A new 3-year international study found that many patients with moderate to severe ulcerative colitis remained in remission following long-term treatment with upadacitinib. The findings came from a phase III clinical trial involving patients who previously responded to short-term treatment with the same drug.
Ulcerative colitis is a chronic inflammatory condition of the colon, marked by abdominal pain, diarrhea, and rectal bleeding. Although multiple therapies are available, maintaining long-term remission remains challenging—particularly among patients who don't respond to biologics or conventional treatments.
In the extension study, 369 patients who completed earlier trials and responded to upadacitinib were followed for up to 96 weeks. The participants were randomly assigned to receive either 15 mg or 30 mg of the oral therapy once daily.
At week 96, 76% of the patients in the 15-mg group and 74% of those in the 30-mg group were in clinical remission, as measured by the adapted Mayo score, which includes stool frequency, rectal bleeding, and endoscopic findings. Most patients who entered the study in remission maintained it throughout.
The findings were consistent across sexes and among those with prior biologic treatment failure. In that subgroup, 76% of patients on 15 mg and 78% on 30 mg remained in remission at week 96.
Endoscopic remission—defined as the absence of visible inflammation during colonoscopy—was achieved by nearly half of the participants by week 96. Among those already in endoscopic remission at study entry, 65% (15 mg) and 73% (30 mg) maintained this outcome.
Many of the patients also achieved corticosteroid-free remission. By week 96, 69% of those using corticosteroids at baseline had discontinued the drugs while remaining in clinical remission.
Safety was assessed over 1,027.9 patient-years of treatment. The most commonly reported adverse events included elevated liver enzymes, lymphopenia, neutropenia, and herpes zoster. Serious adverse events were infrequent. Three deaths were reported during the study period as a result of metastatic pancreatic cancer, pulmonary embolism, and septic shock during COVID-19–related hospitalization.
According to the researchers, the long-term safety results aligned with previous upadacitinib trials. They observed that the drug remained effective over time, including in patients with longstanding disease and prior treatment resistance.
Full disclosures are available in the published study.