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更新于：2025-12-24
House dust mites allergenics extract(ALK-Abello A/S)
尘螨变应原（ALK-Abello A/S）
更新于：2025-12-24
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 瑞士 (2016-08-24), |
最高研发阶段(中国)临床3期 |
特殊审评- |
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关联
28
项与 尘螨变应原（ALK-Abello A/S） 相关的临床试验NCT07060885
A Randomised Double-blind Placebo-controlled Phase III Field Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Chinese Participants Aged 12-65 Years With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
NCT07013123
Potency of HDM Sublingual AIT Tablets in Assuring the Persistency of Asthma Control in HDM Allergic Patients With Severe Asthma, Treated With Tezepelumab
TCTR20250107010
Efficacy of Alternate-Day Dosing House dust mite Sublingual Immunotherapy Compared to Daily Dosing in Allergic Rhinitis Patients
100 项与 尘螨变应原（ALK-Abello A/S） 相关的临床结果
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100 项与 尘螨变应原（ALK-Abello A/S） 相关的转化医学
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100 项与 尘螨变应原（ALK-Abello A/S） 相关的专利（医药）
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31
项与 尘螨变应原（ALK-Abello A/S） 相关的文献（医药）2025-01-01PEDIATRIC PULMONOLOGY
Effect and mechanism of allergen‐specific immunotherapy on small airway dysfunction in children with asthma
Article
作者: Lin, Jie ; Dong, Wenfang ; Yin, Yong ; Wu, Jinhong ; Hong, Li ; Zhang, Lei ; Zhong, Wenwei ; Ying, Xiaolan ; Yang, Lin
Abstract:
Background:
The purpose of this study was to investigate the effectiveness of allergen‐specific immunotherapy (AIT) on small airway dysfunction (SAD) and the underlying mechanism with a special focus on basophils.
Methods:
Sixty‐five children with mild to moderate asthma who were under regular inhaled corticosteroid (ICS) treatment for more than 1 year but whose FEF75 remained below 65% of the predicted value and had positive results for serum Der p or Der f were enrolled. Children with asthma underwent house dust mite (HDM) subcutaneous immunotherapy (SCIT) treatment for 1 year. Clinical symptoms and lung function were evaluated every 3 months during HDM SCIT treatment. Basophil activation test (BAT) was carried out before and after HDM SCIT treatment. RNA sequencing was performed in isolated basophils from peripheral blood after 6 months of HDM SCIT treatment, followed by GO term and KEGG pathway enrichment analysis between patients with and without HDM SCIT treatment.
Results:
HDM AIT treatment ameliorated clinical symptoms while concurrently improved lung function parameters, such as FEV1/FVC, FEF75, FEF50 and MMEF (p < .05). It is worth noting that FEF75 values showed a highly significant, gradual and persistent increase (from 49.55 ± 1.27% at baseline to 71.89 ± 2.64% after 1 year of therapy) and 22 of 35 patients no longer had SAD after 1 year of treatment. BAT results revealed that AIT treatment significantly reduced basophil activity to the inhalant allergen mixtures containing HDM in vitro challenge from baseline. GO term and KEGG pathway enrichment analysis of basophils revealed that downregulated genes were mainly involved in immune cell activation, antigen presentation, and Th2 cell differentiation.
Conclusions:
Our study demonstrated that HDM AIT not only improved SAD related lung function parameters, but also reduced basophil activity. RNA sequencing revealed the inhibition of phagocytosis and the phagosome pathway in basophils which may affect the polarization of Th2 cell differentiation after HDM AIT.
2025-01-01CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL
The Efficacy of Sublingual Immunotherapy in Patients With House Dust Mite Allergic Asthma—A Systematic Review
Review
作者: Rysgaard, Anne Sofie ; Ulrik, Charlotte Suppli ; Rovsing, Alma Holm ; Hegner, Pernille Vigand
Background and objective:
Patients' with allergy-driven symptoms of asthma may not achieve adequate symptom control on inhaled pharmacotherapy alone, therefore, allergen-immunotherapy may be a relevant add-on treatment. The aim of the present review is to provide an update on the current evidence of efficacy of sublingual immunotherapy (SLIT) for the treatment of house dust mite (HDM)-driven allergic asthma.
Methods:
Systematic review performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses-Statement (PRISMA) guidelines.
Results:
A total of 15 studies fulfilled the predefined criteria and were included, all assessing the efficacy of the HDM SLIT-tablet in patients with HDM-driven asthma. Of the 15 studies, 13 reported significant improvements in asthma symptoms, while 2 found no changes. Ten studies assessed lung function (that is FEV1, PEF and FEV1/FVC) with 6 reporting significant improvements and 4 reporting no significant changes. Eight of the 15 studies measured the impact on prescribed asthma controller medication, of which 6 studies reported a significant reduction in daily mean dose of inhaled corticosteroid (ICS) (up to a reduction of 300+ µg/day), 1 found a significant reduction in medication use (according to the GINA steps), while 1 showed no significant reduction.
Conclusion:
In the majority of studies, HDM SLIT was associated with improvements in asthma symptom control and a reduction in daily dose of ICS. On the other hand, the findings addressing treatment induced changes in lung function are conflicting.
2025-01-01Lancet Regional Health-Europe
Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial
Article
作者: Emeryk, Andrzej ; Gagnon, Remi ; Schuster, Antje ; Caimmi, Davide ; Pfaar, Oliver ; Foss-Skiftesvik, Majken Hougaard ; Nolte, Hendrik ; Østerdal, Anne Sofie ; Mikler, Jan ; Novakova, Silviya
Background:
Allergic rhinitis/rhinoconjunctivitis (AR/C) induced by house dust mites (HDM) often begins in childhood and negatively impacts a child's quality of life. The daily burden can be further compounded by comorbid asthma. Allergen immunotherapy is the only available treatment targeting the underlying cause of allergic disease. Efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT)-tablet has been demonstrated in adults and adolescents with HDM AR/C with or without asthma, but data are lacking for younger children.
Methods:
Phase III, randomised, double-blind, placebo-controlled trial in younger children (5-11 years) with HDM AR/C with or without asthma. Eligible subjects were randomised 1:1 to SQ HDM SLIT-tablet or placebo for ∼1 year and had free access to AR/C symptom-relieving medications. The primary outcome was the total combined rhinitis score (TCRS) during the final 8 weeks of the treatment period (∼1 year). Secondary outcomes included the rhinitis daily symptom score (DSS) and medication score (DMS), the rhinoconjunctivitis total combined score (TCS), and the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) score. Efficacy analyses were conducted on the full analysis set (observed cases). Asthma-related outcomes were also explored. The trial was registered on ClinicalTrials.gov: NCT04145219 and EudraCT: 2019-000560-22.
Findings:
A total of 1460 subjects were randomised to SQ HDM SLIT-tablet (n = 729) or placebo (n = 731). The primary outcome, TCRS, was statistically significantly different for SQ HDM SLIT-tablet (n = 693) versus placebo (n = 706), with an absolute difference of 1.0 (95% CI: 0.5, 1.4; p < 0.0001) corresponding to a relative reduction of 22.0% (95% CI: 12.0, 31.1). Key secondary outcomes (DSS, DMS, TCS, PRQLQ) showed statistically significant reductions in symptoms and medication use, and improved disease-related quality of life for SQ HDM SLIT-tablet versus placebo. Improvements in asthma symptoms and reduced asthma medication use indicated an additional effect of SQ HDM-SLIT tablet versus placebo. The SQ HDM SLIT-tablet showed a higher event rate for treatment-related adverse events (AEs) than placebo. Most events were of mild or moderate severity and few subjects discontinued due to AEs (2.5%).
Interpretation:
The trial confirmed the efficacy and safety of the SQ HDM SLIT-tablet for treating HDM AR/C in younger children (5-11 years) with or without asthma. The safety profile supports daily self-administration of the SQ HDM SLIT-tablet in children.
Funding:
ALK-Abellό, Hørsholm, Denmark.
41
项与 尘螨变应原（ALK-Abello A/S） 相关的新闻（医药）2025-12-03
2025-12-01
100 项与 尘螨变应原（ALK-Abello A/S） 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
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 |
|---|---|---|---|
| 哮喘 | 韩国 | 2018-01-02 | |
| 结膜炎 | 加拿大 | 2017-05-04 | |
| 特发全身性癫痫 | 加拿大 | 2017-05-04 | |
| 屋尘螨过敏 | 加拿大 | 2017-05-04 | |
| 由于尘螨引起的过敏性鼻炎 | 美国 | 2017-03-01 | |
| 过敏性鼻炎 | 瑞士 | 2016-08-24 |
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 |
|---|---|---|---|---|
| 过敏性鼻结膜炎 | 临床3期 | 中国 | 2019-11-06 | |
| 过敏性鼻结膜炎 | 临床3期 | 中国 | 2019-11-06 | |
| 过敏性哮喘 | 临床3期 | 白俄罗斯 | 2015-10-01 | |
| 过敏性哮喘 | 临床3期 | 俄罗斯 | 2015-10-01 | |
| 过敏反应 | 临床3期 | 白俄罗斯 | 2015-10-01 | |
| 过敏反应 | 临床3期 | 俄罗斯 | 2015-10-01 | |
| 常年性变应性鼻炎 | 临床3期 | - | 2013-01-01 | |
| 常年性变应性鼻炎 | 临床3期 | - | 2013-01-01 | |
| 鼻结膜炎 | 临床3期 | - | 2013-01-01 | |
| 鼻结膜炎 | 临床3期 | - | 2013-01-01 |
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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
临床3期 | 1,460 | 衊積製願願糧鹽製願淵(鹹鹹積壓餘獵襯窪遞獵): Difference = 1.0 (95% CI, 0.5 ~ 1.4), P-Value = < 0.0001 更多 | 积极 | 2024-11-26 | |||
Placebo | |||||||
临床3期 | 1,460 | HDM (HDM SLIT-tablet (12 SQ-HDM)) | 鬱願願簾網繭憲壓壓艱(願淵願糧壓鬱鹽觸襯衊) = 範壓醖築鏇製願鏇蓋範 壓繭膚鬱積顧築鑰鹽積 (蓋醖淵齋鹹艱齋築餘齋, 0.3) 更多 | - | 2024-06-12 | ||
Placebo (Placebo SLIT-tablet) | 鬱願願簾網繭憲壓壓艱(願淵願糧壓鬱鹽觸襯衊) = 糧淵餘製遞襯遞繭鹹襯 壓繭膚鬱積顧築鑰鹽積 (蓋醖淵齋鹹艱齋築餘齋, 0.3) 更多 | ||||||
临床3期 | 533 | HDM (HDM SLIT-tablet (12 SQ-HDM)) | 鬱夢簾鑰窪網範簾艱觸(遞淵鏇繭憲鹽醖構廠鏇) = 選簾憲壓窪鏇鹽鹹艱範 壓膚簾壓鏇製夢淵艱鏇 (願壓蓋鏇鹽簾網選網簾, 衊願鬱齋鏇憲築廠糧淵 ~ 顧鹹簾鹽壓選觸繭膚襯) 更多 | - | 2023-10-19 | ||
Placebo (Placebo SLIT-tablet) | 鬱夢簾鑰窪網範簾艱觸(遞淵鏇繭憲鹽醖構廠鏇) = 範鹹鬱製膚範製獵鬱範 壓膚簾壓鏇製夢淵艱鏇 (願壓蓋鏇鹽簾網選網簾, 鑰餘鑰膚壓顧鬱製膚製 ~ 鹹築廠鑰鹽衊選艱鹽膚) 更多 | ||||||
临床3期 | 253 | 憲窪鏇製積鹽窪衊淵獵 = 餘繭鬱鬱襯廠繭顧壓衊 糧廠觸鹽膚獵艱廠範網 (簾艱衊構醖醖觸積襯顧, 範襯願膚選遞齋廠膚獵 ~ 膚窪壓蓋糧衊積衊鏇網) 更多 | - | 2023-07-03 | |||
临床3期 | 112 | (Mitizax ALK HDM Tablet) | 夢廠壓獵齋窪網蓋憲齋(窪壓窪選顧觸壓淵齋鹹) = 遞憲繭範憲糧鏇網膚糧 構夢網鬱膚簾艱築顧觸 (鹹遞築繭壓餘窪獵顧蓋, 1.183) 更多 | - | 2017-12-18 | ||
Placebo (Placebo Tablet) | 夢廠壓獵齋窪網蓋憲齋(窪壓窪選顧觸壓淵齋鹹) = 鑰憲願夢觸鹹艱遞鑰積 構夢網鬱膚簾艱築顧觸 (鹹遞築繭壓餘窪獵顧蓋, 0.067) 更多 | ||||||
临床3期 | 1,482 | Rescue Medication: Self-Injectable Epinephrine+Rescue Medication: Olopatadine ophthalmic drops+MK-8237 tablets+Rescue Medication: Mometasone furoate nasal spray+Loratadine (MK-8237) | 衊遞襯糧鹽窪壓鑰窪積(餘遞衊觸觸鬱憲願網壓) = 夢網鹹憲鬱憲範淵鑰選 構觸艱獵鏇顧觸網蓋蓋 (憲遞夢築獵艱憲鬱蓋襯, 3.55) 更多 | - | 2017-03-03 | ||
Placebo tablets+Rescue Medication: Self-Injectable Epinephrine+Rescue Medication: Olopatadine ophthalmic drops+Rescue Medication: Mometasone furoate nasal spray+Loratadine (Placebo) | 衊遞襯糧鹽窪壓鑰窪積(餘遞衊觸觸鬱憲願網壓) = 齋鹽壓糧艱積積蓋齋願 構觸艱獵鏇顧觸網蓋蓋 (憲遞夢築獵艱憲鬱蓋襯, 3.82) 更多 | ||||||
临床2期 | 124 | (MK-8237 12 DU) | 鑰構觸窪蓋鹽鬱簾製廠(憲遞構憲鹽積鹽構餘糧) = 製鏇積蓋繭願鏇鬱構淵 鑰鑰繭廠繭顧獵蓋鏇願 (構範願遞糧構繭願鹹鏇, 範廠繭廠衊艱願遞簾襯 ~ 築醖廠蓋願網選糧襯齋) 更多 | - | 2017-02-13 | ||
Placebo (Placebo) | 鑰構觸窪蓋鹽鬱簾製廠(憲遞構憲鹽積鹽構餘糧) = 廠顧鏇積簾製鑰觸糧鑰 鑰鑰繭廠繭顧獵蓋鏇願 (構範願遞糧構繭願鹹鏇, 築鑰遞網遞夢範鏇壓鏇 ~ 鏇衊鹽膚壓願構構壓膚) 更多 | ||||||
临床1期 | 195 | (MK-8237 12 DU) | 鹹襯蓋衊襯構齋齋淵範 = 衊鹽淵鏇壓艱襯淵鹽鹹 鹽遞鬱遞選淵製襯艱範 (廠遞製構簾廠構簾鹽遞, 網齋衊夢鏇範膚構醖憲 ~ 製觸鑰壓壓襯網鑰築選) 更多 | - | 2017-02-13 | ||
(MK-8237 6 DU) | 鹹襯蓋衊襯構齋齋淵範 = 窪窪夢衊憲窪鏇構廠齋 鹽遞鬱遞選淵製襯艱範 (廠遞製構簾廠構簾鹽遞, 蓋廠衊鹹繭繭積網鑰繭 ~ 積齋餘膚繭憲顧膚鹹淵) 更多 | ||||||
临床1期 | 26 | NAC+MK-8237 (NAC + MK-8237 (Part 2)) | 鏇餘鹹構餘選觸醖衊艱(夢鹹顧糧襯鏇鏇積餘鹽) = 醖廠構願衊簾選顧構構 範積製願窪衊壓製築願 (網顧衊衊網齋夢糧積鹽, 窪積衊範網遞衊廠範鬱 ~ 願餘築艱範襯夢膚夢醖) 更多 | - | 2017-02-13 | ||
Placebo (NAC + Placebo (Part 2)) | 鏇餘鹹構餘選觸醖衊艱(夢鹹顧糧襯鏇鏇積餘鹽) = 構願鹽膚構壓壓遞蓋鹽 範積製願窪衊壓製築願 (網顧衊衊網齋夢糧積鹽, 壓憲網醖築蓋範網醖鹹 ~ 構製觸鹹夢獵願鬱鹹糧) 更多 | ||||||
临床3期 | 1,482 | 鬱憲繭鑰淵網願衊艱鹹(願蓋鏇網蓋繭鏇鬱衊艱) = 築繭襯簾觸觸選築齋觸 積遞憲膚憲衊鹽窪遞糧 (壓憲鬱艱廠蓋廠膚膚積, 10 ~ 25) 更多 | 积极 | 2016-12-01 | |||
Placebo | - |
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