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Showing 15 results for “Phase 3”.

December 2024

Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, phase 2 trial

Lancet Rheumatol. 2024. Epub ahead of print. DOI: 10.1016/S2665-9913(24)00246-7

Askanase et al. assessed the efficacy, safety, and tolerability of cenerimod in patients with moderate-to-severe SLE. While the primary endpoint of reducing mSLEDAI-2K scores at Month 6 was not achieved, cenerimod 4.0mg showed a significant reduction in disease activity versus placebo. Adverse events, including lymphopenia, were dose-dependent but manageable, and overall treatment was well tolerated.

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September 2024

Efficacy and safety of sequential therapy with subcutaneous belimumab and one cycle of rituximab in patients with systemic lupus erythematosus: the phase 3, randomised, placebo-controlled BLISS-BELIEVE study

Ann Rheum Dis 2024;0:1–11 DOI 10.1136/ard-2024-225686.

Aranow et al. evaluated the efficacy and safety of combining subcutaneous belimumab with one cycle of rituximab in SLE. Sequential therapy did not show a statistically significant improvement in disease control over belimumab monotherapy, but did achieve nominally better reductions in disease activity markers.

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April 2024
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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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;38(12):2733–42 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