优特克单抗获准用于治疗银屑病性关节炎

杨森生物技术公司9月23宣布，人白介素-12(IL-12)和白介素-23(IL-23)拮抗剂优特克单抗(ustekinumab)已获准用于治疗成人活动性银屑病性关节炎。

新适应症的用法用量为单独或与甲氨蝶呤联用， 0周、4周及此后每12周皮下注射45 mg；对于伴有中至重度斑块型银屑病且体重>220磅的患者，推荐剂量为90 mg，0周、4周及此后每12周皮下注射。

优特克单抗于2009年获准用于治疗银屑病，由杨森生物技术公司以商品名Stelara上市。据该公司声明，优特克单抗是首个IL-12和IL-23靶向药物。

本批准令是基于2项多中心随机双盲对照III期临床研究结果。研究比较了优特克单抗与安慰剂治疗927例活动性银屑病性关节炎患者的情况，这些患者无论此前是否接受传统药物治疗，其压痛关节和肿胀关节数量均≥5个，C-反应蛋白质(CRP)水平≥0.3 mg/dL。主要终点指标为24个月时 ACR 20应答率。

在第1项试验(PSUMMIT 1)中， 45 mg和90 mg剂量组患者24周ACR 20应答率分别为42%和50%，而安慰剂组为23%。此外，45 mg和90 mg剂量组患者PASI(银屑病面积和严重指数)75应答率分别为57%和62%，而安慰剂组为11%。

在第2项试验(PSUMMIT II)中，45 mg和90 mg剂量组患者达到主要终点指标的比例均为44% ，而安慰剂组为20%。相似，45 mg和90 mg剂量组患者PASI 75应答率分别为51%和56%，而安慰剂组为5%。

PSUMMIT 1研究结果6月13日在线发表在《柳叶刀》杂志上(doi:10.1016/S0140-6736[13]60594-2)。

优特克单抗说明书“警告和注意事项”中包括了与治疗有关的严重感染和其他风险信息。

可点击下载最新修订的优特克单抗说明书。

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By: ELIZABETH MECHCATIE, Internal Medicine News Digital Network

Ustekinumab, a human interleukin-12 and -23 antagonist, has been approved for the treatment of adults with active psoriatic arthritis, the manufacturer has announced.

The approved indication is for use alone or in combination with methotrexate, in the form of a 45-mg subcutaneous injection at weeks 0 and 4, and then every 12 weeks. For patients with coexistent moderate-to-severe plaque psoriasis who weigh more than 220 pounds, the recommended dose is a 90-mg subcutaneous injection at weeks 0 and 4, and then every 12 weeks.

Ustekinumab, approved for treating psoriasis in 2009, is marketed as Stelara by Janssen Biotech, which announced the approval in a press release on Sept. 23. Ustekinumab is the first treatment targeting the cytokines interleukin-12 and interleukin-23, according to the statement.

Approval was based on the results of two phase III multicenter, randomized double-blind studies comparing ustekinumab to placebo in 927 patients with active psoriatic arthritis, with at least five tender and five swollen joints and a C-reactive protein (CRP) level of at least 0.3 mg/dL, despite previous treatment with conventional therapy. The primary endpoint was the ACR 20 response at 24 weeks.

In the first trial, PSUMMIT 1, 42% of those on the 45-mg dose and 50% of those on the 90-mg dose achieved an ACR 20 at 24 weeks, vs. 23% of those on placebo. In addition, 57% of those on the 45-mg dose and 62% of those on the 90-mg dose achieved a PASI (Psoriasis Area and Severity Index) 75 response, vs. 11% of those on placebo.

In the second study, PSUMMIT II, 44% of those on a 45-mg dose and 44% of those on a 90-mg dose met the primary endpoint, vs 20% of those on placebo. Also, 51% of those on the 45-mg dose and 56% of those on the 90-mg dose achieved a PASI 75 response, vs. 5% of those on placebo.

The results of the PSUMMIT 1 study were published online in the Lancet on June 13 (doi:10.1016/S0140-6736[13]60594-2).

The warnings and precautions section of the ustekinumab label includes information about the risk of serious infections and other risks associated with treatment.

The updated label is available here.