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關于重度哮喘<\/u><\/b><\/p> \n

哮喘是一種異質性疾病，據估計影響全球約3.39億人23<\/sup>。其中，高達10%的哮喘患者為重度哮喘24,25<\/sup>。盡管已使用吸入糖皮質激素（ICS）、現有的生物制劑及口服糖皮質激素（OCS）等藥物治療，仍有許多重度哮喘患者的病情未能得到有效控制24-26<\/sup>。由于重度哮喘的復雜性，許多患者的炎癥驅動因素不明確或存在多種誘因，這可能導致其不符合現有生物制劑的適用條件，或對其治療反應不佳25-28<\/sup>。<\/p> \n

由于頻繁的急性發作、肺功能嚴重受限以及生活質量的下降，患者面臨沉重的疾病負擔24,25,29<\/sup>。同時，重度哮喘患者死亡風險更高，且哮喘相關住院風險是持續性哮喘患者的2倍30-32<\/sup>。此外，重度哮喘相關醫療費用約占哮喘患者醫療總成本的50%，為社會帶來沉重的經濟負擔33<\/sup>。<\/p> \n

關于慢性鼻竇炎伴鼻息肉<\/u><\/b><\/p> \n

慢性鼻竇炎伴鼻息肉（CRSwNP）是以鼻腔黏膜持續性炎癥伴良性息肉形成為特征的復雜炎癥性疾病8,9<\/sup>。鼻息肉及其相關炎癥可阻塞鼻腔通道，導致呼吸困難、嗅覺障礙、鼻分泌物增多、面部疼痛及睡眠障礙，嚴重影響生活質量34,35<\/sup>。<\/p> \n

上皮功能障礙和炎癥是慢性鼻竇炎的重要特征，會損害上皮組織作為物理及免疫屏障抵御外界的能力36,37<\/sup>。胸腺基質淋巴細胞生成素（TSLP）是一種上皮細胞因子，通過作用于炎癥級聯反應上游，在重度哮喘及慢性鼻竇炎伴鼻息肉的共同發病機制中發揮關鍵作用36,37<\/sup>。<\/p> \n

現有慢性鼻竇炎伴鼻息肉（CRSwNP）治療手段包括鼻內\/系統性糖皮質激素治療、手術及生物制劑治療9,35,38-43<\/sup>。<\/p> \n

關于<\/u><\/b>DIRECTION III<\/u><\/b>期研究<\/u><\/b><\/p> \n

DIRECTION研究是一項在亞洲進行的多中心、隨機、雙盲、安慰劑對照的III期臨床研究，旨在評估特澤利尤單抗在重度哮喘控制不佳的成年受試者中的有效性和安全性1<\/sup>。該研究共納入包含中國（65家醫院）、韓國（8家醫院）和菲律賓（3家醫院），共計400例年齡在18~80歲范圍內的重度、未控制哮喘患者（未限制基線生物標志物水平），按1:1比例隨機分配，接受每4周皮下注射1次特澤利尤單抗210mg（n=201）或安慰劑（n=199）治療，持續52周1<\/sup>。<\/p> \n

關于<\/u><\/b>WAYPOINT III<\/u><\/b>期研究<\/u><\/b><\/p> \n

WAYPOINT研究是一項雙盲、多中心、隨機、安慰劑對照、平行分組的III期臨床研究，旨在評估特澤利尤單抗在重度慢性鼻竇炎伴鼻息肉（CRSwNP）成人患者中的療效和安全性2,3,44<\/sup>。受試者通過皮下注射方式接受特澤利尤單抗或安慰劑治療。完成52周治療期的受試者還將進入12至24周的治療后隨訪期2,44<\/sup>。<\/p> \n

該研究的共同主要終點為：通過內鏡鼻息肉總評分評估的鼻息肉總體積較基線變化，以及通過患者鼻息肉癥狀日記中作為組成部分的患者自我報告鼻雍阻癥狀評分評估的雙周鼻雍阻均值較基線變化2,44<\/sup>。關鍵次要終點包括：嗅覺喪失評分、評估疾病相關健康生活質量的SNOT-22評分、Lund-Mackay評分、鼻息肉手術決策時間、系統性糖皮質激素使用時間、癥狀日記總癥狀評分以及合并哮喘患者第52周支氣管擴張前第一秒用力呼氣量FEV12,44<\/sup>。<\/p> \n

關于特澤利尤單抗<\/u><\/b><\/p> \n

特澤利尤單抗是由阿斯利康與安進合作開發的全球首創（first-in-class）人源單克隆抗體，可抑制胸腺基質淋巴細胞生成素（TSLP）的活性。TSLP是一種位于多個炎癥級聯反應上游的關鍵上皮細胞因子，在重度哮喘、慢性鼻竇炎伴鼻息肉（CRSwNP）及其他炎癥性疾病相關的過敏性、嗜酸細胞性及上皮驅動型炎癥的啟動和持續過程中具有核心作用36,37<\/sup>。<\/p> \n

多種與哮喘、慢性鼻竇炎伴鼻息肉（CRSwNP）、慢性阻塞性肺疾病（COPD）、嗜酸性粒細胞性食管炎（EoE）等疾病相關的環境觸發因素（包括過敏原、病毒和其他大氣顆粒物等）會刺激上皮細胞釋放TSLP37,45<\/sup>。此類患者體內TSLP表達水平升高，且與疾病嚴重程度相關22,35<\/sup>。<\/p> \n

特澤利尤單抗一次性預充注射器和自動注射器已獲美國、歐盟批準，供患者自我給藥20-22<\/sup>。自2021年起，逾10萬名重度哮喘患者已使用特澤利尤單抗治療46<\/sup>。<\/p> \n

除重度哮喘、慢性鼻竇炎伴鼻息肉（CRSwNP）以外，特澤利尤單抗還在開發用于慢性阻塞性肺疾病（COPD）和嗜酸性粒細胞性食管炎（EoE）47,48<\/sup>。2021年10月，特澤利尤單抗獲美國食品藥品監督管理局（FDA）授予治療嗜酸性粒細胞性食管炎（EoE）的孤兒藥資格認定（Orphan Drug Designation）49<\/sup>。<\/p> \n

阿斯利康與安進的合作<\/u><\/b><\/p> \n

2012年安進與阿斯利康簽署的特澤利尤單抗合作協議目前已經進行修訂。根據協議，阿斯利康在向安進支付中度個位數百分比專利費后，雙方將繼續平攤成本與利潤。阿斯利康負責藥物全球開發，安進負責生產管理。所有合作事項由聯合治理機構監督執行。根據協議，安進和阿斯利康在美國共同商業化特澤利尤單抗。美國市場銷售額計入安進報表，阿斯利康則將其在美國的利潤分成記入合作收入項。在美國以外地區，阿斯利康記錄產品銷售額，安進則將利潤分成記入其他\/合作收入項。<\/p> \n

關于阿斯利康呼吸及自體免疫治療領域<\/u><\/b><\/p> \n

呼吸與自體免疫是阿斯利康生物制藥業務的重要組成部分，是公司聚焦的關鍵疾病領域和業務增長的主要驅動力。<\/p> \n

阿斯利康是呼吸領域的領先企業，深耕呼吸領域50多年，在免疫疾病領域也擁有日益豐富的產品線。公司致力于通過對吸入制劑、生物制劑和針對全新靶點的新療法的管線開發和產品組合，來滿足慢性且具有衰竭性特征的疾病領域的巨大未滿足需求。我們的目標是提供改變患者生命的藥物，幫助消除慢性阻塞性肺病這一主要死亡原因，消除哮喘發作，并實現免疫介導疾病的臨床緩解。<\/p> \n

關于阿斯利康<\/u><\/b><\/p> \n

阿斯利康（LSE\/STO\/NYSE: AZN）是一家科學至上的全球生物制藥企業，專注于研發、生產及營銷處方類藥品，重點關注腫瘤、罕見病以及包括心血管腎臟及代謝、呼吸及免疫在內的生物制藥等領域。阿斯利康全球總部位于英國劍橋，業務遍布超過125個國家，創新藥物惠及全球數百萬患者。更多信息，請訪問www.astrazeneca.com<\/a>或在社交平臺關注@AstraZeneca。<\/p> \n

參考文獻：<\/b><\/p> \n

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