Lupus & antiphospholipid syndrome
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
Authors' conclusion
The primary endpoint was not met. Cenerimod was well tolerated over 12 months.
Study context
- Population
- Adults (18–75 years) with moderate-to-severe systemic lupus erythematosus (SLE) (mSLEDAI-2K ≥6) on standard background therapy; 189 sites in 22 countries810 screened
- Participants
- 427 adults
- Comparison
- Once-daily oral cenerimod 0.5, 1.0, 2.0 or 4.0 mg vs placebo, added to stable background SLE therapy
- Cenerimod 0.5 mgn = 85
- Cenerimod 1.0 mgn = 85
- Cenerimod 2.0 mgn = 86
- Cenerimod 4.0 mgn = 85
- Placebon = 86reference
- Primary endpoint
- Change from baseline in mSLEDAI-2K score (full analysis set)
- Follow-up
- Month 6
Methodological detailsdouble-blind, placebo-controlled, phase 2, international, stratified block randomisation (1:1:1:1:1), hierarchical testing strategy, Recruited Dec 21, 2018, to Aug 25, 2022; followed up for 12 months
- Double-blind
- Placebo-controlled
- Phase 2
- International
- Stratified block randomisation (1:1:1:1:1)
- Hierarchical testing strategy
- Recruited Dec 21, 2018, to Aug 25, 2022; followed up for 12 months
Primary result
As reported in the abstract
LS mean change from baseline in mSLEDAI-2K
Placebo
−2.85
least squares mean · 95% CI −3.60–-2.10
Cenerimod 0.5 mg
−3.24
least squares mean · 95% CI −3.98–-2.49
Cenerimod 1.0 mg
−3.41
least squares mean · 95% CI −4.16–-2.67
Cenerimod 2.0 mg
−2.84
least squares mean · 95% CI −3.58–-2.09
Cenerimod 4.0 mg
−4.04
least squares mean · 95% CI −4.79–-3.28
Each group vs placeboDifference (95% CI)P value
Cenerimod 0.5 mg
−0.39(−1.45 to 0.68)
P = 0.47Cenerimod 1.0 mg
−0.57(−1.62 to 0.49)
P = 0.29Cenerimod 2.0 mg
0.01(−1.05 to 1.08)
P = 0.98Cenerimod 4.0 mg
−1.19(−2.25 to −0.12)
P = 0.029Further findings
| Outcome | Values |
|---|---|
| Deaths due to adverse events | Cenerimod 1.0 mg 2 events |
- Deaths due to adverse events: acute coronary syndrome and upper GI haemorrhage; unrelated to study treatment
Safety
| Outcome | Values |
|---|---|
| Treatment-emergent lymphopenia · month 6 | Cenerimod 0.5 mg 1% · Cenerimod 1.0 mg 6% · Cenerimod 2.0 mg 10% · Cenerimod 4.0 mg 14% · Placebo 0 events |
- Treatment-emergent lymphopenia: 4.0 mg denominator 84
Treatment-emergent adverse events · up to 12 months
- No clear treatment-related or dose-related pattern across the groups
Original publication
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. Published 22 November 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →