Significantly more patients treated with

显著更多的患者接受治疗

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achieved ACR and PASI response rates and had greater improvements in patient-reported quality of life

达到了ACR和PASI的反应率，并且在患者报告的生活质量方面有更大的改善

compared with placebo at Week 16

与安慰剂相比，在第16周

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was well-tolerated in comparison with placebo and apremilast, demonstrating safety consistent with its established clinical profile

与安慰剂和阿普斯特相比，耐受性良好，显示出与其已确立的临床特征一致的安全性。

PRINCETON, N.J.--(BUSINESS WIRE)--

普林斯顿，新泽西州——（商业资讯）——

Bristol Myers Squibb

百时美施贵宝

(NYSE:BMY) today announced positive data from the pivotal Phase 3 POETYK PsA-2 trial (IM011-055) evaluating the efficacy and safety of

(NYSE:BMY) 今天宣布了关键的三期 POETYK PsA-2 试验 (IM011-055) 的积极数据，该试验评估了药物的有效性和安全性。

Sotyktu

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(deucravacitinib) in adults with active psoriatic arthritis (PsA). The POETYK PsA-2 trial met its primary endpoint, with a significantly greater proportion of

(deucravacitinib)用于治疗活动性银屑病关节炎（PsA）成人患者。POETYK PsA-2试验达到了其主要终点，结果显示有显著更高比例的患者。

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-treated patients

- 治疗的患者

achieving

实现

ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) compared with placebo at Week 16 (54.2% versus 39.4%, respectively; p=0.0002). The overall safety profile of

在第16周时，ACR20反应（疾病体征和症状至少改善20%）与安慰剂相比（分别为54.2%和39.4%；p=0.0002）。总体安全性表现为：

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through 16 weeks of treatment was consistent with that established in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials.

通过16周的治疗，结果与在二期PsA临床试验和三期中度至重度斑块型银屑病临床试验中确立的结果一致。

The new data, which represent the first disclosure of data for the Phase 3 POETYK trials in PsA, are being presented as a late-breaking abstract (#66894) at the American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida taking place March 7-11, 2025.

新数据代表了银屑病关节炎 (PsA) 的 III 期 POETYK 试验的首次数据披露，这些数据将在 2025 年 3 月 7 日至 11 日于佛罗里达州奥兰多举行的美国皮肤病学会 (AAD) 年会上作为最新突破性摘要（#66894）展示。

“Given the complex, multifaceted and heterogenous nature of psoriatic arthritis, there continues to be a significant need for safe and effective oral treatments,” said Philip Mease, MD, director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and clinical professor at the University of Washington School of Medicine, Seattle.

“鉴于银屑病关节炎的复杂性、多面性和异质性，对于安全有效的口服治疗药物仍然存在重大需求，”瑞典医学中心/普罗维登斯圣约瑟夫健康中心风湿病研究主任、华盛顿大学医学院（西雅图）临床教授菲利普·米斯博士表示。

“These results are particularly encouraging because they support the potential for .

“这些结果特别令人鼓舞，因为它们支持了 。

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to impact both joint and skin symptoms, as well as patient-reported quality of life outcomes. Combined with a well-tolerated safety profile, these data show

对关节和皮肤症状以及患者报告的生活质量结果都有影响。结合良好的安全性，这些数据表明

Sotyktu

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may serve as an important new treatment option for these patients.”

“可能成为这些患者的重要新治疗选择。”

Additionally, treatment with

此外，治疗过程中使用

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met important secondary endpoints across PsA disease activity at Week 16, demonstrating improvement across clinical signs and symptoms, extra-articular manifestations and patient-reported outcomes. Significantly more

在第16周达到了PsA疾病活动度的重要次要终点，展示了临床体征和症状、关节外表现及患者报告结果的改善。显著更多的

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-treated patients achieved a Psoriasis Area and Severity Index (PASI) 75 response compared with placebo. Treatment with

-治疗的患者达到了银屑病面积和严重程度指数（PASI）75反应，相比之下安慰剂组没有。使用

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also resulted in significantly greater improvements from baseline in the patient-reported Health Assessment Questionnaire-Disability Index (HAQ-DI) compared with placebo (−0.32 versus −0.21, respectively; p=0.0013).

与安慰剂相比，患者报告的健康评估问卷-残疾指数（HAQ-DI）也从基线显著改善（分别为-0.32和-0.21；p=0.0013）。

In the POETYK PsA-2 trial, no new safety signals were identified. In the placebo,

在 POETYK PsA-2 试验中，未发现新的安全信号。在安慰剂组中，

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and apremilast arms, adverse events (AEs) were reported in 54.7%, 62.8% and 73.3% of patients, respectively, and serious AEs in 1.0%, 1.9% and 3.8%, respectively. AEs led to discontinuation in 1.3%, 2.2% and 10.5% in the placebo,

阿普斯特组和对照组中，分别有54.7%、62.8%和73.3%的患者报告了不良事件（AEs），其中严重不良事件分别占1.0%、1.9%和3.8%。在安慰剂组中，不良事件导致的停药率分别为1.3%、2.2%和10.5%。

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and apremilast arms, respectively. Apremilast was included as a safety reference arm in the PsA-2 trial with no formal statistical comparisons planned for efficacy.

和阿普斯特组分别对应。在PsA-2试验中，阿普斯特作为安全性参考组，未计划进行正式的疗效统计比较。

“These promising new data demonstrate the potential of

“这些充满希望的新数据展示了 tiềm năng của”

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as an oral therapy and the first TYK2 inhibitor that may be able to address significant unmet needs of patients living with psoriatic arthritis,” said

“作为一种口服疗法，也是首个可能能够满足银屑病关节炎患者显著未满足需求的TYK2抑制剂，”表示

Edgar Charles

埃德加·查尔斯

, MD, vice president and senior global program lead, Early & Late Development Immunology, Bristol Myers Squibb. “Furthermore, these results support our belief in the capability of

医学博士，副总裁兼早期和晚期开发免疫学全球项目负责人，百时美施贵宝公司。“此外，这些结果支持我们对能力的信心

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in rheumatic conditions and reflect our ongoing commitment to developing medicines for people living with immune-mediated diseases.”

在风湿病条件下，反映了我们对开发针对免疫介导疾病患者的药物的持续承诺。”

Bristol Myers Squibb will work with key investigators to present additional data from the Phase 3 POETYK PsA program at upcoming medical congresses this year and looks forward to discussing these results with health authorities.

百时美施贵宝将与主要研究者合作，在今年即将召开的医学大会上展示POETYK PsA 3期项目的更多数据，并期待与卫生当局讨论这些结果。

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is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis.

在世界众多国家获批用于治疗中度至重度斑块型银屑病成人患者。

Bristol Myers Squibb thanks the patients, investigators and clinical trial sites who participated in POETYK PsA-2.

百时美施贵宝感谢参与POETYK PsA-2的患者、研究人员和临床试验站点。

About the

关于

Sotyktu

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Phase 3 Psoriatic Arthritis Trial Program

第3阶段银屑病关节炎试验计划

The Phase 3

第三阶段

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psoriatic arthritis (PsA) program includes two Phase 3, multicenter, randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety in adults 18 years of age and older with active PsA: POETYK PsA-1 (IM011-054;

银屑病关节炎（PsA）项目包括两项III期、多中心、随机、双盲、安慰剂对照试验，评估18岁及以上活动性PsA成人患者中的疗效和安全性：POETYK PsA-1（IM011-054；

NCT04908202

NCT04908202

) and POETYK PsA-2 (IM011-055;

）和 POETYK PsA-2（IM011-055；

NCT04908189

NCT04908189

).

）。

POETYK PsA-1 enrolled approximately 670 patients with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD naïve). POETYK PsA-2 enrolled approximately 730 patients with active PsA who were bDMARD naïve or had previously received TNFα inhibitor treatment.

POETYK PsA-1 纳入了大约 670 名未接受过生物制剂改善病情抗风湿药（bDMARD 初治）治疗的活动性银屑病关节炎（PsA）患者。POETYK PsA-2 纳入了大约 730 名活动性 PsA 患者，这些患者为 bDMARD 初治或曾接受过 TNFα 抑制剂治疗。

Both trials include a 52-week treatment period comprised of a placebo-controlled treatment period through Week 16, followed by a reallocation and continued active treatment period from Week 16 to Week 52. POETYK PsA-2 also included an apremilast safety reference arm..

两项试验均包括一个 52 周的治疗期，其中包含一个为期 16 周的安慰剂对照治疗期，随后是从第 16 周到第 52 周的重新分配和持续活性治疗期。POETYK PsA-2 还包括一个阿普斯特安全参考组。

The primary endpoint of both trials was the proportion of participants achieving an ACR20 response at Week 16. Important secondary endpoints were also assessed at Week 16 across measures of PsA disease activity.

两项试验的主要终点是第16周时达到ACR20反应的参与者比例。重要的次要终点也在第16周通过PsA疾病活动度的各项指标进行了评估。

Patients in both trials completing 52 weeks of treatment are potentially eligible to enroll in the open-label extension study.

两项试验中完成 52 周治疗的患者有可能符合资格，参与开放标签扩展研究。

About Psoriatic Arthritis

关于银屑病关节炎

Psoriatic arthritis (PsA) is a chronic, immune-mediated, heterogenous disease with multiple musculoskeletal and skin manifestations, including inflammatory arthritis, enthesitis (inflammation where tendon or ligament attaches to the bone), dactylitis (swelling of finger and toe joints) and psoriatic skin and nail lesions.

银屑病关节炎（PsA）是一种慢性、免疫介导、异质性疾病，具有多种肌肉骨骼和皮肤表现，包括炎症性关节炎、肌腱端炎（肌腱或韧带附着于骨处的炎症）、指趾炎（手指和脚趾关节肿胀）以及银屑病皮肤和指甲病变。

Up to 30 percent of patients with psoriasis will develop PsA. In addition to the loss of physical function, pain and fatigue caused by PsA, the disease can significantly impact the mental and emotional well-being of patients. Patients with PsA are also at increased risk of serious comorbidities, including cardiovascular disease, metabolic syndrome, depression and anxiety..

高达30%的银屑病患者会发展为银屑病关节炎（PsA）。除了PsA引起的躯体功能丧失、疼痛和疲劳外，该疾病还可能显著影响患者的心理和情绪健康。PsA患者还面临更高的严重合并症风险，包括心血管疾病、代谢综合征、抑郁和焦虑。

About

关于

Sotyktu

索特库图

(deucravacitinib)

德鲁克拉韦尼布

Sotyktu

索特库图

(deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases.

(deucravacitinib) 是一种口服、选择性、变构酪氨酸激酶 2 (TYK2) 抑制剂，具有独特的机制，代表了一类新的小分子化合物。它是首个在多种免疫介导疾病中进行临床研究的选择性 TYK2 抑制剂。

Bristol Myers Squibb scientists designed .

百时美施贵宝公司的科学家设计了。

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to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases.

选择性靶向TYK2，从而抑制白细胞介素（IL）-23、IL-12和I型干扰素（IFN）的信号传导，这些关键细胞因子参与多种免疫介导疾病的发病机制。

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achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions.

通过与TYK2的调控域结合，实现了高度的选择性，从而导致TYK2及其下游功能的变构抑制。

Sotyktu

索特鲁

selectively inhibits TYK2 at physiologically relevant concentrations. At therapeutic doses,

在生理相关浓度下选择性抑制TYK2。在治疗剂量下，

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does not inhibit JAK1, JAK2 or JAK3.

不抑制 JAK1、JAK2 或 JAK3。

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is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis.

在全球众多国家获批用于治疗中度至重度斑块型银屑病成人患者。

Bristol Myers Squibb: Pursuing Bold Science in Immunology to Transform Patients’ Lives

百时美施贵宝：追求免疫学领域的前沿科学，改变患者生活

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can make simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, we continue to pursue bold science as we work to deliver life-changing medicines that elevate new standards of care across rheumatology, dermatology and pulmonology.

百时美施贵宝秉承着一个愿景——通过科学改变患者的生活。对于患有免疫介导疾病的人来说，长期忍受慢性症状和疾病进展的痛苦现实，可能让简单任务和日常生活变得充满挑战。凭借我们对免疫系统超过20年的深刻理解，我们继续追求前沿科学，致力于提供改变生命的药物，从而在风湿病学、皮肤病学和肺病学领域树立新的治疗标准。

Our sequential immunotherapy research framework aims to address the root cause of disease by controlling inflammation, resetting the immune system and promoting immune homeostasis with the goal of achieving transformational efficacy. By continuously pushing the boundaries of scientific knowledge, we strive to bring forward tailored approaches, treatments and combinations that may lead to durable remissions, improved quality of life and functional cures.

我们的序贯免疫治疗研究框架旨在通过控制炎症、重置免疫系统和促进免疫稳态来解决疾病的根源，以实现变革性的疗效。通过不断拓展科学知识的边界，我们努力推进量身定制的方法、治疗方案和组合，这些可能带来持久的缓解、生活质量的提升以及功能性治愈。

Our collaborations with patients, caregivers, healthcare providers and researchers inform our patient-centric approach as we aim to break efficacy ceilings and deliver what matters most — the promise of living a better life..

我们与患者、护理人员、医疗保健提供者和研究人员的合作为我们的以患者为中心的方法提供了信息，因为我们旨在突破疗效上限，交付最重要的承诺——过上更好生活的希望。

SOTYKTU U.S. INDICATION

SOTYKTU美国适应症

SOTYKTU

索替尤单抗

®

®

(deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

（德鲁克拉维替尼）适用于适合接受系统治疗或光疗的中度至重度斑块型银屑病成人患者。

Limitations of Use:

使用限制：

SOTYKTU is not recommended for use in combination with other potent immunosuppressants.

SOTYKTU 不建议与其他强效免疫抑制剂联合使用。

IMPORTANT SAFETY INFORMATION

重要安全信息

CONTRAINDICATIONS

禁忌症

SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.

SOTYKTU 禁用于对氘可来昔替尼或 SOTYKTU 中任何辅料有过敏反应史的患者。

WARNINGS AND PRECAUTIONS

警告和注意事项

Hypersensitivity:

超敏反应：

Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.

据报道，出现了血管性水肿等超敏反应。如果发生具有临床意义的超敏反应，应采取适当的治疗并停止使用SOTYKTU。

Infections:

感染:

SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection.

SOTYKTU可能会增加感染风险。在接受SOTYKTU治疗的银屑病患者中已有严重感染的报告。与SOTYKTU相关的最常见严重感染包括肺炎和COVID-19。避免在患有活动性或严重感染的患者中使用SOTYKTU。

Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:.

在患者开始使用SOTYKTU治疗之前，应考虑治疗的风险和益处：

with chronic or recurrent infection

慢性或复发性感染

who have been exposed to tuberculosis

曾经接触过结核病的

with a history of a serious or an opportunistic infection

有严重或机会性感染史的

with underlying conditions that may predispose them to infection.

伴有可能使他们易于感染的基础疾病。

Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection.

在治疗期间和治疗后密切监测患者是否出现感染的体征和症状。如果患者在治疗期间发生新的感染，应立即进行全面的诊断测试，开始适当的抗菌治疗，并密切监测。如果患者发生严重感染，应中断SOTYKTU治疗。

Do not resume SOTYKTU until the infection resolves or is adequately treated..

感染消退或得到适当治疗后，方可恢复使用SOTYKTU。

Viral Reactivation

病毒再激活

Herpes virus reactivation (e.g., herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent patient.

在SOTYKTU的临床试验中报告了疱疹病毒再激活（例如，带状疱疹、单纯疱疹）。截至第16周，接受SOTYKTU治疗的患者中有17例（每100患者年6.8例）报告了单纯疱疹感染，而接受安慰剂治疗的患者中有1例（每100患者年0.8例）。在一例免疫功能正常的患者中报告了多皮区带状疱疹。

During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU.

在PSO-1、PSO-2以及开放标签扩展试验中，大多数在接受SOTYKTU治疗期间报告带状疱疹事件的患者年龄小于50岁。SOTYKTU对慢性病毒性肝炎再激活的影响尚不清楚。在开始及进行SOTYKTU治疗期间，应根据临床指南考虑进行病毒性肝炎的筛查并监测其再激活情况。

If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C..

如果出现重新激活的迹象，请咨询乙型肝炎专科医生。SOTYKTU不建议用于活动性乙型肝炎或丙型肝炎患者。

Tuberculosis (TB):

结核病（TB）：

In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU.

在临床试验中，4名接受SOTYKTU治疗并获得适当结核病预防的潜伏性结核患者中，无一人发展为活动性结核（平均随访34周）。一名未患有潜伏性结核的患者在接受54周SOTYKTU治疗后发展为活动性结核。

Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU 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SOTYKTU治疗前，评估患者是否存在潜伏性和活动性结核感染。不要对活动性结核患者使用SOTYKTU。在给予SOTYKTU之前，先启动潜伏性结核的治疗。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SOTYKTU前考虑进行抗结核治疗。

Monitor patients for signs and symptoms of active TB during treatment..

治疗期间，监测患者是否有活动性结核病的体征和症状。

Malignancy including Lymphomas:

包括淋巴瘤在内的恶性肿瘤：

Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU..

在SOTYKTU的临床试验中观察到恶性肿瘤，包括淋巴瘤。在开始或继续使用SOTYKTU治疗之前，应考虑个体患者的获益与风险，特别是对于已知患有恶性肿瘤（除已成功治疗的非黑色素瘤皮肤癌外）以及在SOTYKTU治疗期间出现恶性肿瘤的患者。

Rhabdomyolysis and Elevated CPK:

横纹肌溶解症和CPK升高：

Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo.

SOTYKTU治疗与无症状磷酸肌酸激酶（CPK）升高和横纹肌溶解症的发生率增加相关，相比安慰剂组。

Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.

如果出现显著升高的CPK水平或诊断出或怀疑有肌病，应停止使用SOTYKTU。指示患者及时报告无法解释的肌肉疼痛、压痛或无力，尤其是伴随不适或发热时。

Laboratory Abnormalities:

实验室异常：

Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo.

使用SOTYKTU治疗与甘油三酯水平升高有关。在治疗期间，应根据临床指南定期评估血清甘油三酯水平。与安慰剂相比，SOTYKTU治疗与肝酶升高发生率增加有关。

Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded..

在已知或疑似肝病患者中，根据常规管理方法，在基线时和之后评估肝酶。如果出现与治疗相关的肝酶升高且怀疑药物性肝损伤，应中断SOTYKTU治疗，直到排除肝损伤的诊断。

Immunizations:

免疫接种：

Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated..

在开始使用SOTYKTU治疗之前，根据当前免疫指南，考虑完成所有适龄免疫接种，包括预防性带状疱疹疫苗接种。避免在使用SOTYKTU治疗的患者中使用活疫苗。尚未评估对活疫苗或非活疫苗的反应。

Potential Risks Related to JAK Inhibition:

与JAK抑制相关潜在风险：

It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers.

目前尚不清楚酪氨酸激酶2（TYK2）抑制是否可能与观察到的或潜在的Janus激酶（JAK）抑制的不良反应相关。在一项大型随机的上市后安全性试验中，针对类风湿关节炎（RA）患者使用一种JAK抑制剂，纳入了50岁及以上且至少具有一项心血管风险因素的患者。结果显示，与使用肿瘤坏死因子（TNF）阻滞剂的患者相比，使用JAK抑制剂的患者全因死亡率（包括突发心血管死亡）、主要不良心血管事件、总体血栓形成、深静脉血栓、肺栓塞以及恶性肿瘤（不包括非黑色素瘤皮肤癌）的发生率更高。

SOTYKTU is not approved for use in RA..

SOTYKTU未被批准用于RA。

ADVERSE REACTIONS

不良反应

Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.

最常见的不良反应（≥1%的SOTYKTU治疗患者中出现，且比安慰剂组更频繁）包括上呼吸道感染、血液肌酸磷酸激酶升高、单纯疱疹、口腔溃疡、毛囊炎和痤疮。

SPECIFIC POPULATIONS

特定人群

Pregnancy:

怀孕：

Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072..

关于SOTYKTU在妊娠期间使用的病例报告数据不足以评估药物相关的主要出生缺陷、流产或不良母体或胎儿结局的风险。请向百时美施贵宝公司的不良事件报告热线1-800-721-5072报告妊娠情况。

Lactation:

泌乳：

There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

目前尚无关于SOTYKTU在人乳中是否存在、对哺乳婴儿的影响或对乳汁分泌影响的数据。SOTYKTU存在于大鼠乳汁中。当药物存在于动物乳汁中时，很可能该药物也会存在于人乳中。

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition..

母乳喂养的发育和健康益处应与母亲对SOTYKTU的临床需求以及SOTYKTU或潜在母体状况对母乳喂养婴儿的任何潜在不良影响一并考虑。

Hepatic Impairment:

肝功能损害：

SOTYKTU is not recommended for use in patients with severe hepatic impairment.

SOTYKTU 不建议用于严重肝功能损害的患者。

SOTYKTU is available in 6 mg tablets.

SOTYKTU有6毫克的片剂可供使用。

Please see

请参见

U.S. Full Prescribing Information

美国完整处方信息

, including

，包括

Medication Guide

药品指南

, for SOTYKTU.

，适用于SOTYKTU。

About Bristol Myers Squibb

关于百时美施贵宝

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at

百时美施贵宝是一家全球性的生物制药公司，其使命是发现、开发和提供创新药物，帮助患者战胜严重疾病。如需更多关于百时美施贵宝的信息，请访问我们的网站。

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(apremilast) is a registered trademark of Amgen Inc.

(apremilast) 是安进公司 (Amgen Inc.) 的注册商标。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性陈述的警示声明

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的关于药物产品研发、开发和商业化的“前瞻性声明”。所有非历史事实的声明，或可能被视为前瞻性声明。

Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements.

这些前瞻性陈述基于历史业绩以及我们对未来财务结果、目标、计划和目的的当前预期和预测，涉及固有的风险、假设和不确定性，包括内部或外部因素，这些因素可能会在未来的几年内延迟、转移或改变其中的任何一项，且难以预测，可能超出我们的控制范围，并可能导致我们未来的财务结果、目标、计划和目的与这些陈述中表达或暗示的内容存在重大差异。

These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that .

这些风险、假设、不确定性和其他因素包括但不限于，未来的研究结果可能与迄今为止的结果不一致。

Sotyktu

索特克图

(deucravacitinib) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether .

（氘代克拉维替尼）可能无法在目前预期的时间表内或根本无法获得本公告所述额外适应症的监管批准，任何营销批准若获授予，其使用可能有重大限制，并且，若获批准，是否取得以及取得以及。

Sotyktu

索特库图

for such indication will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission.

因为这样的指示将会取得商业上的成功。任何前瞻性声明都无法得到保证。本新闻稿中的前瞻性声明应结合影响百时美施贵宝公司业务和市场的众多风险和不确定性一起评估，特别是那些在百时美施贵宝公司截至2024年12月31日的年度报告Form 10-K中“警示声明和风险因素”部分所确定的风险，以及我们随后提交的季度报告Form 10-Q、当前报告Form 8-K和其他向证券交易委员会提交的文件中更新的内容。

The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise..

本文件中包含的前瞻性声明仅在本文件发布之日作出，除非适用法律另有规定，百时美施贵宝不承担任何公开更新或修改任何前瞻性声明的义务，无论是否因新信息、未来事件、情况变化或其他原因。

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来源：百时美施贵宝