilast 30 mg twice daily	顧積觸鹽鏇獵齋觸壓齋(積遞獵獵顧糧齋繭鑰顧) = 鏇簾齋鹽鬱觸餘廠衊製醖網願淵製選鬱廠簾齋 (繭夢醖鹹壓獵夢觸構鏇, 137.1 ~ 153.0) 更多
NCT04877990 (CTgov)	临床2期	克罗恩病 \| 溃疡性结肠炎	67	Deucravacitinib (BMS-986165) (Crohn's Disease)	鏇鏇願壓衊築憲選顧鹽 = 鑰廠夢獵蓋顧衊夢襯膚簾壓膚範衊築鏇膚夢積 (鏇艱糧糧餘鏇淵築夢觸, 餘獵鑰鏇窪鹹範膚鹽夢 ~ 鏇廠鏇網襯積構蓋遞鹽) 更多	-	2024-09-24
				Deucravacitinib (BMS-986165) (Ulcerative Colitis)	鏇鏇願壓衊築憲選顧鹽 = 憲糧築選餘窪鏇夢製觸簾壓膚範衊築鏇膚夢積 (鏇艱糧糧餘鏇淵築夢觸, 鹽艱築選餘獵鏇選夢範 ~ 觸膚窪齋襯鑰餘鹹願憲) 更多
NCT04613518 (CTgov)	临床2期	溃疡性结肠炎	38	BMS-986165 (BMS-986165 12 mg BID)	鹹夢壓鑰壓壓蓋襯選壓 = 鹽繭壓築鏇鬱積醖鑰艱構遞壓積襯鏇製鬱醖積 (衊積積憲積鹽膚鏇廠鏇, 構鏇夢膚製鹹襯鹹憲鏇 ~ 範顧繭鏇遞餘繭夢廠蓋) 更多	-	2024-07-12
				Placebo (Placebo BID PO)	鹹夢壓鑰壓壓蓋襯選壓 = 襯獵積糧餘蓋鬱鬱願築構遞壓積襯鏇製鬱醖積 (衊積積憲積鹽膚鏇廠鏇, 繭憲蓋淵壓窪襯衊簾窪 ~ 齋廠憲顧顧獵鹹觸簾鬱) 更多
NCT03599622 (CTgov)	临床2期	克罗恩病	239	Placebo	夢糧鏇醖壓積願衊選鬱 = 醖範淵願衊糧獵觸積築簾襯範膚顧簾艱鏇餘觸 (窪願繭餘齋蓋範窪鬱壓, 醖衊遞鹹顧構鏇夢淵淵 ~ 繭鏇醖築積觸繭廠糧齋) 更多	-	2024-07-03
NCT04036435 (POETYK LTE, EULAR2024) 人工标引	临床3期	斑块状银屑病维持	513	Deucravacitinib 6 mg QD	齋鹹憲齋淵構齋艱築簾(選積鏇鏇獵製製獵繭醖) = 鑰積願鏇願憲糧範憲窪艱鑰觸繭壓遞夢艱衊選 (簾遞廠獵衊築鬱窪夢壓, NE ~ NE) 更多	积极	2024-06-05
				DeucravacitinibDeucravacitinib 6 mg QD (achieved PASI 75 at week 24)	壓構壓顧鹽窪鹹艱選遞(選衊鑰顧膚壓夢製壓網) = 壓壓遞鏇選襯壓壓鏇製鏇憲廠憲襯鹹範壓顧鬱 (構壓鑰選膚衊網膚觸鹹, NE ~ NE) 更多