Towards a novel clinical outcome assessment for systemic lupus erythematosus: first outcomes of an international taskforce

Kathryn Connelly, Laura E. Eades, Rachel L. Koelmeyer, Darshini R Ayton, Vera Golder, Rangi K. Kandane-Rathnayake, Kate Gregory, Hermine Brunner, Laurie Burke, Laurent Arnaud, Anca Dinu Askanase, Cynthia B Aranow, Ed Vital, Guillermo Pons-Estel, Khadija Dantata, Jeanette Andersen, Alain Cornet, Joy Buie, Ying Sun, Yoshiya TanakaLee Simon, Youmna Lahoud, Alan Friedman, Kenneth Kalunian, Qing Zuraw, Victoria Werth, Sandra Garces, Eric F. Morand, the TRM-SLE Consortium

Research output: Contribution to journalReview ArticleResearchpeer-review

1 Citation (Scopus)


Systemic lupus erythematosus (SLE) is a disease of high unmet therapeutic need. The challenge of accurately measuring clinically meaningful responses to treatment has hindered progress towards positive outcomes in SLE trials, impeding the approval of potential new therapies. Current primary end points used in SLE trials are based on legacy disease activity measures that were neither specifically designed for the clinical trial context, nor developed according to contemporary recommendations for clinical outcome assessments (COAs), such as that substantial patient input should be incorporated into their design. The Treatment Response Measure for SLE (TRM-SLE) Taskforce is a global collaboration of SLE clinician-academics, patients and patient representatives, industry partners and regulatory experts, established to realize the goal of developing a new COA for SLE clinical trials. The aim of this project is a novel COA designed specifically to measure treatment effects that are clinically meaningful to patients and clinicians, and intended for implementation in a trial end point that supports regulatory approval of novel therapeutic agents in SLE. This Consensus Statement reports the first outcomes of the TRM-SLE project, including a structured process for TRM-SLE development.

Original languageEnglish
Pages (from-to)592-602
Number of pages11
JournalNature Reviews Rheumatology
Issue number9
Publication statusPublished - Sept 2023

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