Upadacitinib Shows Efficacy Among Biologic-Exposed Patients With Crohn’s Disease

Upadacitinib demonstrated significantly higher rates of clinical remission and endoscopic response compared to placebo in patients with moderate to severe Crohn’s disease, according to data from the U-EXCEL, U-EXCEED, and U-ENDURE trials, investigators reported in Clinical Gastroenterology and Hepatology

Researchers aimed to evaluate upadacitinib's effectiveness based on patients' prior biologic failure status, as biologic failure is often linked with reduced response to subsequent treatments. In the study, patients were initially randomized to either placebo or upadacitinib (45 mg) for 12 weeks of induction treatment. Clinical responders were then rerandomized in the maintenance phase to receive placebo, upadacitinib 15 mg, or upadacitinib 30 mg for 52 weeks. Out of total of 1,021 patients 71.8% had experienced prior biologic failure.

Results showed that upadacitinib significantly outperformed placebo across all groups, including those with prior biologic failure. During the induction phase, clinical remission rates for upadacitinib-treated patients were 54.0% for those without prior biologic failure and 42.2% for those with failure, compared to 28.3% and 14.1% for placebo, respectively.

Similarly, endoscopic response rates were higher in the upadacitinib group. In the maintenance phase, patients with prior biologic failure treated with upadacitinib 30 mg showed substantial improvements, with clinical remission rates of 42.5% compared to 8.7% for placebo.

Patients who had not been exposed to biologics prior to receiving upadacitinib experienced fewer adverse events and slightly better results. However, these findings suggest upadacitinib's potential efficacy regardless of prior biologic exposure.

Reference
Peyrin-Biroulet L, Panaccione R, Louis E, et al. Upadacitinib achieves clinical and endoscopic outcomes in crohn's disease regardless of prior biologic exposure. Clin Gastroenterol Hepatol. Published online March 15, 2024. doi: 10.1016/j.cgh.2024.02.026.