# Upadacitinib’s Effectiveness and Safety as a Second- or Third-Line Therapy in Patients with Ulcerative Colitis: Data from a Real-World Study

## TL;DR

This study shows that upadacitinib is effective and safe for treating ulcerative colitis in real-world patients.

## Contribution

The study provides the first Italian real-world data on upadacitinib's effectiveness and safety in ulcerative colitis patients.

## Key findings

- Clinical remission and response rates were 45.5% and 63.5% at 8 weeks, increasing to 60.2% and 81.7% at follow-up.
- Mucosal healing was achieved in 84.6% of patients at the median follow-up time.
- Adverse events occurred in 2.5% of patients, and 2% required colectomy.

## Abstract

Background: Upadacitinib (UPA), a selective anti-JAK1 agent, obtained refundability from the Italian National Health System in July 2023 for its use in patients with ulcerative colitis (UC) refractory to other therapies, including anti-TNF-α, anti-integrins, and ustekinumab. At present, no Italian data are available about its effectiveness and safety in the real world. Methods: A retrospective assessment of clinical and endoscopic activity was performed according to the Mayo score. The primary endpoints were to evaluate the effectiveness and safety of UPA. Results: We included 202 consecutive UC patients (M/F 119/83, median age 42). The clinical remission and clinical response rates were 45.5% (92/202) and 63.5% (128/202), respectively, at 8 weeks and 60.2% and 81.7%, respectively, at the end of the follow-up. Clinical remission was achieved more frequently when UPA was used as a first-line rather than a second-/third-line treatment (p = 0.609). Mucosal healing was reported in 84.6% of patients at the median follow-up time. Adverse events occurred in six patients (2.5%), whereas four patients (2%) underwent colectomy. Conclusions: This large real-world study shows that UPA is an effective and safe treatment for UC patients.