Emerging drugs in phase 2/3 and selected phase 1/2 cellular-therapy trials: a glimpse into the future of systemic sclerosis treatment
Abstract
Systemic sclerosis (SSc) is a complex autoimmune disease that affects multiple organs. SSc is associated with the highest mortality rate among rheumatic diseases and significantly diminishes quality of life. Consequently, research efforts have focused on understanding its etiopathogenesis and on developing related targeted therapies. Over the past decade, organ-specific therapies (such as tocilizumab and nintedanib for lung fibrosis) have been introduced to manage various manifestations of SSc. However, there is a lack of approved therapies for the overall disease. Currently, many novel compounds are being further evaluated in ongoing clinical trials. This article reviews drugs currently in phase 2 and phase 3 trials and highlights the key disease mechanisms they target in SSc. Recent advances in understanding the pathogenesis of SSc have facilitated the identification of actionable molecular and cellular pathways, leading to the testing of targeted therapeutic strategies. Concurrently, increasing emphasis is being placed on patient stratification and personalised treatment approaches to optimise clinical trial design, improve treatment responsiveness, and enhance the generalisability of trial outcomes. Among emerging treatments, cellular therapies, including chimeric antigen receptor T-cell therapy, represent a significant innovation. This paradigm shift offers substantial potential for improving outcomes in systemic sclerosis.
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BibTeX
@article{naveed2026emerging,
title = {{Emerging drugs in phase 2/3 and selected phase 1/2 cellular-therapy trials: a glimpse into the future of systemic sclerosis treatment}},
author = {Eisha Naveed and Alain Lescoat and Marco Matucci-Cerinic and Masataka Kuwana and Christopher P Denton and Yannick Allanore and John D Pauling and Francesco del Galdo and Zsuzsanna Mcmahan and Jörg H.W. Distler and Janet Pope and Oliver Distler and Shervin Assassi and Robert Spiera and Lorinda Chung and Laura Cooney and Pei-Suen Tsou and John Varga and Dinesh Khanna},
journal = {Annals of the Rheumatic Diseases},
year = {2026},
month = nov,
doi = {10.1016/j.ard.2026.09.015},
url = {https://hal.science/hal-05850296v1},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Emerging drugs in phase 2/3 and selected phase 1/2 cellular-therapy trials: a glimpse into the future of systemic sclerosis treatment
AU - Eisha Naveed
AU - Alain Lescoat
AU - Marco Matucci-Cerinic
AU - Masataka Kuwana
AU - Christopher P Denton
AU - Yannick Allanore
AU - John D Pauling
AU - Francesco del Galdo
AU - Zsuzsanna Mcmahan
AU - Jörg H.W. Distler
AU - Janet Pope
AU - Oliver Distler
AU - Shervin Assassi
AU - Robert Spiera
AU - Lorinda Chung
AU - Laura Cooney
AU - Pei-Suen Tsou
AU - John Varga
AU - Dinesh Khanna
PY - 2026
DA - 2026/11/03
JO - Annals of the Rheumatic Diseases
DO - 10.1016/j.ard.2026.09.015
UR - https://hal.science/hal-05850296v1
AB - Systemic sclerosis (SSc) is a complex autoimmune disease that affects multiple organs. SSc is associated with the highest mortality rate among rheumatic diseases and significantly diminishes quality of life. Consequently, research efforts have focused on understanding its etiopathogenesis and on developing related targeted therapies. Over the past decade, organ-specific therapies (such as tocilizumab and nintedanib for lung fibrosis) have been introduced to manage various manifestations of SSc. However, there is a lack of approved therapies for the overall disease. Currently, many novel compounds are being further evaluated in ongoing clinical trials. This article reviews drugs currently in phase 2 and phase 3 trials and highlights the key disease mechanisms they target in SSc. Recent advances in understanding the pathogenesis of SSc have facilitated the identification of actionable molecular and cellular pathways, leading to the testing of targeted therapeutic strategies. Concurrently, increasing emphasis is being placed on patient stratification and personalised treatment approaches to optimise clinical trial design, improve treatment responsiveness, and enhance the generalisability of trial outcomes. Among emerging treatments, cellular therapies, including chimeric antigen receptor T-cell therapy, represent a significant innovation. This paradigm shift offers substantial potential for improving outcomes in systemic sclerosis.
SN - 0003-4967
SN - 1468-2060
ER -