Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: A Randomized Clinical Trial

Advancements in the Treatment of Cutaneous Lupus Erythematosus and Dermatomyositis: A Review of the Literature

“…Lenabasum, a selective cannabinoid 2 receptor agonist, was evaluated with a Phase 2 double-blinded RCT composed of 22 patients. 69 On day 113 of the trial, participants in the treatment group experienced a statistically significant decrease of 6.5 in their adjusted least square mean CDASI (p = 0.038). Similarly, there were statistically significant differences in secondary outcomes in biomarker changes, such as in IFN-beta and IFN-gamma (p < 0.05).…”

“… CDASI score improvement of −9.3 for 0.6 mg/kg, −8.8 for 1.8 mg/kg, and −7.3 for placebo. However, there was no significant difference in CDASI improvement between placebo and treatment groups (p = 0.238) Cannabinoid receptor agonists Werth (2022) 69 Phase 2 double blinded RCT Lenabasum 20mg daily for 28 days, then 20 mg BID for 56 days, or a placebo (Lenabasum is a cannabinoid receptor type 2 agonist) 22 subjects of ≥ 18 years of age with DM and CDASI activity ≥ 14 At day 113, the lenabasum treatment group, compared to the placebo group, had a lower CDASI adjusted least squares mean of 6.5 [SE = 3.1], p = 0.038. Abbreviations : DM, dermatomyositis; CDASI, cutaneous Dermatomyositis Disease Area and Severity Index; BID, twice daily; QAM, daily every morning; QPM, daily every evening; DAS, skin disease activity score; ILD, idiopathic lung disease; VAS, visual analog score; TLR, toll-like receptor; RCT, randomized controlled trial; SE, standard error.…”

“…Similarly, there were statistically significant differences in secondary outcomes in biomarker changes, such as in IFN-beta and IFN-gamma (p < 0.05). 69 …”

“… 67 , 68 The cannabinoid agonist, lenabasum, was found to significantly decrease patient mean CDASI. 69 …”

Autoimmune Connective Tissue Diseases-Related Pruritus: Proper Diagnosis and Possible Mechanisms

“…Lenabasum (JBT-101, anabasum), a selective cannabinoid receptor type 2 agonist, downregulated the expression of IL-31 from CpG stimulated peripheral blood mononuclear cells in an in vitro study, suggesting a possible role in treatment of DM-related pruritus [ 11 ]. Recently, a phase 2 study showed lenabasum improved skin symptoms with a reduction in the scores of CDASI [ 20 ]. Though the degree of pruritus was not evaluated in that trial, treatment with lenabasum might be efficacious for DM-related pruritus.…”