Clear Search

Showing 27 results for “Safety”.

August 2023
July 2023

Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis

Arthritis Care Res (Hoboken). 2023 Jul;75(7):1399–1408 DOI: 10.1002/acr.25007

Pooled analysis of data from the AURA-LV phase 2 and AURORA 1 phase 3 trials of voclosporin in patients with active LN demonstrated that significantly more patients achieved a complete renal response at 1 year in the voclosporin than the control group (p<0.0001), with no observation of new safety signals.

more…

June 2023

Clinical and biomarker responses to BI 655064, an antagonistic anti-CD40 antibody, in patients with active lupus nephritis: a randomized, double-blind, placebo-controlled, phase II trial

Arthritis Rheumatol. 2023 doi: 10.1002/art.42557. Epub ahead of print.

This phase II study of BI 655064 in patients with active LN did not meet the primary endpoint of CRR at Week 52, however, post-hoc analyses suggest a potential benefit of BI 655064 180 mg in patients with active LN.

more…

March 2023
January 2023
December 2022

A Randomized, Placebo-Controlled Phase III Extension Trial of the Long-Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus

Arthritis Rheumatol. 2022. Epub ahead of print doi: 10.1002/art.42392

Long-term extension study shows an acceptable long-term safety profile of anifrolumab in SLE, in addition to sustained improvements in disease activity and reduction in glucocorticoid use.

more…

November 2022

Safety and Efficacy of Belimumab in Patients with Lupus Nephritis

Clin J Am Soc Nephrol. 2022;17:1620–1630 doi: 10.2215/CJN.02520322

This 28-week, open-label extension of BLISS-LN found no new safety signals and maintained efficacy with belimumab, in patients with lupus nephritis.

more…

Trial of Anti-BDCA2 Antibody Litifilimab for Systemic Lupus Erythematosus

N Engl J Med. 2022;387(10):894–904 doi: 10.1056/NEJMoa2118025

Phase 2 study, in patients with systemic lupus erythematosus, shows that litifilimab is associated with a greater reduction from baseline in the number of swollen and tender joints than placebo, over a period of 24 weeks.

more…