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Rinvoq Shows Strong UC Efficacy, But Will JAK Ghosts Haunt It?

 
• By Alaric DeArment

Safety appears balanced between the drug and placebo arms in upadacitinib’s third Phase III trial in ulcerative colitis, but there were low numbers of MACE and there are lingering safety concerns about the JAK class overall.

Ulcerative colitis endoscopic biopsy
AbbVie announced data from Phase III study of Rinvoq in ulcerative colitis • Source: Shutterstock

AbbVie Inc.’s JAK1 inhibitor Rinvoq (upadacitinib) has a decent shot at US Food and Drug Administration approval in ulcerative colitis (UC) based on positive data from its Phase III studies. The last of three pivotal trials for the indication showed strong efficacy, but also a low incidence of adverse events that have previously drawn regulatory concern, which could feed into lingering worries about the safety of the JAK class.

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