AbbVie announced key results from a phase 2 study of upadacitinib given as monotherapy, or in combination therapy (ABBV-599) with elsubrutinib, a kinase inhibitor Bruton’s tyrosine (“BTK”), once a day in patients with moderately to severely active Systemic Lupus Erythematosus. The SLEek study reached the primary endpoints at week 24 . Based on these results, AbbVie is moving forward with the upadacitinib phase 3 clinical program for SLE .
“Systemic lupus erythematosus is an unpredictable chronic condition and the way the disease affects the patient can change over time. Furthermore, there is a critical need for additional treatment options,” said Dr Roopal Thakkar, Senior Vice President Development and Regulatory Affairs at AbbVie. “With a quarter-century of experience and commitment to the treatment of rheumatic diseases, our focus remains on areas of high unmet need, such as systemic lupus erythematosus, and we look forward to evaluating the potential benefits that upadacitinib can bring to these patients.”
In the phase 2 study, 341 participants were included and subsequently subdivided into five groups according to the treatment regimen.
Adverse events reported with upadacitinib 30 mg were generally consistent with the known safety profile of the drug, with no new signs identified. Adverse effects reported with upadacitinib in combination with elsubrutinib were similar to those reported by patients treated with upadacitinib alone. Full study results will be presented at future medical conferences. The use of upadacitinib for SLE is not approved and its efficacy and safety profile has not yet been evaluated by regulatory authorities, including ANVISA.
Systemic lupus erythematosus is a chronic, autoimmune and complex disease that affects multiple organs and is characterized by the production of pathogenic antibodies and deposition of immune complexes in tissues. In SLE, the immune system attacks healthy tissues of the musculoskeletal system, skin, kidneys and other important organs, leading to symptoms such as fatigue, joint pain and functional disability.
SOURCE: PR Newswire