Lenabasum in Diffuse Cutaneous Systemic Sclerosis: Insights from a Phase 3 Study
In the quest to find effective treatments for diffuse cutaneous systemic sclerosis (dcSSc), researchers have explored lenabasum, a medication that targets the cannabinoid type 2 receptor. A recent Phase 3 study aimed to evaluate the efficacy and safety of lenabasum in patients with dcSSc. Let's delve into the study's findings and what they mean for the treatment of this challenging condition.
The Phase 3 study involved 365 patients with dcSSc who were divided into three groups. Each group received either lenabasum 20 mg, lenabasum 5 mg, or a placebo twice daily. Importantly, all patients continued their background treatments, including immunosuppressive therapies.
Study Results: The study assessed various outcome measures to determine the effectiveness of lenabasum in dcSSc. The primary endpoint, known as the ACR Combined Response Index in dcSSc (ACR-CRISS) score, was measured at Week 52. Unfortunately, the study did not demonstrate a significant difference in ACR-CRISS scores between patients who received lenabasum 20 mg and those who received the placebo.
Another measure evaluated was the change in modified Rodnan Skin Score (mRSS), which indicates the severity of skin involvement. Although there was a slight improvement in mRSS for patients on lenabasum 20 mg compared to placebo, the difference was not statistically significant.
Additional Insights: However, further analysis provided interesting insights. Patients who were already receiving mycophenolate, an immunosuppressive therapy, as part of their background treatment, showed more favorable outcomes. They had higher ACR-CRISS scores, indicating a better response to treatment. Moreover, these patients experienced greater improvement in mRSS, reflecting a positive effect on skin involvement. Similarly, patients who had received immunosuppressive therapies for one year or less also showed better outcomes.
It's worth noting that lenabasum demonstrated a favorable safety profile throughout the study. There were no deaths or significant adverse events directly related to the medication.
While the Phase 3 study did not provide evidence of a significant benefit from lenabasum in dcSSc, it shed light on the importance of immunosuppressive therapies, particularly mycophenolate, in the treatment of this condition. The results highlight the challenges faced when adding investigational treatments to standard care, emphasizing the need to consider the effectiveness of existing therapies.
Moving forward, these findings have implications for trial design in systemic sclerosis and can guide clinical practice. Although lenabasum did not meet expectations in this study, the search for effective treatments for dcSSc continues, fueled by valuable insights gained from rigorous research.
Remember, it's crucial to consult with your healthcare provider to discuss the most appropriate treatment options for your individual needs.
References:
Spiera R, Kuwana M, Khanna D, Hummers L, Frech TM, Stevens W, Matucci-Cerinic M, Kafaja S, Distler O, Jun JB, Levy Y, Leszcyzński P, Gordon J, Steen V, Lee EB, Jankowski T, Litinsky I, Chung L, Hsu V, Mayes M, Sandorfi N, Simms RW, Finzel S, de Vries-Bouwstra J, Constantine S, Dgetluck N, Dinh Q, Bloom BJ, Furst DE, White B, Denton CP; RESOLVE-1 Study Group. Efficacy and Safety of Lenabasum, a Cannabinoid Type 2 Receptor Agonist, in a Phase 3 Randomized Trial in Diffuse Cutaneous Systemic Sclerosis. Arthritis Rheumatol. 2023 Apr 26. doi: 10.1002/art.42510. Epub ahead of print. PMID: 37098795.
Tags: SSc, scleroderma, systemic sclerosis, CTDs