Real-world study reports upadacitinib outcomes in anti-TNF-refractory Crohn’s disease
A retrospective real-world study of 108 Chinese patients with anti-TNF-refractory Crohn’s disease found upadacitinib clinical remission rates of 55.1% at week 12 and 52.5% at week 24.
Upadacitinib was effective, with acceptable safety and favorable treatment persistence, in Chinese patients with moderate-to-severe anti-TNF-refractory Crohn’s disease, according to a retrospective real-world study. A total of 108 patients with moderate-to-severe Crohn’s disease and prior anti-TNF failure or intolerance were included, and clinical remission rates at weeks 12 and 24 were 55.1% and 52.5%, respectively.
Biomarker remission rates were 57.3% and 62.5% at weeks 12 and 24, respectively. Endoscopic reassessment was available for 32 patients. Endoscopic response was achieved in 16 patients (50.0%), of whom 8 (25.0%) attained endoscopic remission.
Pharmacokinetic data from a small subset of 24 patients showed that higher plasma concentrations of upadacitinib were associated with endoscopic remission (p = 0.023). Stricturing Crohn’s disease (OR = 0.32, 95% CI: 0.12–0.84, p = 0.021) and baseline albumin ≤ 35 g/L (OR = 0.22, 95% CI: 0.07–0.62, p = 0.006) were associated with a lower likelihood of clinical remission at week 12.
Twenty patients discontinued treatment, and baseline albumin ≤ 35 g/L (HR = 3.05, 95% CI: 1.26–7.36, p = 0.012) was associated with an increased risk of discontinuation. A total of 22 (20.3%) patients experienced 23 adverse events.
The study included consecutive patients with Crohn’s disease treated with upadacitinib at the First Affiliated Hospital of Anhui Medical University who had at least one follow-up visit. Clinical effectiveness was assessed using the Harvey-Bradshaw Index, and endoscopic effectiveness was evaluated using the Simple Endoscopic Score for Crohn’s Disease.