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Emerging drugs for the treatment of scleroderma: a review of recent phase 2 and 3 trials

David Roofeh1, Alain Lescoat2,3, Dinesh Khanna1

  • 1Division of Rheumatology, Department of Internal Medicine, University of Michigan , Ann Arbor, MI, USA.

Expert Opinion on Emerging Drugs
|October 15, 2020
PubMed
Abstract

Insights

Systemic sclerosis (SSc) treatment is evolving beyond traditional immunosuppressants. New therapies target specific inflammatory and fibrotic pathways, marking a shift towards personalized medicine for early-stage SSc.

Area of Science:

  • Rheumatology
  • Immunology
  • Clinical Pharmacology

Background:

  • Systemic sclerosis (SSc) is a connective tissue disease with high mortality and complex, incompletely understood mechanisms.
  • Current research focuses on clarifying SSc etiopathogenesis to develop targeted therapeutic strategies.

Purpose of the Study:

  • To review the mechanisms of systemic sclerosis (SSc).
  • To survey key recent phase II or III clinical trials evaluating novel SSc therapies.
  • To discuss the emerging role of personalized medicine in SSc treatment.

Main Methods:

  • Literature review of SSc mechanisms.
  • Analysis of four pivotal phase II/III clinical trials in early-stage SSc.
  • Discussion of pathobiology-informed therapeutic approaches.

Main Results:

  • Traditional SSc therapies include immunosuppressive and cytotoxic agents.
  • Emerging therapies target specific inflammatory-fibrotic pathways based on SSc pathobiology.
  • Recent trials focus on early-phase SSc patients, exploring novel agents.

Conclusions:

  • SSc therapy is advancing with targeted agents informed by improved pathobiology understanding.
  • Personalized medicine approaches, identifying molecular subsets, are beginning to influence SSc trial design.
  • Future SSc treatments aim to maximize measurable benefits through enriched cohorts and targeted therapies.
Keywords:
Systemic sclerosisemerging drugsphase 2phase 3

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