The approval was based on the 3 P-III studies i.e., (U-ACHIEVE), (U-ACCOMPLISH) & (U-ACHIEVE) evaluating upadacitinib (45mg, qd as induction therapy) & 15/30mg, qd as maintenance therapy vs PBO for active UC
In an induction & maintenance trial, 26%/33% of patients treated with Rinvoq (45mg) achieved clinical remission @8wk. vs 5% & 4% in PBO; 42% & 52% vs 12% with Rinvoq (15/30mg) & corticosteroid-free remission (57% & 68% vs 22%) for ≥90 days @52wk.
In (U-ACHIEVE) & (U-ACCOMPLISH) trials, 73% & 74% achieved clinical response in 45mg dose @8wk. vs 27% & 25%; clinical response per partial Adapted Mayo Score @2wk. (60% & 63%) vs (27% vs 26%), mucosal healing (36% & 44% vs 7% & 8%) @8wk.; 49% & 62% vs 14% in maintenance study @45wk.
Ref: AbbVie | Image: AbbVie
