FDA批准ILUMYA扩大适应症：可治疗成人活动性银屑病关节炎，美国约240万患者
美国食品药品监管局（FDA）已批准 ILUMYA（tildrakizumab-asmn）的补充生物制品许可申请，将这款白细胞介素-23（IL-23）抑制剂的适用范围扩大到成人活动性银屑病关节炎。生产商 Sun Pharma 10月30日宣布了这一消息。
银屑病关节炎是一种与免疫系统相关的慢性疾病，可造成关节肿胀、疼痛和僵硬，严重时可导致永久性关节损伤；据 Sun Pharma 估计，约240万美国人患有此病，约三分之一的银屑病患者同时患有银屑病关节炎，另有超过15%的银屑病患者可能尚未确诊。ILUMYA 此前已于2018年获 FDA 批准，用于适合系统治疗或光疗的成人中重度斑块状银屑病。
批准的依据是两项三期临床研究 INSPIRE-1 与 INSPIRE-2：两项研究均为52周、全球多中心、随机、双盲、安慰剂对照试验，评估 ILUMYA 100毫克制剂在成人活动性银屑病关节炎患者中的疗效与安全性，以第24周达到 ACR20 应答（关节症状改善至少20%）为主要终点，两项研究均达标，且仅两次给药后即在第24周显示疗效。研究未发现新的安全信号，安全性与该药既有记录一致。
ILUMYA 的一个特点是只能由医护人员在诊所注射给药。Sun Pharma 北美首席执行官 Rick Ascroft 说：「FDA 批准 ILUMYA 用于成人活动性银屑病关节炎，是 Sun Pharma 又一个重要的创新药物里程碑，也建立在 ILUMYA 在斑块状银屑病领域已积累的临床经验之上。」参与两项研究的 Philip Mease（Swedish Medical Center 风湿病临床研究主任）说，银屑病关节炎病情复杂、病程漫长，临床需要多种治疗选择以按每位患者的症状和目标个体化治疗，多一款由医护人员给药的 IL-23 抑制剂，给了医生新的方式。
公司同时提示，ILUMYA 可能增加感染风险，开始治疗前应评估结核感染；银屑病关节炎患者中发生率不低于3%的最常见不良反应为上呼吸道感染与新冠感染。
FDA Approves ILUMYA for Adults With Active Psoriatic Arthritis, Expanding the Drug Beyond Plaque Psoriasis
The U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for ILUMYA (tildrakizumab-asmn), expanding the interleukin-23 (IL-23) inhibitor to the treatment of adults with active psoriatic arthritis. Sun Pharma announced the approval on October 30.
Psoriatic arthritis is a chronic, immune-related disease that causes joint swelling, pain and stiffness and can lead to permanent joint damage. Sun Pharma estimates that about 2.4 million Americans live with the disease; roughly one in three people with psoriasis also has psoriatic arthritis, and more than 15 percent of people with psoriasis may have undiagnosed psoriatic arthritis. ILUMYA was first approved by the FDA in 2018 for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The approval is supported by the Phase 3 INSPIRE-1 and INSPIRE-2 studies, two 52-week, global, multicenter, randomized, double-blind, placebo-controlled trials of ILUMYA 100 mg in adults with active psoriatic arthritis. Both studies met their primary endpoint of ACR20 response at week 24, showing efficacy after only two doses, and identified no new safety signals, with safety consistent with the drug's established profile.
ILUMYA is administered exclusively by a healthcare provider. 'FDA approval of ILUMYA for adults with active psoriatic arthritis represents another important innovative medicine milestone for Sun Pharma and builds on the established clinical experience of ILUMYA in plaque psoriasis,' said Rick Ascroft, North America CEO for Sun Pharma. Philip Mease, director of rheumatology research at Swedish Medical Center in Seattle and lead investigator on the trials, said psoriatic arthritis is a complex and chronic disease and clinicians need a range of options to individualize care, and that a provider-administered IL-23 inhibitor gives them a new way to support patients.
The company noted that ILUMYA may increase the risk of infection and that patients should be evaluated for tuberculosis before starting treatment. The most common adverse reactions in psoriatic arthritis (at least 3 percent) were upper respiratory tract infections and COVID-19.
来源：GSM·美国（原文链接）
图片来源：图：美国食品药品监管局（FDA）白橡树园区一号大楼。照片：美国食品药品监管局／Wikimedia Commons（公共领域）
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