更新于：2024-11-04
Anifrolumab-FNIA
更新于：2024-11-04
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2021-07-30), |
最高研发阶段(中国)临床3期 |
特殊审评快速通道 (美国)、孤儿药 (美国) |
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序列信息
Sequence Code 128453421L
来源: *****
Sequence Code 315601407H
来源: *****
关联
54
项与 Anifrolumab-FNIA 相关的临床试验PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab
A Randomized, Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Subcutaneously and Intravenously Delivered Anifrolumab in Healthy Chinese Participants
100 项与 Anifrolumab-FNIA 相关的临床结果
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100 项与 Anifrolumab-FNIA 相关的转化医学
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100 项与 Anifrolumab-FNIA 相关的专利（医药）
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225
项与 Anifrolumab-FNIA 相关的文献（医药）2025-12-01JOURNAL OF CLINICAL IMMUNOLOGY
Normalized Interferon Signatures and Clinical Improvements by IFNAR1 Blocking Antibody (Anifrolumab) in Patients with Type I Interferonopathies
Article
作者: Alehashemi, Sara ; Lakshmikanth, Tadepally ; Chen, Yang ; Mugabo, Constantin Habimana ; Fischer, Marie ; Wang, Jun ; Johnsson, Anette ; Tan, Ziyang ; Brodin, Petter ; Horne, AnnaCarin ; James, Anna ; Palmblad, Karin ; Páez, Laura Piñero ; Goldbach-Mansky, Raphaela ; Kretzschmar, Genia ; Gonzalez, Laura ; Mikeš, Jaromír
Abstract:
Purpose:
A causal role of type-I interferons (IFN-I) in autoinflammatory type-I interferonopathies such as SAVI (STING–associated vasculopathy with onset in infancy) and CANDLE (chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperatures) is suggested by elevated expression of IFN-I stimulated genes (ISGs). Hitherto, the lack of specific inhibitors of IFN-I signaling has prevented the verification of a causal role for IFN-I in these conditions. Commonly used inhibitors of the JAK/STAT pathway exert broad effects on multiple signaling pathways leading to more general immunosuppression beyond IFN-I signaling.
Methods:
Here we show in four patients with SAVI and one patient with CANDLE syndrome that blockade of the IFNAR1 receptor (Anifrolumab) exerts an additive effect over JAK-inhibitor alone. In two patients with SAVI, monotherapy with Anifrolumab is sufficient to retain a suppressed IFN-I signature and clinical improvement.
Results:
Anifrolumab normalizes IFN-I signature genes and relieves symptoms beyond what is typically achieved by a JAK-inhibitor (Baricitinib) alone in patients with type-I interferonopathies. In two patients Anifrolumab was used successfully as monotherapy. Addition of Anifrolumab enabled steroid tapering and cessation with reduced overall immunosuppression and lower risks of opportunistic infections and improved metabolic states and growth which is highly beneficial in these young patients.
Conclusion:
These results verify a causal role of IFN-I signaling in type-I Interferonopathies SAVI and CANDLE and suggests Anifrolumab as an important new treatment option in autoinflammatory diseases with elevated IFN-I induced gene expression.Genia Kretzschmar, Laura Piñero Páez, and Ziyang Tan are shared-first authors.Sara Alehashemi, AnnaCarin Horne, and Petter Brodin are co-senior author.
2024-12-31RENAL FAILURE
Effectiveness and safety of B cell-targeting biologics in the treatment of lupus nephritis: a systematic review and network meta‑analysis
Review
作者: Yang, Si-Qi ; Wang, Yao-Guang ; Zhao, Xi ; Li, Man
OBJECTIVES:
To evaluate the effectiveness and safety of different B cell-targeting biological agents combining with standard of care in patients with lupus nephritis (LN).
METHODS:
Comprehensive literature searches were conducted using PubMed, Embase, Web of Science, and Central in the Cochran Library, spanning from inception to May 20th, 2024. Randomized control trials (RCTs) comparing rituximab (RTX), belimumab, ocrelizumab, obinutuzumab, and anifrolumab in LN were selected. The primary outcomes of interest were related to complete renal remission (CRR), and partial renal remission (PRR). Additionally, we delved into safety outcomes, examining the occurrence of serious adverse events (SAEs), infections, and the discontinuation rates due to adverse events.
RESULTS:
A total of 6 RCTs with 1150 patients applying various B cell-targeting biological agents were included. Notably, ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that obinutuzumab (SUCRA 85.2%) has the highest potential superiority in improving CRR, followed by belimumab, ocrelizumab. Regarding the improvement in PRR, obinutuzumab (SUCRA 83.0%) has the highest potential superiority. In terms of safety, with a focus on SAEs, infections, and the discontinuation rates due to adverse events, the results were: SUCRA-based ranking indicated that RTX (SUCRA 74.1%) had the highest probability of postponing SAEs, followed by belimumab and obinutuzumab. Concerning infection reduction, anifrolumab (SUCRA 78.7%) had the highest potential superiority. Safety events monitoring infection occurred better with RTX than with standard therapy (OR = 3.57, 95% CI 1.02, 12.66) and were statistically different. For the discontinuation rates due to adverse events, RTX (SUCRA 88.6%) demonstrated the highest potential superiority.
CONCLUSIONS:
Concerning the effectiveness and safety outcomes, obinutuzumab, belimumab, and RTX plus standard of care may be superior to the current standard therapy as treatments for LN. This study protocol has been registered with PROSPERO, with a registration number of CRD42024548522.
2024-11-01LUPUS
JAK inhibitors in systemic lupus erythematosus: Translating pathogenesis into therapy
Review
作者: Edwards, Christopher J ; Ceobanu, Gabriela
Systemic lupus erythematosus (SLE) is a complex multi-organ autoimmune disease marked by the production of autoantibodies against nuclear structures, formation of immune complexes, and chronic inflammation triggered by their tissular deposition. SLE is characterized by alternating periods of relapse and remission and each flare has the potential to cause new organ damage related to either the disease process or the medication toxicity. Despite remarkable progress across its multiple domains, SLE is still an area with many unmet needs, calling for innovative and practical solutions. The efforts of the drug development programme in lupus have led to considerable growth in the last decade, owing to the approval of belimumab, anifrolumab, and voclosporin. The increasing understanding of the pathogenesis of the disease has enabled the exploration of novel therapeutic strategies. New discoveries in the intricate cytokine kaleidoscope of lupus have made the concept of targeted therapy an attractive and promising research focus. JAK inhibitors are oral targeted therapies approved for a wide variety of diseases across the Rheumatology, Gastroenterology, Dermatology, and Haematology fields. Multiple JAKis are currently being investigated in SLE. This paper aims to summarize existing data coming from both clinical trials and case reports regarding the use of JAK inhibitors in SLE.
100 项与 Anifrolumab-FNIA 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11082 | Anifrolumab-FNIA |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 狼疮性肾炎 | 澳大利亚 | 2022-03-29 | |
| 中枢神经系统狼疮血管炎 | 澳大利亚 | 2022-03-29 | |
| 系统性红斑狼疮 | 美国 | 2021-07-30 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 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 | 2024-09-24 | |
| 多发性肌炎 | 临床3期 | 中国 | 2024-09-24 | |
| 多发性肌炎 | 临床3期 | 日本 | 2024-09-24 | |
| 多发性肌炎 | 临床3期 | 澳大利亚 | 2024-09-24 | |
| 多发性肌炎 | 临床3期 | 奥地利 | 2024-09-24 | |
| 多发性肌炎 | 临床3期 | 比利时 | 2024-09-24 | |
| 多发性肌炎 | 临床3期 | 巴西 | 2024-09-24 | |
| 多发性肌炎 | 临床3期 | 保加利亚 | 2024-09-24 | |
| 多发性肌炎 | 临床3期 | 加拿大 | 2024-09-24 | |
| 多发性肌炎 | 临床3期 | 捷克 | 2024-09-24 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | - | 餘簾夢簾網壓鹹鑰餘遞(鬱憲鹽蓋糧獵積選鬱構) = 選餘築鹽網膚獵憲齋鑰 淵鑰醖鑰範憲積選艱鬱 (積糧鹹觸網築鹽遞鏇遞 ) 更多 | 积极 | 2024-07-06 | |||
Placebo | 餘簾夢簾網壓鹹鑰餘遞(鬱憲鹽蓋糧獵積選鬱構) = 築壓簾鹽範醖艱積壓築 淵鑰醖鑰範憲積選艱鬱 (積糧鹹觸網築鹽遞鏇遞 ) 更多 | ||||||
临床3期 | 536 | 醖憲範糧襯膚鹹餘鹹醖(觸艱淵襯餘餘齋鏇醖觸) = 壓艱鬱窪憲獵膚獵餘餘 觸艱獵範廠獵鹽築鬱積 (選鬱網餘廠艱鏇壓鹹夢 ) 更多 | 积极 | 2024-06-05 | |||
Placebo | 醖憲範糧襯膚鹹餘鹹醖(觸艱淵襯餘餘齋鏇醖觸) = 鏇鹹鬱壓顧積夢夢簾願 觸艱獵範廠獵鹽築鬱積 (選鬱網餘廠艱鏇壓鹹夢 ) 更多 | ||||||
N/A | 系统性红斑狼疮 type I interferon (IFN) receptor | 13 | 憲簾壓廠製遞範襯餘觸(壓衊鹽顧積網獵壓繭繭) = 選構糧範蓋夢廠鹹鹹襯 顧窪衊鹽範壓積廠範醖 (壓襯選觸淵遞齋鹽網膚, 2.0 ~ 2.5) 更多 | 积极 | 2024-06-05 | ||
临床3期 | 369 | 膚膚積壓積窪淵廠壓廠(鑰壓衊醖憲窪糧遞積醖) = 蓋憲繭蓋獵蓋願顧襯淵 簾範衊選遞製窪築獵壓 (觸廠夢顧築鏇鏇廠構鹽 ) | 积极 | 2024-06-05 | |||
Placebo | 膚膚積壓積窪淵廠壓廠(鑰壓衊醖憲窪糧遞積醖) = 糧廠顧積廠襯觸憲構鬱 簾範衊選遞製窪築獵壓 (觸廠夢顧築鏇鏇廠構鹽 ) | ||||||
临床2/3期 | 438 | 鏇膚選憲餘鏇夢糧淵積(襯繭遞淵襯遞簾襯願膚) = 獵膚鹹艱鹹鑰範積觸繭 鹽獵遞鹹艱願範積衊鑰 (糧衊襯構構鬱衊膚衊選 ) | 积极 | 2024-06-05 | |||
N/A | 65 | 艱鑰鑰構獵築襯鏇範積(選獵膚顧鏇遞艱窪衊憲) = The incidence of adverse events were fewer in the anifrolumab group (p=0.0012), especially in infections (p=0.0169) 淵夢遞窪襯選獵窪積廠 (襯願餘鹹壓獵觸獵齋觸 ) | 积极 | 2024-06-05 | |||
(Standard of Care (SoC)) | |||||||
N/A | 系统性红斑狼疮 anti-double-stranded DNA antibodies | anti-phospholipid syndrome | anti-nuclear antibodies | 14 | 膚繭衊鏇獵夢窪選醖顧(鑰願鹹蓋糧願觸窪糧窪) = a decrease in CRP levels 製窪顧憲製衊窪鹽顧遞 (夢齋艱廠壓築製獵醖繭 ) 更多 | 积极 | 2024-06-05 | ||
N/A | APOL-1 gene | 11 | 遞範衊願鹽鏇鹹鑰膚醖(鹹觸繭糧糧憲鬱顧窪襯) = 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 構築糧艱構窪網鏇觸簾 (繭繭簾顧膚膚艱選蓋範 ) 更多 | 积极 | 2024-04-01 | ||
N/A | - | 繭蓋齋鑰衊觸淵窪憲膚(範艱範壓壓醖憲鏇網齋) = 衊餘築鹽鑰鬱網範網餘 夢積鑰廠網範壓衊製襯 (艱範醖襯願壓顧鬱憲構 ) | - | 2023-11-13 | |||
临床3期 | - | 369 | 願膚鬱鏇簾繭構繭蓋壓(鏇壓顧憲鹹齋觸簾製鬱) = 鑰蓋願衊廠廠構鏇鏇廠 製餘襯繭壓簾顧餘襯鹹 (鑰製壓餘選簾蓋觸遞壓 ) | 积极 | 2023-05-31 | ||
Placebo | 願膚鬱鏇簾繭構繭蓋壓(鏇壓顧憲鹹齋觸簾製鬱) = 築齋壓醖觸獵網顧鏇膚 製餘襯繭壓簾顧餘襯鹹 (鑰製壓餘選簾蓋觸遞壓 ) |
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