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新基银屑病口服药物Otezla长期用药疗效及安全性良好

  1. apremilast
  2. Otezla
  3. 新基
  4. 银屑病

来源:生物谷 2015-03-30 09:24

Otezla是20年来批准的首个口服药物,销售峰值超过20亿美元。此次公布的数据进一步支持了Otezla在银屑病长期治疗中的疗效和安全性。

2015年3月25日讯 /生物谷BIOON/ --生物技术巨头新基(Celgene)近日在美国旧金山举行的美国皮肤病学会(AAD)第73届年会上公布了银屑病重磅口服药物Otezla(apremilast)III期临床项目ESTEEM的长期疗效和安全性分析数据。来自ESTEEM-1研究长达2年(104周)的长期安全性数据与Otezla临床项目已报道的数据一致,未出现新的安全信号。而来自ESTEEM-2研究的数据显示,Otezla治疗16周时所取得的指甲、头皮、掌跖(手足)银屑病严重程度的显著改善,在整个52周均得以维持。

研究人员表示,在银屑病的临床治疗中,长期疗效和安全性数据至关重要,因为患者可能在整个一生都要跟疾病作斗争。而此次公布的长达2年的安全性以及疗效数据,证实Otezla能够为银屑病难治症状提供长期的缓解,该药对于寻求不同治疗选择的患者提供一个重要的治疗选择。

Otezla是一种首创的口服、选择性磷酸二酯酶4(PDE4)抑制剂,于2014年底和2015年初分别获美欧监管机构批准用于活动性银屑病关节炎(PsA)和中度至重度斑块型银屑病(plaque psoriasis)的治疗。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,该药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。

目前,新基也正在开发Otezla用于其他疾病的治疗,包括活动性Behcet疾病(III期)和溃疡性结肠炎(II期)。新基预计将在今年底提交Otezla的额外监管申请。新基表示,进一步的标签扩展将推动Otezla的销售,预计该药在2017年的销售额将达到15-20亿美元。

银屑病(psoriasis)是一种由不受控免疫反应导致的皮肤慢性炎症性疾病,欧洲患者总数约为1400万例,全球患者总数超过1.25亿例。斑块型银屑病(plaque psoriasis)是最常见的疾病形式,约占银屑病病例的80%。约30%的银屑病患者可能发展为银屑病关节炎(PsA)。

Otezla(apremilast)是一种口服小分子磷酸二酯酶(PDE4)抑制剂,在细胞内调控促炎症和抗炎介质的网络。PDE4是一种环磷酸腺苷(cAMP)特异性PDE,是炎性细胞中主要的PDE。PDE4抑制可提升细胞内cAMP水平,通过调控TNF-α、IL-23和其他炎性细胞因子的表达相应下调炎性反应。cAMP升高也会增加抗炎细胞因子,例如IL-10。(生物谷Bioon.com)

英文原文:Oral OTEZLA? (apremilast) Long-Term Safety and Efficacy Data in Patients with Moderate to Severe Plaque Psoriasis Presented at AAD

Improvements in the severity of preexisting nail, scalp and palmoplantar psoriasis achieved at week 16 were maintained in OTEZLA responders through week 52 in ESTEEM 2

OTEZLA improved the severity of palmoplantar psoriasis at week 16 in a subset of patients across three trials

Long-term safety profile for up to 104 weeks in ESTEEM 1 was consistent with previously reported data from OTEZLA clinical trial programs, with no new safety signals and no clinically meaningful changes in laboratory values

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) today announced that results from long-term efficacy and safety analyses of the ESTEEM phase III clinical trial program of Otezla? (apremilast) were presented at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco, California. OTEZLA is the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4) approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for the treatment of adults with active psoriatic arthritis.

In ESTEEM 1 and 2, patients were randomized to treatment with OTEZLA 30 mg twice daily or placebo for the first 16 weeks. At week 16, patients either continued on OTEZLA or were switched from placebo to OTEZLA 30 mg twice daily through week 32. Patients initially randomized to OTEZLA who achieved a Psoriasis Area and Severity Index (PASI)-75 response (ESTEEM 1) or PASI-50 response (ESTEEM 2) at week 32 were then re-randomized to either OTEZLA 30 mg twice daily or placebo.

"Long-term data are critical in psoriasis, since patients may deal with this disease throughout their lives," said Jeffrey Crowley, M.D., Bakersfield Dermatology, Bakersfield, CA. "Having two-year safety results along with data showing that OTEZLA can provide long-term improvements in difficult-to-treat symptoms can be helpful for dermatologists and patients who are looking for different treatment options."

ESTEEM 2: 52-Week Data Observed in Patients with Nail, Scalp and Palmoplantar Involvement

An analysis of data from ESTEEM 2 presented at AAD showed sustained improvements at week 52 among PASI-50 responders (patients who achieved a 50 percent reduction in PASI at week 32) in difficult-to-treat areas such as nails, scalp and the palms of the hands and soles of the feet (known as palmoplantar psoriasis).

Among patients who had nail psoriasis at baseline with a Nail Psoriasis Severity Index (NAPSI) greater than or equal to one, 45 percent (78/175) of those treated with OTEZLA 30 mg twice daily had at least a 50 percent improvement in NAPSI (NAPSI-50) at week 16, compared with 19 percent (17/91) of those treated with placebo (P < 0.0001). NAPSI-50 achievement was generally maintained for up to 52 weeks in patients (69 percent, n=35) who received OTEZLA at baseline who were PASI-50 responders.

Of those patients who had moderate to very severe scalp psoriasis at baseline, 41 percent (72/176) of those treated with OTEZLA 30 mg twice daily had a Scalp Physician Global Assessment (ScPGA) score of clear (zero) or minimal (one) at week 16, compared with 17 percent (16/93) of those treated with placebo (P < 0.0001). ScPGA score of zero or one achievement was generally maintained for up to 52 weeks in patients (63 percent, n=32) who received OTEZLA at baseline who were PASI-50 responders.

Among patients who had moderate to severe psoriasis on their palms and feet at baseline, 65 percent (17/26) of those treated with OTEZLA 30 mg twice daily had a Palmoplantar Psoriasis Physician Global Assessment (PPPGA) score of clear (zero) or almost clear (one) at week 16, compared with 31 percent (5/16) of those treated with placebo (P=0.0315). PPPGA score of zero or one achievement was sustained up to week 52 (n=4 of 4 patients) in patients randomized to OTEZLA who were PASI-50 responders at week 32.

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