Upadacitinib (RINVOQ; AbbVie), 15 mg or 30 mg and once daily, met the primary endpoint of clinical remission and all secondary endpoints at week 52 in a phase 3 ulcerative colitis study.
Upadacitinib (RINVOQ; AbbVie), 15 mg or 30 mg and once daily, met the primary endpoint of clinical remission and all secondary endpoints at week 52 in a phase 3 ulcerative colitis study. A significant number of patients receiving upadacitinib achieved clinical remission at week 52 versus placebo, according to AbbVie.
"Ulcerative colitis is a disease with unpredictable symptoms and frequent flares, which can make daily life challenging," said Michael Severino, MD, vice chairman and president, AbbVie, in a press release. "We are encouraged by these results that demonstrate upadacitinib's potential as a treatment option for patients with moderate to severe ulcerative colitis."
Adults with moderate to severe ulcerative colitis who achieved a clinical response following an 8-week study period of once-daily upadacitinib induction treatment were analyzed in this study. The patients were re-randomized to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo for an additional 52 weeks.
The study showed all of the secondary endpoints being met, including the achievement of endoscopic improvement, histologic-endoscopic mucosal improvement and corticosteroid-free clinical remission at week 52. Patients treated with upadacitinib, 15 mg (49%) and patients treated with upadacitinib, 30 mg (62%) achieved endoscopic improvement at 52 weeks versus 14% of patients in the placebo group. Additionally, 35% of the 15 mg group and 49% of the 30 mg group achieved histo-endoscopic mucosal improvementcompared to 12% of patients in the placebo group, according to the study authors.
When looking at the patients who were in remission at the completion of the 8-week induction studies, 57% of patients achieved corticosteroid-free remission in the upadacitinib 15 mg group and 68% achieved this in the upadacitinib 30 mg group compared to 22% of patients in the placebo group.
"Ulcerative colitis is a challenging disease to manage, and many patients do not find relief from their most burdensome symptoms," said Remo Panaccione, MD, professor of medicine and director of the IBD unit at the University of Calgary, in the press release. "These positive results demonstrate upadacitinib's potential to achieve improvements in clinical, endoscopic and histological outcomes at 52 weeks. This is promising news for the IBD community."
The safety results in both groups were consistent with the safety profile observed in the phase 3 induction studies in ulcerative colitis, as well as in previous studies across indications, with no new safety risks arising. The most common adverse events observed during the 52-week period were nasopharyngitis, exacerbation of ulcerative colitis, and blood creatine phosphokinase increase. Further, the rate of adverse events leading to treatment discontinuation per 100 patient years were 7.6 events and 7.9 events in patients receiving upadacitinib 15 mg and upadacitinib 30 mg, respectively, compared with 24.3 events in the placebo group, according to the study authors.
Upadacitinib (RINVOQ®) Met the Primary and All Secondary Endpoints in the 52-Week Phase 3 Maintenance Study in Ulcerative Colitis Patients. AbbVie. Published June 29, 2021. Accessed July 1, 2021. https://news.abbvie.com/news/press-releases/upadacitinib-rinvoq-met-primary-and-all-secondary-endpoints-in-52-week-phase-3-maintenance-study-in-ulcerative-colitis-patients.htm