Clinical trials and novel therapeutics in dermatomyositis

ABSTRACT

Introduction

Currently, there are no proven drugs that are FDA approved for the treatment of dermatomyositis (DM), even though multiple clinical trials are ongoing to evaluate safety and efficacy of novel therapeutics in DM. The purpose of this review is to highlight the biological plausibility, existing clinical evidence as well as completed and ongoing clinical trials for various drugs in pipeline for development for use in dermatomyositis.

Areas covered

The drugs with the strongest evidence have been included in this review with a focus on the mechanism of their action pertaining to the disease process, clinical studies including completed and ongoing trials. With better understanding of the underlying pathophysiologic process, there are new molecular targets that have been identified that can be targeted by these novel drugs, predominantly biologic drugs.

Expert opinion

There are various drugs being evaluated in phase II/III clinical trials that hold promise in DM. At the forefront of these are immunoglobulin, Lenabasum, and Abatacept for which phase III clinical trials are ongoing. In addition, promising clinical studies are ongoing or reported for KZR-616, anti-B cell therapy, anti-interferon drugs, and Repository Corticotrophin Injection (RCI).

KEYWORDS:

• Dermatomyositis
• clinical trials
• biologics
• novel therapeutics
• idiopathic inflammatory myopathies

Declaration of interest

R Aggarwal has disclosed consulting fees from Abbvie, Csl Behring, Octapharma, Kezar, Corbus, AstraZeneca, Mallinckrodt, BMS. Research grant from BMS, Genetech and Mallinckrodt. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

A reviewer on this manuscript has disclosed that they are a Principal Investigator in the following dermatomyositis clinical trials: NCT03813160, NCT03181893 and NCT02245841. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.