Lenabasum effective, well tolerated in refractory dermatomyositis
In the treatment of patients with refractory cutaneous dermatomyositis, the cannabinoid receptor type 2 agonist lenabasum yields good outcomes in terms of efficacy and safety, as indicated by improvements in disease activity and no increased risk of serious or severe adverse events, according to the results of a phase II study.
The study included 22 adult patients with at least moderately active dermatomyositis skin activity, as defined by Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity of ≥14 and failure or intolerance to hydroxychloroquine. They were randomized to treatment with either lenabasum 20 mg daily for 28 days, then 20 mg twice a day for 56 days (n=11) or placebo (n=11).
Researchers designated change in CDASI activity as the primary endpoint. They also assessed safety and other secondary efficacy assessments up to day 113.
There were no documented serious or severe adverse events associated with lenabasum. Moreover, none of the patients who received the drug discontinued treatment.
Compared with placebo, lenabasum produced a greater reduction in the adjusted least squares mean for CDASI activity, and the difference was pronounced at day 113 (least squares mean [SE] difference, –6.5; p=0.038). In addition, the study drug conferred numerically greater improvements in multiple secondary efficacy outcomes and biomarkers.