A Multicentre, Randomised, Open-label, Phase I Study to Characterise the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Administered Subcutaneously or Intravenously in Participants With Systemic Lupus Erythematosus

The purpose of this study is to assess the PK, PD, and safety of anifrolumab as SC administration or IV infusion in adult participants with systemic lupus erythematosus (SLE).

开始日期2026-10-30

申办/合作机构

AstraZeneca PLC

[+1]

NCT07431775

/ Not yet recruitingN/A

A Non-Interventional Descriptive Multi-Country Study of Saphnelo™ (Anifrolumab-fnia) Utilization in Females of Reproductive Potential

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by substantial clinical burden-including organ damage, increased morbidity, and mortality-that often presents in young adulthood and disproportionately affects female patients. SAPHNELO™ (anifrolumab-fnia), a fully human IgG1 κ monoclonal antibody, is a novel therapeutic option approved for add-on treatment of moderate-to-severe SLE in the United States (US) on 30 July 2021 and in the European Union on 14 February 2022. To fulfill US Food and Drug Administration (FDA) post-marketing requirements for the evaluation of anifrolumab safety in pregnancy, additional evidence is needed to better understand the real-world drug utilization of anifrolumab in female patients of reproductive potential.

开始日期2026-10-01

申办/合作机构

AstraZeneca PLC

[+1]

NCT07691970

/ Not yet recruiting临床3期

ROSY-S: Rollover Study for Participants Who Have Completed a Previous Study With Anifrolumab (Saphnelo) and Are Assessed by the Investigator to Clinically Benefit From Continued Treatment

The purpose of this study is to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator, while monitoring safety and tolerability.
Study details include:
* Participants can transition in ROSY-S once they complete their participation in the parent study and should have received at least one dose of anifrolumab in the parent study. Participants with a treatment gap from parent studies and/or who are on compassionate use are eligible to rollover to ROSY-S study.
* The earliest that the Enrolment Visit may occur is at the time of the last visit of the parent study (ie, completion of the parent study's final safety follow-up visit). All required assessments from the safety follow-up visit of the parent study must be completed before the Enrolment Visit of ROSY-S study.
* The participants will continue to receive anifrolumab the same way they received it in the parent trial
* A participant is considered to have completed the study when they meet one of the discontinuation criteria.
* Safety will be monitored throughout the study. Both serious and nonserious AEs will be collected up to 12 weeks after the last dose of anifrolumab and will be reported as part of the primary safety endpoint.

开始日期2026-09-01

申办/合作机构

AstraZeneca PLC

100 项与阿尼鲁单抗相关的临床结果

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100 项与阿尼鲁单抗相关的转化医学

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100 项与阿尼鲁单抗相关的专利（医药）

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373

项与阿尼鲁单抗相关的文献（医药）

2026-09-01·ANNALES DE DERMATOLOGIE ET DE VENEREOLOGIE

Anifrolumab for refractory cutaneous manifestations of amyopathic dermatomyositis

Letter

作者: Seneschal, J ; Doutre, M-S ; Horiot, V ; Truchetet, M-E ; Toussaint, C

2026-07-01·LUPUS

Real-world use of anifrolumab in systemic lupus erythematosus: A retrospective study from a Danish tertiary center (2022–2025)

Article

作者: Troldborg, Anne ; Hermansen, Marie-Louise From ; Nørgaard, Laura ; Deleuran, Bent ; Larsen, Mads Lamm

Objective:

To evaluate the real-world safety, efficacy, and steroid-sparing effects of anifrolumab in patients with systemic lupus erythematosus (SLE) treated at a tertiary referral center in Denmark.

Methods:

We conducted a retrospective observational study of all SLE/discoid lupus patients who received at least one infusion of anifrolumab between May 2022 and February 2025 at Aarhus University Hospital. Clinical and laboratory data were extracted from electronic medical records at baseline, 3 months, 6 months, and last follow-up. Disease activity was assessed using SLEDAI-2K, Physician’s Global Assessment (PGA), LLDAS, and DORIS criteria.

Results:

Thirty-six patients (94% female, mean age 52 years) received anifrolumab for a mean of 462 days. Median SLEDAI-2K decreased from 8 at baseline to 2 at month 3, and to 0 at both month 6 and last follow-up. The proportion achieving SLEDAI-2K = 0 increased from 0% at baseline to 52% at both 6 months and last follow-up. At the last follow-up, 87% achieved both PGA ≤0.5 and LLDAS, while 70% achieved DORIS remission. Prednisolone doses declined by >50%. Skin and musculoskeletal involvement showed the greatest improvement. Herpesvirus-related infections were the most frequent adverse events; two severe cases occurred, though treatment was generally continued.

Conclusion:

Anifrolumab was associated with rapid, sustained disease control and significant steroid-sparing effects. Herpesvirus infections were common, underscoring the importance of vaccination prior to treatment initiation. These findings support anifrolumab as an effective therapeutic option for SLE in routine clinical care.

2026-07-01·LUPUS

Clinical outcomes of anifrolumab after belimumab failure in systemic lupus erythematosus: A single-center case series

Article

作者: Kubota, Soichiro ; Kobayashi, Yoshiaki ; Hanai, Shunichiro ; Tanaka-Mabuchi, Nakako ; Nakagomi, Daiki ; Ikeda, Kojiro ; Yazaki, Mayu

Objectives:

To describe clinical outcomes after switching to anifrolumab in patients with systemic lupus erythematosus (SLE) who showed inadequate response to belimumab, and to explore clinical features potentially associated with treatment response in real-world settings.

Methods:

We retrospectively reviewed the cases of eight patients with SLE who were switched from belimumab to anifrolumab because of insufficient clinical response. Clinical data, including the SLE Disease Activity Index 2000 (SLEDAI-2K), serological markers, organ involvement, medication use, and attainment of a lupus low disease activity state (LLDAS), were descriptively evaluated.

Results:

All eight patients were female; most were young and had active mucocutaneous manifestations. Three patients presented with cutaneous vasculitis and one with panniculitis. Three patients had neuropsychiatric manifestations, including mood disorders or cerebrovascular disease, and one patient had membranous lupus nephritis. Following anifrolumab initiation, clinical improvement was observed predominantly in skin and neuropsychiatric manifestations, whereas renal involvement showed limited improvement. Improvements in SLEDAI-2K scores, complement levels, and glucocorticoid dose reduction were observed in most patients. Five patients achieved LLDAS during follow-up. Clinical improvement was more frequently observed among younger patients and those with active skin manifestations and anti-ribonucleoprotein antibody positivity.

Conclusions:

In this exploratory case series, switching from belimumab to anifrolumab was associated with clinical improvement among selected patients with SLE. Certain clinical features, including active skin or neuropsychiatric manifestations and anti-ribonucleoprotein antibody positivity, were more frequently observed among patients who showed improvement after switching therapy. These findings should be interpreted as hypothesis-generating and warrant confirmation in larger prospective studies.

478

项与阿尼鲁单抗相关的新闻（医药）

2026-07-09

·尿大夫

狼疮性肾炎治疗新武器，靶向生物制剂改写患者命运

系统性红斑狼疮（SLE）是一种常见的自身免疫性疾病，会累及全身多个器官，最典型的表现就是血液中存在多种自身抗体。其中，狼疮性肾炎（LN）是SLE最常见且最严重的并发症之一，大约50%的SLE患者会出现肾脏受累，这也是导致患者死亡的第二大原因。更关键的是，如果LN得不到缓解，死亡率会更高。所以，早发现、早干预、选对治疗方案，对改善患者预后至关重要。目前LN的治疗分为两个阶段：积极的诱导治疗和长期的维持治疗。诱导治疗的目标是快速逆转免疫介导的炎症，通过短期大剂量使用免疫抑制剂实现疾病缓解；维持治疗则为了确保长期有效、防止复发。但标准治疗的局限也很明显——完全缓解率不够高、复发风险大、肾脏持续的炎症会让肾功能一步步恶化。不少患者需要反复、长期用药，副作用也很棘手。因此，医生们急需更高效、更安全的靶向新药。 SLE的发病根源是自身免疫反应失调——遗传和环境因素共同作用，让固有免疫和适应性免疫系统对含有核酸的细胞成分产生了不恰当的免疫攻击，导致T细胞、B细胞、巨噬细胞等免疫细胞功能紊乱。针对这些发病机制，一批生物制剂正在走向临床。瞄准B细胞：狼疮治疗的“精准打击” B细胞在狼疮引起系统性器官损伤，尤其是肾脏病变中扮演了“头号推手”的角色。它们产生自身抗体，和抗原形成免疫复合物沉积在肾脏，激活补体，一步步损伤肾功能。所以，以B细胞为靶点的治疗策略已经被写进LN指南，成为当前和未来的研究热点。为什么B细胞会出问题？自身反应性B细胞逃过了中枢和外周的免疫耐受检查点、过度活化、释放刺激T细胞和树突状细胞的细胞因子、表面分子表达失调、细胞内信号通路紊乱……这些都参与了SLE的发病。因此，靶向B细胞及其相关分子和通路，就成了控制狼疮的有效武器。B细胞的存活和成熟依赖于一些关键信号，比如BAFF、CD19、CD20等。利妥昔单抗（Rituximab）它是CD20单抗，原本用于非霍奇金淋巴瘤等疾病。著名的LUNAR研究显示，在激素和霉酚酸酯（MMF）的基础上加用利妥昔单抗，可以显著降低抗dsDNA抗体和补体C3/C4水平，虽然总体反应率没有达到统计学显著差异，但部分反应的患者更多了。贝利尤单抗（Belimumab）这是一种人源化的IgG1γ单抗，能特异性结合可溶性B细胞刺激因子（BLyS），2011年在美国获批，成为首个用于SLE的靶向药。BLISS-LN研究证实，贝利尤单抗能早期改善东亚SLE患者的肾脏预后。不过这项研究排除了1年内接受透析或eGFR低于30的患者。江苏省人民医院肾内科团队在毛慧娟教授指导下，观察了4例接受透析的重症LN患者使用贝利尤单抗（10mg/kg）的情况——最终4位患者都成功脱离了透析，没有发生不良事件。这给贝利尤单抗用于中重度肾功能损伤的LN患者提供了很好的依据。另外，BEAT-LUPUS研究表明，先打2次利妥昔单抗（间隔2周），4~8周后再用贝利尤单抗，能显著降低IgG抗dsDNA抗体水平，并延长严重复发的时间。泰它西普（Telitacicept）它是全球唯一获批治疗SLE的双靶点生物制剂。Ⅱb期研究结果在2019年ACR大会报告，2021年3月在中国获批上市。用药后4周就开始起效，能明显降低蛋白尿水平，240mg组在48周时肾脏受累情况得到改善。 CD19 CAR-T疗法在SLE治疗中，CD19 CAR-T细胞不仅安全、可耐受，而且效果惊人。研究数据显示，它不仅能有效清除患者体内的B细胞，还能让系统性自身免疫病进入无药缓解状态——即使在B细胞重建后，临床效果依然持续。瞄准共刺激通路：另辟蹊径的靶向疗法除了直接打B细胞，科学家们也在拦截那些让免疫系统持续“发疯”的信号通路。阿尼鲁单抗（Anifrolumab）它是Ⅰ型干扰素受体拮抗剂，2021年在美国和日本获批，用于正在接受标准治疗的中重度SLE成人患者。3期TULIP试验显示，在标准治疗基础上，阿尼鲁单抗能让患者更早、更大幅度地达到“狼疮低疾病活动状态”甚至缓解。氘可来昔替尼（Deucravacitinib） TYK2是一种细胞内激酶，负责传递干扰素（IFN）和白细胞介素-10、-12、-23等关键细胞因子的信号——这些因子都参与了SLE发病。氘可来昔替尼就是一种口服的选择性TYK2抑制剂，已被FDA批准用于银屑病。Ⅱ期临床研究PAISLEY证明，它用于SLE也安全有效。巴瑞克替尼（Baricitinib）它是可逆的选择性JAK1和JAK2抑制剂，已用于类风湿关节炎和特应性皮炎。在三期临床研究SLE-BRAVE-I中，它能显著改善SLE疾病活动性。未来展望：更多靶向药在路上，但仍需验证大量靶向B细胞、T细胞、炎症因子和细胞内信号通路的生物制剂已经涌现。但遗憾的是，目前只有少数被写入了LN治疗指南，而且这些新药长期使用的安全性、有效性大多还缺乏充分数据。未来还需要更多临床试验来验证它们，才能真正实现从实验室到病床边的转化。 👉 虽然新药带来了新希望，但具体使用哪种方案，一定要在专科医生指导下，结合自身病情做出决策。切勿自行用药。

2026-07-09

·PRNewswire

Systemic Lupus Erythematosus Market at a Turning Point as 6 Late-Stage Emerging Therapies Set to Redefine Treatment Landscape | DelveInsight

Companies like Biogen and Royalty Pharma (Litifilimab), Biogen and UCB (Dapirolizumab pegol), Idorsia Pharmaceuticals and Viatris (Cenerimod), Novartis (Ianalumab, YTB3231), Kyowa Kirin (KK-4277), and others are advancing late, mid, and early-stage drugs, showing promise in the systemic lupus erythematosus treatment market. LAS VEGAS, July 9, 2026 /PRNewswire/ -- Systemic lupus erythematosus (SLE) is a chronic, complex autoimmune disease that can affect multiple organ systems, with disease severity and clinical manifestations varying considerably among patients. Despite significant advances in understanding its pathophysiology, SLE remains incurable, and current treatment strategies primarily focus on controlling disease activity, achieving remission or low disease activity, preventing irreversible organ damage, minimizing flares, and improving patients' long-term quality of life. The therapeutic landscape for SLE remains limited, with only two therapies currently approved by the US FDA specifically for the disease: BENLYSTA (belimumab) from GlaxoSmithKline and SAPHNELO (anifrolumab) from AstraZeneca. Conventional treatment continues to rely on nonsteroidal anti-inflammatory drugs (NSAIDs), antimalarial agents, glucocorticoids, immunosuppressants, and other supportive therapies. While glucocorticoids remain a cornerstone of disease management, their well-documented long-term toxicities have intensified efforts to reduce steroid exposure through treat-to-target strategies. The persistent need for multiple lines of therapy and the limitations associated with existing treatments highlight the substantial unmet need for safer and more effective disease-modifying options. Discover what is the future of the systemic lupus erythematosus (SLE) drugs market @ The SLE pipeline is robust and increasingly diverse, with several late-stage and emerging therapies targeting novel immune pathways. Prominent investigational candidates include obinutuzumab (Roche), ianalumab (Novartis), dapirolizumab pegol (Biogen/UCB), upadacitinib (AbbVie), deucravacitinib (Bristol Myers Squibb), litifilimab (Biogen and Royalty Pharma), and other innovative agents that have the potential to improve disease control while reducing treatment-related toxicity. Aparna Thakur, Project Manager of Forecasting at DelveInsight, said that Oral small molecules such as cenerimod (S1P1 modulator), deucravacitinib (TYK2 inhibitor), and upadacitinib (JAK1 inhibitor) target multiple immune pathways in SLE, reflecting a shift toward oral multi-pathway immune modulation in treatment. In parallel, CAR T-cell therapies are emerging as a potentially transformative approach for patients with refractory SLE by enabling targeted B-cell depletion and immune system reprogramming that could deliver durable, treatment-free remission. Leading programs in this space include rapcabtagene autoleucel (YTB-323), zolacabtagene autoleucel, resecabtagene autoleucel (CABA-201), and obecabtagene autoleucel (obe-cel, AUCATZYL), signaling a potential shift from lifelong immunosuppression toward one-time disease-modifying interventions. As per Thakur, CD19-directed CAR-T therapies, including rapcabtagene autoleucel, zolacabtagene autoleucel, and resecabtagene autoleucel, show strong potential in SLE by inducing deep B-cell depletion and durable remission, though safety risks such as CRS and ICANS require intensive monitoring. Reflecting the growing innovation and expanding therapeutic opportunities in this space, DelveInsight estimates that the SLE market across the leading markets, including the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately USD 3 billion in 2025 and is projected to grow at a CAGR of 10.4% through 2036. Below, we highlight 6 emerging late-stage therapies poised to reshape the future of the systemic lupus erythematosus treatment market. Biogen and Royalty Pharma's Litifilimab CLEC4C protein inhibitors Litifilimab (BIIB059) is a humanized IgG1 monoclonal antibody designed to target BDCA2 (Blood Dendritic Cell Antigen 2) and is being developed as a potential therapy for systemic lupus erythematosus (SLE). BDCA2 is a receptor primarily found on plasmacytoid dendritic cells (pDCs), a specialized immune cell population involved in the production of inflammatory mediators. By binding to BDCA2, litifilimab suppresses pDC activation, thereby reducing the release of type I interferons (IFN-I) along with other proinflammatory cytokines and chemokines implicated in SLE pathogenesis. Biogen is currently evaluating litifilimab in two global Phase III clinical studies, TOPAZ-1 (NCT04895241) and TOPAZ-2 (NCT04961567), for patients with SLE, with topline results anticipated by the end of 2026. In October 2025, the company announced that patient enrollment had been completed for both Phase III trials and that the expected data readout timeline had been accelerated to the second half of 2026. Earlier, in February 2025, Biogen entered into a funding agreement with Royalty Pharma, under which it is eligible to receive up to USD 200 million in 2025 and an additional USD 50 million in 2026 to help support the ongoing development of the litifilimab program. Roche's Obinutuzumab (GAZYVA/GAZYVARO) TSLP inhibitor Obinutuzumab is a glycoengineered monoclonal antibody designed to target the CD20 protein expressed on the surface of lymphoma and leukemia cells. As a type II anti-CD20 antibody, it exhibits greater antibody-dependent cellular cytotoxicity and stronger direct cell-killing activity compared with conventional CD20 antibodies. After binding to CD20, obinutuzumab promotes B-cell destruction by engaging immune effector cells, directly triggering intracellular death-signaling pathways, and activating the complement cascade. In Europe, the therapy is marketed under the name GAZYVARO. In February 2026, Roche submitted regulatory applications in the United States and Europe seeking approval of obinutuzumab for the treatment of Systemic Lupus Erythematosus. Subsequently, in April 2026, Roche announced that the FDA had accepted its supplemental Biologics License Application (sBLA) for obinutuzumab in SLE. The filing is based on positive results from the Phase III ALLEGORY study, which showed a statistically significant and clinically meaningful improvement in the primary endpoint. The FDA is expected to issue a decision on the application by December 2026. Discover more about which pipeline drugs could transform systemic lupus erythematosus treatment @ Systemic Lupus Erythematosus Market Size Novartis' Ianalumab BAFF-R inhibitor, ADCC-mediated B-cell depletor Ianalumab, a novel monoclonal antibody developed by Novartis, targets the B-cell Activating Factor Receptor (BAFF-R). It is designed to inhibit BAFF-R signaling while simultaneously promoting B-cell depletion through antibody-dependent cellular cytotoxicity (ADCC). The therapy is currently being evaluated in two Phase III clinical studies for systemic lupus erythematosus (SLE): NCT05639114 (SIRIUS-SLE 1) and NCT05624749 (SIRIUS-SLE 2). According to Novartis' 2026 interim financial report, topline results from the Phase III SIRIUS-SLE 1 and SIRIUS-SLE 2 trials are expected in 2027. Pending positive outcomes, the company plans to submit Ianalumab for regulatory approval in SLE in 2028. Johnson & Johnson's Nipocalimab (IMAAVY) FcRn blockade Nipocalimab is an investigational immunoselective therapy engineered to selectively bind with high affinity to the neonatal Fc receptor (FcRn), blocking its activity and lowering circulating pathogenic IgG antibodies while maintaining essential immune functions. The therapy is being evaluated across three major autoantibody-driven disease areas: rheumatologic disorders, rare autoantibody-mediated conditions, and maternal-fetal diseases, where inhibiting IgG interaction with FcRn in the placenta is expected to reduce the transfer of harmful maternal alloantibodies to the fetus. In March 2026, Johnson & Johnson announced that the U.S. Food and Drug Administration granted Fast Track Designation (FTD) to nipocalimab for the treatment of Systemic Lupus Erythematosus. Explore systemic lupus erythematosus competitors Johnson & Johnson marketed products @ Systemic Lupus Erythematosus Marketed Drugs Idorsia Pharmaceuticals and Viatris' Cenerimod Sphingosine 1-phosphate receptor modulators Cenerimod is a highly selective Sphingosine-1-Phosphate Receptor 1 (S1P1) modulator administered as a once-daily oral tablet. Although the exact cause of systemic lupus erythematosus remains unclear, dysregulated T and B lymphocytes are recognized as central drivers of disease pathogenesis. By selectively targeting the S1P1 receptor, cenerimod is designed to modulate lymphocyte trafficking and reduce immune-mediated inflammation. The therapy is currently being evaluated in two Phase III clinical trials, OPUS-1 (NCT05648500) and OPUS-2 (NCT05672576), for the treatment of SLE. The US FDA has also granted Fast Track Designation (FTD) to cenerimod, underscoring its potential to address an unmet medical need in SLE. In February 2025, Idorsia Pharmaceuticals amended its collaboration agreement with Viatris for the development of cenerimod. Under the revised terms, Idorsia's contribution toward the drug's 2025 development costs was reduced by USD 100 million. In exchange, the company agreed to a USD 250 million reduction in future regulatory and commercial milestone payments while granting Viatris expanded territorial commercialization rights for cenerimod. AbbVie's RINVOQ (upadacitinib) JAK 1 inhibitor Upadacitinib (ABT-494) is a selective inhibitor of Janus kinase 1 (JAK1) that is approved for the treatment of several immune-mediated inflammatory diseases, including ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. In addition to its approved indications, the therapy is currently under clinical investigation for potential use in alopecia areata, hidradenitis suppurativa (HS), systemic lupus erythematosus (SLE), Takayasu arteritis, and vitiligo. AbbVie's RINVOQ (upadacitinib) continues to be an interesting lupus asset after its Phase 2 SLEek study showed meaningful activity in moderate to severe systemic lupus erythematosus, with the 30 mg monotherapy arm meeting the primary endpoint and achieving steroid-sparing benefit versus placebo. Updated data presented in 2023 also showed durability through 48 weeks, with fewer flares, longer time to first flare, and sustained improvements in disease-activity measures such as SRI-4, BICLA, and LLDAS, while no new safety signals were reported. The key development story is that AbbVie advanced RINVOQ into Phase 3 lupus testing after the positive Phase 2 readout, but it did not move forward with the ABBV-599 combination because elsubrutinib did not add enough efficacy to justify development. Find out more about top SLE CAR-T pipeline assets @ Systemic Lupus Erythematosus Clinical Trials Source: Systemic Lupus Erythematosus Market Report Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including GlaxoSmithKline, AstraZeneca, Genentech (Roche), AbbVie, Bristol Myers Squibb, Novartis, MorphoSys, UCB Pharma, Biogen, Juno Therapeutics, Johnson & Johnson Innovative Medicine, Idorsia Pharmaceuticals, Viatris, Merck, and others. Related Reports Systemic Lupus Erythematosus Clinical Trial Analysis Complement 3 Glomerulopathy Pipeline Insight – 2026 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key SLE companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Therapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, and others. JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key JAK inhibitors companies, including Incyte Corporation, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Arcutis Biotherapeutics, Reistone Biopharma, and others. FcRn Inhibitors Market FcRn Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key FcRn inhibitors companies, including Immunovant, Viridian Therapeutics, argenx, and others. TSLP Inhibitors Market TSLP Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key TSLP inhibitors companies, including Sanofi, Uniquity Bio, Upstream Bio, Keymed Biosciences, Belenos Bioscience, Biosion, Pfizer, and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

临床3期临床2期临床结果免疫疗法快速通道

2026-07-09

·拓麦Derm

对话作者 | 皮肤型红斑狼疮发病机制、诊断与治疗的最新进展

点击蓝字关注“拓麦Derm” 前言皮肤型红斑狼疮（CLE）涵盖了一系列皮肤表现，这些表现可作为孤立的皮肤病变发生，也可与系统性红斑狼疮（SLE）相关。本综述对CLE的当前知识进行了最新整合，包括其分类、发病机制、临床表现和诊断策略。本文将讨论发病机制的最新进展，特别是I型干扰素和产生干扰素的细胞的核心作用。诊断评估涉及临床评估、组织病理学和免疫学检测，并特别关注CLE的模拟疾病。近年来，经过验证的工具如皮肤红斑狼疮面积和严重程度指数（CLASI）促进了临床试验中的标准化评估。CLE的管理需要多方面的策略，包括一般措施、局部治疗、抗疟药、全身免疫抑制剂和新兴的生物制剂。在本期「对话作者」中，文章作者Dr. François Chasset详细介绍了干扰素来源理解，CLE临床鉴别，以及CLE治疗的未来格局。点击上图，跳转至小程序观看访谈视频肖像经Dr. François Chasset许可后使用 1 干扰素来源的认知转变：靶向细胞还是通路 Dr. François Chasset: 传统观点认为浆细胞样树突状细胞是CLE中I型干扰素的主要来源，但近期研究提示角质形成细胞和常规树突状细胞的作用更为显著。这一认知转变是否意味着治疗策略应随之调整？Dr. François Chasset指出，从机制上推测，阻断I型干扰素受体或抑制下游信号通路可能比靶向单一细胞类型更有效。然而，目前针对浆细胞样树突状细胞的治疗（如Litifilimab）仍是临床开发中最成熟的策略。尽管我们对CLE干扰素生物学的理解不断深化，但不同策略的真实临床影响最终取决于正在进行的三期研究结果。 2 CLE与玫瑰痤疮相似患者特征有哪些关键的临床病理线索来避免误诊 Dr. François Chasset: CLE与玫瑰痤疮常以颧部皮疹和光敏感为共同特征，临床鉴别具有挑战性。Dr. François Chasset总结了关键的鉴别线索：CLE的蝶形红斑通常避开鼻唇沟，且一般无脓疱；光敏感常为延迟性，并伴有真正的炎症性皮损而非短暂性红斑。相比之下，玫瑰痤疮以潮红、毛细血管扩张、丘疹和脓疱为特征，皮损通常严格局限于面部，且眼部受累较为常见。当临床鉴别存疑时，皮肤活检是重要的辅助手段，病理学检查可有效区分两者。 3 新兴靶点百花齐放： CLE治疗的未来格局 Dr. François Chasset: 在干扰素通路、pDC抑制、TLR7/8及JAK/STAT信号等多个新兴靶点中，哪个最有望改变CLE的治疗格局？Dr. François Chasset坦言，他凭借Anifrolumab、Litifilimab和Deucravacitinib在临床实践中的使用经验，三者在CLE患者中均显示出令人鼓舞的疗效。虽尚无TLR7/8抑制剂的个人经验，但其临床试验数据同样前景广阔。他强调，当前最重要的信息并非预测哪条通路最终胜出，而是多种靶向疗法首次在CLE中实现平行开发，这将为迈向更个性化和有效的CLE管理奠定坚实基础。结语 CLE治疗正迎来靶向时代的曙光。干扰素来源的认知转变推动了从细胞靶向到通路抑制的多元策略探索，但其临床价值的验证仍需等待III期研究结果。与此同时，CLE与玫瑰痤疮的精准鉴别——基于避开鼻唇沟的蝶形红斑、无脓疱、延迟性光敏感等线索——仍是正确诊疗的基础。展望未来，多条路径的并行推进，为CLE的个体化治疗提供了前所未有的机遇。我们期待这些新兴疗法最终改变CLE患者的管理格局。 ▼ 相关阅读 ▼ 1 END 1 供稿：Jason 审核：Joy 排版：Vanessa 版权声明：内容仅限医疗卫生专业人士学习交流使用。未经版权所有者事先许可，不得以任何方式或任何手段对内容涉及的任何文档、图片、音频、视频复制、储存在其他第三方平台；未经版权所有者许可不得以任何方式（包括但不限于：嵌套、深度链接、盗播、盗取、盗链等）直接或间接地使用相关视频内容从事任何商业活动，否则将保留追究侵权者相关法律责任的权利。肖像经Dr. François Chasset许可后使用。参考文献： 1. Chasset F, Teboul A. Update on cutaneous lupus erythematosus pathogenesis, diagnosis and management. J Eur Acad Dermatol Venereol. Published online December 2, 2025. doi:10.1111/jdv.70186 #CLE：Cutaneous lupus erythematosus，皮肤型红斑狼疮

100 项与阿尼鲁单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11082	阿尼鲁单抗	L04AA	DB11976

研发状态

批准上市

10 条最早获批的记录,

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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,

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适应症	最高研发状态	国家/地区	公司	日期
皮肤红斑狼疮	临床3期	美国	AstraZeneca PLC	2024-06-29
皮肤红斑狼疮	临床3期	中国	AstraZeneca PLC	2024-06-29
皮肤红斑狼疮	临床3期	日本	AstraZeneca PLC	2024-06-29
皮肤红斑狼疮	临床3期	阿根廷	AstraZeneca PLC	2024-06-29
皮肤红斑狼疮	临床3期	澳大利亚	AstraZeneca PLC	2024-06-29
皮肤红斑狼疮	临床3期	奥地利	AstraZeneca PLC	2024-06-29
皮肤红斑狼疮	临床3期	比利时	AstraZeneca AB	2024-06-29
皮肤红斑狼疮	临床3期	巴西	AstraZeneca PLC	2024-06-29
皮肤红斑狼疮	临床3期	保加利亚	AstraZeneca PLC	2024-06-29
皮肤红斑狼疮	临床3期	加拿大	AstraZeneca PLC	2024-06-29

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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


EULAR2026	N/A	系统性红斑狼疮	19	Anifrolumab (severe haematologic manifestations + Systemic Lupus Erythematosus)	鹽獵鏇窪鏇鬱衊齋夢鬱(網襯鑰衊繭構築繭繭顧) = 1 because developing an adverse event (reactivation of viral B hepatitis), and 2 because of a severe non-hematologic SLE flare (one with renal flare, another with musculoskeletal flare). Only one patient suffered from Herpes Zoster infection, but without leading to ANI discontinuation. 製夢鹹鹽夢餘夢鹹顧遞 (製襯夢齋鏇膚衊蓋憲醖 )	积极	2026-06-11
				Anifrolumab (severe haematologic active patients)
NCT04877691 (TULIP-SC, EULAR2026)	临床3期	系统性红斑狼疮	367	ANIFROLUMAB 120 mg	壓廠膚構願顧膚製鬱製(繭構膚製鏇繭繭齋衊鬱) = 簾襯鏇繭鑰襯夢獵選憲積艱構積窪糧淵遞選餘 (艱獵願製襯獵壓鏇鑰製, 0.8) 更多	积极	2026-06-11
				Placebo	壓廠膚構願顧膚製鬱製(繭構膚製鏇繭繭齋衊鬱) = 餘糧廠觸顧積範壓餘範積艱構積窪糧淵遞選餘 (艱獵願製襯獵壓鏇鑰製, 0.8) 更多
NCT04931563 (AZALEA, EULAR2026)	临床3期	系统性红斑狼疮	185	Anifrolumab 300 mg	糧範網淵鹽觸鏇憲遞簾(壓衊繭願選壓獵製遞壓) = 築積簾鏇膚鑰鏇淵鏇顧簾廠觸餘遞鹹構鏇壓窪 (襯窪窪醖糧遞鹹積衊獵 ) 更多	积极	2026-06-11
				Placebo	糧範網淵鹽觸鏇憲遞簾(壓衊繭願選壓獵製遞壓) = 願淵網餘糧淵鹽鹽鏇繭簾廠觸餘遞鹹構鏇壓窪 (襯窪窪醖糧遞鹹積衊獵 ) 更多
EULAR2026	N/A	系统性红斑狼疮	241	Anifrolumab (Systemic Lupus Erythematosus)	窪觸膚選膚壓鬱繭齋廠(衊蓋選糧構獵簾壓觸襯) = 26 patients discontinued treatment due to primary failure (n=12), secondary failure (n=3), severe infections (n=6), hypotension (n=1), acute anterior uveitis (n=1), autoimmune hemolytic anemia (n=1), thoracic tumor (n=1) and pregnancy desire (n=1). 廠窪鹽構夢壓觸衊選糧 (窪選構夢製糧蓋選襯獵 ) 更多	积极	2026-06-11
NCT05637112 (ASTER, EULAR2026)	N/A	系统性红斑狼疮	530	Anifrolumab	網選衊積糧蓋廠繭襯選(餘製選簾膚憲觸膚艱壓) = 獵醖簾網醖夢齋鏇遞衊積襯簾廠網齋淵築鹹繭 (選遞蓋糧簾顧網鏇醖衊 ) 更多	积极	2026-06-11
				Anifrolumab (DORIS remission)	糧窪鏇壓蓋觸艱餘範壓(夢範獵醖艱鑰獵願窪選) = 餘膚鹹淵繭壓蓋憲鹽觸鏇鏇繭簾構遞窪廠構壓 (憲網鏇蓋淵淵齋襯構網, 45.9 ~ 69.4) 更多
EULAR2026	N/A	系统性红斑狼疮	241	Belimumab exposed	繭網選築鑰壓製鏇獵壓(齋選醖範製築願蓋築遞) = 廠顧築壓蓋製襯膚夢壓範夢築構淵廠範構積遞 (壓築簾構餘願憲網壓憲 ) 更多	积极	2026-06-11
				Belimumab naive	繭網選築鑰壓製鏇獵壓(齋選醖範製築願蓋築遞) = 廠網壓艱夢遞淵願顧繭範夢築構淵廠範構積遞 (壓築簾構餘願憲網壓憲 ) 更多
EULAR2026	N/A	系统性红斑狼疮	164	Anifrolumab	衊蓋衊艱鏇鹹願鑰壓艱(壓鹹範蓋獵積鑰膚夢糧) = 鬱鹽繭遞鏇構夢鹹蓋淵窪遞膚淵蓋鹹鏇醖鏇範 (艱鬱夢繭築範範獵願繭 ) 更多	积极	2026-06-11
EULAR2026	N/A	系统性红斑狼疮	40	Anifrolumab	製壓鬱淵觸鑰繭襯遞壓(鬱淵範積簾積鑰淵憲顧) = 範築構醖廠顧築鏇構選鑰廠製築願蓋觸襯淵廠 (糧齋鏇鹽鬱選淵網憲艱 ) 更多	积极	2026-06-11
EULAR2026	N/A	系统性红斑狼疮	152	Anifrolumab	齋鹹窪艱構積糧鏇蓋淵(醖淵襯餘艱築製網衊憲) = 夢築餘餘艱範壓觸鏇衊製範網蓋鏇鹹鑰鏇遞廠 (鏇廠鑰獵醖壓顧顧遞觸 ) 更多	积极	2026-06-11
NCT04877691 (TULIP-SC, EULAR2026)	临床3期	系统性红斑狼疮	367	-	簾願鏇糧願憲糧鬱鹽襯(網艱選構簾憲選範範選) = 艱獵襯鹽積範積鹽衊窪餘築築蓋繭獵艱構鹹積 (顧願壓網壓積觸醖觸構 ) 更多	积极	2026-06-11
				-	簾願鏇糧願憲糧鬱鹽襯(網艱選構簾憲選範範選) = 製夢製繭夢築艱齋觸選餘築築蓋繭獵艱構鹹積 (顧願壓網壓積觸醖觸構 ) 更多