NEJM:可恢复80%头发生长,FDA批准首款口服抗脱发新药上市

2022-06-17 王聪 “生物世界”公众号

斑秃平均发病年龄在25至35岁之间,但它也会影响老年人、儿童和青少年,并且在男女和所有种族中都可见。斑秃与许多患者的健康相关生活质量差有关,这些患者可能遭受严重的心理障碍,包括抑郁和焦虑。

当地时间2022年6月13日,美国食品和药物管理局(FDA)批准了礼来和 Incyte 公司开发的用于治疗成人斑秃的口服药物 JAK 抑制剂巴瑞替尼(baricitinib)。这也是 FDA 首次批准治疗斑秃的全身性系统疗法(而非身体的特定部位)。

斑秃是一种以斑片状脱发为特征的自身免疫性疾病,是全球发病率第二高的脱发症状,仅次于雄性激素性脱发。斑秃是由于免疫细胞攻击健康毛囊导致的头皮、脸部或身体其他部分的毛发部分或完全脱落。

斑秃平均发病年龄在25至35岁之间,但它也会影响老年人、儿童和青少年,并且在男女和所有种族中都可见。斑秃与许多患者的健康相关生活质量差有关,这些患者可能遭受严重的心理障碍,包括抑郁和焦虑。然而,至今还没有经过 FDA 批准的治疗斑秃的药物或疗法。

2022年3月26日,《新英格兰医学杂志》(NEJM)发表了题为:Two Phase 3 Trials of Baricitinib for Alopecia Areata 的临床试验论文。

该论文公布了两项治疗严重斑秃的3期临床试验结果,该临床试验旨在验证由礼来/Incyte开发的口服 JAK 抑制剂巴瑞替尼(Baricitinib)治疗严重斑秃的效果和安全性。

结果显示,在治疗后第36周,4mg剂量组近4成患者的脱发状况从平均85%以上减少到了20%以下。也就是近4成患者恢复80%的头发。

研究团队进行了两项随机、安慰剂对照的3期临床试验,BRAVE-AA1 和 BRAVE-AA2,前者654名患者参与,后者546名患者参与。参与者均为严重斑秃的成年人,斑秃及脱发程度评分为50-100之间(平均为85.5),分数代表脱发部位占据头皮总面积的百分比,0代表不脱发,100代表完全脱发。也就是说这些患者的头发平均已不足15%。患者分别接受每天 4mg Baricitinib 治疗、每天 2mg Baricitinib 治疗,以及安慰剂。

在治疗的36周时,评估这两组患者的斑秃及脱发程度评分。

BRAVE-AA1 组的4mg剂量治疗的患者的斑秃及脱发程度评分低于20的患者比例为38.8%,2mg剂量治疗的患者的斑秃及脱发程度评分低于20的患者比例为22.8%,安慰剂组则仅为6.2%。

BRAVE-AA2 组的数据分别为35.9%(4mg剂量治疗)、19.4%(2mg剂量治疗)和3.3%(安慰剂)。

在BRAVE-AA1组中,4mg Baricitinib治疗与安慰剂之间的差异为32.6%,2mg Baricitinib治疗与安慰剂之间的差异为16.6%。在BRAVE-AA2组中,相应差异为32.6%和16.1%。

这两项3期临床数据显示,4mg Baricitinib治疗让近4成严重斑秃患者的头发恢复到80%以上的状态,效果显着。与安慰剂相比,Baricitinib治疗的常见副作用有痤疮、肌酸激酶水平升高以及低密度和高密度脂蛋白胆固醇水平升高。

一名几乎完全脱发的女性接受每天4mg Baricitinib治疗,8个月后,其头发几乎完全恢复

在此之前,2021年8月4日,辉瑞公司宣布其开发的斑秃治疗的小分子药物Ritlecitinib 在2b/3期临床试验中获得积极顶线结果。

在这项2b/3期临床试验中,30mg和50mg剂量的 Ritlecitinib 均达到了改善头皮毛发再生的主要疗效终点。治疗6个月后,头皮毛发脱落≤20%的患者比例显着性高于安慰剂组。

这项随机、安慰剂对照、双盲临床试验,共有718位12岁及以上的斑秃患者参与,这些斑秃患者头皮脱发均在50%以上,且斑秃症状至少半年以上。患者随机分配到四组,分别是 Ritlecitinib 50mg、30mg、10mg,以及安慰剂组。主要终点是根据第24周时头皮毛发脱落≤20%的患者比例。其中30mg和50mg剂量的 Ritlecitinib 均达到了改善头皮毛发再生的主要疗效终点。

Ritlecitinib,是由辉瑞公司开发的是一款 JAK3/TEC 抑制剂,它能够抑制 IL-15 和 CD8 细胞因子信号转导,这两个细胞因子是驱动免疫系统杀伤毛囊细胞的重要因素。Ritlecitini 在之前的2期临床试验效果明显,已经获得 FDA 突破性疗法认定。该创新疗法目前已经开始在中国开展临床研究。该疗法还在进行白斑病、类风湿性关节炎、克罗恩病和溃疡性结肠炎相关研究。

原始出处:

Brett King, et al. Two Phase 3 Trials of Baricitinib for Alopecia Areata. N Engl J Med 2022; 386:1687-1699.

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    2022-10-10 lifestar

    美国食品和药物管理局(#FDA#)批准了礼来和 Incyte 公司开发的用于治疗成人#斑秃#的口服药物 #JAK 抑制剂##巴瑞替尼##baricitinib#)。这也是 FDA 首次批准治疗斑秃的全身性系统疗法(而非身体的特定部位)。

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    2022-12-20 bugit
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    2022-06-28 翠花儿

    希望

    0

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    2022-06-17 docwu2019
  6. [GetPortalCommentsPageByObjectIdResponse(id=2092798, encodeId=81082092e98f3, content=美国食品和药物管理局(<a href='/topic/show?id=f336e29134' target=_blank style='color:#2F92EE;'>#FDA#</a>)批准了礼来和 Incyte 公司开发的用于治疗成人<a href='/topic/show?id=015c5e95173' target=_blank style='color:#2F92EE;'>#斑秃#</a>的口服药物 <a href='/topic/show?id=7fa8104913ea' target=_blank style='color:#2F92EE;'>#JAK 抑制剂#</a><a href='/topic/show?id=00664830602' target=_blank style='color:#2F92EE;'>#巴瑞替尼#</a>(<a href='/topic/show?id=e55a3203bc' target=_blank style='color:#2F92EE;'>#baricitinib#</a>)。这也是 FDA 首次批准治疗斑秃的全身性系统疗法(而非身体的特定部位)。, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=1, topicName=null, topicId=null, topicList=[TopicDto(id=7291, encryptionId=f336e29134, topicName=FDA), TopicDto(id=57951, encryptionId=015c5e95173, topicName=斑秃), TopicDto(id=104913, encryptionId=7fa8104913ea, topicName=JAK 抑制剂), TopicDto(id=48306, encryptionId=00664830602, topicName=巴瑞替尼), TopicDto(id=3203, encryptionId=e55a3203bc, topicName=baricitinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aa0e14, createdName=lifestar, createdTime=Mon Oct 10 05:37:51 CST 2022, time=2022-10-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839977, encodeId=405d18399e742, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Dec 20 13:52:51 CST 2022, time=2022-12-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1229256, encodeId=1d761229256ee, content=希望, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20211112/17b0be30a74d42c89f200ee2cf7cf0cb/a565c8b8745c4282bfc5ddd00b38b4fa.jpg, createdBy=e9365684696, createdName=翠花儿, createdTime=Tue Jun 28 20:43:05 CST 2022, time=2022-06-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1676937, encodeId=6c3a16e6937fe, content=<a href='/topic/show?id=086d586212a' target=_blank style='color:#2F92EE;'>#新药上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58621, encryptionId=086d586212a, topicName=新药上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=39db27401213, createdName=zchen, createdTime=Tue Jan 24 07:52:51 CST 2023, time=2023-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1468619, encodeId=314014686190b, content=<a href='/topic/show?id=7f7f443337a' target=_blank style='color:#2F92EE;'>#头发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44333, encryptionId=7f7f443337a, topicName=头发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Fri Jun 17 01:52:51 CST 2022, time=2022-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1243763, encodeId=be7c1243e63ec, content=NEJM上果然牛,感谢梅斯更新及时, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=小元, createdTime=Wed Jun 15 13:52:51 CST 2022, time=2022-06-15, status=1, ipAttribution=)]
    2022-06-15 小元

    NEJM上果然牛,感谢梅斯更新及时

    0

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