- Loftus Jr EV, et al. Rapidity of Symptom Control with Upadacitinib Induction Therapy in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Two Randomized Phase 3 Studies. OP043, UEG Week 2021 Virtual Congress, 3-5 October.
Upadacitinib is an oral, selective and reversible JAK inhibitor. In two recent phase 3 trials, upadacitinib has demonstrated to outperform placebo after 8 weeks of induction therapy in patients with moderately to severely active UC. Rapid symptom control is important for UC patients, since their quality of life is reduced by gastrointestinal symptoms, such as abdominal pain, bowel urgency, and diarrhoea.
Therefore, the current study investigated whether upadacitinib is more efficacious than placebo after only 2 weeks of therapy1. Patients were randomised 2:1 to upadacitinib (45 mg, once daily) or placebo in both the U-ACHIEVE (NCT02819635) and U-ACCOMPLISH trial (NCT03653026). Clinical remission, clinical response, stool frequency (SFS), and rectal bleeding score (RBS) were the clinical endpoints of this study.
Dr Edward Loftus Jr (Mayo Clinic College of Medicine, MN, USA) presented the results. In both trials, all clinical endpoints demonstrated significant patient benefits of upadacitinib over placebo after 2 weeks of therapy. In the U-ACHIEVE trial, the proportions of patients that had reached the clinical endpoints in the upadacitinib arm were 15% to 40% larger than for the placebo arm, depending which endpoint was observed.
The U-ACCOMPLISH trial showed even more benefits of upadacitinib over placebo, with differences on clinical endpoints ranging from 25% to 40%. In addition, inflammatory markers faecal calprotectin and high-sensitivity C-reactive protein were significantly lower after 2 weeks among upadacitinib receivers compared with placebo receivers.