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Showing 7 results for “safety” published 2023.

January 2024

Telitacicept in Patients with Active Systemic Lupus Erythematosus: Results of A Phase 2b, Randomised, Double-blind, Placebo-controlled Trial

Ann Rheum Dis. 2023; DOI: 10.1136/ard-2023-224854

This Phase 2 trial demonstrated the efficacy and acceptable safety profile of telitacicept in patients with SLE. The safety profile of telitacicept was comparable with that observed in clinical trials of other B cell-targeting agents.

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December 2023

Efficacy and Safety of Telitacicept in Patients with Systemic Lupus Erythematosus: A Multicentre, Retrospective, Real-World Study

Lupus Sci. Med. 2023;10(2):e001074 DOI 10.1136/lupus-2023-001074

In this study, telitacicept add-on therapy demonstrated desirable real-world safety and efficacy profiles for the management of SLE, LN, and patients with haematological abnormalities.

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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.

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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;75(11):1983–93 doi: 10.1002/art.42557.

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.

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March 2023