AbbVie  announced the FDA has approved Rinvoq

AbbVie 宣布 FDA 已批准 Rinvoq

(upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA).

乌帕达西替尼，15毫克，每日一次，用于治疗成人巨细胞动脉炎（GCA）。

This comes after the

这发生在

European Commission

欧盟委员会

recently granted marketing authorization of Rinvoq  for the treatment of GCA in adult patients.

近日授予Rinvoq用于治疗成年GCA患者的市场授权。

The approvals are supported by results of the pivotal Phase III 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).

批准得到了关键的III期SELECT-GCA临床试验结果的支持，该试验达到了主要终点，即持续缓解（接受15毫克Rinvoq联合26周类固醇减量方案的患者中有46.4%在第12周到第52周期间实现了持续缓解，而接受安慰剂联合52周类固醇减量方案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. Other important secondary endpoints were also achieved including: a) reduction in disease flares (34.3% UPA 15 mg   vs 55.6% PBO); and b) lower cumulative steroid use by 52 weeks (median exposure of 1615 mg versus 2882 mg, respectively; p<0.001).

在为期52周的安慰剂对照期间，Rinvoq的安全性特征总体上与其他已批准适应症中观察到的一致。其他重要的次要终点也已达成，包括：a) 疾病复发减少（UPA 15 mg组为34.3%，安慰剂组为55.6%）；b) 到第52周时累积类固醇使用量较低（中位暴露量分别为1615 mg和2882 mg；p<0.001）。

Results of this trial were recently published in the .

该试验的结果最近发表在 。

New England Journal of Medicine

新英格兰医学杂志

.

。

SELECT-GCA (M16-852) is a Phase III, multicenter, randomized, double-blind placebo-controlled study  designed to evaluate the safety and efficacy of upadacitinib ( Rinvoq) in 428 patients with GCA ((NCT03725202). The study consists of two periods. The first period, previously reported in

SELECT-GCA（M16-852）是一项III期、多中心、随机、双盲、安慰剂对照研究，旨在评估乌帕替尼（Rinvoq）在428名GCA患者中的安全性和有效性（NCT03725202）。该研究包括两个阶段。第一阶段此前已报告于

April 2024

2024年4月

, 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..

，评估了乌帕达西替尼联合26周皮质类固醇减量方案相较于安慰剂联合52周皮质类固醇减量方案的疗效。此外，该研究还评估了乌帕达西替尼在这些患者中的安全性和耐受性。第二阶段将评估继续使用与停用乌帕达西替尼在维持第一阶段达到持续缓解的参与者中的安全性和疗效。

'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 Dr. Roopal Thakkar, executive VP, research and development, CSO, 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.'.

“此次FDA的批准将为GCA患者提供一种替代治疗选择，使他们有可能逐渐减少类固醇用量并实现持续缓解。”艾伯维公司执行副总裁、研发主管兼首席科学官Roopal Thakkar博士表示，“通过RINVOQ的新适应症，我们再次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的未满足需求的承诺。”

'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 Dr. Peter A. Merkel, chief of rheumatology at the University of Pennsylvania, Philadelphia and SELECT-GCA trial investigator. 'We now have a new option to treat GCA.

“糖皮质激素仍然是治疗GCA的主要方法，但会导致显著的药物相关毒性。此外，这种疾病的患者复发仍然很常见，”宾夕法尼亚大学费城分校风湿病科主任、SELECT-GCA试验研究者彼得·A·默克尔博士说道。“我们现在有了治疗GCA的新选择。”

The results of this clinical trial show that upadacitinib offers patients the chance to reach sustained remission.'.

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。

See citation- Blockmans D, Penn SK, Setty AR, Schmidt WA et al.

参见引用- Blockmans D, Penn SK, Setty AR, Schmidt WA 等。

A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis.

乌帕达西替尼治疗巨细胞动脉炎的3期试验。

N Engl J Med.

新英格兰医学杂志。

2025 Apr 2. doi: 10.1056/NEJMoa2413449. Online ahead of print. PMID: 40174237

2025年4月2日。doi: 10.1056/NEJMoa2413449。在线提前发表。PMID: 40174237

Condition:

条件：

Giant Cell Arteritis

巨细胞动脉炎

Type:

类型：

drug

药物