Benefit-risk profile of upadacitinib: exploratory post hoc analysis of phase 2b/3 studies in patients with moderately to severely active ulcerative colitis or Crohn's disease.

ABSTRACT:

Background and aims

Upadacitinib (UPA)-an oral, reversible selective Janus kinase inhibitor-has a favorable benefit-risk profile for patients with Crohn's disease (CD) and ulcerative colitis (UC). We evaluated the benefit-risk of UPA in select subgroups with CD or UC.

Methods

Patients were randomized to UPA 45 mg (UPA45) once daily (QD) or placebo (PBO) induction for 12 (CD: U-EXCEED, U-EXCEL) or 8 weeks (UC: U-ACHIEVE, U-ACCOMPLISH). Clinical responders were re-randomized to QD UPA 15 mg (UPA15), UPA 30 mg (UPA30), or PBO for 52-week maintenance (CD: U-ENDURE; UC: U-ACHIEVE). This exploratory post hoc analysis assessed efficacy and safety outcomes (adverse events of special interest [AESIs]: serious infections, major adverse cardiovascular [CV] events, malignancies, and ven

SUBMITTER: Vermeire S 

PROVIDER: S-EPMC12795599 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature