新基口服银屑病药物Otezla疗效媲美安进Enbrel

生物技术巨头新基（Celgene）近日在美国旧金山举行的第73届美国皮肤病学会（AAD）年会上公布了银屑病重磅口服药物Otezla（apremilast）IIIb期临床试验LIBERATE的最新数据。研究结果显示，Otezla用于治疗中度至重度斑块型银屑病（plaque psoriasis）时，疗效媲美安进的重磅注射型药物Enbrel（恩利，2013年销售额达83亿美元）。

　　该研究在250例既往未接受任何生物制剂治疗的中度至重度斑块型银屑病患者中开展，评估了口服Otezla（30mg，每日2次）和每周一次皮下注射Enbrel（etanercept，50mg）相对于安慰剂的疗效。数据显示，采用银屑病面积及严重程度指数-75（PASI-75）评估，在研究的16周，Otezla治疗组（n=33/83，40%）和Entrel治疗组（n=40/83，48%）与安慰剂组（n=10/84，12%）相比均表现出统计学意义的显著改善（P＜0.0001）。

　　一项事后分析显示，在研究的16周，Otezla疗效媲美Enbrel，2者无显著性差异。在研究的32周，相比16周Otezla治疗组有更高比例的患者实现PASI-75缓解（53% vs 40%）；此外，Enbrel治疗组在16周转向Otezla治疗后，在研究的32周，也有更高比例的患者实现PASI-75缓解（61% vs 48%）。

　　Otezla是一种首创的口服、选择性磷酸二酯酶4（PDE4）抑制剂，该药是过去20年中获批用于银屑病治疗的首个口服药物，也是过去15年中获批用于银屑病关节炎的首个口服药物。在相关临床试验中，Otezla已被证明能够使患者病情取得具有临床意义的显著持久改善，将为广泛的银屑病患者群体提供了一种有价值的治疗选择，包括以前使用过生物制剂或常规系统性药物治疗的患者群体。

Enbrel（恩利，通用名：Etanercept，依那西普）是安进（Amgen）经生物工艺生产、由人p75肿瘤坏死因子受体与人免疫球蛋白G1的Fc端连接组成的二聚体融合蛋白，该药是全球首个全人源化的、第一个用于治疗类风湿关节炎和强直性脊柱炎的可溶性肿瘤坏死因子拮抗剂。除治疗类风湿关节炎和强直性脊柱炎外，该药还已批准用于银屑病性关节炎、幼年慢性关节炎和银屑病的治疗。

英文原文：Celgene Corporation Psoriasis Drug Otezla As Effective As Amgen, Inc. Enbrel In Trial

Celgene announced positive safety and efficacy results from its Phase III study of Otezla for the treatment of moderate-to-severe plaque psoriasis

Celgene Corporation (NASDAQ:CELG) announced positive results for its psoriasis drug Otezla from a late-stage trial evaluating the drug’s efficacy in treating patients suffering from moderate-to-severe plaque psoriasis.

This brings good news for patients suffering from psoriasis, an immune-mediated chronic inflammatory skin disorder, recurring and non-contagious in nature. Plaque psoriasis constitutes the most common form of psoriasis; 80% of psoriasis patients develop plaque psoriasis. The disease currently affects an estimated 125 million people worldwide, with almost equal incidence rate in both genders.

Celgene’s Otezla works by inhibiting phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP), resulting in raised cAMP levels in the bloodstream. This is believed to regulate the formation of inflammatory immune-mediators as a result.

The positive results came from an ongoing final-stage LIBERATE trial, a Phase IIIb randomized, placebo-controlled study aimed at evaluating the safety and effectiveness of Otezla in patients with moderate-to-severe plaque psoriasis. The study, with a total of 250 treatment-naïve patients, compared the effects on twice-daily 30 mg oral Otezla-treated patients, weekly 50 mg subcutaneous (SC) etanercept-treated patients, and placebo-treated patients at week 16. Otezla’s major competitor, Amgen, Inc.’s (NASDAQ:AMGN) Enbrel, known by its chemical name etanercept, is an injectable drug commonly used to treat autoimmune diseases.

The study most significantly also attempted to evaluate the relative safety of switching etanercept-treated patients to Otezla after week 16.According to the results, at week 16, around 40% of the patients treated with Otezla 30 mg twice daily achieved a Psoriasis Area and Severity Index (PASI)-75 score — a 75% improvement in psoriasis — compared to 12% for patients given placebo.

In addition, the study revealed that a similar PASI-75 score was reached at week 16 by 48% of the patients treated with weekly injections of 50 mg etanercept, compared to 12% for placebo-treated patients. The study, however, was not designed to directly compare Otezla to Amgen’s Enbrel (etanercept).

Further analysis showed that among patients treated with Otezla from the start, a greater percentage of the patients (53%) achieved PASI-75 score by week 32, compared to 40% in week 16. Similarly, among patients switched to Otezla from etanercept at week 16, 61% achieved a PASI-75 score at week 32, compared to 48% in week 16. No safety issues emerged during the switch from etanercept to Otezla after week 16.

The LIBERATE study provided similar safety and tolerability results for Otezla, as reported from previous six final-stage Otezla studies performed in patients with psoriatic arthritis or psoriasis. Only 5% of Otezla-treated patients reported adverse effects including diarrhea, vomiting, nausea, and headache.< magnesium ascorbyl phosphate

Kristian Reich, MD, at SCIderm Research Institute and Dermatologikum Hamburg in Germany, stated regarding the trial results: “The positive results from a third OTEZLA phase III psoriasis trial demonstrating efficacy and consistent safety of OTEZLA through 32 weeks further supports the potential for this therapy to have an impact on the needs of patients suffering from this chronic and debilitating disease.”

Celgene has already received the US Food and Drug Administration’s approval for Otezla in March 2014, for the treatment of active psoriatic arthritis in adults. In September 2014, Otezla was approved for expanded use in treating moderate-to-severe plaque psoriasis in patients who are eligible for systematic therapy. The recent results will prove to further strengthen the drug’s capability via expanded indication that is expected to come soon, further bolstering the growth for the company in 2015 and beyond.

In addition, Otezla was also granted approval by the European Commission in January this year for the treatment of moderate-to-severe plaque psoriasis in patients who are found to be immune to other systematic therapies.

来源生物谷：http://news.bioon.com/article/6667389.html