AbbVie’s Rinvoq supports clinical remission in Phase 3 Crohn’s disease study

AbbVie (NYSE:ABBV) has revealed positive topline results from the U-ENDURE Phase 3 study investigating 15- and 30-mg doses of Rinvoq (upadacitinib) in adults with moderate to severe Crohn’s disease.

Recipients who received either dose met the co-primary endpoints of endoscopic response and clinical remission, AbbVie announced. More than one-third (36%) of participants who received 15 mg of upadacitinib achieved clinical remission at week 52. A total of 46% of those receiving the 30-mg dose achieved the same benchmark, compared with 14% of placebo recipients.

Subjects also achieved the secondary endpoint of endoscopic remission at 52 weeks compared to placebo.

Study participants were poor candidates for conventional or biologic therapy.

The study defined clinical remission using the Crohn’s Disease Activity Index (CDAI) or by stool frequency and abdominal pain score (SF/AP).

Rinvoq first won FDA approval in 2019 for rheumatoid ar…

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