The findings of a double-blind, placebo-controlled, randomised trial have shown positive efficacy and safety for the selective sphingosine-1-phosphate 1 (S1P1) receptor modulator, cenerimod, in the treatment of systemic lupus erythematosus (SLE).
The multicentre study was conducted in two parts. In part A, 49 patients with SLE were randomised to receive oral cenerimod 0.5 mg, 1 mg or 2 mg or placebo once daily for 12 weeks. Following an interim safety review of part A, 18 patients were randomised for part B and received cenerimod 4 mg or placebo once daily for 12 weeks.
Cenerimod was associated with a significant dose-dependent reduction in total lymphocyte count. Compared with placebo, at end of treatment, cenerimod 4 mg was associated with a change from baseline in modified SLE Disease Activity Index-2000 (mSLEDAI-2K) score of −2.420 (P=.0306) and in anti-double-stranded DNA antibodies of −64.55 U/mL (P=.0082), suggesting clinical and biological improvement.
All groups reported similar frequencies of treatment-emergent adverse events (cenerimod 0.5 mg: 41.7%; 1 mg: 41.7%; 2 mg: 46.2%; 4 mg: 38.5%; and placebo: 58.8%). A small, non-clinically relevant decrease in heart rate was observed in the first six hours after initiation.
The authors say the findings call for further investigation of cenerimod in larger patient populations.