Background
The U-ACTIVATE study is looking at how effective and safe the medicine upadacitinib is for people with moderate to severe ulcerative colitis over a long time. This report shares findings after 3 years of treatment.
Study Details
This study is ongoing and will last 288 weeks. It involves 307 centers in 43 countries, starting on January 31, 2017. Patients aged 16 to 75 with active ulcerative colitis for at least 90 days were included. Those who responded well to initial treatment with upadacitinib were eligible for further studies.
Findings
A total of 414 patients were eligible for the long-term study. Out of these, 369 patients received upadacitinib: 142 took 15 mg and 227 took 30 mg. After 48 weeks, 71% of patients on 15 mg and 67% on 30 mg were in clinical remission. By 96 weeks, these numbers improved to 76% and 74%, respectively.
Endoscopic Remission
Endoscopic remission was also assessed. At 48 weeks, 49% of patients on 15 mg and 46% on 30 mg achieved this. By 96 weeks, the rates were 47% for 15 mg and 45% for 30 mg.
Safety Outcomes
In terms of safety, 467 patients were monitored for side effects. The rate of treatment-related adverse events was about 238 events per 100 patient-years for 15 mg and 233 for 30 mg. Serious side effects occurred at a rate of 11.7 and 12.4 events per 100 patient-years, respectively.
Conclusions
The study shows that upadacitinib has a good long-term safety and effectiveness profile for patients with moderately to severely active ulcerative colitis.
Next Steps
Healthcare providers can use these results to set clear treatment goals for patients. It is important to monitor outcomes and adjust treatments as necessary. AI tools can help track patient progress and improve management strategies.
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