维莫德吉（ERIVEDGE）妊娠预防计划：风险意识评估。

Vismodegib (ERIVEDGE) pregnancy prevention programme: assessment of risk awareness.

机构信息

F. Hoffmann-La Roche, Basel, Switzerland.

出版信息

J Dermatolog Treat. 2022 Feb;33(1):466-472. doi: 10.1080/09546634.2020.1770166. Epub 2020 Jun 1.

DOI:10.1080/09546634.2020.1770166

PMID:32406291

Abstract

INTRODUCTION

Vismodegib (Erivedge; Roche), a Hedgehog pathway inhibitor (HPI), is indicated for the treatment of symptomatic metastatic basal cell carcinoma (BCC) and locally advanced BCC inappropriate for surgery or radiotherapy. Due to the known risk of HPI teratogenicity, the Erivedge Pregnancy Prevention Program (PPP) was introduced at approval (2013) as part of the EU Risk Management Plan.

METHODS

Structured, quantitative Web-based surveys were conducted in 2015 (Wave 1), 2016 (Wave 2), and 2017/2018 (Wave 3) among prescribing oncologists and dermato-oncologists in Austria, France, Germany, Hungary, and the United Kingdom to assess the effectiveness of the Erivedge PPP.

RESULTS

Overall, 95%, 87%, and 91% of respondents in Waves 3 ( = 181), 2 ( = 214), and 1 ( = 207), respectively, were vismodegib prescribers. The surveys consistently showed a high awareness about the risk of teratogenicity associated with vismodegib (98%, Wave 3; 95%, Wave 2) and that a high proportion of prescribing physicians took appropriate precautions to minimize this risk (95%, Wave 3; 92%, Wave 2; 88%, Wave 1). Physicians were also highly aware of the Erivedge PPP (70%, Wave 3; 67%, Wave 2; 71%, Wave 1).

CONCLUSION

Survey data suggest that the risk of teratogenicity with vismodegib has been effectively communicated to the prescribing community.

摘要

简介

维莫德吉（Erivedge；罗氏），一种 Hedgehog 通路抑制剂（HPI），被批准用于治疗有症状的转移性基底细胞癌（BCC）和不适合手术或放疗的局部晚期 BCC。由于已知 HPI 的致畸风险，Erivedge 妊娠预防计划（PPP）在批准时（2013 年）作为欧盟风险管理计划的一部分推出。

方法

在 2015 年（第 1 波）、2016 年（第 2 波）和 2017/2018 年（第 3 波）期间，在奥地利、法国、德国、匈牙利和英国的处方肿瘤学家和皮肤肿瘤学家中进行了结构化、定量的网络调查，以评估 Erivedge PPP 的有效性。

结果

在第 3 波（ = 181）、第 2 波（ = 214）和第 1 波（ = 207）中，分别有 95%、87%和 91%的受访者为维莫德吉处方医生。调查结果一致表明，医生高度意识到与维莫德吉相关的致畸风险（第 3 波 98%；第 2 波 95%），且很大比例的处方医生采取了适当的预防措施来尽量降低这种风险（第 3 波 95%；第 2 波 92%；第 1 波 88%）。医生也高度了解 Erivedge PPP（第 3 波 70%；第 2 波 67%；第 1 波 71%）。