AbbVie announced positive results from its M19-130 (SLEek) phase II trial examining the safety and efficacy of upadacitinib in patients with systemic lupus erythematosus. In the new study, researchers assigned 341 patients with moderate to severe lupus to receive one of five treatment combinations administered once daily—upadacitinib in combination with placebo, two different dose levels of upadacitinib in combination with the Bruton’s tyrosine kinase inhibitor elsubrutinib, elsubrutinib in combination with placebo, and placebo alone. The researchers found that patients who took 30 mg of upadacitinib alone met the primary endpoints of improvement by at least four points in the Systemic Lupus Erythematosus Responder Index and steroid doses equivalent to 10 mg or less of prednisone once daily after 24 weeks. “Our focus remains on areas of high unmet need like [additional therapeutic options for patients with] systemic lupus erythematosus, and we look forward to further evaluation of the potential benefits that upadacitinib could bring,” concluded Roopal Thakkar, MD, Senior Vice President of Development and Regulatory Affairs and Chief Medical Officer at AbbVie. As a result of the study’s findings, the researchers plan to continue testing the safety and effectiveness of upadacitinib in this patient population in a phase III clinical trial.
May 25, 2023