BIMZELX（bimekizumab-bkzx）在2025年美国皮肤病学会（AAD）上公布的五年数据显示，对于中度至重度斑块型银屑病患者，其皮肤清除效果和长期疗效得以持续维持-动脉网

BIMZELX[®] (bimekizumab-bkzx) five-year data at AAD 2025 showed sustained skin clearance and long-term efficacy in moderate-to-severe plaque psoriasis

优时比等信源发布 2025-03-07 21:19

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可切换为仅中文

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Sustained complete skin clearance over five years:

五年内持续完全的皮肤清除：

In a subset of 153 patients from the second extension of BE BRIGHT, 67.7% of patients with moderate-to-severe plaque psoriasis (PSO) treated with

在BE BRIGHT的第二次扩展研究中，153名患者亚组中，67.7%的中度至重度斑块型银屑病（PSO）患者接受治疗后，

BIMZELX

(

bimekizumab-bkzx) achieved PASI100

bimekizumab-bkzx 达到 PASI100

at five years

五岁的时候

Durable and broad efficacy across patient subgroups

在不同患者亚组中具有持久和广泛的疗效

at four years:

四岁时：

Consistently high rates of complete or near-complete skin clearance seen at four years regardless of baseline weight or baseline cardiometabolic comorbidities such as hypertension, hyperglycemia or elevated BMI

四年时观察到持续较高的完全或接近完全的皮肤清除率，无论基线体重或基线心脏代谢合并症（如高血压、高血糖或体重指数升高）如何。

High response rates in patients at risk of psoriatic arthritis at three years:

三年时，有银屑病关节炎风险的患者高应答率：

Data showed 68.7–71.6% of PSO patients at risk of developing psoriatic arthritis (PsA) achieved

数据显示，68.7%-71.6%的银屑病患者存在发展为银屑病关节炎（PsA）的风险，已达到目标。

complete skin clearance

完全的皮肤清除

，

generally consistent with the overall treated group. Similar results were seen in all patients with PSO, including those with PsA at baseline

总体上与整个治疗组基本一致。所有PSO患者，包括基线时患有PsA的患者，都观察到了类似的结果。

Dual inhibition:

双重抑制：

BIMZELX

is the first and only approved medicine designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F)

是首个也是唯一获批的旨在选择性抑制白细胞介素17A（IL-17A）和白细胞介素17F（IL-17F）的药物。

Brussels (Belgium), March 7, 2025 –

布鲁塞尔（比利时），2025年3月7日 –

14:00 (CET)

14:00（欧洲中部时间）

– UCB, a global biopharmaceutical company, today announced further long-term data from the Phase 3 trials, and their open-label extensions, investigating BIMZELX

优时比（UCB），一家全球生物制药公司，今天宣布了来自3期试验及其开放标签扩展的更多长期数据，这些试验研究了BIMZELX。

(

bimekizumab

比美珠单抗

-bkzx) in adults with moderate-to-severe plaque psoriasis (PSO). Dual inhibition with bimekizumab-bkzx demonstrated high efficacy and sustained clinical benefits across different adult patient populations living with this common inflammatory skin condition.

-bkzx）用于治疗中度至重度斑块型银屑病（PSO）成人患者。比美吉珠单抗-bkzx 的双重抑制作用在不同成年患者群体中显示出高效性和持续的临床益处，这些患者均患有这种常见的炎症性皮肤病。

[i]

，

[ii]

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[iii]

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“A primary treatment goal for people living with psoriasis is durable, high rates of complete skin clearance. These five-year bimekizumab-bkzx results provide valuable evidence for clinical decision-making,” said Dr Andrew Blauvelt, MD, MBA, Chair, Medical Board, National Psoriasis Foundation. “The sustained complete skin clearance offers important insights into the potential of bimekizumab-bkzx’s dual inhibition to provide long-term management of this chronic inflammatory condition.”.

Among patients with PSO only at baseline, who were at risk of progression to

在基线时仅有PSO的患者中，这些患者有进展为

psoriatic arthritis, 68.7–71.6% achieved

银屑病关节炎，68.7-71.6% 达成目标

complete skin clearance (Psoriasis Area and Severity Index, [PASI]100)

完全皮肤清除（银屑病面积和严重程度指数，[PASI]100）

at three years, generally consistent with the overall treated group, who achieved 72%.

三年时，总体上与整个治疗组一致，达到了72%。

Similar results were seen in all patients with PSO, including those with PsA at baseline.

所有PSO患者，包括基线时患有PsA的患者，都观察到了类似的结果。

Among the 153 US/Canadian patients who completed an open-label extension period to five years,

在完成为期五年的开放标签延长试验期的153名美国/加拿大患者中，

67.7% achieved PASI100, while 84.9% achieved PASI90.

67.7% 的患者达到了 PASI100，而 84.9% 的患者达到了 PASI90。

In this subgroup over the five-year period, bimekizumab-bkzx was generally well tolerated with no unexpected safety findings.

在此亚组的五年期间，bimekizumab-bkzx 通常耐受性良好，未发现意外的安全性问题。

“Psoriasis is a chronic condition that increases the risk of developing other serious health issues,

“银屑病是一种慢性疾病，会增加引发其他严重健康问题的风险，

” said Fiona du Monceau

”菲奥娜·杜·蒙索说

, Executive Vice President, Head of Patient Evidence, UCB. “These five-year results highlight the robust potential of bimekizumab-bkzx in transforming patient outcomes by offering the possibility of lasting, complete skin clearance. Bimekizumab-bkzx is aiming to set a new standard for treatment success, and our belief in its innovative dual inhibition approach is reflected in our dedication to head-to-head trials, including the BE BOLD Phase 3 trial in psoriatic arthritis.”.

，执行副总裁，UCB患者证据主管。“这些五年的结果突显了bimekizumab-bkzx在通过提供持久、完全的皮肤清除可能性来改变患者预后的强大潜力。Bimekizumab-bkzx旨在为治疗成功设定新标准，我们对其创新的双重抑制方法的信心反映在我们对头对头试验的投入中，包括针对银屑病关节炎的BE BOLD三期试验。”

UCB’s data for bimekizumab-bkzx in moderate-to-severe PSO will be presented as six posters at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, U.S., 7–11 March.

优时比公司将在于2025年3月7日至11日在美国佛罗里达州奥兰多举行的美国皮肤病学会（AAD）年会上，通过六张海报展示bimekizumab-bkzx在中度至重度银屑病（PSO）中的数据。

，

二

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，

[vi]

These abstracts complement other bimekizumab-bkzx data presented at AAD in hidradenitis suppurativa,

这些摘要补充了在 AAD 上展示的其他 bimekizumab-bkzx 在化脓性汗腺炎中的数据，

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psoriatic arthritis

银屑病关节炎

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，

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and axial spondyloarthrits,

轴向脊柱关节炎，

[xvii]

，

[xviii]

emphasizing UCB’s leadership in addressing unmet health needs for people living with immune-mediated inflammatory diseases.

强调UCB在满足免疫介导的炎症性疾病患者的未满足健康需求方面的领导地位。

PASI100: 100% improvement from baseline in Psoriasis Area and Severity Index, indicating complete skin clearance.

PASI100：银屑病面积和严重程度指数较基线改善100%，表示皮肤完全清除。

我

，

四

All patients received bimekizumab-bkzx every four weeks (Q4W) to Week 16, then received either Q4W or Q8W depending upon response to treatment. Receiving Q4W to Week 16, then Q8W thereafter is the approved dosing regimen (Q4W/Q8W). Results included patients receiving both Q4W/Q8W and Q4W/Q4W.

所有患者每四周（Q4W）接受一次bimekizumab-bkzx治疗，直至第16周，然后根据对治疗的反应，分别接受Q4W或Q8W。接受Q4W至第16周，此后接受Q8W是获批的给药方案（Q4W/Q8W）。结果包括接受Q4W/Q8W和Q4W/Q4W的患者。

Notes to Editors:

编辑须知：

Further detail on selected bimekizumab-bkzx data in PSO presented at AAD 2025:

在2025年美国皮肤科学会（AAD）上展示的关于银屑病（PSO）中选定的比美珠单抗（bimekizumab-bkzx）数据的更多细节：

Five-year efficacy and safety:

五年疗效与安全性：

A US/Canadian subgroup of 153 patients* completing BE VIVID/BE SURE/BE READY and the BE BRIGHT open-label extension could enter a second 48-week extension (OLE2), where all patients received Q8W.

一个由153名患者组成的美国/加拿大亚组完成了BE VIVID/BE SURE/BE READY和BE BRIGHT开放标签扩展试验后，可以进入第二个48周的扩展期（OLE2），在此期间所有患者均接受Q8W治疗。

Bimekizumab-bkzx demonstrated high rates of clinical and health-related quality of life responses, which were highly durable to Year 5.

Bimekizumab-bkzx 表现出高比率的临床和健康相关生活质量反应，这些反应在第5年仍然高度持久。

†

It was generally well tolerated in this patient subgroup, with no unexpected safety findings, over five years:

在这一患者亚组中，五年内通常耐受性良好，未发现意外的安全性问题：

Of the 153* patients analyzed, 75.2% and 67.7% patients achieved PASI100 at one year and five years, respectively. Similarly, 92.8% and 84.9% achieved PASI90 at one year and five years, respectively

在分析的153名患者中，分别有75.2%和67.7%的患者在一年和五年时达到了PASI100。同样，分别有92.8%和84.9%的患者在一年和五年时达到了PASI90。

Over five years, in the subgroup of 153 patients*, the four most common treatment emergent adverse events (TEAEs) were: nasopharyngitis (9.7/100PY), oral candidiasis (7.6/100PY), coronavirus infection (6.1/100PY) and upper respiratory tract infection (5.8/100PY).

在五年的时间里，在153名患者*的亚组中，最常见的四种治疗相关不良事件（TEAEs）为：鼻咽炎（9.7/100人年）、口腔念珠菌病（7.6/100人年）、冠状病毒感染（6.1/100人年）和上呼吸道感染（5.8/100人年）。

Weight stratification:

体重分层：

Bimekizumab-bkzx demonstrated long-term efficacy across four years regardless of patients’ weight subgroup at baseline (either <90 kg or ≥90 kg):

Bimekizumab-bkzx 在四年的时间里展示了长期疗效，无论患者基线体重亚组（<90公斤或≥90公斤）如何：

†≠

Of the 420 patients analyzed who were <90 kg, 88.5%/67.4% achieved PASI90/PASI100 at four years

在分析的420名体重<90公斤的患者中，88.5%/67.4%在四年时达到了PASI90/PASI100。

Of the 351 patients analyzed who were ≥90 kg, 83.0%/61.6% achieved PASI90/PASI100 at four years

在分析的351名体重≥90公斤的患者中，83.0%/61.6%在四年时达到了PASI90/PASI100。

Skin clearance rates in patients with cardiometabolic comorbidities:

合并心脏代谢共病患者的皮肤清除率：

High and durable levels of complete or near-complete skin clearance were achieved after four years of bimekizumab-bkzx treatment in 771 patients with PSO, regardless of baseline hypertension, elevated BMI, or hyperglycemia:

在接受了四年的bimekizumab-bkzx治疗后，771名银屑病患者无论基线时是否患有高血压、体重指数偏高或高血糖，都达到了高度且持久的完全或接近完全的皮肤清除效果：

†≠

Of the 375 patients with baseline hypertension, 82.8%/59.3%, respectively, achieved PASI90/PASI100 at four years

在375名基线高血压患者中，分别有82.8%/59.3%的患者在四年时达到了PASI90/PASI100。

Of the 344 patients with baseline elevated BMI, 82.5%/60.7%, respectively, achieved PASI90/PASI100 at four years

在344名基线体重指数（BMI）升高的患者中，分别有82.5%/60.7%的患者在四年时达到了PASI90/PASI100。

Of the 62 patients with baseline hyperglycemia, 80.4%/56.9%, respectively, achieved PASI90/PASI100 at four years

在62名基线高血糖患者中，分别有80.4%/56.9%的患者在四年时达到了PASI90/PASI100。

Patients at risk of progressing to psoriatic arthritis (PsA):

有进展为银屑病关节炎（PsA）风险的患者：

The rates of complete skin clearance (PASI100) were high after three years in bimekizumab-bkzx-treated patients with PSO and risk factors for progression to PsA, or who screened PsA-positive, consistent with the overall bimekizumab-bkzx-treated group. Outcomes were similar when the analysis was restricted to patients with only psoriasis at baseline..

三年后，接受bimekizumab-bkzx治疗的具有银屑病（PSO）和进展为银屑病关节炎（PsA）风险因素或筛查为PsA阳性的患者，其皮肤完全清除率（PASI100）较高，与整体接受bimekizumab-bkzx治疗的群体一致。当分析仅限于基线时仅有银屑病的患者时，结果相似。

†¥

所有患者每四周（Q4W）接受一次bimekizumab-bkzx治疗，直至第16周，然后根据治疗反应接受Q4W或Q8W。在第16周前接受Q4W，之后接受Q8W是获批的给药方案（Q4W/Q8W）。结果包括接受Q4W/Q8W和Q4W/Q4W的患者。

†

Modified non‑responder imputation.

修改后的无应答者填补法。

≠

Data were pooled from the 52/56-week Phase 3 trials: BE VIVID, BE SURE, BE READY, and their open-label extension (OLE) BE BRIGHT.

数据汇总自为期52/56周的III期试验：BE VIVID、BE SURE、BE READY，及其开放标签扩展（OLE）试验BE BRIGHT。

Data were pooled from BE VIVID, BE SURE, BE READY, the first 96 weeks of their open-label extension (OLE) BE BRIGHT, and BE RADIANT (48-week double-blinded period, plus 96-week OLE).

数据汇总自BE VIVID、BE SURE、BE READY、其开放标签扩展（OLE）BE BRIGHT的前96周，以及BE RADIANT（48周双盲期加96周OLE）。

About Plaque Psoriasis

关于斑块状银屑病

Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin.

银屑病是一种常见的、慢性炎症性疾病，主要累及皮肤。

[xix]

This skin condition affects men and women of all ages and ethnicities.

这种皮肤状况影响所有年龄和种族的男性和女性。

[xx]

Psoriasis signs and symptoms can vary, but may include red patches of skin covered with silvery-white scales; dry, cracked skin that may bleed; and thickened, pitted or ridged nails.

银屑病的体征和症状可能有所不同，但可能包括覆盖着银白色的鳞屑的红色皮肤斑块；干燥、开裂并可能出血的皮肤；以及增厚、凹陷或有脊纹的指甲。

[xxi]

[二十一]

Psoriasis affects nearly three percent of the total population, or about 125 million people worldwide.

牛皮癣影响着全球近百分之三的人口，也就是全世界大约有一亿两千五百万人。

[xxii]

[二十二]

About Psoriatic Arthritis

关于银屑病关节炎

Psoriatic arthritis is a serious, highly heterogeneous, chronic, systemic inflammatory condition affecting both the joints and skin with a prevalence of 0.02 percent to 0.25 percent of the population.

银屑病关节炎是一种严重的、高度异质性的、慢性的、系统性炎症性疾病，影响关节和皮肤，患病率为总人口的0.02%至0.25%。

[xxiii]

[二十三]

Psoriatic arthritis affects approximately 30 percent of people living with psoriasis.

银屑病关节炎影响大约30%的银屑病患者。

[xxiv]

[二十四]

It manifests as joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis) and inflammation of the sites where tendons or ligaments insert into the bone (enthesitis).

它表现为关节疼痛和僵硬、皮肤斑块、脚趾和手指肿胀（指炎）以及肌腱或韧带附着于骨骼的部位发炎（附着点炎）。

[xxv]

The burden on those living with PsA extends beyond physical discomfort to reduced quality of life, with comorbidities including hypertension, cardiovascular disease, anxiety, and depression.

银屑病关节炎 (PsA) 患者除了身体不适外，还面临生活质量下降的负担，并伴有高血压、心血管疾病、焦虑和抑郁等合并症。

[xxvi]

[二十六]

About BIMZELX

关于BIMZELX

(bimekizumab-bkzx)

（比美珠单抗-bkzx）

BIMZELX is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.

BIMZELX 是一种人源化的单克隆 IgG1 抗体，旨在选择性抑制白细胞介素 17A（IL-17A）和白细胞介素 17F（IL-17F），这两种关键的细胞因子会驱动炎症过程。

[xxvii]

[二十七]

Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.

在病灶性银屑病皮肤中发现IL-17A和IL-17F水平升高。

xxvii

二十七

The approved indications for BIMZELX in the U.S. are:

美国批准的BIMZELX适应症为：

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二十七

Plaque psoriasis:

斑块型银屑病:

BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

BIMZELX 获批用于治疗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。

Psoriatic arthritis:

银屑病关节炎：

BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis

BIMZELX 适用于治疗患有活动性银屑病关节炎的成年患者

Non-radiographic axial spondyloarthritis:

非放射学中轴型脊柱关节炎:

BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation

BIMZELX 适用于治疗具有客观炎症迹象的活动性非放射学中轴型脊柱关节炎成年患者。

Ankylosing spondylitis:

强直性脊柱炎：

BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis

BIMZELX 适用于治疗活动性强直性脊柱炎的成年患者。

Hidradenitis suppurativa:

化脓性汗腺炎:

BIMZELX is indicated for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa

BIMZELX 适用于治疗中度至重度化脓性汗腺炎的成年患者。

BIMZELX U.S. IMPORTANT SAFETY INFORMATION

BIMZELX 美国重要安全信息

IMPORTANT SAFETY INFORMATION

重要安全信息

Suicidal Ideation and Behavior

自杀意念与行为

BIMZELX (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B.

BIMZELX（比美珠单抗-bkzx）可能会增加自杀意念和行为（SI/B）的风险。尚未明确确立BIMZELX治疗与SI/B风险增加之间的因果关系。对于有严重抑郁或SI/B病史的患者，处方者在使用BIMZELX前应权衡潜在的风险和益处。

Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment..

建议监测抑郁、自杀意念或其他情绪变化的出现或恶化。如果发生此类变化，应指示患者立即寻求医疗关注，视情况转诊给心理健康专业人士，并重新评估继续治疗的风险和益处。

Infections

感染

BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX.

BIMZELX可能会增加感染风险，包括严重感染。在任何临床上重要的活动性感染得到解决或充分治疗之前，不要开始使用BIMZELX治疗患者。对于慢性感染或有反复感染史的患者，在开BIMZELX处方前应权衡风险和益处。

Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves..

指导患者如果出现提示有临床重要感染的体征或症状，应寻求医疗建议。如果患者发生这样的感染或对标准疗法无反应，应密切监测患者，并且在感染解决之前不要给予BIMZELX。

Tuberculosis

结核病

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX 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BIMZELX治疗前，评估患者是否存在结核病（TB）感染。避免在活动性结核病患者中使用BIMZELX。在给予BIMZELX之前，开始对潜伏性结核进行治疗。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BIMZELX前考虑抗结核治疗。

Closely monitor patients for signs and symptoms of active TB during and after treatment. .

在治疗期间和治疗后密切监测患者是否有活动性结核病的体征和症状。

Liver Biochemical Abnormalities

肝脏生化异常

Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded.

在BIMZELX的临床试验中报告了血清转氨酶升高。在开始使用BIMZELX治疗前、治疗期间定期以及根据常规患者管理要求，检测肝酶、碱性磷酸酶和胆红素。如果出现与治疗相关的肝酶升高并怀疑药物引起的肝损伤，应中断BIMZELX治疗，直至排除肝损伤的诊断。

Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis..

如果患者出现因果相关的转氨酶和胆红素联合升高，应永久停止使用BIMZELX。避免在患有急性肝病或肝硬化的患者中使用BIMZELX。

Inflammatory Bowel Disease

炎症性肠病

Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.

已有使用IL-17抑制剂（包括BIMZELX）治疗的患者出现炎症性肠病 (IBD) 的报告。避免在活动性IBD患者中使用BIMZELX。在BIMZELX治疗期间，应监测患者是否出现IBD的症状和体征，如果出现新发或症状和体征恶化，应停止治疗。

。

Immunizations

免疫接种

Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.

在开始使用BIMZELX治疗之前，根据现行免疫指南完成所有适龄疫苗接种。避免在使用BIMZELX治疗的患者中使用活疫苗。

Most Common Adverse Reactions

最常见的不良反应

Most common (≥ 1%) adverse reactions in plaque psoriasis and hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue. .

斑块状银屑病和化脓性汗腺炎中最常见（≥1%）的不良反应包括上呼吸道感染、口腔念珠菌病、头痛、注射部位反应、癣感染、胃肠炎、单纯疱疹感染、痤疮、毛囊炎、其他念珠菌感染和疲劳。

Most common (≥ 2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections.

银屑病关节炎中最常见（≥2%）的不良反应包括上呼吸道感染、口腔念珠菌病、头痛、腹泻和尿路感染。

Most common (≥ 2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections.

非放射学中轴型脊柱关节炎最常见的（≥2%）不良反应包括上呼吸道感染、口腔念珠菌病、头痛、腹泻、咳嗽、疲劳、肌肉骨骼疼痛、肌痛、扁桃体炎、转氨酶升高和尿路感染。

Most common (≥ 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infection.

最常见的（≥2%）强直性脊柱炎不良反应包括上呼吸道感染、口腔念珠菌病、头痛、腹泻、注射部位疼痛、皮疹和外阴阴道真菌感染。

Please see Important Safety Information below and full U.S. Prescribing Information at

请参阅下面的重要安全信息，并在美国处方信息中查看完整内容。

http://www.ucb-usa.com/Innovation/Products/BIMZELX

。

About BIMZELX

关于BIMZELX

▼

(bimekizumab)

（比美珠单抗）

EU/EEA*

欧盟/欧洲经济区*

The approved indications for bimekizumab

比美珠单抗的获批适应症

▼

in the European Union are:

在欧盟是：

[xxviii]

Plaque psoriasis:

斑块型银屑病：

Bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy

Bimekizumab 适用于系统治疗的中度至重度斑块型银屑病成人患者。

Psoriatic arthritis:

银屑病关节炎：

Bimekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs)

Bimekizumab，单独使用或与甲氨蝶呤联合使用，适用于治疗对一种或多种疾病修饰抗风湿药物（DMARDs）反应不足或不耐受的活动性银屑病关节炎成年患者。

Axial spondyloarthritis:

轴向脊柱关节炎:

Bimekizumab is indicated for the treatment of adults with active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP), and/or magnetic resonance imaging (MRI), who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

Bimekizumab 适用于治疗具有炎症客观体征（如C反应蛋白（CRP）升高和/或磁共振成像（MRI）所示）的活动性非放射学中轴型脊柱关节炎成年患者，这些患者对非甾体抗炎药（NSAIDs）反应不足或不耐受；以及用于治疗对常规疗法反应不足或不耐受的活动性强直性脊柱炎成年患者。

Hidradenitis suppurativa:

化脓性汗腺炎:

Bimekizumab is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy

比美珠单抗适用于治疗对传统全身性HS治疗反应不佳的成人中重度活动性化脓性汗腺炎（HS；反向痤疮）。

The label information may differ in other countries where approved. Please check local prescribing information.

标签信息在其他已批准的国家可能会有所不同。请查阅当地的处方信息。

BIMZELX

▼

(bimekizumab) EU/EEA* Important Safety Information

（比美珠单抗）欧盟/欧洲经济区*重要安全信息

The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS, respectively).

比美珠单抗最常见的不良反应是上呼吸道感染（在斑块型银屑病、银屑病关节炎、轴向脊柱关节炎（axSpA）和化脓性汗腺炎中分别为14.5%、14.6%、16.3%、8.8%）以及口腔念珠菌病（在PSO、PsA、axSpA和HS中分别为7.3%、2.3%、3.7%、5.6%）。

Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, vulvovaginal mycotic infection (including vulvovaginal candidiasis), headache, rash, dermatitis and eczema, acne, injection site reactions (injection site erythema, reaction, oedema, pain, swelling, haematoma), fatigue.

常见的不良反应（≥1/100 至 <1/10）包括口腔念珠菌病、癣感染、耳部感染、单纯疱疹感染、口咽部念珠菌病、胃肠炎、毛囊炎、外阴阴道真菌感染（包括外阴阴道念珠菌病）、头痛、皮疹、皮炎和湿疹、痤疮、注射部位反应（注射部位红斑、反应、水肿、疼痛、肿胀、血肿）、疲劳。

Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab..

老年人在使用bimekizumab时可能更容易出现某些不良反应，如口腔念珠菌病、皮炎和湿疹。

Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis).

比美珠单抗禁用于对活性物质或任何辅料过敏的患者，以及患有临床重要活动性感染（如活动性结核病）的患者。

Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops an infection the patient should be carefully monitored.

比美珠单抗可能会增加感染的风险。任何有临床重要性活动性感染的患者都不应开始使用比美珠单抗治疗。接受比美珠单抗治疗的患者应被指导在出现提示感染的体征或症状时寻求医疗建议。如果患者发生感染，应仔细监测患者。

If the infection becomes serious or is not responding to standard therapy, treatment should be discontinued until the infection resolves. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB.

如果感染变得严重或对标准治疗无反应，应停止治疗直到感染消退。在开始使用比美珠单抗治疗之前，应对患者进行结核病（TB）感染评估。比美珠单抗不应给予患有活动性结核病的患者。

Patients receiving bimekizumab should be monitored for signs and symptoms of active TB..

接受比美珠单抗治疗的患者应监测活动性结核病的体征和症状。

Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated..

使用Bimekizumab已报告出现新的或炎症性肠病加重的病例。不建议炎症性肠病患者使用Bimekizumab。如果患者出现炎症性肠病的症状和体征，或原有的炎症性肠病加重，应停止使用Bimekizumab并开始适当的医疗管理。

Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated.

使用IL-17抑制剂已观察到严重的超敏反应，包括过敏性反应。如果发生严重的超敏反应，应立即停止使用bimekizumab，并启动适当的治疗。

Live vaccines should not be given in patients treated with bimekizumab.

接受比美珠单抗治疗的患者不应接种活疫苗。

Please consult the summary of product characteristics in relation to other side effects, full safety and prescribing information.

请查阅与其它副作用、完整安全性和处方信息相关的产品特性总结。

European SmPC date of revision: January 2025.

欧洲药品说明书修订日期：2025年1月。

https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf

*EU/EEA means European Union/European Economic Area.

*欧盟/欧洲经济区指欧洲联盟/欧洲经济区。

Last accessed: March 2025.

最后访问时间：2025年3月。

▼

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

该药品受到额外的监控。这将有助于快速识别新的安全信息。医疗专业人员被要求报告任何可疑的不良反应。

For further information, contact UCB:

如需更多信息，请联系UCB：

Investor Relations

投资者关系

Antje Witte

安特耶·维特

T +32.2.559.94.14

电话：+32.2.559.94.14

电子邮件

antje.witte@ucb.com

Corporate Communications

企业传播

Laurent Schots

劳伦特·肖茨

T +32.2.559.92.64

电话：+32.2.559.92.64

电子邮件

laurent.schots@ucb.com

Brand Communications

品牌传播

Amy Cheshire

艾米·切希尔

T +44 7786 743 577

电话：+44 7786 743 577

电子邮件

amy.cheshire@ucb.com

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