Sub-setting systemic lupus erythematosus by combined molecular phenotypes defines divergent populations in two phase III randomized trials.

ABSTRACT:

Objectives

Heterogeneity of SLE patients in clinical trials remains a challenge for developing new therapies. This study used a combinatorial analysis of four molecular biomarkers to define key sources of heterogeneity.

Methods

Combinations of IFN (high/low), anti-dsDNA (+/-) and C3 and C4 (low/normal) were used to subset n = 1747 patients from two randomized phase III trials. A dichotomous classification scheme defined SLE (+) as: IFN (high), anti-dsDNA (+), C3 (low) and/or C4 (low). SLE (-) required all of the following: IFN (low), anti-dsDNA (-), C3 (normal) and C4 (normal). Additional analyses subset the data further by IFN, anti-dsDNA and complement.

Results

The trials enrolled n = 2262 patients of which n = 1747 patients had data for IFN, anti-dsDNA, C3 and C4 a

SUBMITTER: Petri M 

PROVIDER: S-EPMC8783538 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature