AbbVie Says Phase 3 Ulcerative Colitis Maintenance Study Met Primary Endpoint – Quick Facts

AbbVie (ABBV) announced Tuesday that upadacitinib (15 mg or 30 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all secondary endpoints at one-year (week 52) in the Phase 3 ulcerative colitis maintenance study.

Significantly more upadacitinib-treated patients achieved clinical remission at week 52 compared to placebo (15 mg: 42 percent and 30 mg: 52 percent versus placebo: 12 percent).

In this study, adults with moderate to severe ulcerative colitis who achieved a clinical response (per partial Adapted Mayo Score) following an 8-week study period of once-daily upadacitinib (45 mg) induction treatment were re-randomized to receive upadacitinib 15 mg, upadacitinib 30 mg or placebo for an additional 52 weeks.

All secondary endpoints were met, including the achievement of endoscopic improvement, histologic-endoscopic mucosal improvement (HEMI) and corticosteroid-free clinical remission at week 52.

Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon.

The Phase 3 maintenance study is an ongoing, Phase 3 multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of upadacitinib in patients with moderate to severe ulcerative colitis.

The objective of this maintenance study is to evaluate the efficacy and safety of upadacitinib 15 mg and 30 mg, once daily, as a maintenance therapy compared to the placebo group.

Results from the induction studies, U-ACHIEVE and U-ACCOMPLISH, were announced in December 2020 and February 2021, respectively.

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