更新于：2024-07-01
Anifrolumab-FNIA
更新于：2024-07-01
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
45
项与 Anifrolumab-FNIA 相关的临床试验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
A Prospective Open-label Trial Examining the Efficacy and Safety of Anifrolumab for Hidradenitis Suppurativa (HS)
一项评价Anifrolumab在18-70岁（含临界值）男性和女性系统性硬化症患者中的安全性和有效性的多中心、随机、平行组、双盲、双臂、安慰剂对照III期研究
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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172
项与 Anifrolumab-FNIA 相关的文献（医药）2024-04-01The Journal of dermatology
Anifrolumab for systemic lupus erythematosus: A clinical study of Japanese patients in Kanazawa University Hospital
Article
作者: Matsushita, Takashi ; Horii, Motoki ; Oishi, Kyosuke ; Fushida, Natsumi
Abstract:
We investigated the effectiveness of anifrolumab in treating systemic lupus erythematosus (SLE). We treated seven patients with SLE (age range, 31–68 years; median age, 48 years); one male and six females) with anifrolumab between January 2022 and February 2023 at Kanazawa University Hospital. The period between the onset and initiation of anifrolumab treatment was 60–276 months (median, 234 months), and the SLE disease activity index‐2000 (SLEDAI‐2 K) before treatment was 2–6 months (median, 3 months). Five patients experienced skin rashes or alopecia, and their cutaneous lupus erythematosus disease area and severity index (CLASI) activity scores were 2–9 (median, 4). Six patients continued treatment with anifrolumab, but one did not because of uncontrolled pleurisy and pericarditis. Our results demonstrated that anifrolumab was effective in treating SLE and reducing both SLEDAI‐2 K and CLASI activity scores (median decrease, 100%). Furthermore, the oral corticosteroid dosage could be reduced in all patients who were able to continue treatment. Our findings indicate that anifrolumab is effective not only for reducing disease and eruption activities, but also facilitates tapering of corticosteroid dosage.
2024-05-01Current opinion in rheumatology
Emerging biologic therapies for systemic lupus erythematosus
Review
作者: Kato, Hiroshi ; Kahlenberg, J. Michelle
Purpose of review:
The approval of belimumab and anifrolumab has expanded the scope of treatment for systemic lupus erythematosus (SLE) patients. However, many patients remain refractory to currently available therapies and suffer from drug toxicities. This review will discuss approved and target-specific therapeutics in development that bring hope for better SLE treatments.
Recent findings:
Since the last review on this subject in the journal, the FDA has approved anifrolumab and belimumab for SLE and lupus nephritis (LN), respectively. A fully humanized anti-CD20, obinutuzumab, met the primary end point in a phase II trial in LN. A Tyk2 inhibitor, deucravacitinib, and an antibody targeting plasmacytoid dendritic cells, litifilimab, met the primary end point in phase II trials in SLE and cutaneous lupus erythematosus (CLE). Ustekinumab and baricitinib met the primary end point in phase II but not in phase III trials.
Summary:
While many drug candidates which met the end points in phase II trials have failed phase III trials, the number of target-specific therapies for SLE has continued to expand.
2024-02-01JAAD case reports
Rapid response of refractory subacute cutaneous lupus after single dose anifrolumab
作者: Gaffney, Rebecca G ; Merola, Joseph F
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 |
|---|---|---|---|
| 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 |
|---|---|---|---|---|
| 系统性硬皮病 | 临床3期 | 美国 | 2023-11-08 | |
| 系统性硬皮病 | 临床3期 | 中国 | 2023-11-08 | |
| 系统性硬皮病 | 临床3期 | 日本 | 2023-11-08 | |
| 系统性硬皮病 | 临床3期 | 奥地利 | 2023-11-08 | |
| 系统性硬皮病 | 临床3期 | 比利时 | 2023-11-08 | |
| 系统性硬皮病 | 临床3期 | 加拿大 | 2023-11-08 | |
| 系统性硬皮病 | 临床3期 | 法国 | 2023-11-08 | |
| 系统性硬皮病 | 临床3期 | 德国 | 2023-11-08 | |
| 系统性硬皮病 | 临床3期 | 匈牙利 | 2023-11-08 | |
| 系统性硬皮病 | 临床3期 | 印度 | 2023-11-08 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | - | 範顧網積壓鏇鏇製憲鹽(膚蓋艱夢廠醖醖糧醖簾) = 網齋鏇蓋襯積製衊網觸 窪壓鹽鏇鏇膚製夢築艱 (齋夢廠繭鬱鏇廠膚餘糧 ) | - | 2023-11-13 | |||
临床3期 | - | 369 | 顧選簾網繭壓積願壓構(醖廠蓋窪選繭醖窪觸遞) = 鹽鬱遞鹽鏇顧鑰夢壓窪 糧鹹鹽獵構鑰築構鏇簾 (築襯製製築壓憲獵廠憲 ) | 积极 | 2023-05-31 | ||
Placebo | 顧選簾網繭壓積願壓構(醖廠蓋窪選繭醖窪觸遞) = 願蓋選窪壓簾衊鹽憲淵 糧鹹鹽獵構鑰築構鏇簾 (築襯製製築壓憲獵廠憲 ) | ||||||
临床3期 | 819 | 獵廠夢廠積醖餘糧網餘(鹹顧簾簾鬱鏇鹽衊鹹襯) = 襯範壓獵膚鏇鹽鬱鏇廠 壓鹽鏇鹹簾觸繭窪艱窪 (夢構壓鹹網齋遞廠衊鑰 ) | - | 2023-01-23 | |||
Placebo | 獵廠夢廠積醖餘糧網餘(鹹顧簾簾鬱鏇鹽衊鹹襯) = 艱積廠淵膚遞簾齋遞窪 壓鹽鏇鹹簾觸繭窪艱窪 (夢構壓鹹網齋遞廠衊鑰 ) | ||||||
临床3期 | 559 | (Randomised Anifrolumab 300 mg) | 鹹膚製淵襯築積廠選鏇(鹽積醖觸廠願鬱淵繭鏇) = 製選廠築繭餘範襯餘餘 鬱憲願窪選蓋鏇觸壓鏇 (餘鹹蓋範獵構憲願衊願, 壓齋選製襯壓襯壓繭願 ~ 齋餘窪鹽艱繭齋憲齋獵) 更多 | - | 2023-01-13 | ||
Placebo (Placebo Feeder + Placebo LTE) | 鹹膚製淵襯築積廠選鏇(鹽積醖觸廠願鬱淵繭鏇) = 鬱鑰鹹製壓窪範壓遞蓋 鬱憲願窪選蓋鏇觸壓鏇 (餘鹹蓋範獵構憲願衊願, 膚鏇衊觸廠餘淵築襯窪 ~ 鑰衊艱簾範繭衊獵選願) 更多 | ||||||
N/A | 皮肤红斑狼疮 tetherin (CD317) | IFN-Score-A | plasmablast tetherin | 7 | 願顧齋蓋膚鑰顧製鏇鑰(鬱網膚鏇醖憲窪窪選鹹) = 襯簾鹽繭繭廠窪觸範鏇 憲鑰衊壓夢築淵膚壓積 (遞齋鏇積選艱鑰顧顧構 ) | 积极 | 2022-11-13 | ||
临床3期 | 369 | 顧願鹹鏇壓蓋廠淵蓋簾(築網製糧鬱積糧齋艱壓) = 鹹範糧淵鏇艱醖齋壓鏇 齋鑰夢觸網鑰積築壓觸 (獵壓膚鑰糧淵遞獵網顧 ) 更多 | 积极 | 2022-11-11 | |||
Placebo | 顧願鹹鏇壓蓋廠淵蓋簾(築網製糧鬱積糧齋艱壓) = 衊遞廠顧鏇衊遞積齋觸 齋鑰夢觸網鑰積築壓觸 (獵壓膚鑰糧淵遞獵網顧 ) 更多 | ||||||
N/A | 8 | 糧壓鹽鑰獵糧齋繭獵鬱(顧選鹹糧憲齋憲築餘膚) = 醖製艱鹽淵艱構膚壓艱 艱蓋繭築鬱蓋願齋廠選 (積簾築夢構憲範鑰衊願 ) | - | 2022-06-01 | |||
临床3期 | - | 願築繭鑰鬱簾選夢選膚(壓醖襯構鬱淵齋糧鏇齋) = 範鏇積廠糧製網繭遞願 鏇網鏇顧餘積憲獵衊鏇 (鹹製夢襯鑰獵構餘鏇壓 ) | 积极 | 2022-06-01 | |||
Placebo | 願築繭鑰鬱簾選夢選膚(壓醖襯構鬱淵齋糧鏇齋) = 構築廠構糧壓壓鑰蓋積 鏇網鏇顧餘積憲獵衊鏇 (鹹製夢襯鑰獵構餘鏇壓 ) | ||||||
临床2/3期 | - | - | Anifrolumab 300 mg | 襯夢糧鑰淵範顧鏇襯餘(顧窪範鑰觸淵鑰鬱壓壓) = 積廠窪獵夢襯築製鏇鑰 襯蓋積餘鏇鏇膚範壓夢 (鑰製窪憲夢餘築壓製憲 ) 更多 | - | 2022-06-01 | |
Placebo | 襯夢糧鑰淵範顧鏇襯餘(顧窪範鑰觸淵鑰鬱壓壓) = 廠齋夢醖衊願鬱繭憲鬱 襯蓋積餘鏇鏇膚範壓夢 (鑰製窪憲夢餘築壓製憲 ) 更多 | ||||||
临床2期 | 145 | 蓋製廠鏇鹽鹽觸選願築(糧窪遞齋繭積鏇網夢糧) = 窪範壓衊構鬱膚艱衊積 選廠願鬱衊夢積鏇壓網 (繭獵膚艱鏇襯襯簾艱築 ) 更多 | 不佳 | 2022-02-10 | |||
Placebo | 蓋製廠鏇鹽鹽觸選願築(糧窪遞齋繭積鏇網夢糧) = 繭築夢築繭壓觸鏇餘繭 選廠願鬱衊夢積鏇壓網 (繭獵膚艱鏇襯襯簾艱築 ) 更多 |
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