Additional prespecified endpoint,
not controlled for multiplicity.
*Bio-naïve defined as without prior biologic failure and includes patients who had previous exposure to biologics but did not experience treatment failure.
†Bio-failure refers to prior treatment failure to at least 1 biologic therapy.
Clinical remission per aMs: SFS ≤1 and not greater than baseline, RBS of 0 and ESS of 0 or 1 without friability.
aMs: adapted Mayo score; ESS: endoscopic subscore; QD: once daily; RBS: rectal bleeding subscore; SFS: stool frequency subscore.
REFERENCES
- RINVOQ Summary of Product Characteristics.
- Danese S, Vermeire S, Zhou W, et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022;399(10341):2113–2128.