Uceris获准用于诱导溃疡性结肠炎缓解

圣路易斯(MD Consult)——2013年1月14日，Santarus宣布美国食品药品管理局(FDA)已批准Uceris(布地奈德)缓释片用于诱导活动性轻至中度溃疡性结肠炎(UC)患者的缓解。

Uceris片芯含有布地奈德和聚合物，后者可使关键成分缓慢释放。布地奈德是一种合成的皮质类固醇。

为支持这项批准，在共计970例活动性轻至中度UC成人患者中进行了2项类似设计的随机、双盲、安慰剂对照研究。2项研究均对Uceris 9 mg和6 mg与安慰剂进行了比较，并包括活性对照组(研究1为2.4 g美沙拉明；研究2为未获准用于治疗UC的9 mg布地奈德)。主要终点为治疗8周后缓解诱导作用。两项研究均表明，Uceris 9 mg缓释片的诱导缓解作用均优于安慰剂。

与Uceris相关的最常见不良反应包括头痛、恶心、血液皮质醇水平下降、上腹疼痛、乏力、胃肠气胀、腹胀、痤疮、尿路感染、关节痛以及便秘。

Uceris说明书中包含了有关使用Uceris时发生肾上腺皮质功能亢进、肾上腺抑制以及免疫抑制风险的警告和注意事项内容。当患者由较大全身效应的糖皮质激素治疗转为较小全身效应的治疗时(如 Uceris)，可出现肾上腺功能损害风险。若转换用药，在开始服用Uceris之前，应缓慢降低以前服用的糖皮质激素剂量。

这次获准的成人患者给药方案为每日早晨口服1片9 mg片剂，持续8周。Santarus公司预计在2013年3月上市销售Uceris。

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ST LOUIS (MD Consult) - On January 14, 2013, Santarus announced that the US Food and Drug Administration has approved Uceris (budesonide) extended-release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC).

The Uceris tablet core contains budesonide with polymers that provide for extended release of the the key ingredient. Budesonide is a synthetic corticosteroid.

To support this approval, 2 similarly-designed, randomized, double-blind, placebo-controlled studies were conducted in a total of 970 adult patients with active, mild to moderate UC. Both studies compared the use of Uceris 9 mg and 6 mg with placebo and included an active reference arm (mesalamine 2.4 g in study 1; and budesonide 9 mg not approved for the treatment of UC in study 2). The primary end point was induction of remission after 8 weeks of treatment. In both studies, Uceris 9 mg extended-release tablets demonstrated superiority to placebo in inducing remission.

The most common adverse reactions associated with Uceris use include headache, nausea, decreased blood cortisol levels, upper abdominal pain, fatigue, flatulence, abdominal distension, acne, urinary tract infection, arthralgia, and constipation.

The Uceris label contains Warnings and Precautions concerning the risks of hypercorticism and adrenal suppression as well as immunosuppression when using Uceris. A risk of impaired adrenal function exists when therapy with higher systemic effects of glucocorticoid treatment is changed to therapy that involves lower systemic effects (ie, Uceris). During such a transition, dosing of the previous glucocorticoid should be slowly tapered before starting Uceris.

The approved dosing regimen for adult patients is one 9 mg tablet taken orally once daily in the morning for up to 8 weeks. Santarus expects to commence the commercial launch of Uceris in March 2013.