Data Presented at American Academy of Dermatology Shows Significant Improvement in Moderate-to-Severe Nail Psoriasis with No New Safety Signals

美国皮肤病学会发布的数据显示，中度至重度甲银屑病显著改善，且没有新的安全信号出现。

PRINCETON, N.J.

普林斯顿，新泽西州

,

，

March 7, 2025

2025年3月7日

/PRNewswire/ -- Sun Pharmaceutical Industries, Inc.,

/PRNewswire/ -- 太阳制药工业公司，

USA

美国

, a wholly owned subsidiary of Sun Pharmaceutical Industries Limited (Sun Pharma), today presented the results of a Phase

，太阳制药工业有限公司（Sun Pharma）的全资子公司，今天公布了其第三阶段的研究结果

3b

3b

, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of ILUMYA

随机、双盲、安慰剂对照的临床试验，评估ILUMYA的安全性和有效性

®

®

(tildrakizumab-asmn) for the treatment of moderate-to-severe psoriasis affecting the nails. The study, which included 99 patients with moderate-to-severe plaque psoriasis, found that ILUMYA significantly improved nail psoriasis severity compared to placebo, marking forward progress in addressing this difficult-to-treat condition..

（替尔德拉珠单抗）用于治疗影响指甲的中度至重度牛皮癣。这项研究包含了99名中度至重度斑块型牛皮癣患者，发现与安慰剂相比，ILUMYA显著改善了指甲牛皮癣的严重程度，标志着在解决这一难以治疗的病症方面取得了进展。

This trial showed that:

该试验表明：

Patients treated with ILUMYA demonstrated a significantly higher rate of 75% improvement from baseline in the Nail Psoriasis Severity Index (mNAPSI 75) at Week 28 (25.5% mNAPSI 75 response rate vs. 4.5% in the placebo group; P=0.003).

接受ILUMYA治疗的患者在第28周时，指甲银屑病严重程度指数（mNAPSI 75）较基线改善75%的比例显著更高（mNAPSI 75反应率为25.5%，而安慰剂组为4.5%；P=0.003）。

29.4% of patients treated with ILUMYA achieved normal nails or nails with minimal psoriasis (ViSENPsO

接受ILUMYA治疗的患者中有29.4%指甲恢复正常或仅有轻微银屑病（ViSENPsO）。

®

®

score of 0 or 1), compared to 4.2% in the placebo group (P = 0.0008). ViSENPsO is a clinical tool used for detecting and assessing psoriasis including a visual medical scale to evaluate nail psoriasis severity and Patient Global Assessment (PGA) questionnaires.

评分为0或1），相比之下，安慰剂组为4.2%（P = 0.0008）。ViSENPsO是一种用于检测和评估银屑病的临床工具，包括用于评估指甲银屑病严重程度的视觉医学量表和患者总体评估（PGA）问卷。

The safety profile was consistent with the known safety profile of ILUMYA, and no serious adverse events related to ILUMYA treatment occurred in this clinical trial.

该安全性特征与ILUMYA已知的安全性特征一致，在这项临床试验中未发生与ILUMYA治疗相关的严重不良事件。

'Nail psoriasis is understood as a difficult to treat population, and many current therapies fall short of providing lasting relief or are slow to produce results,' said Dr.

“指甲银屑病被认为是一种难以治疗的群体，许多当前的治疗方法无法提供持久的缓解，或者见效缓慢，”博士说道。

Paul Yamauchi

保罗·山内

, MD, lead investigator of the ILUMYA study. 'While other IL-23 inhibitors do not have a dedicated study to evaluate efficacy in nail psoriasis, these trial results clearly demonstrate the promise for ILUMYA to ease discomfort and improve patient outcomes.'

医学博士，ILUMYA研究的首席研究员。“虽然其他IL-23抑制剂没有专门的研究来评估其在甲银屑病中的疗效，但这些试验结果清楚地表明了ILUMYA在缓解不适和改善患者预后方面的潜力。”

Nail psoriasis impacts approximately 50% of patients living with plaque psoriasis and can have an increased negative impact on quality of life.

指甲银屑病影响大约50%的斑块型银屑病患者，并且可能对生活质量产生更大的负面影响。

1

1

Effective, long-term treatments for nail psoriasis have been limited due to the complicated nature of the treatment area, making the condition difficult to manage.

由于治疗部位的复杂性，对于指甲银屑病的有效长期治疗方法一直很有限，使得该病症难以控制。

'Psoriasis affecting the nails can have a profound impact on a patient's daily life, causing both physical discomfort and emotional distress. Although highly prevalent in people with plaque psoriasis, nail psoriasis has been challenging to treat,' said

“影响指甲的银屑病可能会对患者的日常生活产生深远的影响，导致身体不适和情绪困扰。尽管在斑块型银屑病患者中非常普遍，但指甲银屑病一直难以治疗，”

Marek Honczarenko

马雷克·洪恰连科

, M.D., PhD, Senior Vice President, Head of Development, Sun Pharma,

医学博士，高级副总裁，研发主管，太阳制药公司，

North America

北美

. 'As a company dedicated to developing innovative therapies which help improve quality of life for patients, these data, along with our existing data in scalp psoriasis, reinforces the benefits of ILUMYA in difficult to treat populations.'

“作为一家致力于开发创新疗法以帮助改善患者生活质量的公司，这些数据以及我们在头皮银屑病方面的现有数据，进一步证实了ILUMYA在难治人群中的益处。”

The most common (≥1%) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea. The results of this study contribute to the growing body of evidence supporting ILUMYA as a promising treatment for patients living with moderate-to-severe plaque psoriasis, including those with scalp and nail involvement..

与安慰剂组相比，ILUMYA治疗最常见的（≥1%）不良反应包括上呼吸道感染、注射部位反应和腹泻。本研究的结果增加了越来越多的证据，支持ILUMYA作为中度至重度斑块型银屑病患者（包括头皮和指甲受累的患者）的一种有前景的治疗选择。

About ILUMYA

关于ILUMYA

(tildrakizumab-asmn)

（替德拉珠单抗-asmn）

ILUMYA (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, in .

ILUMYA（替德拉珠单抗-asmn）是一种人源化的lgG1/k单克隆抗体，旨在选择性结合白细胞介素-23（IL-23）的p19亚基，并抑制其与IL-23受体的相互作用，从而抑制促炎性细胞因子和趋化因子的释放。ILUMYA适用于治疗适合系统治疗或光疗的中度至重度斑块型银屑病成人患者。

the United States

美国

. ILUMYA has also been approved for moderate-to-severe plaque psoriasis in

ILUMYA 还被批准用于中度至重度斑块型银屑病的治疗。

Australia

澳大利亚

and

和

Japan

日本

, and under the brand name ILUMETRI

，并以品牌名称 ILUMETRI

®

®

in

在

Europe

欧洲

, where it is marketed by Almirall.

，它由Almirall公司销售。

INDICATIONS AND USAGE

适应症和用法

ILUMYA (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

ILUMYA（替德拉珠单抗-asmn）适用于需要系统治疗或光疗的中度至重度斑块型银屑病成人患者。

CONTRAINDICATIONS

禁忌症

ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.

ILUMYA禁用于既往对替德拉珠单抗或任何辅料有严重超敏反应的患者。

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNINGS AND PRECAUTIONS

警告与注意事项

Hypersensitivity

超敏反应

Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.

在临床试验中，接受ILUMYA治疗的受试者出现了血管性水肿和荨麻疹的病例。如果发生严重的过敏反应，应立即停止使用ILUMYA并开始适当的治疗。

Infections

感染

ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated.

ILUMYA可能会增加感染风险。在临床上重要的活动性感染患者中，不应开始使用ILUMYA治疗，直至感染消退或得到适当治疗。

Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA until the infection resolves..

在为患有慢性感染或反复感染史的患者开具ILUMYA之前，应考虑治疗的风险和益处。告知接受ILUMYA治疗的患者，如果出现临床上重要的慢性或急性感染的迹象或症状，需寻求医疗帮助。如果患者出现临床上重要或严重的感染，或对标准治疗无反应，应密切监测并考虑暂停使用ILUMYA，直至感染痊愈。

Pretreatment Evaluation for Tuberculosis

结核病的预处理评估

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

在开始使用 ILUMYA 治疗前，应对患者进行结核病 (TB) 感染评估。不要对活动性结核病感染的患者使用 ILUMYA。在给予 ILUMYA 前，应先开始治疗潜伏性结核病。对于有潜伏性或活动性结核病史且无法确认已接受足够疗程的患者，在开始使用 ILUMYA 前应考虑抗结核治疗。

Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after treatment..

接受ILUMYA治疗的患者在治疗期间和治疗后应密切监测活动性结核病的体征和症状。

Immunizations

免疫接种

Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines.

在开始使用ILUMYA治疗之前，根据当前的免疫指南，考虑完成所有适龄的免疫接种。接受ILUMYA治疗的患者不应接种活疫苗。

Adverse Reactions

不良反应

The most common (≥1%) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea.

与安慰剂组相比，ILUMYA治疗最常见的（≥1%）不良反应包括上呼吸道感染、注射部位反应和腹泻。

Please see

请参见

Full Prescribing Information

完整处方信息

.

。

About Sun Pharmaceutical Industries Limited

关于太阳制药工业有限公司

Sun Pharma is the world's leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in

太阳制药是全球领先的专业仿制药公司，在专业药物、仿制药和消费保健产品领域均有涉足。它是最大的制药公司之一。

India

印度

and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries.

并且是美国以及全球新兴市场领先的仿制药公司。太阳制药高增长的全球专科药组合涵盖皮肤科、眼科和皮肤肿瘤科的创新产品，占公司销售额的18%以上。公司垂直整合的业务为超过100个国家的医生和消费者提供值得信赖的高质量药物。

Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit .

其生产设施遍布六大洲。太阳制药为拥有来自 50 多个国家/地区的多元文化员工队伍而感到自豪。欲了解更多信息，请访问 。

www.sunpharma.com/usa

www.sunpharma.com/usa

& follow us on Twitter @SunPharma_

并在Twitter上关注我们 @SunPharma_

Disclaimer

免责声明

Statements in this 'Document' describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be 'forward looking statements' within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.

本“文件”中描述公司目标、预测、估计、预期、计划或预测或行业状况或事件的声明，可能是适用证券法律法规和规定所指的“前瞻性声明”。实际结果、业绩或成就可能与这些声明明示或暗示的结果有重大差异。

The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof..

公司不承担更新或修改前瞻性声明的义务，以反映此后出现的发展或情况，或反映本日期之后发生的意外发展/情况。

References

参考文献

https://www.psoriasis.org/hands-feet-nails/

https://www.psoriasis.org/hands-feet-nails/

SOURCE Sun Pharmaceutical Industries Inc.,

源太阳制药工业公司，

USA

美国

(Sun Pharma)

（太阳制药）

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