Systemic sclerosis & Raynaud's
Efficacy and Safety of Lenabasum, a Cannabinoid Type 2 Receptor Agonist, in a Phase 3 Randomized Trial in Diffuse Cutaneous Systemic Sclerosis
Authors' conclusion
A benefit of lenabasum in dcSSc was not demonstrated.
Study context
- Population
- Patients with diffuse cutaneous systemic sclerosis (dcSSc) on background treatments, including immunosuppressive therapies (IST)randomized 1:1:1
- Participants
- 365 patients
- Comparison
- Lenabasum 20 mg or 5 mg twice daily vs placebo, added to background treatments including IST
- Primary endpoint
- ACR combined response index in dcSSc (CRISS), lenabasum 20 mg twice a day vs placebo
- Follow-up
- Week 52
Methodological detailsphase 3, multinational, double-blind, placebo-controlled
- Phase 3
- Multinational
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
CRISS score
Lenabasum 20 mg
0.888
Placebo
0.887
P = 0.4972
Further findings
| Outcome | Lenabasum 20 mg | Placebo | P value |
|---|---|---|---|
| Change in mRSS · week 52Lenabasum 20 mg vs Placebo · MMRM | −6.7 | −8.1 | P = 0.1183 |
Prespecified analyses: background mycophenolate and IST for ≤1 year
- Higher CRISS scores, greater improvement in mRSS and lower decline in FVC in patients on background mycophenolate and those taking IST for ≤1 year
Deaths and serious or severe AEs related to lenabasum
- No deaths or excess in serious or severe adverse events related to lenabasum
Original publication
Efficacy and Safety of Lenabasum, a Cannabinoid Type 2 Receptor Agonist, in a Phase 3 Randomized Trial in Diffuse Cutaneous Systemic Sclerosis. Arthritis Rheumatol. Published 15 June 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →