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AbbVie presents 18 abstracts in Crohn's disease and ulcerative colitis
艾伯维在克罗恩病和溃疡性结肠炎方面展示了18篇摘要
Breadth of data from real-world evidence and clinical trials reinforce risankizumab and upadacitinib efficacy, safety profile, and durability
真实世界证据和临床试验的数据广度进一步证实了risankizumab和upadacitinib的疗效、安全性和持久性。
NORTH CHICAGO, Ill.
伊利诺伊州北芝加哥市
,
,
May 5, 2026
2026年5月5日
/
/
PRNewswire
美通社
/ -- AbbVie (NYSE: ABBV) today announced the presentation of new data across its gastroenterology portfolio at the 2026 Digestive Disease Week (DDW) Annual Meeting, May 2-5 in Chicago. AbbVie will present 18 abstracts, including real-world evidence and long-term findings for SKYRIZI
/ -- 艾伯维(AbbVie,纽约证券交易所代码:ABBV)今天宣布,在2026年5月2日至5日于芝加哥举行的消化疾病周(DDW)年会上,将展示其胃肠病学产品组合中的新数据。艾伯维将展示18份摘要,其中包括SKYRIZI的真实世界证据和长期研究结果。
®
®
(risankizumab-rzaa) and RINVOQ
(利桑珠单抗-rzaa)和RINVOQ
®
®
(upadacitinib) in Crohn's disease and ulcerative colitis.
乌帕达西替尼在克罗恩病和溃疡性结肠炎中的应用。
'As a leader in gastroenterology, AbbVie remains focused on advancing the understanding of IBD and helping raise the standard of care through scientific innovation and a broad portfolio of marketed and investigational therapies,' said Andrew Anisfeld, Ph.D., vice president, global medical affairs, immunology, AbbVie.
“作为胃肠病学领域的领导者,艾伯维依然专注于推进对IBD的理解,并通过科学创新以及广泛的应用和研究中的治疗方案组合来提高护理标准,”艾伯维免疫学全球医学事务副总裁安德鲁·阿尼菲尔德博士表示。
.
。
'Our research presented at DDW adds to the growing body of evidence demonstrating the sustained durability of clinical and endoscopic response, as well as the established safety profile, of risankizumab and upadacitinib for people living with IBD.'
“我们在DDW上展示的研究增加了越来越多的证据,证明了risankizumab和upadacitinib在治疗IBD患者中的临床和内镜反应的持久性,以及其已确立的安全性。”
Real-World Data for Patients on Risankizumab in Crohn's Disease
克罗恩病患者使用Risankizumab的真实世界数据
Sustained symptom relief and reduced need for concomitant therapy:
持续的症状缓解和减少对伴随治疗的需求:
A 52-week follow-up of adults with moderately to severely active Crohn's disease treated with risankizumab from the ASPIRE-CD study showed rapid and sustained improvements in abdominal pain, bowel urgency and liquid/soft stools. Among patients with extraintestinal manifestations of arthritis and skin conditions, 25% and 46%, respectively, reported experiencing relief at Week 52.
ASPIRE-CD 研究中对接受 risankizumab 治疗的中度至重度活动性克罗恩病成人患者进行的 52 周随访显示,腹痛、排便紧迫感和水样/软便症状得到了快速且持续的改善。在患有肠外表现的关节炎和皮肤疾病的患者中,分别有 25% 和 46% 在第 52 周报告症状有所缓解。
By Week 52, the use of corticosteroids decreased from 34% at baseline to 7%, and over-the-counter therapies had decreased from 72% at baseline to 49%..
到第52周时,皮质类固醇的使用从基线时的34%下降到7%,非处方疗法也从基线时的72%下降到49%。
Improved quality of life:
生活质量的提高:
In an analysis of health-related quality of life (HRQL) and treatment satisfaction after initiating risankizumab in patients enrolled in the ASPIRE-CD study, 77% reported improvement in life enjoyment by Week 52. In addition, patients had improved general wellbeing, including improved sexual health and improved work productivity and daily activity levels one year after starting risankizumab.
在对参加ASPIRE-CD研究的患者启动利桑珠单抗治疗后健康相关生活质量(HRQL)和治疗满意度的分析中,77%的患者报告在第52周时生活乐趣有所改善。此外,患者的整体幸福感有所提升,包括性健康改善,以及在开始使用利桑珠单抗一年后工作生产力和日常活动水平的提高。
Overall satisfaction with Crohn's disease treatments improved among all patients (from 50% at baseline to nearly 87% at Week 52), particularly patients who were still being treated with risankizumab at Week 52 (92% satisfaction)..
对克罗恩病治疗的总体满意度在所有患者中都有所提高(从基线的50%提高到第52周的近87%),特别是那些在第52周仍在接受利生奇单抗治疗的患者(满意度为92%)。
Low Switch Rate for Risankizumab Among Crohn's Disease Patients
克罗恩病患者使用Risankizumab的转换率低
Treatment persistence:
治疗持续性:
A real-world study of US claims data analyzed the switch rates over a 24-month period among patients with Crohn's disease initiating a new biologic therapy. It found the switch rate was 14% for risankizumab, compared with 21% for ustekinumab, 30% for vedolizumab, 33% for infliximab, and 36% for adalimumab.
一项基于美国索赔数据的真实世界研究分析了克罗恩病患者在开始新的生物疗法后24个月内的转换率。研究发现,risankizumab的转换率为14%,而ustekinumab为21%,vedolizumab为30%,infliximab为33%,adalimumab为36%。
This pattern was also seen among biologic-naïve patients..
这种模式在生物制剂初治患者中也可见到。
Lower Odds of Hospitalization Observed After Switch to Upadacitinib
转换为乌帕达西替尼后观察到住院几率降低
Biologic dose-escalation vs. switching to upadacitinib in a real-world setting:
在真实世界环境中,生物制剂剂量递增与转换为乌帕替尼的比较:
A retrospective analysis of US claims data found that among patients with Crohn's disease or ulcerative colitis treated with a biologic therapy, patients who were switched to upadacitinib had a 31% lower odds of hospitalization and 26% lower odds of emergency department visits than those who increased average weekly dose of the biologic therapy..
对美国索赔数据的回顾性分析发现,在使用生物疗法治疗的克罗恩病或溃疡性结肠炎患者中,与增加生物疗法平均每周剂量的患者相比,转用乌帕达西替尼的患者住院几率降低31%,急诊就诊几率降低26%。
Endoscopic Improvements in Difficult-to-Treat Crohn's Disease
难治性克罗恩病的内镜改善
Treating patients with Perianal Fistulizing Crohn's disease:
治疗肛周瘘管克罗恩病患者:
Among patients with Perianal Fistulizing Crohn's disease (PFCD), in two Phase 3 trials, those who responded to upadacitinib 45 mg were re-randomized to receive maintenance treatment with upadacitinib (15 mg or 30 mg) or placebo for 52 weeks. In this post-hoc analysis, upadacitinib-treated patients showed endoscopic improvements through 52 weeks, regardless of fistula response, as demonstrated by reductions in Simple Endoscopic Score for Crohn's disease (SES-CD).
在两项 III 期试验中,患有肛周瘘管克罗恩病 (PFCD) 的患者中,那些对乌帕达西替尼 45 毫克有反应的患者被重新随机分配接受乌帕达西替尼(15 毫克或 30 毫克)或安慰剂的维持治疗,持续 52 周。在这项事后分析中,无论瘘管反应如何,接受乌帕达西替尼治疗的患者在 52 周内均显示出内镜改善,这通过克罗恩病简化内镜评分 (SES-CD) 的降低得到了证明。
Majority of these patients were without an adequate response to anti-tumor necrosis factor (TNF) therapy..
大多数患者对抗肿瘤坏死因子(TNF)治疗无充分反应。
Select AbbVie abstracts are highlighted below, and all the 2026 DDW Annual Meeting posters are available
以下重点介绍了AbbVie的部分摘要,所有2026年DDW年会的海报均可查阅。
here
这里
:
:
Abstract Title
摘要标题
Presentation Number
演示编号
Real-World Switching Rates Among Patients with Crohn's Disease
克罗恩病患者的实际转换率
Treated with Biologics in the United States
在美国使用生物制剂治疗
Su1657
苏1657
Improvements in Simple Endoscopic Scores for Crohn's Disease in
改进克罗恩病的简单内镜评分
Upadacitinib-Treated Patients with Perianal Fistulizing Disease:
乌帕达西替尼治疗的肛周瘘管病患者:
Post Hoc Analysis of the Phase 3 Trials
三期试验的事后分析
Su1495
苏1495
Risankizumab Reduces Crohn's Disease-Related Symptoms and
Risankizumab减轻克罗恩病相关症状和
Concomitant Therapy Use in Adults with Crohn's Disease: Year 1
成人克罗恩病的伴随治疗使用:第1年
Results From the ASPIRE-CD Study
ASPIRE-CD 研究结果
Sa1504
萨1504
Risankizumab Improves Health-Related Quality of Life in Adults
Risankizumab 改善成年人的健康相关生活质量
with Crohn's Disease: Year 1 Results from the ASPIRE-CD Study
克罗恩病患者:ASPIRE-CD研究的第1年结果
Mo1674
钼1674
Comparative Real-World Outcomes Following Dose Escalation of
剂量递增后的比较真实世界结果
Current Biologic Therapy Versus Switching to Upadacitinib Among
当前的生物疗法与转换为乌帕达西替尼之间的比较
Patients with Crohn's Disease or Ulcerative Colitis: A Propensity
克罗恩病或溃疡性结肠炎患者:倾向
Score Matched Analysis
得分匹配分析
Tu1655
Tu1655
About SKYRIZI
关于SKYRIZI
®
®
(risankizumab-rzaa)
(利桑珠单抗-rzaa)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that blocks IL-23 by selectively binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.
SKYRIZI 是一种白细胞介素-23(IL-23)抑制剂,通过选择性结合其p19亚基来阻断IL-23。IL-23是一种参与炎症过程的细胞因子,被认为与多种慢性免疫介导疾病有关。
1
1
SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderately to severely active ulcerative colitis, plaque psoriasis, psoriatic arthritis and Crohn's disease.
SKYRIZI 已获美国食品和药物管理局 (FDA) 批准,用于治疗中度至重度活动性溃疡性结肠炎、斑块状银屑病、银屑病关节炎和克罗恩病。
1
1
On April 27, 2026,
2026年4月27日,
AbbVie announced submission
艾伯维宣布提交
of an application to the FDA seeking approval of SKYRIZI
向美国食品药品监督管理局(FDA)提交的申请,寻求批准SKYRIZI
®
®
for subcutaneous induction for the treatment of adult patients with moderately to severely active CD.
用于治疗中度至重度活动性CD的成人患者,进行皮下诱导。
SKYRIZI
天空里奇
®
®
(risankizumab-rzaa) U.S. Uses and Important Safety Information
(利桑珠单抗-rzaa)美国用途和重要安全信息
1
1
SKYRIZI is a prescription medicine used to treat adults with:
SKYRIZI是一种用于治疗成人以下疾病的处方药:
moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
中度至重度斑块型银屑病患者,可能受益于注射或口服药物(系统治疗)或使用紫外线或UV光(光疗)的治疗。
active psoriatic arthritis.
活动性银屑病关节炎。
moderate to severe Crohn's disease.
中度至重度克罗恩病。
moderate to severe ulcerative colitis.
中度至重度溃疡性结肠炎。
IMPORTANT SAFETY INFORMATION
重要安全信息
What is the most important information I should know about SKYRIZI
我应该了解的关于SKYRIZI的最重要的信息是什么
®
®
(risankizumab-rzaa)?
(利桑珠单抗-rzaa)?
SKYRIZI is a prescription medicine that may cause serious side effects, including:
SKYRIZI 是一种处方药,可能会引起严重副作用,包括:
Serious allergic reactions:
严重过敏反应:
Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:
如果出现以下严重过敏反应的症状,请立即停止使用SKYRIZI并寻求紧急医疗帮助:
fainting, dizziness, feeling
昏厥、头晕、感觉
lightheaded (low blood pressure)
头晕(低血压)
swelling of your face, eyelids, lips,
脸部、眼睑、嘴唇肿胀,
mouth, tongue, or throat
嘴、舌头或喉咙
trouble breathing or throat tightness
呼吸困难或喉咙紧缩
chest tightness
胸闷
skin rash, hives
皮疹,荨麻疹
itching
瘙痒
Infections:
感染:
SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB.
SKYRIZI 可能会降低免疫系统抵抗感染的能力,并可能增加感染的风险。在开始使用 SKYRIZI 治疗之前,您的医疗保健提供者应检查您是否患有感染和结核病 (TB),如果您有结核病史或患有活动性结核病,可能会在您开始使用 SKYRIZI 治疗前对您进行结核病治疗。
Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI..
您的医疗保健提供者在您使用SKYRIZI治疗期间及之后,应密切观察您是否有结核病的迹象和症状。
Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
如果您有感染或感染症状,请立即告诉您的医疗保健提供者,包括:
fever, sweats, or chills
发烧、出汗或发冷
cough
咳嗽
shortness of breath
呼吸急促
blood in your mucus (phlegm)
痰中带血
muscle aches
肌肉酸痛
warm, red, or painful skin
温暖、发红或疼痛的皮肤
or sores on your body
身体上的疮或溃疡
different from your
不同于你的
psoriasis
银屑病
weight loss
减肥
diarrhea or stomach pain
腹泻或胃痛
burning when you urinate
排尿时灼痛
or urinating more often
或更频繁地排尿
than normal
比平常更严重
Do not use SKYRIZI if you are
如果您是以下情况,请勿使用SKYRIZI:
allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.
对risankizumab-rzaa或SKYRIZI中的任何成分过敏。有关完整成分列表,请参阅药物指南或消费者简要摘要。
Before using SKYRIZI, tell your healthcare provider about all of your medical conditions,
使用SKYRIZI之前,请告诉您的医疗保健提供者您的所有医疗状况,
including if you:
包括如果你:
have any of the conditions or symptoms listed in the section
具有本节中列出的任何情况或症状
'What is the most important information I should know about SKYRIZI?'
“关于SKYRIZI,我应该知道的最重要的信息是什么?”
have an infection that does not go away or that keeps coming back.
感染一直不好或者反复发作。
have TB or have been in close contact with someone with TB.
患有结核病或与结核病患者有过密切接触。
have recently received or are scheduled to receive an immunization (vaccine). Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI.
最近已接种或计划接种疫苗(免疫)。与免疫系统相互作用的药物可能会增加您在接种活疫苗后感染的风险。在使用SKYRIZI治疗之前、期间或之后,应避免接种活疫苗。
Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine..
在接种疫苗前,请告知您的医疗保健提供者您正在服用SKYRIZI。
are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.
怀孕或计划怀孕。目前尚不清楚SKYRIZI是否会伤害您未出生的宝宝。
are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.
正在哺乳或计划哺乳。目前尚不清楚SKYRIZI是否会进入您的母乳中。
become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry.
在服用SKYRIZI期间怀孕。我们鼓励您注册妊娠登记处,该登记处用于收集您和宝宝的健康信息。请与您的医疗保健提供者交谈或拨打1-877-302-2161注册此登记处。
Tell your healthcare provider about all the medicines you take,
告诉您的医疗保健提供者您所服用的所有药物,
including prescription and over-the-counter medicines, vitamins, and herbal supplements.
包括处方药和非处方药、维生素以及草本补充剂。
What are the possible side effects of SKYRIZI?
SKYRIZI 可能的副作用有哪些?
SKYRIZI may cause serious side effects. See 'What is the most important information I should know about SKYRIZI?'
SKYRIZI 可能会引起严重的副作用。请参阅“关于 SKYRIZI,我应该了解的最重要的信息是什么?”
Liver problems may happen while being treated for Crohn's disease or ulcerative colitis:
治疗克罗恩病或溃疡性结肠炎期间可能会出现肝脏问题:
A person with Crohn's disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and at least up to 12 weeks of treatment, and may stop treatment with SKYRIZI if you develop liver problems.
一名患有克罗恩病的患者通过手臂静脉注射SKYRIZI后,出现了肝功能血液检测值变化并伴随皮疹,导致住院。您的医疗提供者将在治疗前、治疗期间以及至少治疗开始后的12周内进行血液检测以检查您的肝功能,如果您出现肝脏问题,可能会停止使用SKYRIZI治疗。
Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine..
如果出现以下症状,请立即告知您的医疗保健提供者:无法解释的皮疹、恶心、呕吐、腹痛、疲倦、食欲不振、皮肤和眼睛发黄(黄疸)以及尿液变深。
The most common side effects of SKYRIZI in people treated for Crohn's disease and ulcerative colitis include:
接受SKYRIZI治疗克罗恩病和溃疡性结肠炎的人最常见的副作用包括:
upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, urinary tract infection, and rash.
上呼吸道感染、头痛、关节痛、胃(腹)痛、注射部位反应、红细胞减少(贫血)、发烧、背痛、尿路感染和皮疹。
The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include:
接受SKYRIZI治疗斑块状银屑病和银屑病关节炎的患者最常见的副作用包括:
upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections.
上呼吸道感染、头痛、疲倦感、注射部位反应和真菌性皮肤感染。
These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects.
这些并非 SKYRIZI 的所有可能副作用。如需了解有关副作用的医疗建议,请咨询您的医生。
Use SKYRIZI exactly as your healthcare provider tells you to use it.
请严格按照您的医疗保健提供者的指示使用SKYRIZI。
SKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.
SKYRIZI(利桑珠单抗-rzaa)提供150毫克/毫升预充式注射器和笔,600毫克/10毫升静脉输注瓶,以及180毫克/1.2毫升或360毫克/2.4毫升单剂量预充式卡式瓶配合体外注射器。
This is the most important information to know about SKYRIZI. For more information, talk to your HCP.
这是关于SKYRIZI最重要的信息。欲了解更多信息,请咨询您的医疗保健提供者。
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
我们鼓励您向 FDA 报告处方药的负面副作用。访问
www.fda.gov/medwatch
www.fda.gov/medwatch
or call 1-800-FDA-1088.
或拨打1-800-FDA-1088。
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit
如果您在支付药品费用方面遇到困难,AbbVie 可能能够提供帮助。请访问
AbbVie.com/PatientAccessSupport
AbbVie.com/PatientAccessSupport
to learn more.
了解更多。
Please click here for the
请点击这里以获取
Full Prescribing Information
完整处方信息
and
和
Medication Guide
药品指南
.
。
About RINVOQ
关于RINVOQ
®
®
(upadacitinib)
乌帕达西替尼
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3 and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known..
由AbbVie科学家发现和开发的RINVOQ是一种JAK抑制剂,目前正在研究用于多种免疫介导的炎症性疾病。基于酶和细胞测定,RINVOQ对JAK-1的抑制效力比对JAK-2、JAK-3和TYK-2更强。目前尚不清楚特定JAK酶抑制与治疗效果和安全性之间的相关性。
Upadacitinib is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo. The use of upadacitinib for these diseases is not FDA approved, and its safety and efficacy has not been established for these diseases..
乌帕达西替尼正在针对斑秃、化脓性汗腺炎、高安动脉炎、系统性红斑狼疮和白癜风进行三期临床试验。乌帕达西替尼用于这些疾病的治疗尚未获得FDA批准,其在这些疾病中的安全性和有效性尚未确立。
RINVOQ
瑞诺奎
®
®
(upadacitinib) U.S. Uses and Important Safety Information
乌帕达西替尼(upadacitinib)美国用途及重要安全信息
2
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RINVOQ is a prescription medicine used to treat:
RINVOQ是一种处方药,用于治疗:
Adults with moderate to severe rheumatoid arthritis (RA)
患有中度至重度类风湿性关节炎(RA)的成人
when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
当使用一种或多种称为肿瘤坏死因子(TNF)抑制剂的药物时,效果不佳或无法耐受。
Adults with active psoriatic arthritis (PsA)
患有活动性银屑病关节炎(PsA)的成年人
when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
当使用一种或多种称为TNF阻滞剂的药物时,效果不佳或无法耐受。
Adults with active ankylosing spondylitis (AS)
患有活动性强直性脊柱炎(AS)的成年人
when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
当使用一种或多种称为TNF阻滞剂的药物时,效果不佳或无法耐受。
Adults with active non-radiographic axial spondyloarthritis (nr-axSpA)
患有活动性非放射学中轴型脊柱关节炎(nr-axSpA)的成人
with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated.
当使用肿瘤坏死因子(TNF)阻断剂药物时,出现炎症的客观体征,但效果不佳或无法耐受。
Adults with giant cell arteritis (GCA)
患有巨细胞动脉炎(GCA)的成年人
.
。
Adults with moderate to severe ulcerative colitis (UC)
中度至重度溃疡性结肠炎(UC)的成人
when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers.
当使用一种或多种称为TNF阻滞剂的药物效果不佳或无法耐受时,或者在您的医疗保健提供者不推荐使用TNF阻滞剂的情况下,改用其他注射剂或药丸(全身治疗)后。
Adults with moderate to severe Crohn's disease (CD)
中度至重度克罗恩病(CD)的成年人
when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers.
当使用一种或多种称为TNF阻滞剂的药物效果不佳或无法耐受时,或在使用其他注射剂或药丸(全身治疗)后,而您的医疗保健提供者不推荐使用TNF阻滞剂时。
It is not known if RINVOQ is safe and effective in children with ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease.
不知道RINVOQ对患有强直性脊柱炎、非放射学轴向脊柱关节炎、溃疡性结肠炎或克罗恩病的儿童是否安全有效。
Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD])
12岁及以上患有中度至重度湿疹(特应性皮炎[AD])的成人和儿童
that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended.
对之前的治疗无反应,且其湿疹通过其他药物或注射(包括生物制剂)无法得到良好控制,或不建议使用其他药物或注射。
It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.
尚不清楚RINVOQ对于12岁以下的特应性皮炎儿童是否安全有效。
It is not known if RINVOQ LQ is safe and effective in children with atopic dermatitis.
不知道RINVOQ LQ对患有过敏性皮炎的儿童是否安全有效。
RINVOQ/RINVOQ LQ is a prescription medicine used to treat:
RINVOQ/RINVOQ LQ 是一种处方药,用于治疗:
Children 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA)
2岁及以上患有活动性多关节幼年特发性关节炎 (pJIA) 的儿童
when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
当使用一种或多种称为TNF阻滞剂的药物时,效果不佳或无法耐受。
Children 2 to less than 18 years of age with active psoriatic arthritis (PsA)
2至未满18岁的活动性银屑病关节炎(PsA)儿童患者
when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
当使用一种或多种称为TNF阻滞剂的药物时,效果不佳或无法耐受。
It is not known if RINVOQ/RINVOQ LQ is safe and effective in children under 2 years of age with polyarticular juvenile idiopathic arthritis or psoriatic arthritis.
不清楚RINVOQ/RINVOQ LQ对于2岁以下患有多关节幼年特发性关节炎或银屑病关节炎的儿童是否安全有效。
IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)
RINVOQ/RINVOQ LQ(乌帕达西替尼)的重要安全信息
What is the most important information I should know about RINVOQ*?
我应该了解的关于RINVOQ*的最重要信息是什么?
RINVOQ may cause serious side effects, including:
RINVOQ可能会引起严重的副作用,包括:
Serious infections.
严重感染。
RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ.
RINVOQ可能会降低您抵抗感染的能力。在服用RINVOQ期间,已发生严重感染,包括结核病(TB)以及由细菌、真菌或病毒引起的可扩散至全身的感染。有些人因这些感染而死亡。您的医疗保健提供者(HCP)应在开始使用RINVOQ之前对您进行结核病检测,并在RINVOQ治疗期间密切检查您是否有结核病的体征和症状。
You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster)..
如果患有任何类型的感染,除非您的医疗保健提供者 (HCP) 告诉您没问题,否则您不应开始服用 RINVOQ。如果您得了严重感染,您的医疗保健提供者可能会停止您的治疗,直到您的感染得到控制。您可能有更高的风险患上带状疱疹(疱疹病毒)。
Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.
50岁及以上且至少有1项心脏病(心血管)风险因素的人群死亡风险增加。
Cancer and immune system problems.
癌症和免疫系统问题。
RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ.
RINVOQ 可能会增加某些癌症的风险。可能会发生淋巴瘤和其他癌症,包括皮肤癌。现有或曾经的吸烟者患某些癌症(包括淋巴瘤和肺癌)的风险更高。在使用 RINVOQ 治疗期间,请遵循您的医疗保健提供者关于检查皮肤癌的建议。
Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen..
限制你在阳光下度过的时间。当你在阳光下时,穿防护服并使用防晒霜。
Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker.
50岁及以上且至少有1种心脏病(心血管)风险因素的人群,尤其是当前或曾经的吸烟者,发生主要心血管(CV)事件(如心脏病发作、中风或死亡)的风险增加。
Blood clots.
血块。
Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.
腿部、肺部和动脉的静脉中可能会出现血凝块。这可能是危及生命的并导致死亡。腿部和肺部静脉中的血凝块在50岁及以上且至少有1个心脏病(CV)风险因素的人群中发生更频繁。
Allergic reactions.
过敏反应。
Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away..
服用RINVOQ的人群中已观察到可能出现皮疹(荨麻疹)、呼吸困难、感到虚弱或头晕、或嘴唇、舌头、喉咙肿胀等症状,这可能意味着您正在发生过敏反应。其中一些反应较为严重。如果在使用RINVOQ治疗期间出现任何这些症状,请立即停止服用RINVOQ并马上寻求紧急医疗帮助。
Tears in the stomach or intestines
胃或肠道的溃疡
. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting.
这种情况最常发生在服用非甾体抗炎药 (NSAIDs) 或皮质类固醇的人群中。如果出现胃部疼痛、发烧、发冷、恶心或呕吐,请立即就医。
Changes in certain laboratory tests.
某些实验室检测指标的变化。
Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.
在您开始服用 RINVOQ 之前以及服用期间,您的医疗保健提供者 (HCP) 应该进行血液检查。如果这些血液检查结果发生变化,您的 HCP 可能会根据需要暂停您的 RINVOQ 治疗一段时间。
Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ.
如果您对乌帕替尼或RINVOQ中的任何成分过敏,请勿服用RINVOQ。
See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.
请参阅药品指南或消费者简要摘要以获取完整的成分列表。
What should I tell my HCP BEFORE starting RINVOQ?
在开始使用RINVOQ之前,我应该告诉我的医疗保健提供者(HCP)什么?
Tell your HCP if you:
如果您有以下情况,请告诉您的医疗保健提供者 (HCP):
Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection, such as:
正在接受感染治疗、有反复发作或持续存在的感染,或有感染症状,例如:
Fever, sweating, or chills
发热、出汗或寒战
Shortness of breath
呼吸急促
Warm, red, or painful skin or
温暖、发红或疼痛的皮肤或
sores on your body
身体上的疮痍
Muscle aches
肌肉酸痛
Feeling tired
感到疲倦
Blood in phlegm
痰中带血
Diarrhea or stomach pain
腹泻或胃痛
Cough
咳嗽
Weight loss
减肥
Burning when urinating or
排尿时灼烧感或
urinating more often
尿频
than normal
比平常更多
Have TB or have been in close contact with someone with TB.
患有结核病或与结核病患者有过密切接触。
Are a current or past smoker.
您是现在或以前吸烟的人。
Have had a heart attack, other heart problems, or stroke.
曾经心脏病发作、有其他心脏问题或中风。
Have or have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
曾经或目前患有任何类型的癌症、乙型或丙型肝炎、带状疱疹(疱疹性神经痛)、腿部或肺部静脉血栓、憩室炎(大肠部分发炎)或胃肠道溃疡。
Have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
患有其他医疗状况,包括肝脏问题、血细胞计数低、糖尿病、慢性肺病、艾滋病毒或免疫系统薄弱。
Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP.
居住、曾经居住或旅行到美国某些地区,如俄亥俄河谷、密西西比河谷和西南部,这些地方会增加你感染某些真菌的风险。如果你不确定是否去过这些地区,请咨询你的医疗保健提供者。
Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
最近已接种或计划接种疫苗。服用RINVOQ的人不应接种活疫苗。
Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose..
怀孕或计划怀孕。根据动物研究,RINVOQ可能会对您的未出生婴儿造成伤害。在您开始使用RINVOQ之前,您的医疗保健提供者将检查您是否怀孕。在使用RINVOQ治疗期间以及最后一剂后的4周内,您应采取有效的避孕措施以避免怀孕。
There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110.
RINVOQ有一个妊娠监测计划。该计划的目的是收集您和您的宝宝的健康信息。如果您在服用RINVOQ期间怀孕,建议您通过拨打1-800-633-9110报告怀孕情况。
Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose.
正在哺乳或计划哺乳。RINVOQ可能会进入您的母乳中。在使用RINVOQ治疗期间以及最后一剂后的6天内,请勿哺乳。
Tell your HCP about all the medicines you take,
告诉您的医疗保健提供者您所服用的所有药物,
including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.
包括处方药和非处方药、维生素以及草本补充剂。RINVOQ 和其他药物可能会相互影响,导致副作用。
Especially tell your HCP if you take:
特别是要告诉你的医疗保健提供者(HCP)你是否服用:
Medicines for fungal or bacterial infections
用于真菌或细菌感染的药物
Rifampicin or phenytoin
利福平或苯妥英
Medicines that affect your immune system
影响免疫系统的药物
If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.
如果您不确定是否正在服用任何这些药物,请咨询您的医疗保健提供者或药剂师。
What should I avoid while taking RINVOQ?
服用RINVOQ时应该避免什么?
Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects.
在使用RINVOQ治疗期间,避免食用或饮用含有葡萄柚的食物或饮料,因为它可能会增加副作用的风险。
What should I do or tell my HCP AFTER starting RINVOQ?
开始使用RINVOQ后,我应该做什么或告诉我的医疗保健提供者?
Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
如果出现任何感染症状,请立即告知您的医疗保健提供者。RINVOQ 可能会增加感染的可能性,或使您现有的感染加重。
Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including:
如果您在服用RINVOQ时出现心脏病发作或中风的任何症状,请立即获得紧急帮助,包括:
Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
胸口中央持续数分钟以上的不适感,或这种感觉时有时无。
Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
胸部、喉咙、颈部或下巴出现严重的紧绷感、疼痛、压迫感或沉重感
Pain or discomfort in your arms, back, neck, jaw, or stomach
手臂、背部、颈部、下巴或胃部感到疼痛或不适
Shortness of breath with or without chest discomfort
呼吸急促,伴或不伴胸部不适
Breaking out in a cold sweat
冷汗直冒
Nausea or vomiting
恶心或呕吐
Feeling lightheaded
感到头晕
Weakness in one part or on one side of your body
身体某部分或一侧的虚弱
Slurred speech
含糊不清的言语
Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including:
如果你在使用RINVOQ治疗期间出现任何血栓的迹象或症状,请立即告诉你的医疗保健提供者,包括:
Swelling
肿胀
Pain or tenderness in one or both legs
一条腿或两条腿疼痛或压痛
Sudden unexplained chest or upper back pain
突然无法解释的胸部或上背部疼痛
Shortness of breath or difficulty breathing
呼吸急促或呼吸困难
Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits.
如果出现持续不退的发烧或腹部疼痛,以及排便习惯的改变,请立即告知您的医疗保健提供者。
What are other possible side effects of RINVOQ?
RINVOQ 还可能有哪些其他副作用?
Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, swelling of the feet and hands (peripheral edema), increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis)..
常见的副作用包括上呼吸道感染(普通感冒、鼻窦感染)、带状疱疹(疱疹性神经痛)、单纯疱疹病毒感染(包括唇疱疹)、支气管炎、恶心、咳嗽、发热、痤疮、头痛、手脚肿胀(外周水肿)、肌酸磷酸激酶血液水平升高、过敏反应、毛囊炎、腹部(腹腔)疼痛、体重增加、流感、疲倦、某些类型白细胞减少(中性粒细胞减少、淋巴细胞减少、白细胞减少)、肌肉疼痛、类似流感的疾病、皮疹、血液胆固醇水平升高、肝酶水平升高、肺炎、红细胞减少(贫血)以及胃肠道感染(胃肠炎)。
A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ.
在使用RINVOQ治疗的特应性皮炎患者中,发生了视网膜脱离(眼睛后部内层的分离或撕裂)。如果在使用RINVOQ治疗期间视力突然发生变化,请立即联系您的医疗保健提供者。
Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your HCP.
一些服用RINVOQ的人可能会在粪便中看到药物残留(一整片药片或药片碎片)。如果发生这种情况,请联系您的医疗保健提供者。
These are not all the possible side effects of RINVOQ.
这些并非 RINVOQ 的所有可能副作用。
How should I take RINVOQ/RINVOQ LQ?
我应该如何服用RINVOQ/RINVOQ LQ?
RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. RINVOQ LQ is taken twice a day with or without food. RINVOQ LQ is available in a 1 mg/mL oral solution.
RINVOQ 每天一次,随餐或不随餐服用均可。不要分割、压碎或咀嚼药片。请严格按照您的医疗保健提供者的指示使用 RINVOQ。RINVOQ 有 15 毫克、30 毫克和 45 毫克的缓释片剂。RINVOQ LQ 每天服用两次,随餐或不随餐均可。RINVOQ LQ 为 1 毫克/毫升的口服溶液。
RINVOQ LQ is not the same as RINVOQ tablets. Do not switch between RINVOQ LQ and RINVOQ tablets unless the change has been made by your HCP..
RINVOQ LQ 与 RINVOQ 片剂并不相同。除非您的医疗保健提供者 (HCP) 已做出更改,否则请勿在 RINVOQ LQ 和 RINVOQ 片剂之间切换。
*Unless otherwise stated, 'RINVOQ' in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ.
除非另有说明,重要安全信息中的“RINVOQ”指的是RINVOQ和RINVOQ LQ。
This is the most important information to know about RINVOQ. For more information, talk to your HCP.
这是关于RINVOQ最重要的信息。欲了解更多信息,请咨询您的医疗保健提供者。
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
我们鼓励您向 FDA 报告处方药的负面副作用。访问
www.fda.gov/medwatch
www.fda.gov/medwatch
or call 1-800-FDA-1088.
或拨打1-800-FDA-1088。
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit
如果您在支付药品费用方面遇到困难,AbbVie 可能能够提供帮助。请访问
AbbVie.com/PatientAccessSupport
AbbVie.com/患者获取支持
to learn more.
了解更多。
Please click here for the
请点击这里获取
Full Prescribing Information
完整处方信息
and
和
Medication Guide
药品指南
.
。
About AbbVie
关于艾伯维
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio.
艾伯维的使命是发现并提供创新药物和解决方案,以解决当今严重的健康问题,并应对未来的医疗挑战。我们努力在包括免疫学、神经科学和肿瘤学在内的几个关键治疗领域,以及我们艾尔建美学产品组合中的产品和服务,对人们的生活产生显著影响。
For more information about AbbVie, please visit us at .
欲了解有关艾伯维的更多信息,请访问我们的网站。
www.abbvie.com
www.abbvie.com
. Follow @abbvie on
关注 @abbvie
LinkedIn,
领英,
,
,
,
,
X
X
and
和
YouTube.
YouTube。
Forward-Looking Statements
前瞻性声明
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words 'believe,' 'expect,' 'anticipate,' 'project' and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements.
本新闻稿中的某些陈述,或者可能被视为1995年《私人证券诉讼改革法案》所指的前瞻性陈述。 “相信”、“预期”、“预计”、“预测”等词语及类似表达和未来或条件动词的使用,通常用于识别前瞻性陈述。
AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations.
AbbVie警告称,这些前瞻性陈述受到可能导致实际结果与前瞻性陈述中明示或暗示的结果存在重大差异的风险和不确定性的约束。这些风险和不确定性包括但不限于知识产权方面的挑战、来自其他产品的竞争、研发过程中固有的困难、不利的诉讼或政府行为、适用于我们行业的法律法规的变化、全球宏观经济因素的影响,如经济衰退或不确定性、国际冲突、贸易争端和关税,以及其他与全球业务运营相关的不确定性和风险。
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, 'Risk Factors,' of AbbVie's 2025.
有关可能影响艾伯维公司运营的经济、竞争、政府、技术及其他因素的更多信息,请参见艾伯维公司2025年年报中的第1A项“风险因素”。
Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law..
已向证券交易委员会提交的年度报告(表格10-K),并经其季度报告(表格10-Q)及其他后续文件更新,这些文件由艾伯维公司提交给证券交易委员会,以更新、补充或取代相关信息。艾伯维不承担公开发布因后续事件或发展而对前瞻性声明进行修订的义务,并明确表示拒绝这样做,除非法律要求。
References
参考文献
SKYRIZI [Package Insert]. North Chicago, IL: AbbVie Inc.; 2026.
SKYRIZI [包装说明书]. 伊利诺伊州北芝加哥:AbbVie Inc.;2026。
RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025
RINVOQ [包装说明书]. 伊利诺伊州北芝加哥:艾伯维公司;2025
Global Media:
全球媒体:
Giovanna Chandler
乔凡娜·钱德勒
giovanna.chandler@abbvie.com
乔瓦娜·钱德勒@abbvie.com
U.S. Media:
美国媒体:
Stephanie Tennessen
史蒂芬妮·田内森
stephanie.tennessen@abbvie.com
stephanie.tennessen@abbvie.com
Investors:
投资者:
Liz Shea
莉兹·谢伊
liz.shea@abbvie.com
liz.shea@abbvie.com
SOURCE AbbVie
来源:艾伯维