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FDA Approves Upadacitinib for Ulcerative Colitis
The US Food and Drug Administration (FDA) has approved the Janus kinase (JAK) inhibitor upadacitinib as a treatment option for adults with ulcerative colitis (UC) who have had an inadequate response or intolerance to 1 or more tumor necrosis factor (TNF) inhibitors.
This approval is based on the results from three phase 3, multicenter, randomized, double-blind, placebo-controlled studies: U-ACHIEVE and U-ACCOMPLISH for induction therapy, and U-ACHIEVE for maintenance therapy. In the induction studies, upadacitinib was investigated at 45 mg once daily for 8 weeks. In the maintenance study, upadacitinib was used at 15 mg or 30 mg once daily. Across all 3 clinical trials, “significantly more patients treated with RINVOQ [upadacitinib] achieved clinical remission at weeks 8 and 52, based on stool frequency subscore (SFS) ≥ 1 and not greater than baseline, rectal bleeding subscore (RBS) = 0, endoscopy subscore (ES) ≤ 1 without friability, compared to placebo.”
Specifically, in the 2 induction therapy trials, 33% patients treated with upadacitinib achieved clinical remission compared with 5% and 4% of patients on placebo, from the U-ACHIEVE and U-ACCOMPLISH trials respectively. In the maintenance study, the corticosteroid-free clinical remission endpoint was also met. All studies also met the secondary endpoints of endoscopic improvement and histologic-endoscopic mucosal improvement. The safety profile for patients with UC was similar to that observed in the treatment of patients with rheumatoid arthritis and atopic dermatitis with upadacitinib.
Upadacitinib has previously been approved by the FDA for treatment of adults with moderate to severe rheumatoid arthritis and active psoriatic arthritis when 1 or more TNF inhibitor has failed to produce response or was could not be tolerated.
—Allison Casey
