Allergic rhinoconjunctivitis

关于特应性皮炎 特应性皮炎（atopic dermatitis，AD）是一种慢性、复发性、炎症性皮肤病。由于患者常合并过敏性鼻炎、哮喘等其他特应性疾病，故被认为是一种系统性疾病。特应性皮炎患者往往有剧烈瘙痒，严重影响生活质量。过去30年全球范围内AD患病率逐渐增加，发达国家儿童AD患病率达10%-20%，我国AD患病率的增加晚于西方发达国家和日本、韩国，但近10年来增长迅速1。 特应性皮炎的临床表现 该病呈慢性经过，临床表现多种多样，最基本的特征是皮肤干燥、慢性湿疹样皮损和明显瘙痒。 AD患者疾病诊断的特征性表现包括，皮肤干燥、鱼鳞病、毛周角化、掌纹症、手足部皮炎/湿疹、眼睑湿疹、乳头湿疹、唇炎、复发性结膜炎、眶下褶痕、鼻下和耳根皱褶处湿疹、眶周黑晕、白色糠疹、出汗时瘙痒、对羊毛敏感、过度虫咬反应、白色划痕等。部分患者可同时有其他过敏性疾病，如过敏性哮喘、过敏性鼻结膜炎等。 此外，由于长期慢性炎症反应，慢性病程患者合并发生精神神经系统疾病、眼部疾病、肥胖、淋巴瘤风险明显增高。特应性皮炎带来的慢性湿疹样皮损和反复瘙痒为患者带来了严重的身体、心理和生活负担，如果得不到及时、规范、长期的治疗，易引发疾病加重或复发，所以对于特应性皮炎这种需要长期治疗的疾病，还需要从长远角度综合考虑治疗的安全性、有效性和长期治疗成本。 特应性皮炎的常见治疗手段 治疗的目的是缓解或消除临床症状，消除诱发及加重因素，减少和预防复发，减少或减轻合并症，提高患者的生活质量。 AD患者阶梯式治疗模式 基础治疗：健康教育，使用保湿润肤剂，寻找并避免或回避诱发因素（非特异因素、过敏原回避等）。 轻度AD患者：根据皮损及部位选择局部用糖皮质激素（TCS）/局部用钙调神经磷酸酶抑制剂（TCI）对症治疗，必要时口服抗组胺药治疗合并过敏症（荨麻疹、过敏性鼻炎）或止痒；对症抗感染治疗。 中度AD患者：根据皮损及部位选择TCS/TCI控制症状，必要时湿包治疗控制急性症状；TCS/TCI主动维持治疗，窄谱中波紫外线（NB-UVB)或中大剂量长波紫外线（UVA1）治疗。 重度AD患者：住院治疗，系统用免疫抑制剂，短期用糖皮质激素（控制急性严重顽固性皮损），NB-UVB或UVA1治疗1。 如果您或您的家人有特应性皮炎的症状，请及时到正规医院就诊检查咨询,正规和良好的治疗及疾病管理可使AD症状完全消退或显著改善，享受正常生活。 作为创新型国际化制药企业，恒瑞医药在深耕传统优势的肿瘤领域同时，积极开辟慢病管理新赛道，经过多年的沉淀和布局，在自身免疫领域公司已有近20款产品在研。其中JAK1抑制剂围绕特应性皮炎目前已开展了多项临床研究，并且已有成人和12岁及以上青少年中度至重度特应性皮炎等3项适应症上市许可申请获得国家药监局受理。此外，公司IL-4Rα注射剂关于特应性皮炎的临床研究已推进至3期。 未来，公司将一如既往秉持“以患者为中心”的理念，继续深耕自身免疫治疗领域，以聚焦解决患者未获满足的临床需求进行创新研发，努力研制更多新药、好药，造福更多患者。 参考文献： 1.中华皮肤科杂志2020年2月第53卷第2期 Chin J Dermatol, February 2020, Vol. 53, No.2. 内容：程梦真 排版：程梦真 责编：王玲 往期精选 |  研发创新  | 慢病创新里程碑！恒瑞首个自免创新药夫那奇珠单抗获批上市 恒瑞医药新突破！中国首个自研阿片类镇痛创新药富马酸泰吉利定获批上市 |  国际化  | 海外BD再传捷报！恒瑞医药GLP-1类创新药组合实现海外许可 恒瑞医药与默克达成合作，携手推进癌症创新疗法 |  重磅奖项  | 喜报！恒瑞医药荣获2023年度国家科技进步奖 恒瑞医药连续六年入选全球制药企业50强榜单！ |  社会公益  | “健康中国行·重走长征路”项目启动仪式圆满举行！恒瑞提供公益支持，助力健康中国 恒瑞医药集团向中国扶贫基金会捐赠3000万设立“健康帮扶基金”

The Phase 3 efficacy and safety trial of ALK’s tree tablet involved 952 children aged 5 to 17 in Canada and Europe.ALK has now successfully completed pivotal clinical development for all five respiratory allergy immunotherapy tablets across all relevant age groups. ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced top-line results from a Phase 3 paediatric clinical trial of its sublingual allergy immunotherapy tablet for the treatment of tree-pollen-induced allergic rhinoconjunctivitis. The tree tablet is marketed as ITULAZAX® in Europe and as ITULATEK® in Canada for patients aged 18 to 65. The trial achieved its primary endpoint and confirmed the effect of the tree tablet with an improvement of 22% in the total combined rhinoconjunctivitis score (TCS) during the birch pollen season compared to placebo. Results were highly statistically significant (p=0.0004), with a lower bound of the 95%-confidence interval of 10.6%. The trial also demonstrated improvement in TCS during the entire tree pollen season (key secondary endpoint). In addition, the trial demonstrated that treatment with the tree tablet was well tolerated and had a favourable safety profile, similar to the safety profile reported in other trials. The trial was well conducted with 96% of patients completing the trial. This trial confirms previous results reported in ALK’s tablet trials and was conducted in accordance with ALK’s strategy to focus on children and to treat allergies at an early stage in life. The trial, which involved 952 children in Canada and Europe, was a Phase 3, randomised, placebo-controlled trial to study the efficacy and safety of ALK’s tree tablet in children aged 5 to 17 with a clinical history of moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch trees as well as from other trees belonging to the birch homologous group. The trial was designed to confirm the effect of treatment with the tree tablet as measured by improvement in allergy symptoms and reduction in allergy pharmacotherapy use during the 2022 and 2023 pollen seasons. ALK’s Executive Vice President of Research and Development, Henriette Mersebach, says: “With the outcome of this large clinical trial, we have now successfully completed our paediatric development of all of ALK’s sublingual AIT tablets in respiratory allergies. The study results are consistent with previous tablet trial results and clearly confirms the benefits of treating respiratory allergies with our AIT tablets already from early childhood. This positive outcome is also important for ALK’s long-term growth ambitions and our ability to transform the medical treatment of children with allergies.” Globally, it is estimated that more than 10 million children have uncontrolled respiratory allergies, and the number is growing. Tree pollen is a common cause of these uncontrolled allergies. ALK will now pursue a dialogue with relevant regulatory authorities about expanding the current product indications. Subject to approval, the tree tablet could become available for young patients in Europe and Canada in 2025. ALK expects to present further details from the trial at a scientific congress in 2024. In line with ALK’s commitment to secure approvals for all of ALK’s respiratory tablets covering paediatric, adolescent, and adult use, ALK has also recently successfully completed a pivotal, Phase 3 paediatric trial with its house dust mite tablet (ACARIZAX®). ALK-Abelló A/S For further information please contact: Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 Media: Maiken Riise Andersen, tel. +45 5054 1434 This information is information that ALK is obliged to make public pursuant to the EU Market Abuse Regulation. About ALKALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,700 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. Attachment FM_14_23UK_11102023

HAMBURG, Germany, June 11, 2023 /PRNewswire/ -- A study conducted by researchers from the ALL-MED Medical Research Institute and the Department of Clinical Immunology at Wroclaw Medical University in Poland has validated the use of an allergen exposure chamber (AEC) in assessing the clinical outcomes of house dust mite (HDM) allergen immunotherapy (AIT) in patients with allergic rhinoconjunctivitis. The study focused on evaluating the efficacy and safety of AEC-derived clinical outcomes of subcutaneous HDM AIT, a treatment designed to alleviate symptoms triggered by HDM allergies. Fifty patients with HDM-triggered allergic rhinoconjunctivitis were included in the study, with HDM allergy confirmed through various diagnostic tests such as skin prick tests, serum-specific IgE, and basophil activation tests. During the study, patients were assessed in the allergen exposure chamber before commencing AIT and after 12 months of treatment. The chamber provided a controlled environment, allowing patients to be exposed to HDM allergen under stable and well-regulated conditions. Various clinical endpoints, including total nasal symptom score (TNSS), visual analog scale (VAS), and objective parameters such as acoustic rhinometry, peak nasal inspiratory flow (PNIF), and nasal secretion weight, were used to assess the effectiveness of AIT. The results of the study demonstrated a statistically significant reduction in TNSS (p<0.005) after one year of AIT, indicating the positive impact of the treatment on nasal symptoms. There was a high reduction in nasal symptoms observed using other objective parameters (PNIF, nasal secretion, acoustic rhinometry-MCA). These findings suggest the potential of AEC as a valuable tool for data collection, proof-of-concept studies, and biomarker analysis. "The study findings demonstrate that the Allergen Exposure Chamber (AEC) challenge is consistent and safe, allowing researchers to collect data quickly and of high quality. Moreover, the results indicate that the clinical measurements obtained in the AEC align well with the effectiveness evaluation using the Combined Symptom and Medication Score (CSMS) in real-life conditions. This suggests that the AEC could serve as an alternative to traditional trial designs. Specifically, the Total Nasal Symptom Score (TNSS) measured in the AEC is identified as a reliable primary endpoint in clinical trials. However, nasal provocation tests (NPT) may not be suitable as a primary endpoint since they do not correlate well with CSMS in real-life conditions and TNSS in the AEC", says Professor Marek Jutel from Wroclaw. The researchers emphasize the importance of further validating clinical endpoints using immunological biomarkers for the continued development and application of AEC in clinical trials. The study also suggests that accelerated dose escalation of native HDM AIT is both safe and convenient. A movie on Allergen Chamber test is available here: In conclusion, the study confirms that the allergen exposure chamber challenge is an effective, reproducible, and safe method for assessing the outcomes of HDM AIT in patients with allergic rhinoconjunctivitis. Ongoing research is being conducted to validate clinical endpoints using immunological biomarkers, offering promising prospects for improved diagnostic and treatment approaches. About EAACI: The European Academy of Allergy and Clinical Immunology (EAACI) is an association of clinicians, researchers and allied health professionals founded in 1956. EAACI is dedicated to improving the health of people affected by allergic diseases. With more than 15 000 members from 125 countries and over 75 National Allergy Societies, EAACI is the primary source of expertise in Europe and worldwide for all aspects of allergy. Contact: EAACI Headquarters, Hagenholzstrasse 111, 3rd Floor 8050 Zurich, CH- Switzerland Tel: +41799561865 [email protected] Logo: SOURCE EAACI