Phuong Christina, Maibach Howard I
a University of California, Department of Dermatology , Surge Building Room 110, 90 Medical Center Way, San Francisco, CA 94143-0989, USA +1 415 673 9690 ; +1 415 673 3533 ;
Expert Opin Investig Drugs. 2015;24(11):1483-91. doi: 10.1517/13543784.2015.1081382. Epub 2015 Sep 28.
Dermatology is a relatively small field concerned with conditions of the hair, skin, nails and their related diseases; yet there is considerable active research and development within the field. Pharmaceutical companies seek more effective treatments through various therapeutic classes and delivery routes. However, 28 drugs have been discontinued for the treatment of dermatologic diseases in 2014.
Herein, the authors summarize the details about each discontinued drug in 2014. The dermatological conditions covered are: psoriasis, eczema, leg ulcers, wounds, allergies, acne, scleroderma, lupus erythematosus, urticaria, mastocytosis, epidermolysis bullosa, onychomycosis and one other unspecified disease. The authors also provide suggestions for improving and accelerating the future of dermatological drug development.
It is clear that improved metrics, especially for early assessment, emphasizing clinical relevance, are necessary to increase success rate. Transparency and clear communication within the field is necessary to reduce and salvage the waste that accumulates from these costly studies. Focused attention on how preclinical and early clinical studies failed to indicate subsequent toxicity profiles in patients would accelerate drug development. Distinguishing between disappointing study results and business/financial factors is important when analyzing discontinuations. A reformed approach toward study design would aid both. Ultimately, relevance and practicality for the patient must be kept in mind at all times.
皮肤病学是一个相对较小的领域,关注头发、皮肤、指甲及其相关疾病;然而该领域仍有大量积极的研究与开发工作。制药公司通过各种治疗类别和给药途径寻求更有效的治疗方法。然而,2014年有28种治疗皮肤病的药物已停止使用。
在此,作者总结了2014年每种停用药物的详细信息。所涵盖的皮肤病状况包括:银屑病、湿疹、腿部溃疡、伤口、过敏、痤疮、硬皮病、红斑狼疮、荨麻疹、肥大细胞增多症、大疱性表皮松解症、甲癣以及另一种未明确说明的疾病。作者还为改善和加速未来皮肤病药物研发提供了建议。
显然,为提高成功率,需要改进衡量标准,尤其是用于早期评估的标准,并强调临床相关性。该领域内的透明度和清晰沟通对于减少和挽救这些成本高昂的研究中积累的浪费是必要的。集中关注临床前和早期临床研究未能表明患者后续毒性特征的情况将加速药物研发。在分析药物停用情况时,区分令人失望的研究结果与商业/财务因素很重要。对研究设计进行改革的方法将对两者都有帮助。最终,必须始终牢记对患者的相关性和实用性。