食品药品监管局批准艾伯维SKYRIZI皮下诱导方案：克罗恩病患者可在家启动治疗
艾伯维（AbbVie，NYSE: ABBV）10月23日在伊利诺伊州 North Chicago 宣布，美国食品药品监管局（FDA）已批准 SKYRIZI（risankizumab-rzaa）的皮下注射诱导方案，用于治疗成人中重度活动性克罗恩病。获批后，患者可选择在家启动治疗：诱导期用贴身注射器（OBI）给药，进入维持期后继续用同一装置每八周注射一次。
新方案的诱导剂量为 720 毫克，分别在第 0、2、4、8 周经贴身注射器皮下给药；患者也可以选择原有静脉方案（600 毫克，第 0、4、8 周）。维持治疗从第 12 周开始，每八周一次。SKYRIZI 是一种白细胞介素-23（IL-23）抑制剂，此前已获批用于中重度活动性溃疡性结肠炎、斑块状银屑病、银屑病关节炎与克罗恩病。
批准依据是三期 AFFIRM 研究：共 274 名中重度活动性克罗恩病患者按 2 比 1 随机分组。在第 12 周，皮下 SKYRIZI 组临床缓解率为 56%、安慰剂组为 30%，内镜应答率为 43% 对 15%，两项共同主要终点均显著优于安慰剂。此前未经历过进阶治疗失败的患者效果更明显：临床缓解率 74% 对 27%，内镜应答率 60% 对 15%。公司称，皮下诱导的安全性与该药在克罗恩病中的已知安全性一致，未见新的安全风险。
艾伯维执行副总裁兼首席科学官 Roopal Thakkar 说，克罗恩病患者需要从一开始就能有效控制病情的治疗，皮下诱导获批在保持疗效的同时，让患者和医生在如何启动治疗上有了更大的灵活性。AFFIRM 研究主要研究者、北卡罗来纳大学教堂山分校胃肠与肝病科主任 Millie D. Long 说，这项批准回答了患者关心的第二个问题——治疗如何融入生活：患者现在可以在家启动治疗，并以同样方式进入维持期。
FDA 同时批准更新 SKYRIZI 全部适应症的美国处方信息：将结核病（TB）相关警告改为由医疗提供者根据临床判断决定是否需要做结核检测，启动治疗前不再强制要求结核检测。克罗恩病是一种累及消化道的慢性炎症性疾病，最常见于小肠末端与结肠，症状包括持续腹泻与腹痛，病情可随时间进展。
FDA Approves Subcutaneous Induction for AbbVie's SKYRIZI in Crohn's Disease, Letting Patients Start Treatment at Home
AbbVie (NYSE: ABBV) announced in North Chicago, Illinois, on October 23 that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) induction regimen for SKYRIZI (risankizumab-rzaa) for adults with moderately to severely active Crohn's disease. Patients can now choose to start treatment at home, with induction doses delivered by an on-body injector (OBI), and then continue with the same device once every eight weeks for maintenance.
The SC induction regimen is 720 mg given by OBI at weeks 0, 2, 4 and 8; patients can also choose the existing intravenous option of 600 mg at weeks 0, 4 and 8. Maintenance dosing begins at week 12, once every eight weeks. SKYRIZI is an interleukin-23 (IL-23) inhibitor already approved for moderately to severely active ulcerative colitis, plaque psoriasis, psoriatic arthritis and Crohn's disease.
The approval rests on the Phase 3 AFFIRM study, which randomized 274 patients with moderately to severely active Crohn's disease 2-to-1. At week 12, clinical remission was 56% on SC SKYRIZI versus 30% on placebo, and endoscopic response was 43% versus 15%, meeting both co-primary endpoints. Results were strongest in patients without prior advanced therapy failure, with clinical remission of 74% versus 27% and endoscopic response of 60% versus 15%. AbbVie said the safety profile of SC induction was generally consistent with the known profile in Crohn's disease, with no new safety risks identified.
Roopal Thakkar, AbbVie's executive vice president for research and development and chief scientific officer, said people living with Crohn's disease need treatments that deliver meaningful disease control from the start, and that subcutaneous induction gives patients and physicians greater flexibility in how treatment is initiated. Millie D. Long of the University of North Carolina at Chapel Hill, the lead investigator of AFFIRM, said the approval answers the second question patients ask — how treatment fits into their lives — since patients can now start at home and continue the same way through maintenance.
The FDA also approved an update to the SKYRIZI U.S. prescribing information across all indications, revising the tuberculosis (TB) language so healthcare providers use clinical judgment when determining whether TB testing is needed; there is no mandatory TB test before starting SKYRIZI. Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract, most commonly affecting the area between the small intestine and the colon, causing persistent diarrhea and abdominal pain and worsening over time.
来源：GSM·美国（原文链接）
图片来源：艾伯维位于伊利诺伊州 North Chicago 的园区入口（资料图，右侧可见 AbbVie 标识）。照片：LittleT889 摄，CC BY 4.0，经维基共享资源／Entrance to AbbVie's North Chicago, Illinois campus (file photo). Photo: LittleT889, CC BY 4.0, via Wikimedia Commons
