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Showing 2 results for “background therapy”.

October 2025

A Phase 3 trial of telitacicept for systemic lupus erythematosus

N Engl J Med 2025;393:1475-85 Doi: 10.1056/NEJMoa2414719

In this 52-week trial involving participants with active SLE who were receiving background therapy, the incidence of a clinical response was higher with telitacicept than with PBO. van Vollenhoven et al. report efficacy and safety results of a Phase 3 trial of telitacicept at a dose of 160mg weekly as compared with PBO in Chinese persons with active SLE.

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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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