Abstract
BackgroundDermatomyositis (DM) is a rare autoimmune condition involving skin manifestations often resistant to standard treatments like immunosuppressants and antimalarials. Biopsies show elevated inflammatory cells such as CD4+ T cells, dendritic cells, and cytokines. Lenabasum, a selective CB2 agonist, has demonstrated significant benefits in treating autoimmune skin diseases. ObjectivesThis study utilizes data from the open-label extension (OLE) phase of the lenabasum phase 2 trial and additional post-OLE follow-up data. Key aims include evaluating the drug's long-term effectiveness and assessing disease manifestation recurrence. MethodsThe phase 2 lenabasum trial enrolled patients with treatment-resistant, skin-predominant DM. The OLE consisted of a 3-year period during which 20 patients were on the drug for the entire duration, with assessments every 8 weeks to evaluate drug safety and efficacy. Subsequently, a follow-up retrospective chart review was performed on patients who completed the OLE, as well as on control subjects with DM who did not participate in the lenabasum trial. ResultsBy week 68, patients exhibited reductions in CDASI activity score (-21.8), Patient Skin Activity VAS (-3.0), and Skindex-29 (-28.0) from OLE baseline. Post-OLE, 58.3% maintained stable disease, significantly higher than controls (p=0.035), with 41.7% not experiencing flares compared to 91.6% of controls. Additionally, 50% of patients reported sustained pruritus improvement. ConclusionsData from OLE and subsequent follow-up periods demonstrate lenabasum's efficacy in maintaining disease stability, reducing flares, and improving DM symptoms, suggesting it is a promising option for treatment-resistant skin-predominant DM patients.
Published Version
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call