Lupus & antiphospholipid syndrome
Efficacy and safety of enpatoran, a Toll-like receptor 7/8 inhibitor, in patients with skin manifestations of cutaneous lupus erythematosus or systemic lupus erythematosus: findings from Cohort A of a multicentre, international, double-blind, placebo-controlled, dose-finding phase 2 trial
Authors' conclusion
Enpatoran showed a significant and dose-dependent effect on disease activity in participants with active cutaneous manifestations of CLE or SLE, and was well tolerated.
Study context
- Population
- Adults aged 18–75 years with cutaneous lupus erythematosus (CLE) only or systemic lupus erythematosus (SLE) with mild or no extra-mucocutaneous activity (BILAG-2004 1B, C or D) and CLASI-A score ≥8100 analysed for efficacy
- Participants
- 102 adults
- Comparison
- Enpatoran 25 mg, 50 mg or 100 mg twice per day vs placebo for 24 weeks, with standard of care
- Enpatoran 25 mgn = 23
- Enpatoran 50 mgn = 25
- Enpatoran 100 mgn = 26
- Placebon = 26reference
- Primary endpoint
- Dose-response of percentage change from baseline in CLASI-A total score (multiple comparison procedure-modelling)
- Follow-up
- Week 16
Methodological detailsphase 2, double-blind, placebo-controlled, basket, dose-finding, multicentre (132 centres, 22 countries), Cohort A
- Phase 2
- Double-blind
- Placebo-controlled
- Basket
- Dose-finding
- Multicentre (132 centres, 22 countries)
- Cohort A
Primary result
As reported in the abstract
Enpatoran 25 mg
−64
adjusted mean · 95% CI −70–-58 · percentage points
Enpatoran 50 mg
−68
adjusted mean · 95% CI −75–-61 · percentage points
Enpatoran 100 mg
−72
adjusted mean · 95% CI −80–-64 · percentage points
Placebo
−44
adjusted mean · 95% CI −55–-33 · percentage points
P = 0.0002 for dose-response relationship
Safety
Upper respiratory tract infection (most common TEAE) · safety population
Denominator Enpatoran 25 mg 24 · Enpatoran 50 mg 26 · Enpatoran 100 mg 26 · Placebo 26
| Outcome | Enpatoran 25 mg | Enpatoran 50 mg | Enpatoran 100 mg | Placebo |
|---|---|---|---|---|
| Serious adverse events | 8% | 0 events | 4% | 4% |
Original publication
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