Phase II Randomized Trial of Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis.

ABSTRACT:

Objective

To assess the safety, mechanism of action, and preliminary efficacy of rituximab followed by belimumab in the treatment of refractory lupus nephritis (LN).

Methods

In a multicenter, randomized, open-label clinical trial, 43 patients with recurrent or refractory LN were treated with rituximab, cyclophosphamide (CYC), and glucocorticoids followed by weekly belimumab infusions until week 48 (RCB group), or treated with rituximab and CYC but no belimumab infusions (RC group). Patients were followed up until week 96. Percentages of total and autoreactive B cell subsets in the patients' peripheral blood were analyzed by flow cytometry.

Results

Treatment with belimumab did not increase the incidence of adverse events in patients with refractory LN. At week 48, a co

SUBMITTER: Atisha-Fregoso Y 

PROVIDER: S-EPMC7839443 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature