Towards a novel clinical outcome assessment for systemic lupus erythematosus: first outcomes of an international taskforce.
Journal
Nature reviews. Rheumatology
ISSN: 1759-4804
Titre abrégé: Nat Rev Rheumatol
Pays: United States
ID NLM: 101500080
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
accepted:
09
06
2023
medline:
24
8
2023
pubmed:
12
7
2023
entrez:
11
7
2023
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 37433880
doi: 10.1038/s41584-023-00993-7
pii: 10.1038/s41584-023-00993-7
doi:
Types de publication
Journal Article
Review
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
592-602Investigateurs
Alessandro Sorrentino
(A)
Anna Stevens
(A)
Catherine Barbey
(C)
Elaine Karis
(E)
Eric Morand
(E)
Erika Noss
(E)
Eve Md Smith
(E)
George Stojan
(G)
Jorge Ross Teres
(JR)
Justine Maller
(J)
Maya Hojnik
(M)
Nikolay Delev
(N)
Laura Eades
(L)
Maria Dall'Era
(M)
Patrick Marquis
(P)
Richard Furie
(R)
Ronald van Vollenhoven
(R)
Tim Coulom
(T)
Cailin Sibley
(C)
Christian Stach
(C)
Cristina Vazquez-Mateo
(C)
Eric Zollars
(E)
Heath Guay
(H)
Hussein Al-Mossawi
(H)
Joan Merrill
(J)
Jorge Ross Terres
(JR)
Karen Costenbader
(K)
Maria Silk
(M)
Marta Mosca
(M)
Nicki Bush
(N)
Subhashis Banerjee
(S)
Thierry Sornasse
(T)
Blanca Rubio
(B)
Dalila Tremarias
(D)
Dalilah Kalla
(D)
Gonzalo Tobar Carrizo
(GT)
Imasha Adisa
(I)
Shiori Nagamori
(S)
Sibongile Komati
(S)
Stephanie Scoggins
(S)
Susanne Udengaard Gydesen
(SU)
Toni Grimes
(T)
Vinita Haroun
(V)
Zoe Karakikla-Mitsa
(Z)
Ann Eldred
(A)
Bianca Fedriz
(B)
Catharine Lindholm
(C)
Charlotte Lupton
(C)
Dennis Grasela
(D)
Erik Thomas
(E)
Maria Juarez
(M)
Nitin Kumar
(N)
Oliver Guenther
(O)
Samantha Pomponi
(S)
Sanjeev Roy
(S)
Shelly Kafka
(S)
Thomas Morel
(T)
Yulia Pincus
(Y)
Informations de copyright
© 2023. Springer Nature Limited.
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