AbbVie (NYSE: ABBV) today announced positive topline results from its Phase 3 TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant (QULIPTA® / AQUIPTA®, 60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100 mg/day) in adult patients with a history of four or more migraine days per month

艾伯维 (NYSE: ABBV) 今天宣布了其 3 期 TEMPLE 多中心、随机、双盲、头对头研究的积极顶线结果，该研究评估了 atogepant (QULIPTA ® / AQUIPTA ®，60 毫克，每日一次) 与最高耐受剂量托吡酯 (50、75 或 100 毫克/天) 相比在每月偏头痛发作天数为四天或以上的成年患者中的耐受性、安全性和有效性。

The study met the primary endpoint of treatment discontinuation due to adverse events (AEs), demonstrating that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, had fewer discontinuations due to AEs than topiramate, an anticonvulsant medication also approved for migraine prevention. Over the 24-week double-blind treatment period, discontinuation due to AEs was significantly lower with atogepant (12.1%) compared to topiramate (29.6%), representing a relative risk of 0.41 (95% CI: 0.28, 0.59; p<0.0001).

该研究达到了因不良事件 (AE) 导致的治疗停药这一主要终点，表明降钙素基因相关肽 (CGRP) 受体拮抗剂阿托吉潘 (atogepant) 因 AE 导致的停药率低于托吡酯（一种同样获批用于预防偏头痛的抗惊厥药物）。在 24 周的双盲治疗期间，阿托吉潘 (atogepant) 因 AE 导致的停药率 (12.1%) 显著低于托吡酯 (29.6%)，相对风险为 0.41 (95% CI: 0.28, 0.59; p<0.0001) 。

The study also met all six secondary endpoints, including a key measure of clinical efficacy: 64.1% of patients on atogepant achieved a ≥50% reduction in mean monthly migraine days (MMD) during months 4 to 6 of the double-blind treatment period compared to 39.3% of patients on topiramate (p<0.0001).1

该研究还达到了所有六个次要终点，包括一项关键的临床疗效指标：在双盲治疗期间的第 4 至 6 个月内，64.1% 的 Atogepant 组患者平均每月偏头痛天数 (MMD) 减少 ≥50%，而托吡酯组患者这一比例仅为 39.3% (p<0.0001) 。

"These TEMPLE data affirm recommendations from the American Headache Society and International Headache Society, highlighting the role of CGRP pathway inhibitors as first-line preventive treatment options for migraine," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "This study demonstrates our commitment to improving treatment options and advancing care standards for people living with this debilitating disease."

艾伯维研发执行副总裁兼首席科学官Roopal Thakkar医学博士表示：“TEMPLE 的这些数据印证了美国头痛学会和国际头痛学会的建议，凸显了 CGRP 通路抑制剂作为偏头痛一线预防治疗方案的作用。这项研究表明了我们致力于改善治疗方案，并提升偏头痛这一致残疾病患者的护理标准。”

Migraine continues to be underdiagnosed and undertreated, despite significant burden on patients' lives.2 It is a complex neurological disease that affects approximately 14% of the global population and ranks as the second leading cause of disability worldwide.2 Despite its prevalence and disabling impact, there are numerous gaps in patient care related to the standards for preventive treatment. Notably, over 50% of people currently using preventive medications still qualify for further preventive treatment, indicating that their current therapies may not be providing sufficient relief.

偏头痛给患者的生活带来沉重负担，但其诊断和治疗仍然不足。2 偏头痛 是一种复杂的神经系统疾病，影响着全球约 14% 的人口，是全球第二大致残原因。2尽管偏头痛普遍存在且具有致残性，但在患者护理方面，与预防性治疗标准相关的问题仍然存在诸多差距。值得注意的是，目前使用预防性药物的患者中，超过 50% 仍有资格接受进一步的预防性治疗，这表明他们目前的疗法可能无法提供足够的缓解。

"Far too often, people living with migraine struggle with meeting their treatment goals despite available and accessible preventive options," said Jaclyn Duvall, M.D., neurologist and founder of Headache Specialists of Oklahoma. "The TEMPLE data provide a patient-centered measure of treatment effectiveness by capturing both efficacy and tolerability, representing a meaningful way to evaluate the real-world impact of treatment persistence in migraine prevention."

俄克拉荷马州头痛专家协会创始人、神经病学家Jaclyn Duvall医学博士表示：“尽管存在各种可用的预防方案，偏头痛患者仍常常难以达到治疗目标。TEMPLE数据通过记录疗效和耐受性，提供了一种以患者为中心的治疗效果衡量标准，为评估坚持治疗对偏头痛预防的现实影响提供了一种有意义的方法。”

The AE profile of atogepant observed in this active-controlled study was generally consistent with its established safety profile from prior studies.

在本项活性药物对照研究中观察到的 atogepant 不良事件概况与先前研究确定的安全性概况基本一致。

Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries. Atogepant is a once-daily oral CGRP receptor antagonist, proven to prevent both episodic and chronic migraine in adults.

Atogepant 已在 60 个国家/地区获批，在欧盟以AQUIPTA ®的商品名上市，在美国、加拿大、以色列和波多黎各以 QULIPTA ® 的商品名上市。Atogepant 是一种每日一次口服的 CGRP 受体拮抗剂，经证实可预防成人发作性和慢性偏头痛。TEMPLE 研究的完整结果将在即将召开的医学会议上公布。

About the TEMPLE Study

关于TEMPLE研究

TEMPLE is a Phase 3, multicenter, randomized, double-blind, active-controlled trial evaluating the tolerability, safety, and efficacy of atogepant versus topiramate in adult patients with a history of four or more migraine days per month. The trial randomized 545 participants with episodic or chronic migraine aged 18 and older across 73 sites in Europe, Israel and Canada.

TEMPLE是一项3期多中心、随机、双盲、阳性药对照试验，旨在评估阿托吉潘特对比托吡酯在每月偏头痛发作天数≥4天的成年患者中的耐受性、安全性和有效性。该试验在欧洲、以色列和加拿大的73个研究中心随机分组了545名18岁及以上发作性或慢性偏头痛患者。

The study was conducted in two distinct periods. In the initial 24-week Double-Blind Treatment Period, which included a 6-week up-titration phase and an 18-week maintenance phase, participants were randomized to receive either atogepant (60 mg once daily) or the highest tolerated dose of topiramate (ranging from 50 to 100 mg/day). Following this, eligible participants continued into a 52-week Open-Label Treatment Period, during which all received atogepant (60 mg once daily). Throughout the study, patient reported outcomes were regularly collected and patients were continuously monitored for safety and tolerability through clinical assessments and lab tests.

该研究分为两个不同的阶段进行。在最初的24周双盲治疗期（包括6周的剂量递增阶段和18周的维持期）中，受试者随机分配接受阿托吉潘特（60毫克，每日一次）或最高耐受剂量的托吡酯（50至100毫克/天）。之后，符合条件的受试者继续进入为期52周的开放标签治疗期，在此期间所有受试者均接受阿托吉潘特（60毫克，每日一次）治疗。在整个研究过程中，我们定期收集患者报告的治疗结果，并通过临床评估和实验室检测持续监测患者的安全性和耐受性。

The primary endpoint was the percentage of patients who discontinued the study treatment due to AEs during the 24-week double-blind treatment period. An electronic diary (eDiary) was used to collect data on headache frequency, duration, symptoms, acute medication use, and various patient-reported outcomes.

主要终点是24周双盲治疗期间因不良事件（AE）而停止研究治疗的患者百分比。使用电子日记（eDiary）收集头痛频率、持续时间、症状、急性用药情况以及患者报告的各种结局数据。

About Atogepant

关于 Atogepant

Atogepant is a once-daily orally administered CGRP receptor antagonist specifically developed for the preventive treatment of migraine in adults. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks. Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries.

Atogepant 是一种每日一次口服的降钙素基因相关肽 (CGRP) 受体拮抗剂，专门用于预防成人偏头痛。CGRP 及其受体在与偏头痛病理生理相关的神经系统区域表达。研究表明，偏头痛发作期间 CGRP 水平会升高。Atogepant在欧盟以AQUIPTA®为商品名上市，在美国、加拿大、以色列和波多黎各以QULIPTA® 为商品名上市，已在 60 个国家/地区获批。