AbbVie announced positive top-line results from U-EXCEL, a Phase 3 induction study, showing upadacitinib (45 mg once daily) achieved both primary endpoints of clinical remissiona, and endoscopic responsec at week 12.1 U-EXCEL is the second of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe Crohn's disease who had an inadequate response or were intolerant to conventional or biologic therapy.1
"The results from this study reaffirm the data from U-EXCEED and demonstrate the potential impact that upadacitinib could have on clinical and endoscopic outcomes in patients with moderate to severe Crohn's disease," said Michael Severino, M.D., vice chairman and president, AbbVie. "Our decades of collaboration with the gastroenterology community demonstrates AbbVie's commitment to the discovery and development of multiple treatment options for patients with inflammatory bowel diseases."
U-EXCEL included the same primary and key secondary endpoints as U-EXCEED, with clinical remission measured by the Crohn's Disease Activity Index (CDAI) and by the patient-reported symptoms of stool frequency/abdominal pain (SF/AP).1 A significantly greater proportion of patients treated with a 12-week induction regimen of upadacitinib 45 mg daily achieved clinical remission per CDAI at week 12 compared to placebo (49 percent versus 29 percent; p<0.0001).1 Similar results were observed with clinical remission per SF/AP (51 percent in upadacitinib-treated patients versus 22 percent in placebo-treated patients; p<0.0001).1 At week 12, a significantly greater proportion of patients treated with upadacitinib 45 mg achieved endoscopic response compared to the placebo group (46 percent versus 13 percent; p<0.0001).1
Consistent with results from the U-EXCEED induction study, a significantly higher proportion of patients receiving upadacitinib 45 mg also achieved steroid-free clinical remissiond per CDAI and per SF/AP compared to placebo at week 12 among patients taking corticosteroids at baseline.1 Early symptom improvement measured by CR-100 (defined as reduction of CDAI ≥100 points from baseline) at week two as well as clinical remission at week four were also achieved by a significantly higher proportion of patients receiving upadacitinib 45 mg.1
"It is impressive to see the meaningful response that was achieved in this study in patients with moderate to severe Crohn's disease who have had inadequate response to an immunosuppressant or a biologic," said Edward V. Loftus Jr., M.D., professor of medicine in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota, and U-EXCEL study investigator. "These results suggest that upadacitinib may help patients who are unable to control their disease, including symptoms and intestinal inflammation, despite prior conventional or biologic treatment options."