Upadacitinib stays effective for 1 year in real-world UC patients

Treatment with upadacitinib appears to yield high and durable remission rates in patients with ulcerative colitis (UC), according to 1-year data from a real-world study.

In an ongoing multicentre cohort of patients who received upadacitinib in routine clinical practice, 62.5 percent of patients achieved the primary outcome of clinical remission at 1 year. Three-quarters (75.9 percent) of patients had endoscopic response, of which 58.6 percent were in remission, and a total of 66.6 percent had histologic remission. [Huang K, et al, CCC 2026]

These outcomes occurred earlier for many patients, noted first author Dr Katherine Huang from the Washington University School of Medicine in St. Louis, Missouri, US. At 6 months, clinical remission was observed in 51.6 percent of patients, endoscopic response in 75 percent, and histologic remission in 40.8 percent.

Further analysis demonstrated the durability of outcomes, with most patients maintaining their responses over time, Huang added. Thirty out of 42 patients who achieved clinical remission at 6 months remained in remission at 1 year (71.4 percent). Similarly, 11 out of 24 patients had durable endoscopic improvement (45.8 percent), and seven out of 20 patients showed durable histologic remission (35 percent).

Treatment was safe, with adverse events (AEs) reported in 12.7 percent of patients. Herpes zoster occurred in seven patients (2.1 percent). One patient aged 53 years sustained an episode of transient ischaemic attack after 1 year on upadacitinib at 15 mg and without pre-existing cardiovascular risk factors. This patient is still using upadacitinib at the same dose, according to Huang.

“There were no reported episodes of worsening of pre-existing cardiovascular disease or deep vein thrombosis/pulmonary embolism,” she added.

Recapturing responses

A notable finding was that dose re-escalation to 45 mg successfully recaptured response in the subset of 35 patients who relapsed (n=18) or had an incomplete initial response (n=17), Huang pointed out.

All 17 patients who had an incomplete response during induction treatment achieved clinical response after dose re-escalation, with 11 (64.7 percent) having gone into remission. Meanwhile, for 13 of the 18 patients (72.8 percent) who relapsed, remission was recaptured following dose re-escalation.

Overall, more than half of the patients who underwent dose re-escalation (54.3 percent) continued treatment at 45 mg daily.

Overall, tThe findings provide further evidence to support the American Gastroenterological Association’s guideline, which classifies upadacitinib as a high-efficacy medication in adult patients with UC, Huang said. [Gastroenterology 2024;167:1307-1343] 

“Ongoing recruitment will provide further evidence on long term effectiveness and safety,” she added.

Study details

A total of 416 patients who were started on upadacitinib for active UC were included in the study. The median age at treatment initiation 36 years, 52.4 percent were male, 73.6 percent were White, and the median BMI was 26 kg/m². The median disease duration was 7 years, and 66.1 percent of patients had extensive colitis.

Of the patients, 206 (49.52 percent) had available follow-up data at 1 year. The duration of induction treatment was 8 weeks in 86.5 percent of patients and 16 weeks in 4.8 percent. Most patients received an induction dose of 45 mg (97.1 percent) and maintenance dose of 30 mg (85.8 percent).