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.
This study investigated cenerimod as a selective S1P1 receptor modulator for SLE patients on stable background therapy. It evaluated dose-dependent efficacy and safety outcomes over 6 to 12 months, with results supporting further investigation of the 4.0mg dose in ongoing Phase 3 trials.
