PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab

Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and serum (maternal and infant) among lactating individuals who receive anifrolumab therapeutically.

开始日期2024-11-29

申办/合作机构

AstraZeneca PLC

[+1]

NCT06015737 / Recruiting临床3期

A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus Who Are Refractory and/or Intolerant to Antimalarial Therapy

This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus (CLE).

开始日期2024-06-29

申办/合作机构

AstraZeneca PLC

[+1]

NCT06374212 / Recruiting临床2期IIT

A Prospective Open-label Trial Examining the Efficacy and Safety of Anifrolumab for Hidradenitis Suppurativa (HS)

This clinical trial aims to study if a drug called anifrolumab works to treat Hidradenitis Suppurativa (HS) as well as its effect in quality of life before and after treatment. Anifrolumab is a monoclonal antibody that inhibits several processes that have been shown to be involved in the development of HS.
The study lasts approximately 40 weeks separated into a screening, treatment, and follow-up phase. Researchers determine if it is safe for the you to receive the drug and if you are eligible for the study during Screening. If eligible for the study, the treatment phase lasts 24 weeks (or six months) with one follow-up visit 12 weeks after the last visit in the treatment phase.
During the treatment phase, participants will be asked to come to clinic every two weeks for the first month of treatment, and monthly thereafter for a total of eight treatment visits. Participants will be asked to:
* Complete questionnaires asking about the effect of HS in their daily lives and their perception of HS and treatment received.
* Receive related medical evaluation
* Receive the study drug intravenously
* Stay 20 minutes after the infusion for monitoring

开始日期2024-06-21

申办/合作机构

The University of North Carolina at Chapel Hill

[+1]

100 项与 Anifrolumab-FNIA 相关的临床结果

登录后查看更多信息

100 项与 Anifrolumab-FNIA 相关的转化医学

登录后查看更多信息

100 项与 Anifrolumab-FNIA 相关的专利（医药）

登录后查看更多信息

213

项与 Anifrolumab-FNIA 相关的文献（医药）

2024-10-01·LUPUS

Anifrolumab for systemic lupus erythematosus with multi-refractory skin disease: A case series of 18 patients

Article

作者: Fanouriakis, Antonis ; Boumpas, Dimitrios ; Repa, Argyro ; Karamanakos, Anastasios ; Katsifis-Nezis, Dimitrios ; Flouda, Sofia ; Emmanouilidou, Evgenia ; Koumaki, Dimitra ; Bertsias, George

Objective:

Skin involvement is common in systemic lupus erythematosus (SLE), but may be resistant to conventional treatment. We sought to evaluate the efficacy of anifrolumab (ANI) in refractory cutaneous manifestations of SLE.

Methods:

Case series of patients with refractory cutaneous SLE from three Rheumatology Departments in Greece. Outcome measures were improvement in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), physician global assessment (PGA) and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI). Clinically relevant improvement in skin was defined as decrease ≥50% (CLASI50) from baseline values.

Results:

Eighteen patients received ANI; all had active skin involvement at baseline. Mean (SD) SLEDAI and PGA at ANI initiation were 7.4 (2.7) and 1.4 (0.5), respectively, with a mean prednisone dose 4.9 (4.5) mg/day. Mean CLASI (Activity/Damage) at baseline was 13.9 (9.7)/2.9 (4.6). Patients were refractory to a mean 6.3 (1.5) immunomodulatory agents (including hydroxychloroquine and glucocorticoids) before the initiation of ANI. After a mean 8.5 (4.6) months, 89% ( n = 16/18) of patients demonstrated significant improvement in general lupus and cutaneous disease activity, and glucocorticoid tapering. Mean SLEDAI and mean CLASI at last visit were 3.4 (1.9) and 2.1 (2.4)/1.4 (2.2), respectively, and mean daily prednisone dose decreased to 2.4 (2.2). Of note, in this group of highly refractory patients CLASI50 was achieved in 16/18 (89%) patients. One patient discontinued ANI after 4 infusions due to a varicella-zoster virus infection and one patient, who initially responded to treatment with ANI, experienced a skin flare due to temporary discontinuation due to Covid 19 infection. DORIS remission and LLDAS were attained in two (11.1%) and eleven (61.1%) patients, respectively.

Conclusion:

Anifrolumab is highly effective in various skin manifestations of SLE, even after prior failure to multiple treatments.

2024-09-01·Rheumatology (Oxford, England)

Safety and efficacy of anifrolumab therapy in systemic lupus erythematosus in real-world clinical practice: LOOPS registry

Article

作者: Todoroki, Yasuyuki ; Tanaka, Hiroaki ; Nakayamada, Shingo ; Funada, Masashi ; Tanaka, Yoshiya ; Miyagawa, Ippei ; Kubo, Satoshi ; Fukuyo, Shunsuke ; Hanami, Kentaro ; Sonomoto, Koshiro ; Miyazaki, Yusuke ; Yamaguchi, Ayako ; Ueno, Masanobu

Abstract:

Objective:

To determine the safety and efficacy of anifrolumab in patients with systemic lupus erythematosus (SLE) classified based on the Lupus Low Disease Activity State (LLDAS) in real-world clinical practice.

Methods:

This retrospective observational study involved SLE patients who started anifrolumab therapy. The primary end point was the retention rate over 26 weeks after initiating anifrolumab therapy; 45 patients followed up for 12 weeks or longer were analysed in the following groups to determine the safety and efficacy up to week 12 after treatment initiation: (i) non-LLDAS achievement group and (ii) minor flare group. Safety and efficacy were compared between the minor flare group and the standard of care (SoC) group (treated by adding glucocorticoids [GCs] or immunosuppressants) after adjustment with inverse probability of treatment weighting using propensity score (PS-IPTW).

Results:

The retention rate of anifrolumab was 89.7% at week 26.The LLDAS achievement rates at week 12 were 42.9% and 66.7% in the non-LLDAS achievement and minor flare groups, respectively. In both groups, GC doses and SELENA–SLEDAI score significantly decreased. When the anifrolumab group with minor flare was compared with the SoC group or the GC dose increase group, the GC dose and SLEDAI score were significantly lower in the anifrolumab group than in either of the other groups; there was no significant difference in LLDAS achievement.

Conclusion:

At week 26 after initiating anifrolumab therapy, ∼90% of patients remained on therapy. Anifrolumab might lower disease activity without initiating GCs and reduce GC doses, especially in patients who experience minor flares after LLDAS achievement.

2024-09-01·Rheumatology (Oxford, England)

Real-world data on anifrolumab, the new kid on the block in lupus

Article

作者: Gómez-Puerta, José A

项与 Anifrolumab-FNIA 相关的新闻（医药）

2024-09-19

·CPHI制药在线

浅谈系统性硬化病治疗进展，在研疗法作用靶点、药物类型多样

关注并星标CPHI制药在线系统性硬化病（SSc），又称硬皮病，是一种以局限性或弥漫性皮肤及内脏器官纤维化或硬化为特征的自身免疫性结缔组织病，2018年5月被列入中国第一批罕见病目录。SSc常累及全身多系统，包括胃肠道、心脏、肺、肾等脏器，其中肺部受累是SSc是常见且严重的内脏损害之一，主要表现为肺间质病变（ILD）和肺动脉高压（PAH），这两者占SSc相关死亡原因的60%。根据皮肤受累范围及临床特点，SSc可分为四型：局限皮肤型SSc、弥漫皮肤型SSc、重叠综合征和无皮肤硬化型SSc。流行病学数据显示：SSc的全球总患病率为17.6/10万，发病高峰年龄在 45~65岁，女性发病率高于男性，但男性SSc患者往往病情较重，更易出现弥漫性皮肤病变、指端溃疡和肺动脉高压（PAH），预后相对较差。 SSc治疗现状 SSc发病机制复杂，包括自身免疫学说、血管病学说和胶原合成异常学说等。但由于病因未明，SSc长期以来缺乏有效的治疗手段。临床上主要通过免疫药物及一些对症治疗来控制疾病进展，环磷酰胺、甲氨蝶呤、长春新碱等免疫抑制剂抑制来免疫系统的异常反应，减轻炎症和纤维化等病理过程。硫唑嘌呤等免疫调节剂调节免疫系统的功能，减轻自身免疫反应。此外，临床上还使用非甾体抗炎药、钙剂、免疫球蛋白及糖皮质激素等对症支持来控制病情。 2019年9月，FDA批准勃林格殷格翰的Ofev（nintedanib，尼达尼布）用于延缓系统性硬化症相关间质性肺病（SSc-ILD）成人患者的肺功能下降。该药是一种口服小分子酪氨酸激酶抑制剂，通过竞争性抑制成纤维细胞生长因子受体、血管内皮生长因子受体、血小板源性生长因子受体等受体酪氨酸激酶，阻断对成纤维细胞的增殖、迁徙和转换起关键作用的信号传导，从而抑制肺纤维化病变。 2021年3月，FDA批准罗氏IL-6受体抑制剂Actemra/RoActemra（tocilizumab，托珠单抗）皮下注射液，用于延缓SSc-ILD成人患者肺功能下降的速度。这使Actemra/RoActemra成为FDA批准的第一款用于治疗SSc-ILD的生物疗法。在研SSc药物进展据不完全统计，目前全球已出现多款在研SSc新药，详见下表。在研SSc新药作用靶点多样，且药物类型也非常多样化，涉及化药、单抗、干细胞疗法等。具体品种来看，Anifrolumab是一款首创Ⅰ型干扰素受体（IFNAR1）拮抗剂，已被批准用于治疗系统性红斑狼疮。研究表明，I型干扰素能够直接影响T细胞的增殖与活化，因此，Anifrolumab作为一种中和干扰素的药物，能够减少SSc患者T细胞的活化与增值，从而达到治疗SSc的目的。目前，Anifrolumab治疗SSc的3期临床试验正在进行中。贝利尤单抗是GSK研发的一款靶向B淋巴细胞刺激因子（BLyS）的单克隆抗体，通过特异性结合BLyS抑制B细胞的存活和增殖，其静脉注射剂已被批准成人和儿童系统性红斑狼疮，以及活动性狼疮肾炎。与静脉注射相比，贝利尤单抗的皮下注射剂型具有缩短治疗时间和提高治疗便利性的潜力。目前，贝利尤单抗皮下注射液正在国内开展一项针对SSc-ILD成人患者的国际多中心（含中国）2/3期研究。 Amlitelimab由赛诺菲与ImmuNext合作开发，是一种皮下注射的全人源化、非耗竭性单克隆抗体，通过与OX40L结合，旨在恢复促炎及调节性T细胞之间的免疫稳态，从而有潜力治疗许多免疫介导及炎症性疾病。此外，amlitelimab在抑制T细胞依赖性炎症的同时，不会导致免疫细胞的清除，从而潜在避免了免疫抑制的副作用。Amlitelimab被开发用于治疗特应性皮炎、哮喘、多发性硬化、化脓性汗腺炎、SSc等自免疾病，其中针对SSc相关间质性肺疾病（SSc-ILD）的临床试验处于2期阶段。 BI 685509是一种不依赖一氧化氮的可溶性鸟苷酸环化酶（sGC）刺激剂，可增加环磷酸鸟苷（cGMP）的产生。cGMP升高与血管舒张、血管床中的适当内皮功能以及抗纤维化、抗增殖和抗炎作用相关。BI 685509可能针对导致SSc表现的基础血管病变和纤维化。目前，BI 685509针对SSc的临床试验处于2期阶段。 FT011是一种口服药物，旨在阻断GPR68蛋白受体的活性。GPR68是一种特定的G蛋白偶联受体(GPCR)，可介导与炎症和纤维化相关的信号通路，其在健康组织中处于沉默状态，但在受伤或患病后被激活。证据表明：GPR68在导致炎症和纤维化的多个下游通路中发挥作用。临床试验数据显示：FT011在改善肺功能和缓解身体残疾方面表现出显著疗效。2024年7月，FT011被EMA授予孤儿药资格，用于SSc。 RY_SW01是一款人脐带间充质干细胞来源的干细胞疗法。与传统疗法相比，脐带间充质干细胞（MSCs）可以通过多通路进行免疫调节，并分泌细胞因子达到抗纤维化的作用；安全性方面，不会引起类似免疫抑制剂带来的不良反应。2023年8月，RY_SW01治疗SSc的临床试验申请获CDE批准。 CABA-201是Cabaletta Bio开发的一款使用4-1BB共刺激信号的全人源CD19 CAR-T疗法，有望成为B细胞驱动的自身免疫性疾病的潜在治疗方法。2024年1月，CABA-201治疗SSc的1期临床试验启动。2024年3月，该药被FDA授予治疗SSc的孤儿药资格。 VUM02是中源协和自主研发的冷冻保存型干细胞制剂，是由经筛选的健康新生儿脐带组织通过体外分离、扩增、收获、冻存后制备的人脐带源间充质干细胞（UC-MSC）候选药物。2024年9月，VUM02治疗SSc的临床试验申请获CDE批准。 RJMty19是瑞顺生物基于人源化CD19-CAR全球专利开发的一款创新现货通用型第二代DNT细胞治疗候选药物被，被开发用药治疗难治性系统性红斑狼疮、复发/难治性B细胞非霍奇金巴瘤、CD19阳性成人复发/难治性B细胞急性淋巴细胞白血病和SSc等。今年9月，RJMty19治疗SSc的临床试验申请获CDE批准。此外，Blinatumomab也被开发用于治疗SSc。该药是一种双特异性抗体结构，通过结合T细胞上的CD3和B细胞上的CD19，介导T细胞与B细胞的相互作用，导致后者被前者破坏。Blinatumomab已被证实能引起血液肿瘤患者的B细胞耗竭及免疫球蛋白水平下降。 2024年6月，来自德国慕尼黑大学附属医院(LMU)血液科的Marion Subklewe等人在《European Journal Of Cancer》杂志上发表了题为"Application of blinatumomab, a bispecific anti-CD3/CD19 T-cell engager, in treating severe systemic sclerosis: A case study"的案例研究论文结果显示：Blinatumomab安全有效，治疗过程中所有剂量下的耐受性良好，SSc患者的症状得到有效改善。总结整体来看，近些年罕见病系统性硬化症（SSc)的治疗进展有限，最新获批的两款药物--尼达尼布、托珠单抗也仅被批准用于延缓系统性硬化症相关间质性肺病（SSc-ILD）成人患者的肺功能下降，并不能从根上治愈SSc。纵观在研SSc药物，其作用靶点非常多样，这从一定程度上可以看出SSc的发病机制并不十分明确。期待在药企的不懈努力下，SSc治疗早日迎来重大突破。 END END END END 【智药研习社直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

临床研究细胞疗法免疫疗法临床申请

2024-09-17

·FiercePharma

Lupus landscape 'poised for evolution' as US doctors eagerly await new entrants

Biogen's litifilimab "stands out as an especially strong competitor" to Benlysta and Saphnelo, according to Spherix Global Insights analysts. New biologics such as GSK's Benlysta and AstraZeneca's Saphnelo, along with off-label drugs, have been the mainstay for systemic lupus erythematosus (SLE) treatment for many years. However, the landscape may be about to change with the introduction of new medicines and indications from other approved treatments.That's according to Spherix Global Insights analysts who spoke to 101 U.S. rheumatologists about current and future treatments for SLE, a landscape they see as “poised for evolution.”There are several types of lupus, with SLE the most common. The condition is caused by an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage. Organ damage can occur in up to 48% of people living with lupus, most within five years of diagnosis, with lupus flares also upping the risk of organ damage.GSK’s SLE drug Benlysta, which was approved by the FDA in 2011, has now become a blockbuster medicine, while AstraZeneca’s new challenger Saphnelo, FDA-approved in 2021, remains some way behind the market leader in Benlysta in terms of sales.Doctors have also relied on off-label use of other older medicines, including rituximab. However, Spherix found in a 2023 report, this use has begun to lose favor among rheumatologists as they turn to newer biologics.Now, Spherix has found that an experimental drug from Biogen, litifilimab, “stands out as an especially strong competitor” to Benlysta and Saphnelo, according to its report. Talking to rheumatologists, Spherix analysts said that they believe litifilimab’s latest midstage data, notably its 26% improvement in SRI-4 response (a measurement on how well a patient responds to treatment) over placebo, “demonstrates a superior treatment profile compared to existing biologics and other promising therapies.”There is also hope from new indications from already-approved drugs in the form of AbbVie’s blockbuster immunology drug Rinvoq, which is in phase 3 testing for SLE, and Bristol Myers Squibb’s Sotyktu, which presented positive data in SLE at the start of the year.Spherix found that these oral therapies “offer convenience for patients and may appeal to rheumatologists seeking alternative treatment options.”Getting patients to stay on them, however, can be a “challenge,” while black box warnings on JAKs (i.e., Rinvoq) “may prevent use in earlier lines of SLE treatment,” according to Spherix. Despite that, rheumatologists “are most eager to see Rinvoq approved for SLE, followed by Sotyktu and litifilimab, all of which are believed to be potentially effective for skin manifestations,” the report found.There are also other investigational contenders in the form of UCB Pharma’s dapirolizumab pegol and Idorsia’s cenerimod.All new entrants must, however, be mindful of the “dominance” of Benlysta, the analysts conclude, which “remains a preferred choice” in both SLE and lupus nephritis.

临床结果上市批准临床3期

2024-08-20

·药精通Bio

CAR-T治疗红斑狼疮，国内药企取得重大进展

近日，据中国国家药监局药品审评中心（CDE）官网公示，石药集团附属公司石药集团中奇制药技术（石家庄）有限公司（以下简称“石药集团”）的CAR-T产品SYS6020细胞注射液获批临床，拟用于难治性活动性系统性红斑狼疮（systemic lupus erythematosus,SLE)。此次获批为石药在细胞治疗领域的重要成果。据悉，目前在全球范围尚无CAR-T疗法获批用于治疗系统性红斑狼疮。SYS6020细胞注射液针对BCMA抗原，有望为SLE患者提供新的治疗选择，且成本较低。 SYS6020为一款基于mRNA-LNP的嵌合抗原受体（CAR）-T细胞注射液，也是全球首款获批临床试验的基于mRNA-LNP的CAR-T细胞治疗候选药物。该产品通过表达可特异性识别BCMA抗原的CAR，与成熟B淋巴细胞和浆细胞表面的BCMA结合，靶向杀伤免疫细胞，消除升高的自身抗体，从而达到治疗目的，是SLE患者一种全新的、安全有效的潜在治疗选择。与传统的CAR-T产品相比，SYS6020具有细胞活率高、CAR阳性率高、无基因组整合引起的致瘤风险，以及细胞因子风暴（CRS）等副作用低的优点。临床前研究显示，该产品可显著杀伤BCMA抗原阳性的骨髓瘤细胞，并具有良好的安全性。在成本方面，使用LNP转染T细胞，可以降低使用慢病毒载体的高昂成本，减轻患者的负担。 SYS6020也是石药集团布局的首个细胞治疗在研产品。在此前的今年6月底，SYS6020细胞注射液在中国首次获批临床，拟开发治疗复发或难治性多发性骨髓瘤（MM）。临床前研究显示，它可显著杀伤BCMA抗原阳性的骨髓瘤细胞，并具有良好安全性和有效性。彼时，石药集团公告指出，除了多发性骨髓瘤适应症，SYS6020还潜在可用于治疗系统性红斑狼疮、重症肌无力等自身免疫性疾病。此次SLE适应症临床试验的获批，是石药集团在细胞治疗领域布局的又一重要成果，为其他细胞治疗产品，如体内生成CAR-T的开发奠定了良好基础。系统性红斑狼疮（SLE）是机体免疫系统攻击自身组织导致的一种复杂的慢性系统性自身免疫性疾病，发病机制复杂。根据《中国狼疮性肾炎诊断和治疗指南》，我国系统性红斑狼疮人群发病率为30.13-70.41/10万人，对应患者人数达到42.2万至98.6万人。此病难以根治，需要长期服药，但传统治疗方式易产生副作用。中国系统性红斑狼疮研究协作组（CSTAR）的数据显示，我国84.13%的SLE患者正在使用激素治疗，其中部分患者用于维持治疗的激素剂量偏大，不良反应也随着剂量增加而增多。生物制剂是近年来改变SLE治疗理念的新兴疗法，通过干预免疫系统的信号传导途径，抑制异常的免疫反应，降低免疫系统对自身组织的攻击，同时通过调节特定的免疫细胞，如T细胞和B细胞，以减少它们对身体组织的攻击。生物制剂降低了系统性红斑狼疮患者对激素的依赖，但目前全球获批上市的仅有3款药物，分别是贝利尤单抗，泰它西普和Anifrolumab。近年来，CAR-T细胞疗法在难治性系统性红斑狼疮中展现出了惊人的疗效，为这片黑暗领域带来了一线曙光。相比传统治疗方式，CAR-T治疗有着独特的优势。首先，基于SLE的重要发病机制之一是B细胞的“叛变”，将自身组成成分识别为“外敌”，从而启动免疫反应，产生针对自身组织的抗体，造成多器官损害。因此，清除体内“叛变”的B细胞以及其产生的抗体是系统性红斑狼疮治疗的一大方向。CAR-T通过将T细胞进行体外改造，带上能特异性识别“叛变”B细胞的蛋白，而后将改造后的T细胞进行回输，清除“叛变”的B细胞，可以实现精准攻击。相较于传统治疗的无差别攻击，CAR-T治疗的精准攻击是最大的优势。其次，CAR-T治疗重建后的B细胞分泌的抗体类型与治疗前大不相同，这表明自身免疫B细胞的清除起到了更广泛的免疫重塑作用。此外，生物制剂需要反复输注，来实现相关信号通路的持续阻断，而CAR-T治疗只需要单次输注就可以持续深度地清除靶向B细胞。这也是传统治疗以及生物制剂无法实现的。不仅如此，红斑狼疮比B细胞肿瘤更容易成为CAR-T细胞治疗的靶点，在B细胞肿瘤治疗中，由于肿瘤抗原的异质性，需要制备装配不同类型的CAR-T，靶向不同抗原，因此肿瘤CAR-T靶点的选择是其应用过程中的重点和难点。目前在SLE 治疗中，临床研究多数是设计成靶向CD19 CAR-T，通过结合基于T细胞的疗法和治疗前的淋巴耗尽方案，可以成功清除功能失调的B细胞并重建免疫系统，从而使SLE得到有效控制。在剂量和副作用方面，细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICANS）是CAR-T治疗的常见副作用。由于SLE患者体内靶向的B细胞数量明显低于肿瘤患者，因而CAR-T疗法所引发CRS的风险将更小。另一方面，较低的B细胞数量减少了需要输注的CAR-T细胞数量，进而限制了不必要的CAR-T细胞毒性，减少免疫效应细胞相关神经毒性综合征的发生。因此，相较于肿瘤患者，由于靶向细胞的比例较小，SLE患者接受CAR-T治疗将有着更好的安全性。但仍需要更大样本的研究和更长时间的随访来证实其长期的安全性。 CAR-T疗法为治疗系统性红斑狼疮提供了新的方向，但CAR-T疗法迟迟未走向SLE治疗的临床应用？究其原因，CAR-T疗法对于患者的长期疗效和安全性还需要进一步研究，该疗法的可行性也还需进一步验证。目前，CAR-T治疗仅限于小样本的临床研究，要真正实现临床应用，需要更大样本的临床研究证实CAR-T治疗的有效性和安全性。同时，虽然在理论上CAR-T治疗会精准清除B细胞，并重建B细胞的功能，能有效控制SLE的活动，但是其长期有效性尚无相关数据。另外，虽然目前的小样本临床研究证实CAR-T细胞治疗自身免疫性疾病的总体安全性非常好，部分患者仅表现为轻度细胞因子释放综合征（CRS），但长期的安全性需要更长时间的随访和证实。经过CAR-T治疗的SLE患者在长期随访中是否会增加相关肿瘤和感染发生的风险？总体的预期寿命是否能够延长？这些都尚未可知。目前，国内外多家细胞治疗公司均已积极布局CAR-T药物用于治疗系统性红斑狼疮等自免疾病的研发管线，包括药明巨诺的瑞基奥仑赛注射液、亘喜生物的CD19/BCMA 双靶CAR-T等。据不完全统计，目前全球7款在研的治疗SLE适应症的CAR-T药物管线中，有3款已经进入临床试验阶段，进度较快的为Cabaletta Bio的CABA-201，正在开展SLE临床Ⅰ/Ⅱ期研究，并获得FDA授予的快速通道资格。其中，中国正在开发治疗SLE的CAR-T产品管线已有不少，但绝大多数尚处于由研究者发起的临床研究（IIT）中，迈入注册性临床开发阶段的管线数量仍然屈指可数。未来，CAR-T治疗红斑狼疮是否能够成功，还需要更多的临床数据说话，期待这些临床试验取得好的结果，推动CAR-T成为SLE患者更安全、更有效、真正临床可用的疗法。参考资料: CAR-T治红斑狼疮？医生：长期有效性安全性尚无数据——澎湃新闻多家药企布局CAR-T治红斑狼疮，全面铺开还需时间——人民日报健康客户端内容来源于网络，如有侵权，请联系删除。

细胞疗法免疫疗法信使RNA临床申请临床研究

100 项与 Anifrolumab-FNIA 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11082	Anifrolumab-FNIA	L04AA	DB11976

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
狼疮性肾炎	澳大利亚	AstraZeneca Pty Ltd.	2022-03-29
中枢神经系统狼疮血管炎	澳大利亚	AstraZeneca Pty Ltd.	2022-03-29
系统性红斑狼疮	美国	AstraZeneca AB	2021-07-30

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
多发性肌炎	临床3期	美国	AstraZeneca AB	2024-09-24
多发性肌炎	临床3期	中国	AstraZeneca AB	2024-09-24
多发性肌炎	临床3期	日本	AstraZeneca AB	2024-09-24
多发性肌炎	临床3期	澳大利亚	AstraZeneca AB	2024-09-24
多发性肌炎	临床3期	奥地利	AstraZeneca AB	2024-09-24
多发性肌炎	临床3期	比利时	AstraZeneca AB	2024-09-24
多发性肌炎	临床3期	巴西	AstraZeneca AB	2024-09-24
多发性肌炎	临床3期	保加利亚	AstraZeneca AB	2024-09-24
多发性肌炎	临床3期	加拿大	AstraZeneca AB	2024-09-24
多发性肌炎	临床3期	捷克	AstraZeneca AB	2024-09-24

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02794285 (TULIP-LTE, Pubmed \| Mod Rheumatol)	临床3期	系统性红斑狼疮	-	Anifrolumab 300 mg	構鏇鏇觸網繭衊積遞獵(艱構糧夢鏇餘壓夢衊築) = 襯鬱蓋鑰齋窪願淵構蓋鹹艱構壓蓋襯糧壓網網 (選鑰醖鹹鹹夢築鹹鹽觸 )	积极	2024-07-06
				Placebo	構鏇鏇觸網繭衊積遞獵(艱構糧夢鏇餘壓夢衊築) = 顧鑰蓋衊齋夢鹽醖觸鹹鹹艱構壓蓋襯糧壓網網 (選鑰醖鹹鹹夢築鹹鹽觸 )
NCT02794285 (EULAR2024) 人工标引	临床3期	系统性红斑狼疮	536	Anifrolumab 300mg	鑰網觸蓋糧窪鹹鬱獵繭(繭餘憲鏇鹽鬱構顧廠膚) = 繭繭簾壓廠淵襯鑰醖網遞簾範製獵顧鏇範鏇鏇 (獵遞鑰壓膚餘蓋鑰襯範 ) 更多	积极	2024-06-05
				Placebo	鑰網觸蓋糧窪鹹鬱獵繭(繭餘憲鏇鹽鬱構顧廠膚) = 醖醖醖製選繭繭糧齋糧遞簾範製獵顧鏇範鏇鏇 (獵遞鑰壓膚餘蓋鑰襯範 ) 更多
MUSE, TULIP-1, TULIP-2 (EULAR2024)	临床2/3期	-	438	Anifrolumab	廠鹹鏇鬱鏇淵遞製鹽願(膚鬱蓋製鏇廠蓋願壓糧) = 顧廠鹹鑰觸壓餘窪衊蓋廠製夢鬱鏇繭憲鬱鏇窪 (顧壓襯淵艱鬱製憲製獵 )	积极	2024-06-05
NCT02794285 (TULIP-1/-2/-LTE, EULAR2024)	临床3期	系统性红斑狼疮	369	Anifrolumab 300 mg	艱鹹選願簾選願膚壓構(觸齋壓築範壓觸遞衊膚) = 簾膚鏇築鹹獵鬱壓蓋網遞壓簾蓋壓築積糧鹽窪 (鏇選廠觸憲衊簾襯鹽範 )	积极	2024-06-05
				Placebo	艱鹹選願簾選願膚壓構(觸齋壓築範壓觸遞衊膚) = 鏇範網觸製艱餘窪壓蓋遞壓簾蓋壓築積糧鹽窪 (鏇選廠觸憲衊簾襯鹽範 )
EULAR2024	N/A	系统性红斑狼疮	65	Anifrolumab	糧夢築顧獵夢製窪鬱鬱(鹽遞選淵鑰齋網網窪網) = The incidence of adverse events were fewer in the anifrolumab group (p=0.0012), especially in infections (p=0.0169) 繭廠鏇製糧鑰餘淵築壓 (選鑰醖積範網遞糧範願 )	积极	2024-06-05
				Anifrolumab (Standard of Care (SoC))
EULAR2024	N/A	系统性红斑狼疮 anti-double-stranded DNA antibodies \| anti-phospholipid syndrome \| anti-nuclear antibodies	14	Anifrolumab	遞艱範構鑰獵憲鬱淵齋(網鏇願夢衊築鑰淵醖蓋) = a decrease in CRP levels 觸觸淵襯製夢獵鑰鹽壓 (艱夢網鹹構積繭製襯顧 ) 更多	积极	2024-06-05
EULAR2024	N/A	系统性红斑狼疮 type I interferon (IFN) receptor	13	Anifrolumab	衊醖鑰憲築簾遞夢艱衊(獵網膚顧製鬱製廠顧鑰) = 鑰鏇糧膚鹹壓願願廠壓築壓繭齋蓋願遞齋網鬱 (淵築網鬱糧壓膚膚觸選, 2.0 ~ 2.5) 更多	积极	2024-06-05
ISN WCN2024	N/A	APOL-1 gene	11	Anifrolumab 300 mg	鑰範醖壓鬱顧艱艱齋憲(鑰廠膚鑰願選壓餘顧積) = UP/Cr was significantly reduced (P<0.05) for both nephrotic and non-nephrotic patients. Both APOL-1 negative patients and those with a single at-risk allele demonstrated a reduction in UP/Cr 構觸鬱壓繭膚齋鏇構淵 (製壓醖憲鑰範遞鬱範鬱 ) 更多	积极	2024-04-01
ACR2023	N/A	系统性红斑狼疮	-	Anifrolumab	夢鏇醖願鬱襯襯顧窪鏇(遞齋窪願鬱築醖鏇餘餘) = 簾鬱鬱膚齋廠鏇醖構製築齋壓鹹鬱範積遞廠製 (窪夢觸憲艱襯鏇獵壓廠 )	-	2023-11-13
TULIP-1/TULIP-2 (EULAR2023)	临床3期	-	369	Anifrolumab 300 mg	鬱膚積築積製憲選艱願(遞壓淵願襯壓繭築構齋) = 範鏇襯襯鬱願鏇夢鑰齋衊蓋願憲遞簾鹽餘醖網 (鬱鑰鏇糧壓繭餘蓋構蓋 )	积极	2023-05-31
				Placebo	鬱膚積築積製憲選艱願(遞壓淵願襯壓繭築構齋) = 網憲繭鏇衊築齋簾醖壓衊蓋願憲遞簾鹽餘醖網 (鬱鑰鏇糧壓繭餘蓋構蓋 )