AbbVie presented positive data of Rinvoq in patients with giant cell arteritis
AbbVie released positive outcomes from the SELECT-GCA trial, indicating that upadacitinib (RINVOQ; 15 mg, once daily) combined with a 26-week steroid taper regimen successfully met its primary endpoint of sustained remission from week 12 through week 52 among adults diagnosed with giant cell arteritis (GCA). In this investigation, 46 percent of patients on upadacitinib 15 mg, in conjunction with the steroid taper, achieved sustained remission, compared to 29 percent on placebo with a 52-week steroid taper regimen.
GCA, an autoimmune condition primarily affecting individuals over 50, particularly women, leads to inflammation in cranial and large arteries, potentially causing symptoms like headache, jaw pain, and vision disturbances.Key secondary endpoints were also achieved, with a significantly higher percentage of patients receiving upadacitinib 15 mg maintaining complete remission compared to those on placebo (37 percent versus 16 percent). Additionally, fewer patients in the upadacitinib 15 mg group experienced disease flares compared to the placebo group (34 percent versus 56 percent). Notably, the study found that upadacitinib 7.5 mg did not meet primary or secondary endpoints.
Safety observations during the 52-week period indicated a profile consistent with approved indications, with no new safety concerns identified in the GCA population. Further detailed results across all treatment groups will be disclosed at upcoming medical conferences. It's important to note that the use of upadacitinib for GCA is not yet approved, and regulatory authorities have not evaluated its safety and efficacy for this condition.