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Showing 16 results for “Phase 3”.

November 2023

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

Expert Opin Emerg Drugs 2023; 20:1-17 DOI: 10.1080/14728214.2023.2273536 Epub ahead of print

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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August 2023

Effect of Belimumab on Kidney-related Outcomes in Patients with Lupus Nephritis: Post Hoc Subgroup Analyses of the Phase 3 BLISS-LN Trial

Nephrol Dial Transplant. 2023 doi: 10.1093/ndt/gfad167 Epub ahead of print.

These data highlight the consistent benefit of belimumab versus placebo, combined with standard therapy, on kidney outcomes in both newly diagnosed and relapsed patients, and regardless of the use of GC pulses at induction.

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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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April 2023

Sustained Glucocorticoid Tapering in the Phase 3 Trials of Anifrolumab: A post hoc Analysis of the TULIP-1 and TULIP-2 Trials

Rheumatology (Oxford). 2023 doi: 10.1093/rheumatology/keac491

Pooled analysis of the TULIP trials demonstrates that sustained glucocorticoid (GC) tapering is associated with several clinical benefits in patients with moderate-to-severe SLE.

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March 2023
February 2023

Lupus Low Disease Activity State Attainment in the Phase 3 TULIP Trials of Anifrolumab in Active Systemic Lupus Erythematosus

Ann Rheum Dis. 2023. doi: 10.1136/ard-2022-222748

Post-hoc anaylsis of TULIP trials shows that, compared with placebo, anifrolumab treatment was associated with earlier, more frequent, and more prolonged and sustained lupus low disease activity state (LLDAS).

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July 2022

Phase 3, multicentre, randomised, placebo-controlled study evaluating the efficacy and safety of ustekinumab in patients with systemic lupus erythematosus

van Vollenhoven RF, et al. Ann Rheum Dis. 2022. Epub ahead of print. doi:10.1136/ard-2022-222858.

Phase 3 study evaluating the efficacy and safety of ustekinumab in patients with active SLE, despite receiving standard-of-care, does not achieve primary and key secondary endpoints.

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March 2022