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

Overview

Journal J Invest Dermatol

Publisher Elsevier

Specialty Dermatology

Date 2022 May 1

PMID 35490744

Authors

Victoria P Werth

Emily Hejazi

Sandra M Pena

Jessica Haber

Majid Zeidi

Nithin Reddy

Joyce Okawa

Rui Feng

Muhammad M Bashir

Kirubel Gebre

Arvin S Jadoo

Josef Symon S Concha

Nancy Dgetluck

Scott Constantine

Barbara White

Affiliations

Soon will be listed here.

Abstract

Background: Treatment options are limited for skin disease in dermatomyositis. Lenabasum is a cannabinoid receptor type 2 agonist that triggers the resolution of inflammation.

Objective: The objective of this study was to evaluate the safety and efficacy of lenabasum in patients with refractory cutaneous dermatomyositis.

Design: This study was a single-center, double-blind, randomized, placebo-controlled phase 2 study conducted from July 2015 to August 2017.

Population: The population included subjects aged ≥18 years with at least moderately active dermatomyositis skin activity by Cutaneous Dermatomyositis Disease Area and Severity Index activity ≥ 14 and failure or intolerance to hydroxychloroquine.

Intervention: Participants received 20 mg lenabasum daily for 28 days and then 20 mg twice per day for 56 days or placebo.

Main Outcomes And Measures: The primary outcome was a change in Cutaneous Dermatomyositis Disease Area and Severity Index activity. Safety and other secondary efficacy assessments were performed till day 113.

Results: A total of 22 subjects were randomized to lenabasum (n = 11) or placebo (n = 11). No serious or severe adverse events were related to lenabasum, and no participants discontinued the study. The adjusted least-squares mean for Cutaneous Dermatomyositis Disease Area and Severity Index activity decreased more for lenabasum, and the difference was significant on day 113 (least-squares mean [standard error] difference = ‒6.5 [3.1], P = 0.038). Numerically greater improvements were seen in multiple secondary efficacy outcomes and biomarkers with lenabasum.

Conclusion: Lenabasum treatment was well tolerated and was associated with greater improvement in Cutaneous Dermatomyositis Disease Area and Severity Index activity and multiple efficacy outcomes.

Trial Registration: This study was registered at ClinicalTrials.gov, NCT02466243.

Citing Articles

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Long-Term Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: Follow-Up Data from a 3-Year Open-Label Extension Study.

Stone C, Ahuja G, Lopes Almeida Gomes L, Poroye J, Faden D, Xie L JID Innov. 2024; 5(1):100311.

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Updates in Dermatomyositis: Newer Treatment Options and Outcome Measures From Dermatologic Perspectives.

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Hile G, Werth V Arthritis Rheumatol. 2024; 77(1):1-11.

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