Rapid symptom control for UC patients on upadacitinib

In a population of patients with moderately to severely active ulcerative colitis (UC), control of symptoms was achieved for a significantly greater proportion of patients receiving upadacitinib than for patients receiving placebo after 2 weeks of therapy. This result was consistent for 2 phase 3 induction trials, U-ACHIEVE and U-ACCOMPLISH.

Upadacitinib is an oral, selective, and reversible JAK inhibitor. In 2 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 therapy [1]. 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 score, and rectal bleeding score were the clinical endpoints of this post-hoc analysis of these 2 trials. Dr Edward Loftus Jr (Mayo Clinic College of Medicine, MN, USA) presented the results.

In both trials, all clinical endpoints demonstrated significant patient benefits for upadacitinib over placebo after 2 weeks of therapy. In the U-ACHIEVE trial, the proportion of patients that had reached the clinical endpoints in the upadacitinib arm was 15% to 40% larger than for the placebo arm, depending on the observed endpoint. 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.

1. 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, 03–05 October.

 

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Posted on 27 October, 20218 April, 2024