By Chris Wack

 

AbbVie Inc. said that upadacitinib 15 mg or 30 mg, once daily, met the primary endpoint of clinical remission and all secondary endpoints at one-year in a Phase 3 ulcerative colitis maintenance study.

The pharmaceutical company said significantly more upadacitinib-treated patients achieved clinical remission at week 52 compared to placebo.

In the study, adults with moderate to severe ulcerative colitis who achieved a clinical response following an 8-week study period of once-daily upadacitinib 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 and corticosteroid-free clinical remission at week 52. 49% of patients treated with upadacitinib 15 mg and 62% of patients treated with upadacitinib 30 mg achieved endoscopic improvement at 52 weeks versus 14% of patients in the placebo group. In addition, 35% of patients on upadacitinib 15 mg and 49% of patients on upadacitinib 30 mg achieved HEMI, compared to 12% of patients in the placebo group.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

June 29, 2021 08:50 ET (12:50 GMT)

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