Upadacitinib Extended Induction Therapy Safe, Effective for UC

An additional 8 weeks of therapy with upadacitinib 45 mg resulted in a clinically meaningful response among patients with moderately to severely active ulcerative colitis (UC) who did not respond to an initial 8-week induction period therapy, a recent study published in Alimentary Pharmocology and Therapeutics found.

“This shows that 16 weeks of extended induction treatment with upadacitinib 45 mg led to achievement of clinical response in a clinically meaningful proportion of patients who do not respond to 8 weeks of induction therapy,” the authors of the study wrote.

Patients without clinical response to 8 weeks' upadacitinib 45 mg once daily induction therapy were eligible for an additional 8 weeks of therapy. After 16 weeks, these patients were rerandomised either to upadacitinib 15 or upadacitinib 30 mg once daily for 52-week maintenance therapy.

The primary end points were efficacy and safety of the drug at induction week 16 and maintenance week 52.

Of the 663 patients initially enrolled for 8 weeks, 127 patients (19.2%) did not achieve clinical response to upadacitinib 45 mg at week 8 and received an additional 8 weeks of therapy. After the additional 8 weeks, 75 of these patients (59.1%) subsequently achieved clinical response at week 16 and entered the maintenance trial.

At week 52, 43.6% of patients receiving upadacitinib 30 mg and 26.5% of patients receiving upadacitinib 15 mg achieved clinical remission. The investigators found that the rates of herpes zoster were higher among patients in the extended 16-week induction trial compared to the patients in the 8-week induction cohort.

There were no adjudicated gastrointestinal perforations, adjudicated venous thromboembolic events, or malignancies identified in either the induction or maintenance trials.

Reference:
Panaccione R, Danese S, Zhou W et al. Efficacy and safety of upadacitinib for 16-week extended induction and 52-week maintenance therapy in patients with moderately to severely active ulcerative colitis. Aliment Pharmacol Ther. 2024: 59; 393–408. DOI: https://doi.org/10.1111/apt.17816