AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA).1 This comes after the European Commission recently granted marketing authorization of RINVOQ for the treatment of GCA in adult patients.

艾伯维 (NYSE: ABBV) 今天宣布，美国食品药品监督管理局 (FDA) 已批准 RINVOQ® ( upadacitinib)，15 毫克，每日一次，用于治疗成人巨细胞动脉炎 (GCA)。1此前，欧盟委员会最近已批准 RINVOQ 用于治疗成人 GCA。

The approvals are supported by results of the pivotal Phase 3 SELECT-GCA clinical trial, which met the primary endpoint of sustained remission* (46.4% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission from week 12 to week 52, compared to 29.0% of patients receiving placebo in combination with a 52-week steroid taper regimen; p=0.002).

此项批准基于关键性 III 期 SELECT-GCA 临床试验的结果，该试验达到了持续缓解的主要终点*（接受 RINVOQ 15 毫克联合 26 周类固醇减量方案治疗的患者中，46.4% 的患者从第 12 周到第 52 周达到持续缓解，而接受安慰剂联合 52 周类固醇减量方案治疗的患者中，这一比例为 29.0%；p=0.002）。

During the 52-week, placebo-controlled period, the safety profile of RINVOQ was generally consistent with that observed in other approved indications.

在 52 周的安慰剂对照期内，RINVOQ 的安全性与其他获批适应症的安全性基本一致。

"This FDA approval will now provide an alternative treatment option that can offer patients with GCA the possibility of tapering off steroids and achieving sustained remission," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "With this new indication for RINVOQ, we are underscoring AbbVie's commitment to exploring how we can identify and address unmet needs for patients with immune-mediated diseases."

艾伯维研发执行副总裁兼首席科学官Roopal Thakkar医学博士表示：“FDA 的批准将为巨细胞动脉炎 (GCA) 患者提供一种替代治疗方案，帮助他们逐渐减少类固醇用量，并实现持续缓解。RINVOQ获批这一新适应症，彰显了艾伯维致力于探索如何识别和满足免疫介导疾病患者未满足需求的承诺。”

GCA is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries. If left untreated, the disease can lead to debilitating symptoms and potentially severe outcomes, such as blindness, aortic aneurysm, or stroke.2 Caucasian women over the age of 50 – most commonly between the ages of 70 and 80 years – have the highest risk of developing GCA. Although women are more likely than men to develop GCA, research suggests that men are more likely to have ocular manifestations with their disease.

巨细胞动脉炎 (GCA) 是一种自身免疫性疾病，会导致颞动脉、其他脑动脉、主动脉以及其他大中动脉的炎症。如果不及时治疗，该疾病可能导致严重的症状，甚至可能导致失明、主动脉瘤或中风等严重后果。2 50 岁以上（最常见于 70 至 80 岁）的白人女性 患 GCA 的风险最高。尽管女性比男性更容易患 GCA，但研究表明，男性更容易在患病的同时出现眼部症状。

"Glucocorticoids remain a mainstay of treatment of GCA but lead to substantial drug-associated toxicities. Additionally, relapse remains common for patients with this disease," said Peter A. Merkel, M.D., MPH, chief of rheumatology at the University of Pennsylvania, Philadelphia, and SELECT-GCA trial investigator. "We now have a new option to treat GCA. The results of this clinical trial show that upadacitinib offers patients the chance to reach sustained remission."

宾夕法尼亚大学费城分校风湿病学主任、SELECT-GCA 试验研究者Peter A. Merkel博士（医学博士、公共卫生硕士）表示：“糖皮质激素仍然是巨细胞动脉炎 (GCA) 的主要治疗方法，但会导致严重的药物相关毒性。此外，复发仍然是该病患者的常见症状。我们现在有了治疗 GCA 的新选择。这项临床试验的结果表明，upadacitinib 为患者提供了达到持续缓解的机会。”

RINVOQ SAFETY CONSIDERATIONS RINVOQ may cause serious side effects, including: Serious infections. RINVOQ can lower ability to fight infections. Serious infections, some fatal, occurred, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses. Increased risk of death in people age 50+ with at least 1 heart disease risk factor. Cancer and immune system problems. Increased risk of some cancers, including lymphoma and skin. Current or past smokers have higher risk for lymphoma and lung cancer. Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50+ with at least 1 heart disease risk factor, especially in current or past smokers. Blood clots, some fatal, in veins of the legs or lungs and arteries. This occurred more often in people 50+ with at least 1 heart disease risk factor. Serious allergic reactions. Do not take if allergic to RINVOQ or its ingredients. Tears in the stomach or intestines; changes in certain laboratory test results. *Sustained remission was defined as having an absence of GCA signs and symptoms from week 12 through week 52 and adherence to the protocol-defined corticosteroid taper regimen.

RINVOQ 安全注意事项 RINVOQ 可能会引起严重的副作用，包括： 严重感染。RINVOQ可能会降低抵抗感染的能力。一些严重感染甚至可能致命，包括结核病 (TB) 以及由细菌、真菌或病毒引起的感染。 50 岁以上且至少有 1 种心脏病风险因素的人死亡风险增加。 癌症和免疫系统问题。某些癌症的风险增加，包括淋巴瘤和皮肤癌。目前或过去吸烟者患淋巴瘤和肺癌的风险更高。 对于年龄 50 岁以上且至少具有 1 种心脏病风险因素的人群，发生心脏病发作、中风或死亡等重大心血管事件的风险会增加，尤其是目前或过去吸烟的人。 腿部静脉、肺部和动脉出现血栓，有些甚至致命。这种情况在50岁以上且至少存在1种心脏病风险因素的人群中更常见。 严重过敏反应。如果您对 RINVOQ 或其成分过敏，请勿服用。 胃或肠撕裂；某些实验室测试结果发生变化。 *持续缓解的定义是从第 12 周到第 52 周没有出现 GCA 体征和症状，并且遵守方案定义的皮质类固醇减量方案。

About SELECT-GCA

关于 SELECT-GCA

SELECT-GCA (M16-852) is a Phase 3, multicenter, randomized, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib (RINVOQ) in 428 patients with GCA. The study consists of two periods. The first period, previously reported in April 2024, evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen compared to placebo in combination with a 52-week corticosteroid taper regimen. In addition, the study assessed the safety and tolerability of upadacitinib in these patients. The second period will evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in the first period.1 For more information regarding this study, please visit ClinicalTrials.gov (Identifier NCT03725202).

SELECT-GCA (M16-852) 是一项 3 期、多中心、随机、双盲、安慰剂对照研究，旨在评估 upadacitinib (RINVOQ) 对 428 名 GCA 患者的安全性和有效性。该研究分为两个阶段。第一阶段先前于2024 年 4 月报告，评估了 upadacitinib 联合 26 周皮质类固醇减量方案与安慰剂联合 52 周皮质类固醇减量方案的疗效对比。此外，该研究还评估了 upadacitinib 对这些患者的安全性和耐受性。第二阶段将评估在第一阶段获得持续缓解的参与者中继续使用和停用 upadacitinib 在维持缓解方面的安全性和有效性。1有关 本研究的更多信息，请访问 ClinicalTrials.gov（标识符 NCT03725202）。