中轴型脊柱关节炎 (axSpA) 是一类以慢性炎症性背痛为特征的长期炎症性疾病，根据X射线检测结果可以分成：放射学阴性中轴型脊柱关节炎 (nr-axSpA，即X射线下尚不可见结构损伤) 和强直性脊柱炎 (AS，X射线下已可见结构损伤) 两种。这两种疾病的症状负担相似，包括夜间疼痛、疲劳、晨僵和功能性致残。
近日，诺华公布了有关PREVENT研究的最新积极数据。该研究评估了司库奇尤单抗（俗称“苏金单抗”）在放射学阴性中轴型脊柱关节炎 (nr-axSpA) 患者治疗中的疗效和安全性，该研究达到了16周主要临床终点（即ASAS40应答率）以及所有次要终点。
结果显示，相较于安慰剂组，接受司库奇尤单抗治疗的患者其疾病活动度被显著降低，结果具有临床学意义。司库奇尤单抗在该研究中体现了良好的安全性，与既往临床研究一致1,7,8,9。
目前，诺华已向欧洲药品管理局 (EMA) 递交了nr-axSpA的新适应症申请。同时，PREVENT研究的52周数据有望在今年晚些时候公布，届时将用于支持向美国食品药品监督管理局 (FDA) 递交的新适应症申请。
“诺华在强直性脊柱炎领域积累了长期经验。在此基础上，这些研究成果将推动我们向更新治疗方案迈进，帮助中轴型脊柱关节炎患者更早实现疾病缓解。如果获批，这将成为司库奇尤单抗在全球范围内获批的第4个适应症。”
——
John Tsai医学博士
诺华全球药品开发负责人兼首席医务官
此次研究数据是对现有证据的补充，进一步证实了司库奇尤单抗是一种适用于中轴型脊柱关节炎、银屑病关节炎和银屑病相关疾病的综合疗法，快速起效、持续获益，拥有超过100项真实世界研究支持，迄今已惠及全球逾25万患者10,11。更多详细数据将在未来的科学会议上予以发布。
关于PREVENT研究
PREVENT是一项正在进行中的、为期两年的随机、双盲、安慰剂对照III期研究（含2年延长期），旨在评估司库奇尤单抗在活动性放射学阴性中轴型脊柱关节炎 (nr-axSpA) 患者中的疗效和安全性。该研究共纳入555名男性和女性nr-axSpA成年患者（发病年龄小于45岁、脊柱疼痛VAS评分≥40/100、Bath强直性脊柱炎活动性指数 (BASDAI) ≥4) ，同时这些患者在研究开始前已服用了至少两种非甾体抗炎药 (NSAID) 的最高剂量达4周，或已接受一种（不超过一种）TNF抑制剂治疗但应答不佳。在555名入组患者中，501名 (90%) 患者未接受过生物制剂治疗。患者被分为三个治疗组：负荷给药皮下注射司库奇尤单抗150mg（诱导期：皮下注射司库奇尤单抗150mg/周，共4周，随后维持期司库奇尤单抗150mg/月）；司库奇尤单抗150mg无负荷给药（皮下注射司库奇尤单抗150mg/月）；或安慰剂（诱导期为每周皮下注射，共4周，随后每月一次维持治疗）1。
该研究主要终点为司库奇尤单抗150mg治疗第16周和第52周达到ASAS40应答的患者比例。次要终点包括BASDAI随时间的变化，以及基于C反应蛋白 (CRP) 计算的强直性脊柱炎疾病活动度评分 (ASDAS-CRP) 的变化1。
ASAS40应答指以下方面至少3项基于百分制量表达到40%改善、或者改善幅度至少为10个单位：患者整体评估、疼痛评估、功能（Bath强直性脊柱炎功能指数，简称BASFI）和炎症（晨僵严重程度和持续时间）。BASDAI 从以下6个方面评估患者疾病活动程度：疲劳、脊柱疼痛、关节疼痛/肿胀、附着点炎、晨僵持续时间和晨僵严重程度11。
关于司库奇尤单抗
司库奇尤单抗是目前首个也是唯一一个可直接抑制白介素-17A (IL-17A) 的全人源生物制剂。白介素-17A (IL-17A) 是参与银屑病关节炎 (PsA)、银屑病 (PsO) 和强直性脊柱炎 (AS) 炎症产生及疾病进展的核心细胞因子2,12。
司库奇尤单抗拥有有力的临床证据支持，包含银屑病、银屑病关节炎和强直性脊柱炎三大适应症的5年数据以及真实世界证据6,7,8,13-22。这些数据进一步强化了司库奇尤单抗作为银屑病、银屑病关节炎及强直性脊柱炎的综合治疗方案，快速起效、持续获益。自上市以来，司库奇尤单抗已惠及全球逾25万患者10。
* 强直性脊柱炎、银屑病关节炎及放射学阴性中轴型脊柱关节炎适应症尚未在中国大陆获批。
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