Autoimmune skin diseases are a kind of diseases caused by the immune response to self-antigens, resulting in damages to skin with or without to other tissues and organs. The traditional immunosuppressants exert their curative effect, but accompanied by a wide range of adverse reactions. In-depth understanding of pathogenesis facilitated the development of various cytokine-based therapies or drugs targeting the signaling pathways, which has significantly improved the patient's condition. However, these therapies often require long-term maintenance treatment, and the targeting pathways of many autoimmune skin diseases are still not quite clear. Therefore, emerging therapeutic strategies and innovative drugs are still in need to balance the homeostasis of the immune system and induce the long-term remission of the disease, providing new hope for the treatment of autoimmune skin diseases. This review discusses the development of drugs treating autoimmune skin diseases according to different mechanisms of action and targets.

This study used "microneedles" as the keyword to search for relevant literature in CNKI and PubMed databases from 2017 to 2022. This article reviews the research progress of the carriers of microneedles based on structures, preparation methods, pharmacodynamics and clinical applications. A total of 1 040 valid kinds of literature were retrieved from the two databases. The structure of microneedles can be divided into solid microneedles, coated microneedles, dissolve microneedles, hydrogel microneedles, and hollow microneedles. The microneedles preparation methods involve microcasting, drawing lithography, and 3D printing methods. Some microneedle carrier pharmacodynamics studies include the treatment of skin, metabolic diseases, immune system diseases, and eye diseases. The microneedles' clinical application researches include vaccine, radiofrequency therapy and biological diagnosis. The main direction of future microneedle research is to develop a new transdermal microneedle drug delivery system, which is combined with the new pharmaceutical preparation technology. This study provides reference for further development of microneedle transdermal delivery formulations. The authors expect to provide a reference for the related research on microneedles.

Psoriasis is a chronic immune-mediated inflammatory skin disease. A growing understanding of the mechanism has led to the advent of biological agents that specifically target the cytokines which are involved in the pathogenesis. Because of the significant efficacy with high safety shown in the treatment of psoriasis, biologic agents have becoming more and more usual in clinical practice. Rapid progress in biotechnology allows the development of an increasing number of novel biologic agents, such as biologics targeting existing and promising inflammatory mediators, bispecific agents targeting multiple different antigens and agents including nanobodies and peptides. This review summarizes the current application of biologic agents in clinical practice, new drugs that are under study, potential targets and novel technology of biologics.

Atopic dermatitis is a chronic inflammatory disease of skin that is commonly seen and easy to relapse. Treatments nowadays still have many drawbacks and adverse effects, thus cannot meet the needs of clinicians and patients. In recent years, our expanding knowledge of the complex pathomechanisms of atopic dermatitis has given rise to new interventions of targeted therapy, which will help clinicians better treat and manage the atopic dermatitis. This review summarizes the advances in new medications for pediatric atopic dermatitis.

Model-informed drug development (MIDD) is a major shift of new mode of drug development based on the establishment of PK-PD model using blood concentration- (i.e., exposure, PK) and efficacy/safety (i.e., response, PD)-corresponding data, in order to analyze exposure-response relationship, replace dose-response relationship that is difficult to obtain, and establish the chain of evidence on drug safety and efficacy. The above model can integrate data from in vitro and in vivo, animals and human beings, adults and children, literature and trials, original and new dosage forms, domestic and foreign trials, and other sources to solve a wide range of key clinical problems. It is particularly important to transform the exploration paradigm of new drug development into a model verification mode. Therefore, MIDD is not only related to the change of technical means, but also the integration of multidisciplinary research, as well as a change of research and development strategy and scientific regulatory. It greatly improves the efficiency and success rate of new drug research and development. Based on the summary of MIDD success cases, this paper tries to clarify the basic principle, concept and method, implementation path, and takes anti-psoriasis monoantibody as an example to establish a complete MIDD working mode.

Since the reform of the drug review and approval system, with the support of a series of policies and technology that encourages innovation, a large number of clinical trial application of new drugs for skin disease has been approved. In addition, innovative drugs, high-quality generic drugs, and biosimilar products have been accelerately approved, which meets the availability and accessibility of drugs to a certain extent. In order to guide innovation and scientific development of new drugs for skin disease, this article reviews the reform of drug review and approval system, the continuous improvement of the drug regulatory system, and the progress in development, evaluation and approval of new drugs for skin disease in China. We focus on the challenges, opportunities, and improvement measures faced in the development, evaluation, and regulation of drugs in this field. With multiple measures simultaneously taken, the goal is to meet the urgent clinical medication needs of patients with skin disease, so that effective and safe drugs can benefit patients as soon as possible.

Vitiligo is a kind of refractory depigmentation skin disease, which seriously affects the appearance and psychology of patients. At present, the pathogenesis of vitiligo includes heredity, oxidative stress, autoimmunity and environmental factors. The treatment includes systematic application of glucocorticoid, local application of glucocorticoid or calcineurin inhibitor, phototherapy and melanocyte transplantation. In this article, we reviewed the commonly used therapeutic drugs for vitiligo in the past and summarized the new progress of therapeutic drugs for the treatment of vitiligo. The emergence of new small-molecule targeted drugs, such as Janus kinase inhibitor baricitinib, has brought hope for vitiligo.