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Showing 7 results for “Phase 2” 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

Kidney Outcomes and Preservation of Kidney Function with Obinutuzumab in Patients with Lupus Nephritis: A Post Hoc Analysis of the NOBILITY Trial

Arthritis Rheumatol. 2023 DOI 10.1002/art.42734

This post hoc analysis of the Phase 2 NOBILITY trial determined that obinutuzumab plus standard of care improved the likelihood of long-term preservation of kidney function and improved kidney function with less glucocorticoid use in patients with lupus nephritis.

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November 2023

Emerging Immunotherapeutic Strategies for Cutaneous Lupus Erythematosus: An Overview of Recent Phase 2 and 3 Clinical Trials

Expert Opin Emerg Drugs 2023;28(4):257–73 DOI: 10.1080/14728214.2023.2273536

Current treatments for refractory CLE are insufficient, often leading to suboptimal disease control, and demanding escalated therapies associated with systemic toxicities. However, recent Phase 2 & 3 trials offer promising results, suggesting new therapeutics approved for CLE are on the horizon.

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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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May 2023

Litifilimab (BIIB059), a Promising Investigational Drug for Cutaneous Lupus Erythematosus

Expert Opin Investig Drugs 2023;15:1-9 doi 10.1080/13543784.2023.2212154

Cho, et al. discuss the current challenges in the approval of CLE drugs and suggest outcome measures that could streamline the process. They also discuss the pharmacodynamics of litifilimab and the current status of clinical trials.

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March 2023