Efficacy and Safety of the Bruton's Tyrosine Kinase Inhibitor Evobrutinib in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Trial.

Daniel J WallaceThomas DörnerDavid S PisetskyJorge Sanchez-GuerreroAnand C PatelDana Parsons-RichClaire Le BolayElise E DrouinAmy H KaoHans GuehringMaria Dall'Era

Published in: ACR open rheumatology (2022)

This phase II, dose-ranging trial in SLE failed to show a treatment effect of evobrutinib versus placebo at any dose. Evobrutinib was generally well tolerated, with no dose effect observed for TEAEs. These results suggest that BTK inhibition does not appear to be an effective therapeutic intervention for patients with SLE.

Keyphrases

phase ii
placebo controlled
double blind
phase iii
clinical trial
open label
systemic lupus erythematosus
study protocol
phase ii study
randomized controlled trial
disease activity
tyrosine kinase
radiation therapy