Efficacy and Safety of Lenabasum, a Cannabinoid Type 2 Receptor Agonist, in a Phase 3 Randomized Trial in Diffuse Cutaneous Systemic Sclerosis.
Robert F SpieraMasataka KuwanaZsuzsanna H McMahanLaura K HummersTracy M FrechWendy StevensMarco Matucci-CerinicSuzanne KafajaAnastasiia KozlovaJae Bum JunYair LevyPiotr LeszcyzńskiJessica K GordonVirginia SteenEun Bong LeeTomasz JankowskiIrena LitinskyLorina ChungVivien HsuMaureen D MayesNora SandorfiRobert W SimmsStephanie FinzelJeska de Vries-BouwstraScott ConstantineNancy DgetluckQuinn DinhBradley J BloomDaniel E FurstBarbara WhiteChristopher P Dentonnull nullPublished in: Arthritis & rheumatology (Hoboken, N.J.) (2023)
A benefit of lenabasum in dcSSc was not demonstrated. The majority of patients were treated with background IST, and treatment with MMF in particular was associated with better outcomes. This supports the use of IST in the treatment of dcSSc, and highlights the challenge of demonstrating a treatment effect when investigational treatment is added to standard of care IST. These findings have relevance to trial design in SSc, as well as clinical care. This article is protected by copyright. All rights reserved.