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更新于：2025-06-05
Ixekizumab
依奇珠单抗
更新于：2025-06-05
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 (2016-03-22), |
最高研发阶段(中国)批准上市 |
特殊审评临床急需境外新药 (中国)、优先审评 (中国) |
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结构/序列
Sequence Code 110759H
来源: *****
Sequence Code 110762L
来源: *****
关联
77
项与 依奇珠单抗 相关的临床试验NCT06374979
Efficacy and Safety of Ixekizumab in Patients with Refractory Guttate Psoriasis
NCT06786936
Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms
NCT05309616
Effects of IL-17A Inhibition on Idiopathic Subglottic Stenosis
100 项与 依奇珠单抗 相关的临床结果
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100 项与 依奇珠单抗 相关的转化医学
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100 项与 依奇珠单抗 相关的专利（医药）
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1,103
项与 依奇珠单抗 相关的文献（医药）2025-06-01RHEUMATOLOGY
Incidence rates of tuberculosis and inflammatory bowel disease in patients with ankylosing spondylitis treated with biologics in Korea
Article
作者: Park, Min-Chan ; Paul, Thomas ; Yang, Juyeon ; Lee, Hye Sun ; Kwon, Oh Chan ; Lee, Youkyung ; Jin, Hyerim
Abstract:
Objective:
To describe the incidence rates of inflammatory bowel disease (IBD) and tuberculosis (TB) in Korean patients with ankylosing spondylitis receiving biologics.
Methods:
Data from a Korean claims database between 2010 and 2021 was used to calculate crude incidence rates of TB and IBD using number of events and total patient-years (PYs).
Results:
Overall, 43 643 and 43 396 patients were included in TB and IBD cohorts, respectively. Exposure-adjusted incidence rates (EAIRs) of TB for non-exposure, TNF inhibitors (TNFis), and IL-17 inhibitors (IL-17is) were 0.14, 0.25 and 0.12 and of IBD were 0.18, 0.19 and 0.44 per 100 PYs, respectively. Incidence rates during biologic DMARD (bDMARD) non-exposure, adalimumab, etanercept, golimumab, infliximab, secukinumab and ixekizumab exposures for TB were 13.96, 27.79, 14.28, 21.19, 33.62, 12.74 and 0.00 and for IBD were 18.29, 19.98, 22.41, 18.85, 15.73, 44.99 and 0.00 per 10 000 PYs, respectively. Compared with bDMARD non-exposure, adalimumab, golimumab and infliximab exposures were associated with a significantly higher risk of TB. Etanercept and secukinumab exposure showed no significant increase in risk of TB. Compared with bDMARD non-exposure, exposure to biologics did not show a significant difference in risk of IBD.
Conclusion:
EAIRs of TB and IBD with use of IL-17is in patients with AS were within anticipated low range. IL-17is had numerically lower incidence of TB, and numerically higher incidence of IBD compared with TNFis. Notably, secukinumab showed no increased risk of TB compared with bDMARD non-exposure. Neither TNFis nor IL-17is showed increased risk of IBD compared with bDMARD non-exposure.
2025-05-30MEDICINE
Psoriasis complicated with polymyositis successfully treated with Ixekizumab: A case report.
Article
作者: Liu, Jifeng ; Chen, Shengli
RATIONALE:
Psoriasis is an immune-mediated chronic inflammatory skin disease that is rarely complicated by polymyositis in clinical practice. Here, we report a patient with psoriasis, following treatment with Etanercept, who exhibited an increase in creatine kinase (CK) levels and a decline in muscle strength. After combined treatment with methylprednisolone, methotrexate, and Ixekizumab, the psoriasis rash completely subsided and CK levels returned to normal.
PATIENT CONCERNS:
The patient was a 22-year-old female with systemic erythema and scale itching for 3 months, and her serum CK level was 1711 U/L without muscle pain and muscle weakness. She was diagnosed with psoriasis and myositis awaiting investigation and was then treated with Etanercept at 50 mg weekly. At the 6-month follow-up with ongoing Etanercept treatment, her serum CK level was elevated to 3465 U/L. Electromyography and thigh magnetic resonance imaging revealed myositis. After methylprednisolone and methotrexate tablet treatment for polymyositis, she developed pulmonary pneumonia, and methotrexate and methylprednisolone tablets were withdrawn. Although the pneumonia was controlled, the facial erythema, plaques, scales, and rash gradually increased and spread all over the body. Moreover, gastrocnemius pain and fatigue persisted. The patient was treated with subcutaneous injection of 160 mg of Ixekizumab combined with methylprednisolone tablet (8 mg/d), after 2 weeks, the dosage was reduced to 80 mg once every 2 weeks, and the patient's psoriastic rash had completely disappeared after 4 weeks. The patient continued to receive subcutaneous injections of Ixekizumab 80 mg once a month and methylprednisolone tablet 6 mg every day. Six months later, no rash recurrence was noted and her CK level was within the normal range.
DIAGNOSES:
The patient was diagnosed with psoriasis with polymyositis.
INTERVENTIONS:
After combined treatment with methylprednisolone, methotrexate, and Ixekizumab, the psoriasis rash completely subsided and CK levels returned to normal.
OUTCOMES:
Our case shows that Ixekizumab is an effective treatment for psoriasis complicated with polymyositis, which is worth clinical application.
LESSONS:
Although Etanercept can be used to treat psoriasis and dermatomyositis, it can also aggravate the myositis. Ixekizumab is an effective treatment for psoriasis complicated by polymyositis.
2025-05-23CLINICAL AND EXPERIMENTAL DERMATOLOGY
Safety of interleukin-17A inhibitors in 306 patients with psoriasis with or without latent tuberculosis: a dual-centre retrospective study in China
Article
作者: Lv, Chengzhi ; Liu, Yizhang ; Duan, Yongfang ; Zhang, Mi ; Hu, Kun ; Jian, Lu ; Sha, Yang ; Kuang, Yehong
Abstract:
Background:
New interleukin (IL)-17A inhibitors seem to demonstrate smaller effects on tuberculosis (TB) reactivation than expected.
Objectives:
To evaluate the risk of TB reactivation, to assess serial interferon (IFN)-γ levels, and to weigh up the risks and benefits of TB chemoprophylaxis in patients with psoriasis treated with IL-17A inhibitors.
Methods:
This dual-centre study included patients with psoriasis who were treated with IL-17A inhibitors. The incidence of active TB, serial IFN-γ levels tested by IFN-γ release assays (IGRAs), adverse events (AEs) and effectiveness were evaluated through 1 year in patients with psoriasis treated with IL-17A inhibitors. According to the chemoprophylaxis treatment regimen, patients with latent TB infection (LTBI) were classified into three groups: a complete chemoprophylaxis dose regimen (CCP), an incomplete chemoprophylaxis (ICCP) or no chemoprophylaxis (NCP).
Results:
In 220 IGRA-negative patients, 17 of 220 (7.3%) became IGRA positive after receiving a mean of 69.1 weeks of IL-17A inhibitor treatment. Only one case of new-onset TB was observed after 52 weeks of ixekizumab therapy. Significant changes in IFN-γ levels were observed in IGRA-negative patients. Similarly, IFN-γ levels [listed as the mean (SD)] significantly increased at 1 year compared with baseline among IGRA-positive patients in the NCP [105 (68.7) vs. 236 (80.8) pg mL−1, P < 0.01] and ICCP [75.3 (48.3) vs. 608 (249) pg mL−1, P < 0.001] groups, whereas the changes were not significant [125 (26.6) vs. 131 (21.7) pg mL−1, P = 0.70] in the CCP group.
Conclusions:
During IL-17A inhibitor therapy, there is a need for increased awareness of annual screening and assessment of individual risk for early detection of TB infection. LTBI treatment is generally well tolerated and is effective in preventing increased IFN-γ responses in patients with psoriasis treated with IL-17A inhibitors.
100 项与 依奇珠单抗 相关的药物交易
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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 |
|---|---|---|---|
| 中轴性脊柱关节炎 | 中国 | 2022-07-26 | |
| 强直性脊柱炎 | 加拿大 | 2016-08-11 | |
| 非放射性轴性脊柱关节炎 | 加拿大 | 2016-08-11 | |
| 脊椎关节炎 | 加拿大 | 2016-08-11 | |
| 红皮病性银屑病 | 日本 | 2016-07-04 | |
| 银屑病 | 日本 | 2016-07-04 | |
| 寻常性银屑病 | 日本 | 2016-07-04 | |
| 脓疱型银屑病 | 日本 | 2016-07-04 | |
| 银屑病关节炎 | 欧盟 | 2016-04-25 | |
| 银屑病关节炎 | 冰岛 | 2016-04-25 | |
| 银屑病关节炎 | 列支敦士登 | 2016-04-25 | |
| 银屑病关节炎 | 挪威 | 2016-04-25 | |
| 斑块状银屑病 | 美国 | 2016-03-22 |
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 |
|---|---|---|---|---|
| 肥胖 | 临床3期 | 美国 | 2024-09-24 | |
| 肥胖 | 临床3期 | 波多黎各 | 2024-09-24 | |
| 附着点炎相关关节炎 | 临床3期 | 阿根廷 | 2021-04-13 | |
| 附着点炎相关关节炎 | 临床3期 | 比利时 | 2021-04-13 | |
| 附着点炎相关关节炎 | 临床3期 | 捷克 | 2021-04-13 | |
| 附着点炎相关关节炎 | 临床3期 | 丹麦 | 2021-04-13 | |
| 附着点炎相关关节炎 | 临床3期 | 法国 | 2021-04-13 | |
| 附着点炎相关关节炎 | 临床3期 | 德国 | 2021-04-13 | |
| 附着点炎相关关节炎 | 临床3期 | 意大利 | 2021-04-13 | |
| 附着点炎相关关节炎 | 临床3期 | 墨西哥 | 2021-04-13 |
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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2期 | 7 | 構襯鑰壓鬱鹽衊願夢壓 = 願鏇遞範鑰憲選鹽製範 簾鏇鏇壓遞製壓齋鏇鬱 (蓋鑰範膚遞艱範醖齋齋, 選範憲壓鹹膚窪鑰願鏇 ~ 網艱簾齋築艱襯選醖觸) 更多 | - | 2025-05-20 | |||
临床3期 | 中轴性脊柱关节炎 C-reactive protein level | 147 | Ixekizumab 80 mg every 4 weeks | 糧齋積廠鏇鏇製鑰鹹簾(積齋構簾鑰積齋鬱衊衊) = 壓窪鏇願衊願簾遞醖範 製築鏇構衊遞艱夢窪夢 (齋獵網積遞襯網製網鏇 ) | 积极 | 2025-05-09 | |
Placebo | 糧齋積廠鏇鏇製鑰鹹簾(積齋構簾鑰積齋鬱衊衊) = 構醖願膚壓襯鹹鬱襯鹽 製築鏇構衊遞艱夢窪夢 (齋獵網積遞襯網製網鏇 ) | ||||||
临床3期 | 289 | 餘鏇衊範衊鏇夢顧鑰蓋(憲襯鬱齋製壓遞衊蓋壓) = AEs were comparable in patients who received continuous treatment and retreatment 築範醖膚範構鏇顧鏇鑰 (鹹簾齋獵獵積網糧製糧 ) | 积极 | 2024-11-13 | |||
临床3期 | 中轴性脊柱关节炎 bDMARD-naïve | r-axSpA | 81 | Ixekizumab 80 mg every 4 weeks | 獵選構衊積鏇觸夢鹹齋(醖窪襯夢範鑰衊製淵積) = 淵築餘獵餘鹽鑰廠顧鹹 築選襯蓋淵鑰鹹獵糧鹹 (鹹憲膚願壓鏇遞構淵鬱 ) 更多 | 积极 | 2024-07-01 | |
临床3期 | 101 | (All IXE) | 構鬱築膚積製遞膚窪餘(蓋鑰鏇鹹製範簾鑰夢餘) = 觸蓋選膚築簾遞蓋齋餘 餘襯繭糧廠壓憲醖繭窪 (糧糧網網簾鹽淵選製範 ) 更多 | 积极 | 2024-06-12 | ||
(Bio-Naive) | 構鬱築膚積製遞膚窪餘(蓋鑰鏇鹹製範簾鑰夢餘) = 壓鏇觸積窪糧衊遞範衊 餘襯繭糧廠壓憲醖繭窪 (糧糧網網簾鹽淵選製範 ) 更多 | ||||||
N/A | - | Ixekizumab 80mg every 4 weeks | 繭鬱夢選鹽鹹壓構壓壓(鹹鏇製構夢製鹽遞衊鹽) = 夢範糧憲鑰願鹹築廠製 鹹製遞窪鏇膚淵範醖鏇 (糧簾餘鹽蓋遞遞鹽膚夢 ) | - | 2024-06-05 | ||
N/A | - | 鑰願醖鑰網膚壓積獵觸(餘鑰顧鏇夢獵夢蓋網願) = 憲獵鏇鏇蓋遞觸餘積壓 獵網鏇鹽鏇簾網鑰鹹蓋 (鑰糧築鬱淵廠醖艱衊蓋 ) 更多 | 积极 | 2024-06-05 | |||
鑰願醖鑰網膚壓積獵觸(餘鑰顧鏇夢獵夢蓋網願) = 醖膚衊蓋遞膚淵觸艱壓 獵網鏇鹽鏇簾網鑰鹹蓋 (鑰糧築鬱淵廠醖艱衊蓋 ) 更多 | |||||||
临床3期 | 341 | 顧鹹廠簾鹽壓淵蓋遞構(壓鹹鑰憲範襯憲遞積糧) = 願壓積艱網選糧製糧壓 醖簾襯網範廠鹹範鏇積 (餘鑰醖憲遞積齋糧積遞 ) 更多 | 积极 | 2024-06-05 | |||
顧鹹廠簾鹽壓淵蓋遞構(壓鹹鑰憲範襯憲遞積糧) = 夢齋鏇網廠範壓鹽鑰鹹 醖簾襯網範廠鹹範鏇積 (餘鑰醖憲遞積齋糧積遞 ) 更多 | |||||||
N/A | 335 | 鬱顧鹽鹽鏇觸簾顧繭餘(餘衊製範願繭襯襯鏇簾) = 憲積廠壓獵蓋鬱淵鏇夢 鬱願獵鹹壓鏇構窪築選 (壓艱願顧夢鬱範憲膚齋, 64.0 ~ 74.3) | 积极 | 2024-06-05 | |||
N/A | - | Ixekizumab 80 mg every 4 weeks | 簾製築衊齋選鑰鹹壓衊(襯淵淵遞鏇網觸壓醖顧) = 窪廠獵觸鑰繭膚齋壓蓋 襯簾糧鹹選顧糧衊築範 (壓蓋鑰膚淵鑰簾壓選繭 ) 更多 | - | 2024-06-05 | ||
Placebo | 簾製築衊齋選鑰鹹壓衊(襯淵淵遞鏇網觸壓醖顧) = 襯壓艱顧鑰構觸遞襯鏇 襯簾糧鹹選顧糧衊築範 (壓蓋鑰膚淵鑰簾壓選繭 ) 更多 |
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