AbbVie’s upadacitinib meets primary endpoint in trial for systemic lupus erythematosus
pharmafile | March 29, 2023 | News story | Research and Development |
AbbVie has shared that upadacitinib (Rinvoq) has been shown to be effective in treating patients with moderately-to-severely-active systemic lupus erythematosus (SLE). The drug met the primary endpoint of SLE Responded Index (SRI-4) and steroid dose less than or equal to 10-mg prednisone, according to results from the phase 2 study.
Following the results of the trial, AbbVie plans to advance its clinical programme of upadacitinib in a phase 3 trial for SLE.
The phase 2 study included 341 patients, split into five groups depending on their treatment regimen.
The primary outcome of the study was the achievement of the SRI-4 with a steroid dose less than or equal to 10-m prednisone equivalent once daily at week 24. SRI-4 was defined as a greater or equal to 4-point reduction in the SLE Disease Activity Index 2000 score without worsening of the overall condition and without developing any other disease activity in another organ system.
The safety profile for the drug appeared consistent with the known information, with similar adverse effects reported for upadacitinib combined with elsubrutinib and upadacitinib alone.
Roopal Thakkar, MD, senior vice president of development and regulatory affairs and chief medical officer at AbbVie, commented: “[SLE] is a very unpredictable life-long condition, and the way it affects a patient can change over time. Therefore, there is a critical need for additional treatment options. […] With a quarter-century if experience and commitment to the treatment of rheumatic diseases, our focus remains on areas of high unmet need like SLE, and we look forward to further evaluation of the potential benefits that upadacitinib could bring to patients.”
Full results from this study are expected at a later date.
Betsy Goodfellow
