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奥马珠单抗治疗慢性自发性荨麻疹在华获批,开启生物制剂治疗新时代

2022-04-14 诺华 诺华

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2022414日,诺华(中国)今日宣布,其创新生物制剂茁乐®(奥马珠单抗)获得国家药品监督管理局批准,用于治疗采用H1抗组胺药治疗后仍有症状的成人和青少年(12岁及以上)慢性自发性荨麻疹患者。这也是目前我国唯一批准用于治疗慢性自发性荨麻疹的生物制剂。

诺华制药(中国)总裁张颖表示:茁乐®慢性自发性荨麻疹适应症的获批是诺华在皮科领域的又一次创新探索。相信这一前沿疗法将为中国广大慢性自发性荨麻疹患者带去健康希望。未来,我们还将在这一疾病领域继续深耕,将更多创新治疗方案带到中国,为中国患者的美好生活保驾护航。

症状烦、易反复、难控制,慢性自发性荨麻疹疾病负担沉重,困扰女性及青少年尤甚

荨麻疹是由于皮肤、黏膜小血管扩张及渗透性增加后出现的一种局限性水肿反应,临床表现为大小不等的风团伴瘙痒,约20%的患者伴有血管性水肿。虽症状常见于皮肤,但荨麻疹绝不是简单的皮肤病。病情严重者可伴有发热、恶心、呕吐、腹痛、腹泻等全身症状,若累及喉头或心脏可出现胸闷、气喘、呼吸困难等症状,严重的喉头水肿甚至会发生窒息进而危及生命。荨麻疹可根据持续时间、是否有特定诱因等因素进一步分型。其中,风团每天发作或间歇发作、持续时间>6周且诱因不明的荨麻疹被称为慢性自发性荨麻疹

慢性自发性荨麻疹是一常见病,属于变态反应性(又称过敏性)炎症性疾病的范畴。虽然医学界一直在努力寻找其过敏原,但真正找到食入、吸入性过敏原的很少。上海交通大学医学院附属瑞金医院终身教授、中华医学会皮肤性病学分会前任主任委员郑捷教授表示:经典教科书《希氏内科学》(Cecil Medicine)中说即使将一个荨麻疹患者关在仅有清洁空气的房间,每天仅给予米与水,荨麻疹仍旧发作,说明慢性荨麻疹是自发性的,是机体的内源性过敏而不是外源性

正因为如此,慢性自发性荨麻疹有起因不明、反复发作、迁延不愈的特点。我国有超千万慢性荨麻疹患者,其中约68%为慢性自发性荨麻疹,且女性患者约占六成。患者病程通常为2-5,部分患者病程可达5年以上,某些罕见病例的病程甚至可长达50年之久,严重影响患者生活质量的同时也给他们带来了巨大的身心负担。有研究显示,慢性自发性荨麻疹患者合并精神、过敏及自身免疫性疾病风险高,,超过30%的慢性自发性荨麻疹患者都伴有心理健康损害,出现如焦虑、抑郁和躯体形式障碍等情况。值得注意的是,慢性荨麻疹对女性和青少年患者影响尤其明显。有数据表明,女性慢性荨麻疹患者的平均病程比男性患者长近8个月,因急诊和治疗产生的医疗负担比男性患者更重,且疾病导致的瘙痒、社交尴尬和外貌损伤也使得女性患者生活质量受损程度比男性患者更为严重。在青少年人群中,慢性自发性荨麻疹患者的睡眠障碍、焦虑和抑郁的患病风险是一般人群的3.5倍、1.7倍和1.6倍。

创新疗法全新机制,直击疾病发病源头

在治疗上,抗组胺药物是目前临床上最常用的治疗方案,可以在一定程度上控制症状。但临床中发现,有超过1/2的患者在使用标准剂量抗组胺药治疗后效果不佳,增加剂量后仍有近1/3患者的症状无法被有效控制,未被满足的治疗需求依然巨大。

随着近年来对慢性自发性荨麻疹研究的不断深入,其发病机制已经明确,肥大细胞活化、释放炎症介质、引起复杂炎症反应是核心三部曲。简单来说,肥大细胞就像个装满各种炎症颗粒的盒子,表面插着许多把钥匙(配体)。正常情况下,当有细菌、病毒侵入时,人体免疫系统会启动钥匙打开(激活)肥大细胞这个盒子,通过释放炎症颗粒、产生炎症反应来保护人体安全。但慢性自发性荨麻疹患者因为免疫系统发生紊乱,使得一些钥匙被错误启动,盒子被错误打开,免疫系统攻击人体自身从而导致疾病症状产生。而IgE(免疫球蛋白E)就是其中一把钥匙

此次获批的茁乐®是一种抗IgE人源化单克隆抗体,通过特异性结合血清内游离的IgE、阻断其致炎通路发挥作用。多项研究结果证实了茁乐®在治疗慢性自发性荨麻疹方面的多重获益:

  • 中国III期临床研究显示,在接受300mg茁乐®治疗12周后,75%的患者瘙痒症状得到明显改善,风团数量较基线减少73%,且不良事件和严重不良事件总体发生率及严重程度与安慰剂组相似。
  • 另有多项研究表明*,在使用茁乐®治疗慢性自发性荨麻疹的患者中,最快当天可见症状缓解,,真实世界治疗应答率超90%,可显著改善患者生活质量评分近80%,且在特殊人群(妊娠/哺乳/肝肾损伤患者)中也体现了良好的安全性,,

作为奥马珠单抗慢性自发性荨麻疹中国III期临床研究负责人,郑捷教授对该研究结果表示肯定:“IgE是导致荨麻疹发生的关键致病分子。此次瑞金医院皮肤科在主持针对IgE的特异性抗体奥马珠单抗的III期临床试验中观察到,无论在有效性、安全性、疗效的稳定性与长期性上,该疗法均达到甚至超过预期目标,为慢性自发性荨麻疹患者提供了一种全新的治疗选择。该疗法在欧美国家已成为治疗慢性自发性荨麻疹的常用药物。

2003年海外上市以来,茁乐®已在包括欧盟在内的90多个国家和地区批准用于过敏性哮喘和慢性自发性荨麻疹的治疗。在中国,茁乐®分别于2017年及2018年获得批准,用于治疗成人及6岁以上儿童的中重度过敏性哮喘。

参考资料

1中华医学会皮肤性病学分会荨麻疹研究中心.中华皮肤科杂志.2019;52(1):1-5.

2 Zhao ZT, et al.J Allergy Clin Immunol.2016;137(6):1742-1750.e1744.

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9,Thomsen SF, Pritzier EC, Anderson CD et al. J Eur Acad Dermatol Venereol 2017; 31:1048–55.

10,Gregoriou S, et al.J Cutan Med Surg.2009;13(4):198-203.

11,Broder MS, et al.Am J Clin Dermatol.2015;16(4)313-321.

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15,Yuan W, et al. Dermatol Ther. 2022 Jan 4:e15303.

16,Marcus Maurer,et al. J Allergy Clin Immunol. 2011 Jul;128(1):202-209.e5.

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    2021-11-10 zhaojie88
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    2021-11-10 sodoo
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