Filgotinib or lanraplenib in moderate to severe cutaneous lupus erythematosus: A phase 2, randomised, double-blind, placebo-controlled study
Rheumatology Sep 14, 2021
Werth VP, Fleischmann R, Robern M, et al. - The primary outcome (change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity [CLASI-A] score at week 12) was not satisfied. Filgotinib (FIL), a Janus kinase 1 inhibitor, treatment response was numerically greater in certain subgroups when compared with placebo (PBO). Lanraplenib (LANRA) and FIL were well tolerated in general.
It was a phase 2, randomized, double-blind, placebo-controlled, exploratory, proof-of-concept study.
Forty-five of the 47 randomised patients were treated (N = 9 PBO, N = 19 LANRA, N = 17 FIL).
The least-squares mean (standard error) CLASI-A score change from baseline was –8.7 (1.85) with FIL, –4.5 (1.91) with LANRA, and –5.5 (2.56) with PBO.
In select subgroups, numerical disparities between FIL and PBO were higher.
A ≥ 5-point improvement in CLASI-A score was achieved by 50.0%, 56.3%, and 68.8% of participants in the PBO, LANRA, and FIL arms, respectively, at week 12.
At week 12, a numerically greater proportion of patients in the FIL arm (50%) also scored ≥ 50% improvement in CLASI-A score (37.5% PBO, 31.3% LANRA).
The majority of the adverse events were mild to moderate in severity.
With LANRA, there were two serious adverse events reported, and one with FIL.
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