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Phase III study of Rinvoq meets primary and secondary endpoints in ulcerative colitis.- AbbVie

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Published:1st Jul 2021
AbbVie announced that Rinvoq (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 III 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; p<0.001). 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. In addition 49 percent of patients treated with upadacitinib 15 mg and 62 percent of patients treated with upadacitinib 30 mg achieved endoscopic improvement at 52 weeks versus 14 percent of patients in the placebo group (p<0.001). also, 35 percent of patients on upadacitinib 15 mg and 49 percent of patients on upadacitinib 30 mg achieved hemi compared to 12 percent of patients in the placebo group (p><0.001).></0.001).></0.001).>

Of patients who were in remission at the completion of the 8-week induction studies, corticosteroid-free remission was achieved in 57 percent of patients in the upadacitinib 15 mg group and 68 percent of patients in the upadacitinib 30 mg group compared to 22 percent of patients in the placebo group (p<0.001). the safety results of upadacitinib (15 mg or 30 mg) were consistent with the safety profile observed in the phase iii induction studies in ulcerative colitis, as well as in previous studies across indications.></0.001).>

Condition: Ulcerative Colitis
Type: drug

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