A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of Risankizumab in Breast Milk of Lactating Women With Inflammatory Bowel Disease Who Are Receiving Risankizumab Therapeutically

Inflammatory bowel disease (IBD) is a chronic inflammatory disease that requires lifelong treatment. This study will asses the concentrations of risankizumab in the breast milk of lactating women with IBD
Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and Crohn's Disease. This is an open-label milk-only study lactation study to evaluate the presence of risankizumab in the milk of lactating women. Approximately 10 adult lactating women with IBD will be enrolled from approximately 3 sites in Israel and or the United States.
Participants will receive risakizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study. The study duration is approximately 7 months.
Participants will attend regular visits during the study at a hospital or clinic. The participants will also be completing questionnaires and will have medical assessments, checking for side effects.

开始日期2024-05-06

申办/合作机构

AbbVie, Inc.

NCT06298188 / Not yet recruitingN/AIIT

Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study

The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.
This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study.

开始日期2024-03-01

申办/合作机构

Shaare Zedek Medical Center

NCT06100744 / Recruiting临床3期

Open-label, Randomized, Assessor-blinded, Efficacy, Safety, Tolerability, and Pharmacokinetics Study of Subcutaneous Risankizumab With an Adalimumab Reference Arm in Children With Active Juvenile Psoriatic Arthritis

Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms.
Risankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide.
Participants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

开始日期2024-01-16

申办/合作机构

AbbVie, Inc.

100 项与瑞莎珠单抗相关的临床结果

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100 项与瑞莎珠单抗相关的专利（医药）

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401

项与瑞莎珠单抗相关的文献（医药）

2024-03-01·Annals of Pharmacotherapy

Choosing Systemic Agents for Psoriasis

作者: Kontzias, Christina ; Feldman, Steven R ; Chandy, Rithi

Treatment options for moderate-to-severe psoriasis depend on drug efficacy and safety, patient preferences, comorbidities, and cost—no drug dominates across all dimensions. Interleukin (IL)-17 inhibitors may be preferred for fast-acting treatment, while the 3-month schedule of risankizumab, ustekinumab, or tildrakizumab may be attractive for patients who prioritize fewer injections. Phototherapy is suitable for patients who wish to avoid systemic agents or when cost is a concern. For patients with poor adherence, infliximab or tildrakizumab may be well suited as they require in-office administration. Dermatologists can educate patients on available therapies to find a regimen best suited to their needs.

2024-03-01·Journal of the European Academy of Dermatology and Venereology

Risankizumab for the treatment of genital psoriasis: A 1‐year, real‐world experience

Letter

作者: Narcisi, A ; Gargiulo, L ; Sperduti, I ; Pacifico, A ; Valenti, M ; Ibba, L ; Frascione, P ; Costanzo, A ; Assorgi, C ; Orsini, D

2024-04-01·Rheumatology and Therapy

Efficacy and Safety of Risankizumab in Patients with Psoriatic Arthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Review

作者: Zhou, Hao-Nan ; Cheng, Ting ; Xia, Guo-Mei ; Huo, Yue-Hong ; Liu, Yu-Xin ; Zhang, Rui-Yuan ; Su, Chang ; Tian, Hong-Yuan ; Zhang, Sheng-Xiao ; Su, Qin-Yi ; Li, Qian ; Zhang, He-Yi

INTRODUCTION:

Currently, the cause of psoriatic arthritis (PsA) is unknown, and the effectiveness of current drug treatments is unsatisfactory. In March 2019, the US Food and Drug Administration (FDA) approved risankizumab, a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, for the treatment of PsA in adults. This study aimed to conduct a meta-analysis of double-blind, randomized, placebo-controlled trials to evaluate the effectiveness and safety of risankizumab in moderate-to-severe PsA.

METHODS:

We conducted a thorough search of relevant databases from the establishment of the databases to October 1, 2023. We conducted a meta-analysis using Stata 12.0 and utilized I² and Egger tests to assess heterogeneity and publication bias among the studies. Bias assessment was performed using the risk bias map and bias risk summary diagram generated by Revman5.4 software. The review protocols were registered on PROSPERO (CRD42023451894) and adhered to the preferred reporting item of system evaluation (PRISMA) guideline.

RESULTS:

Six randomized controlled trials (RCTs) involving 5038 patients with PsA treated with either risankizumab or placebo were included in the analysis. At 24 weeks, the risankizumab group demonstrated a significantly higher American College of Rheumatology-20 (ACR20) response rate compared to the placebo group (RR 1.760, 95% CI 1.568-1.977, P < 0.001). Additionally, the risankizumab group showed a significantly higher Minimal Disease Activity (MDA) response rate compared to the placebo group (RR 1.827, 95% CI 1.048-3.184, P < 0.05). The risankizumab group also exhibited improvement in Short Form 36 Questionnaire (SF-36) score (SMD 0.51, 95% CI 0.33-0.69, P < 0.001), with significantly lower Health Assessment Questionnaire Disability Index (HAQ-DI) score (SMD - 0.27, 95% CI - 0.37 to - 0.17, P < 0.001) and higher Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score (SMD 0.27, 95% CI 0.20-0.35, P < 0.001) compared to the placebo group. Moreover, the risankizumab group had a significantly lower Psoriasis Area and Severity Index (PASI) score (SMD - 6.12, 95% CI - 10.02 to 2.23, P < 0.001). A study by Mease et al. indicated that patients receiving risankizumab generally demonstrated numerical improvements in the Leeds Enthesitis Index (LEI), although the small sample size limits the evidence. Further research is necessary to provide evidence-based guidelines. There were no significant differences in the incidence of serious adverse events (SAE) and serious treatment-emergent adverse events (STEAE) between the risankizumab and placebo groups (RR 0.76, 95% CI 0.45-1.28, P = 0.31; RR 0.99, 95% CI 0.49-1.99, P = 0.97, respectively), and the overall incidence of adverse events (AE) was not comparable (RR 1.10, 95% CI 0.63-1.94, P = 0.73).

CONCLUSION:

Risankizumab showed superior efficacy across multiple outcome measures compared to placebo, with no significant increase in adverse events. Our findings endorse risankizumab as an excellent treatment option for PsA, offering valuable insights for clinicians and patients when choosing appropriate therapeutic interventions.

TRIAL REGISTRATION:

Retrospectively registered (CRD42023451894, 16 August 2023).

419

项与瑞莎珠单抗相关的新闻（医药）

2024-04-26

·Firstwordpharma

AbbVie hikes full-year outlook as Skyrizi, Rinvoq offset Humira slump

AbbVie's first-quarter results presentation Friday revealed that newer anti-inflammatory treatments like Rinvoq and Skyrizi helped mitigate a 36% drop in Humira sales following the entry of biosimilar competition last year. Humira brought in $2.3 billion in the first three months of 2024, which was in line with analyst expectations, but well below the $3.5 billion it generated a year ago."First-quarter results were well ahead of our expectations, driven by excellent performance from our ex-Humira growth platform," stated chief operating officer Robert Michael, who is due to replace long-time CEO Richard Gonzalez in July.Other products in the company's immunology portfolio did the heavy lifting. Skyrizi posted sales of $2 billion, up 48% from the prior year, while Rinvoq contributed $1.1 billion, a 59% increase. The performances helped drive AbbVie's overall revenue to $12.3 billion, up nearly 1% from the same time last year, and exceeding consensus estimates of $11.9 billion.Holding on to Humira marketNine Humira biosimilars have been launched in the US since last year, although AbbVie still clings to a formidable 98% share of the drug's market (see – Physician Views Results: Lack of financial incentive and prescriber confidence stalling adoption of biosimilar Humira products). Earlier this month, Boehringer Ingelheim confirmed plans to let go some sales staff amid lower-than-expected uptake of its Humira biosimilar in the US.Bucking the trend is Sandoz's Hyrimoz, which unlike other Humira biosimilars, has seen a recent "explosion" in new prescriptions, according to an analyst note from Evercore ISI. The shift follows a decision by CVS Caremark, one of the largest pharmacy benefit managers in the US, to drop Humira from its major national commercial formularies earlier this year."As we round out the first year with biosimilar competition to Humira, we believe the company has managed the erosion well," remarked William Blair analyst Tim Lugo.'Firing on all cylinders'In other first-quarter results, AbbVie said blood cancer treatment Imbruvica generated $838 million in the quarter, a gain of 4.5% year-over-year, beating estimates of $744 million. Some investors have been worried about the possibility of mandated price cuts for the drug starting in 2026 after it was selected as one of 10 products subject to pricing talks with Medicare.Revenues from the company's neuroscience portfolio are also up, including the atypical antipsychotic Vraylar (+24% to $694 million), and the migraine treatments Ubrelvy (+34% to $203 million) and Qulipta (+98% to $131 million).AbbVie now expects adjusted profit of between $11.13 and $11.33 per share for this year, compared with $10.97 to $11.17 estimated previously.Commenting on the Q1 results, Lugo said AbbVie is "firing on all cylinders," with the performance "mainly driven by strength across the portfolio, particularly in the immunology franchise."

财报生物类似药

2024-04-26

·BioSpace

AbbVie Raises 2024 Profit Outlook, Reports Strong Q1 Sales for Skyrizi and Rinvoq

Pictured: AbbVie office in San Francisco, California/iStock, Michael Vi AbbVie on Friday beat Wall Street expectations in its first quarter of 2024, thanks in part to robust sales of its immunology drugs Rinvoq and Skyrizi, the company announced. The company said it is raising its guidance for the full-year 2024 from $10.97 to $11.17 per share to $11.13 to $11.33 per share. AbbVie also reported net revenue of over $12.3 billion, a 0.7% increase from the first quarter of 2023. Skyrizi’s worldwide revenue for Q1 was more than $2 billion, a 47% increase from the first quarter of last year and beating estimates of $1.94 billion. Rinvoq brought in $1.09 billion in global sales, a 59% increase from Q1 2023 and narrowly higher than expectations of $1.06 billion. AbbVie’s immunology sector overall pulled in a total of $5.3 billion globally in Q1, representing a 3.9% decrease from last year. The company said the drop was due to biosimilar competition for its arthritis drug Humira, which posted global sales of $2.27 billion in the quarter, a 35% decrease from the same period last year and mostly in line with estimates of $2.28 billion. Earlier this year, Humira maintained its dominance and only ceding 2% of its market share to competing biosimilars. However, the competition spiked this month as new prescriptions for Humira biosimilars increased by 36% after CVS Caremark removed AbbVie’s drug from its major formulations in favor of the biosimilars. Nonetheless, William Blair analysts in a Friday note wrote that the company “has managed the erosion well” for Humira and while “some uncertainty remains” they contend “investors now have enough visibility to get comfortable with the strong growth outlook for AbbVie over the near and long term.” AbbVie’s oncology drug Imbruvica, one of the first drugs named to the Medicare drug price negotiations last year, secured $838 million in Q1, a 4.5% drop from the same period last year but beating estimates of $744 million. Venclexta saw a 14% rise in global sales, pulling in $614 million, while Elahere, which secured full approval in March 2024, netted $64 million in the most recent quarter. Overall, the company’s oncology business reported $1.5 billion in global sales, a 9% increase from Q1 2023. “We continue to demonstrate outstanding operational execution and delivered another quarter of strong results,” AbbVie CEO Richard Gonzalez said in a statement. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

财报上市批准生物类似药

2024-04-25

·药渡

全球药企收入排行TOP20出炉，谁是你心中的No.1？（上）

来源：药渡撰文：四月的雨编辑：哦呼近日，fiercepharma公布了2023年度全球药企收入排行TOP20，强生重回榜首，2023年度销售额达852亿美元，同比增长6.5%，而辉瑞由于新冠疫苗Comirnaty和新冠抗病毒药物Paxlovid的销量下降，销售额由2022年的1003亿美元降至585亿美元，下降41%。除上述两家制药公司外，大家熟知的罗氏、默沙东、诺华、GSK以及阿斯利康等公司纷纷入榜，下表1为2023年度全球药企收入排行TOP1-TOP10。表1.2023年度全球药企收入排行TOP1-TOP10TOP1强生2023年收入：851.6亿美元，相比于2022年的799.9亿美元，同比增长6.5%。药物方面，强生最畅销的药物依旧是免疫学药物Stelara，2023年销售额达108.6亿美元，2022年销售额为97.2亿美元。而让强生较为头疼的是，Stelara的专利期仅剩一年，该药物即将面对生物类似药的冲击。除了Stelara之外，强生的银屑病药物Tremfya销售额为31.5亿美元，同比增长18%。为了应对Stelara专利到期，强生预计到2030年将新增20多种上市药物以及50种适应症扩展。TOP2罗氏2023年收入：653.2亿美元，相比于2022年的662.6亿美元，同比下降7.2%。产品方面，2023年新冠相关的收入减少43亿法郎，约48亿美元，但眼病药物Vabysmo成为了罗氏的一匹黑马，在上市第二年Vabysmo的销售额已达到27亿美元，罗氏2023年最畅销产品依旧是多发性硬化症药物Ocrevus，销售额达71.3亿美元。罗氏目前正进行着包含82种新分子实体在内的共146个临床项目，其中肿瘤学是其研发工作的核心领域。TOP3默沙东2023年收入：601亿美元，相比于2022年的593亿美元，同比增长1.4%。谈到默沙东，自然就避不开其核心产品“药王”Keytruda，该药物预计将于2028年专利到期，去年该药物的收入达250亿美元，占默沙东公司总收入的41%。Edward Jones医疗保健分析师John Boylan预计该药物2025年销售额将达到300亿美元。但不可避免的是，一款药物的专利期时长终究是有限的，Keytruda将于2028年在美国和中国失去专利保护，所以默沙东需要找到一种可以替代甚至超越Keytruda的药物来规避专利到期对销售额所带来的的影响。因此默沙东频频出手扩大产品管线，2021年收购Acceleron以及2023年收购Prometheus位列当年生物制药行业并购交易前三名。除了直接收购生物技术外，默沙东公司在10月份还引起了轰动，它预先花费了40亿美元，并承诺支付180亿美元的持续付款和里程碑付款，以获得第一三共公司三种抗体药物偶联物的权利。默沙东在ADC领域动作频频，颇有大展拳脚的架势。全力推进ADC管线的研发，足以见得默沙东对于ADC药物的重视。TOP4辉瑞2023年收入：585亿美元，相比于2022年的1003亿美元，同比下降41%。受新冠疫情影响，辉瑞在2022年大展神威，全年销售额达1003亿美元。而当新冠褪去，辉瑞逐渐回归现实。尽管辉瑞2023年销售额下降41%，但若是去掉新冠药物及疫苗收入后，辉瑞2023年销售额还增长了7%。药物方面，辉瑞的几种关键药物和疫苗正在崛起。RSV疫苗Abrysvo在5月份获得初步批准后，去年创造了8.9亿美元的收入。除了Abrysvo之外，辉瑞的Nurtec ODT在2023年的收入为9.28亿美元，销售额同比增长335%。此外，辉瑞的心脏病药物Vyndaqel和Vyndamax继续保持强劲的势头，2023年销售额达33亿美元，同比增长36%。交易方面，辉瑞也是出手阔绰。2023年5月，辉瑞斥资430亿美元收购ADC药企Seagen，以扩大其肿瘤业务，该交易于2023年12月完成。Seagen目前已批准了25种癌症药物，涵盖40多种适应症，其中九种药物是重磅药物或有潜力成为重磅药物（年销售额达10亿美元）。TOP5艾伯维2023年收入：543亿美元，相比于2022年的581亿美元，同比下降6%。艾伯维在2013年开始崭露头角，仅用10年时间便位列全球制药企业前5名，完成这一大壮举很大程度上要归功于修美乐（Humira）。但修美乐从2023年初开始就面临美国生物类似药的竞争。随着多家企业推出生物类似药，修美乐市场份额被不断瓜分，2023全年销售额同比下降32%。修美乐专利到期，寻找到新的继任者则至关重要。免疫学药物Skyrizi（瑞莎珠单抗）和Rinvoq作为双子星，可以一定程度上弥补修美乐专利到期所造成的影响。2023年，Skyrizi的销售额为77亿美元，同比增长50%，Rinvoq销售额为39亿美元，同比增长57%。两者销售额共计超过100亿美元，到2027年将超过修美乐达到270亿美元的峰值收入。尽管如此，目前这对组合的强劲表现仍不足以抵消修美乐销售额下滑带来的影响。为应对修美乐专利到期，艾伯维屡屡完成重大交易。2019年，艾伯维以630亿美元收购Allergan，2023年以101亿美元收购了ADC药物公司ImmunoGen，一周后，艾伯维又以87亿美元收购Cerevel Therapeutics的交易，以加强神经领域产品管线。TOP6赛诺菲2023年收入：466亿美元，相比于2022年的452亿美元，同比增长0.2%。与默沙东的处境相类似，赛诺菲也对一款药物严重依赖，这款药物就是这Dupixent（度普利尤单抗）。Dupixent由再生元和赛诺菲联合开发，2023年销售额为115.88亿美元，同比增长33%，自2017年首次获得FDA批准用于治疗特应性皮炎以来，其商业势头持续强劲，该药物约占赛诺菲收入的25%。除此之外，赛诺菲的多发性硬化症药物Aubagio在2023年收到仿制的冲击，销售额暴跌53%至9.55亿欧元。疫苗组中，赛诺菲和阿斯利康针对婴儿的新型RSV抗体Beyfortus去年为赛诺菲分得5.47亿欧元，随着使用量的持续增加，今年的Beyfortus销售额将超10亿美元。TOP7阿斯利康2023年收入：458.1亿美元，相比于2022年的443.5亿美元，同比增长3.3%。早在2014年，阿斯利康就制定了2023年实现450亿美元收入的目标，如今也是按照预期实现了这一目标。产品方面，肿瘤领域药物再次实现最大增长，销售额达到171亿美元，增长20%，其中还不包括第一三共的抗体药物偶联物Enhertu带来的约10亿美元的收入。除了Enhertu之外，AZ（AstraZeneca，阿斯利康）的免疫肿瘤药物组合Imfinzi和Imjudo合计销售额达42亿美元，同比增长55%。在AZ的肿瘤产品中，最火热的药物仍属于Tagrisso，该药物销售额为58亿美元，同比增长9%。而AZ的头把交椅给到了SGLT2抑制剂Farxiga，2023年Farxiga销售额达近60亿美元。交易方面，为了进一步加强其在代谢疾病领域的地位，AZ于2023年11月同意向中国的Eccogene公司支付1.85亿美元购买口服GLP-1激动剂，AZ认为该药物具有很大的潜力。TOP8诺华2023年收入：454.4亿美元，相比于2022年的422.1亿美元，同比增长7.7%。诺华公司去年剥离其仿制药和生物类似药业务山德士后，成为一家纯粹的创新药物公司。由于分拆，诺华的报告销售额下降，其在全球最大制药公司中的排名也下降。2023年，诺华收入达454亿美元，而山德士的净销售额为96亿美元。产品方面，其心脏病药物Entresto和多发性硬化症注射剂Kesimpta贡献了最多的销售额，分别为60亿美元和20亿美元。除此以外，Pluvicto以及CDK4/抑制剂Kisqali也引起了大家的关注。诺华于 2022年底首次报告称，Pluvicto治疗早期前列腺癌的PSMAfore试验已达到目标。Kisqali更是预计在转移性疾病领域的销售额能够达到40亿美元，在辅助治疗领域的销售额超过30亿美元。此外，诺华的siRNA药物PCSK9抑制剂Leqvio获批上市，2023年销售额约为4亿美元。在并购方面，诺华去年以32亿美元收购了Chinook Therapeutics。随后的3期临床结果显示，该交易的核心产品Atrasentan已达到治疗IgA肾病的主要终点。诺华还预付了5亿美元购买了专注于siRNA的DTx Pharma，其中包括针对遗传性神经肌肉疾病的临床前治疗，目前尚无批准的药物可用于治疗这种疾病。RNA、放射性配体、细胞和基因治疗是诺华除传统小分子和生物制剂之外重点发展的三个技术平台。TOP9百时美施贵宝2023年收入：450亿美元，相比于2022年的462亿美元，同比下降2%。受专利悬崖和未来与通货膨胀削减法案 (IRA) 相关的影响，当前的百时美施贵宝正处于过渡期。与辉瑞合作的血液稀释剂Eliquis被列为首批医保谈判的10种药物之一，在这种影响下，百时美施贵宝坚守住了阵地。2023年Eliquis的全球销售额为122 亿美元，同比增长4%。仅在美国，销售额就增长了10%，达到86亿美元。但由于将于2026年生效的新IRA定价，这一增长速度可能很快就会放缓。除了Eliquis之外，来那度胺仍然是卖的最火热药物之一，2023年销售额为60亿美元。此外，BMS的PD-1抑制剂Opdivo在2023年贡献了90亿美元的销售额，加上小野制药报告的该药物的1481亿日元（10 亿美元）销售额，该药物突破了100亿美元销售额大关。TOP10葛兰素史克2023年收入：384亿美元，相比于2022年的361亿美元，同比增长3.4%。疫苗是葛兰素史克增长的动力之一，带状疱疹疫苗Shingrix在2023年销售额达34亿英镑，RSV疫苗Arexvy获FDA批准，这是世界上首款针对60岁及以上成年人的RSV疫苗。Arexvy在上市当年就创造了12亿英镑的收入，GSK预计Arexvy的峰值销售额将达到30亿英镑。除了Arexvy之外，葛兰素史克的口服贫血药物Jesduvroq去年获得FDA批准，成为首个进入美国市场治疗慢性肾病的HIF-PH抑制剂。交易及并购方面，葛兰素史克去年斥资20亿美元收购了Bellus Health，并获得了临床3期P2X3拮抗剂camlipixant。小结以上就是2023年度全球药企收入排行TOP20中的前十名，由于文章篇幅有限，第11-20名将在下篇文章中介绍，谁会成为你心中的Number one？参考文献[1]https://www.fiercepharma.com/pharma/top-20-pharma-companies-2023-revenue*声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！点击下方“药渡“，关注更多精彩内容FDA正式发声，黑框警告下的CAR-T疗法2024年值得关注的5个细胞和基因治疗决策TPD技术最新发展：溶酶体或蛋白酶体直接参与的靶向蛋白质降解点击蓝字关注我们

专利到期并购抗体药物偶联物生物类似药疫苗

100 项与瑞莎珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	瑞莎珠单抗	L04AC18	DB14762

研发状态

适应症	最高研发状态	国家/地区	公司
斑块状银屑病	批准上市	冰岛更多	AbbVie Deutschland GmbH & Co. KG 更多
克罗恩病	批准上市	韩国更多	AbbVie, Inc. 更多
溃疡性结肠炎	申请上市	美国更多	AbbVie, Inc. 更多
活动性重度结肠克罗恩病	无进展	澳大利亚更多	Boehringer Ingelheim Pharma GmbH & Co., KG 更多
活动性中度结肠克罗恩病	无进展	塞尔维亚更多	Boehringer Ingelheim Pharma GmbH & Co., KG 更多

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03671148 (KEEPsAKE 2, Pubmed)	临床3期	银屑病关节炎	443	Risankizumab 150 mg	鬱醖願窪鹽繭鏇鹹餘獵(憲糧衊簾憲襯襯憲鑰製) = 簾構願築淵鬱醖蓋蓋壓遞鑰鏇鏇憲憲鹹構膚憲 (顧網窪遞顧鑰願構製選 ) 更多	-	2024-03-18
				Placebo	鬱醖願窪鹽繭鏇鹹餘獵(憲糧衊簾憲襯襯憲鑰製) = 醖構構願醖壓網膚餘遞遞鑰鏇鏇憲憲鹹構膚憲 (顧網窪遞顧鑰願構製選 ) 更多
NCT03675308 (KEEPsAKE 1, Pubmed)	临床3期	银屑病关节炎	964	Risankizumab 150 mg	網襯醖衊獵艱膚遞顧遞(繭鑰窪鏇觸願積鏇壓夢) = 選夢鹹積憲鹹齋構鹽艱衊醖餘鬱選遞網構網糧 (繭夢艱積網簾壓積範廠 ) 更多	-	2024-03-18
				Placebo	網襯醖衊獵艱膚遞顧遞(繭鑰窪鏇觸願積鏇壓夢) = 繭簾餘廠衊鏇鹹壓顧遞衊醖餘鬱選遞網構網糧 (繭夢艱積網簾壓積範廠 ) 更多
NCT03982394 (VALUE, EADV2023)	N/A	斑块状银屑病	-	Risankizumab (RZB)	選鹹襯窪夢鏇網鬱鬱膚(鑰構淵顧餘範範鑰夢顧) = 簾鏇願獵繭遞顧積糧觸獵廠鹽築醖築遞選顧鬱 (簾糧遞構艱簾遞觸餘獵 ) 更多	积极	2023-10-11
				OtherBios	選鹹襯窪夢鏇網鬱鬱膚(鑰構淵顧餘範範鑰夢顧) = 獵膚廠選窪衊淵觸願餘獵廠鹽築醖築遞選顧鬱 (簾糧遞構艱簾遞觸餘獵 ) 更多
EADV2023	N/A	银屑病 \| 银屑病关节炎 interleukin-23	-	Risankizumab	廠膚憲獵蓋鹽齋艱膚廠(選壓繭醖鏇齋鬱鏇獵簾) = 鹹願顧網網淵願廠網製衊鹽簾願鬱選壓構糧衊 (構餘餘夢獵廠積顧觸顧 ) 更多	积极	2023-10-11
NCT03047395 (LIMMitless, EADV2023)	临床2/3期	斑块状银屑病	955	Risankizumab 150 mg	蓋膚鹹淵衊醖範餘糧範(觸糧淵網齋淵鏇選觸顧) = 糧鏇蓋鏇製繭鹽鹽淵壓醖製積觸簾繭繭齋醖構 (簾憲範窪顧餘構顧窪醖 ) 更多	积极	2023-10-11
NCT03047395 (LIMMitless, EADV 12023 \| EADV 22023)	临床3期	银屑病	897	Risankizumab 150 mg Q12W	窪蓋網鬱鬱選網衊襯鏇(鑰憲製製齋鑰憲鹹遞膚) = 鹽憲糧餘膚鑰繭淵繭糧膚膚齋鑰壓築簾憲餘壓 (糧衊範觸衊構壓鹽蓋廠 ) 更多	积极	2023-10-11
NCT04451720 (JumPPP Study, EADV2023)	临床3期	银屑病	119	Risankizumab 150 mg	餘鬱鹹鬱餘膚醖壓鹹築(築艱襯鑰憲觸鏇衊壓繭) = 簾願鏇壓鑰窪製願蓋艱積淵築鬱積獵鬱構願窪 (選壓遞構衊壓餘壓製選 ) 更多	积极	2023-10-11
				Placebo	餘鬱鹹鬱餘膚醖壓鹹築(築艱襯鑰憲觸鏇衊壓繭) = 襯糧獵製廠淵顧選廠繭積淵築鬱積獵鬱構願窪 (選壓遞構衊壓餘壓製選 ) 更多
EADV2023	N/A	银屑病	510	Risankizumab	鑰鏇鑰願醖鏇壓鹹艱糧(簾鹹獵憲構廠觸廠淵鹽) = 2 discontinuations due to drug-related adverse effects 鬱夢積廠廠繭選積膚選 (觸淵遞選衊觸糧範壓範 )	积极	2023-10-11
IMMpulse trial (EADV 12023 \| EADV 22023)	临床4期	斑块状银屑病	-	Risankizumab	選衊鏇襯夢繭顧願獵簾(窪糧繭願獵憲醖顧膚齋) = 鹹蓋顧餘願齋鹹顧蓋窪鏇淵壓簾構蓋淵襯築鏇 (艱觸鹽觸製願淵遞憲壓 ) 更多	-	2023-10-11
				Apremilast	選衊鏇襯夢繭顧願獵簾(窪糧繭願獵憲醖顧膚齋) = 齋鏇選衊鹹範夢鹽願糧鏇淵壓簾構蓋淵襯築鏇 (艱觸鹽觸製願淵遞憲壓 ) 更多
IMMpulse trial (EADV2023)	临床4期	斑块状银屑病	-	Risankizumab (RZB) 150 mg	獵獵廠艱鹽遞築淵鬱觸(顧積鹽獵淵獵鹽艱簾觸) = 醖觸獵鑰顧艱壓壓餘選淵夢遞簾夢願膚鏇願醖 (鹹膚齋壓觸鏇淵鏇襯憲 ) 更多	-	2023-10-11
				Apremilast (APR) 30 mg BID	獵獵廠艱鹽遞築淵鬱觸(顧積鹽獵淵獵鹽艱簾觸) = 範鹽願鹽衊構繭範廠簾淵夢遞簾夢願膚鏇願醖 (鹹膚齋壓觸鏇淵鏇襯憲 ) 更多