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Updated: Jun 4, 2025

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
Published on: April 7, 2023
Upadacitinib induction is effective and safe in ulcerative colitis patients including those with prior exposure to
Robert Gilmore1,2, Richard Fernandes1,2, Imogen Hartley3
1Department of Gastroenterology, Mater Hospital, Brisbane, Australia.
Background/Aims:
Upadacitinib is a novel selective Janus kinase inhibitor approved for use in ulcerative colitis. Clinical trials had rigorous criteria and excluded many patient subgroups. Given limited real-world effectiveness data, we examined outcomes of patients treated with upadacitinib for ulcerative colitis in a real-world population.
Methods:
Patients that commenced upadacitinib for moderate-to-severe ulcerative colitis from September 2022 until March 2023 were identified at 13 inflammatory bowel disease centers across Australia. Clinical, biochemical, endoscopic, and intestinal ultrasound outcomes were recorded retrospectively at baseline, week 8, and week 16.
Results:
One hundred and fifty-two patients (61 female [40%], median age 38 years [interquartile range, 28-50]) were included. The primary endpoint of clinical remission was met in 79% at week 8, and 84% at week 16. A total of 42 patients (28%) with prior tofacitinib exposure were included. No significant difference in clinical remission was observed by week 16 between tofacitinib experienced compared to tofacitinib naïve patients (86% vs. 84%, P= 0.67). Complete intestinal ultrasound data was available for 36 patients, showing transmural remission in 64% at week 8 and 81% at week 16, with a decrease in median bowel wall thickness of 2.3 mm and 2.4 mm, respectively.
Conclusions:
Upadacitinib resulted in high rates of clinical remission at 8 and 16 weeks in this large real-world cohort of ulcerative colitis patients. Upadacitinib is effective in patients with prior tofacitinib exposure. Intestinal ultrasound shows significant rates of transmural remission at week 8, sustained through week 16.
Insights
Upadacitinib effectively treats ulcerative colitis, achieving high clinical remission rates in real-world use. It is also effective in patients previously treated with tofacitinib.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Upadacitinib is a selective Janus kinase inhibitor approved for ulcerative colitis treatment.
- Clinical trials often exclude diverse patient subgroups, limiting real-world effectiveness data.
- This study evaluates upadacitinib outcomes in a real-world ulcerative colitis population.
Purpose of the Study:
- To assess the real-world effectiveness and outcomes of upadacitinib in patients with ulcerative colitis.
- To compare upadacitinib efficacy in tofacitinib-experienced versus tofacitinib-naïve patients.
- To evaluate transmural healing using intestinal ultrasound.
Main Methods:
- Retrospective analysis of 152 patients with moderate-to-severe ulcerative colitis treated with upadacitinib across 13 Australian centers.
- Data collected at baseline, week 8, and week 16, including clinical, biochemical, endoscopic, and intestinal ultrasound outcomes.
- Comparison of remission rates between tofacitinib-experienced and -naïve groups.
Main Results:
- High clinical remission rates observed: 79% at week 8 and 84% at week 16.
- No significant difference in week 16 remission between tofacitinib-experienced (86%) and -naïve (84%) patients.
- Intestinal ultrasound showed significant transmural remission (64% at week 8, 81% at week 16) with reduced bowel wall thickness.
Conclusions:
- Upadacitinib demonstrates high clinical remission rates in a real-world ulcerative colitis cohort.
- Upadacitinib is effective in patients with prior tofacitinib exposure.
- Intestinal ultrasound confirms significant and sustained transmural remission.
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