A significantly greater proportion or patients treated with either 15 or 30 mg show remission or endoscopic response or remission at week 52 compared with the placebo.
AbbVie announced positive topline results from U-ENDURE, a phase 3 maintenance study that evaluated upadacitinib in adults with moderate-to-severe Crohn disease who had an inadequate response or were intolerant to a biologic or conventional therapy, the company said in a statement.
The study results showed that more individuals treated with either the 15- or 30-mg dosage of upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response, as well as the secondary endpoint of endoscopic remission, at 1 year compared with the placebo.
Use of upadacitinib in Crohn disease has not been evaluated by health authorities, and the results of the maintenance study, in addition to results from the U-EXCEED or U-EXCEL induction studies, will be included in future regulatory submissions, AbbVie said.
In the U-ENDURE maintenance study, individuals from the U-EXCEED and U-EXCEL who responded to 12 weeks of upadacitinib at 45 mg oral induction treatment were re-randomized to receive upadacitinib at 15 mg, 30 mg, or the placebo.
Investigators defined clinical remission by the Crohn Disease Activity Index (CDAI) or by the stool frequency and abdominal pain score (SF/AP).
A significantly higher proportion of individuals who received either dose of upadacitinib achieved clinical remission per the CDAI at week 52, at 37% for the 15-mg arm and 48% for the 30-mg arm compared with 15% for the placebo arm.
The results showed that 36% and 46% of individuals who received the 15- and 30-mg doses, respectively, achieved clinical remission at 52 weeks per the SF/AP compared with 14% in the placebo group.
At week 52, 28% and 40% of individuals who received the doses, respectively, achieved endoscopic response compared with 7% of individuals taking the placebo. Additionally, 19% and 29%, respectively, of individuals who received upadacitinib achieved endoscopic remission compared with 5% on the placebo.
A higher proportion of individuals who received upadacitinib at either dosage achieved corticosteroid-free clinical remission per the CDAI and per the SF/AP compared with the placebo at week 52 among those taking corticosteroids at baseline.
The safety results of upadacitinib were generally consistent with the safety profile observed in the phase 3 induction studies in Crohn disease, as well as the known safety profile of upadacitinib. No deaths were reported throughout the study, and no new safety risks were identified.
The most common adverse events were arthralgia, exacerbation of Crohn disease, and pyrexia.
Investigators included a total of 673 individuals who completed the 12-week upadacitinib induction treatment with clinical response and received at least 1 dose of the study drug in the placebo-controlled maintenance period.
The U-ENDURE phase 3 study was designed to evaluate the efficacy and safety of upadacitinib as maintenance therapy compared with the placebo in individuals with moderate-to-severe Crohn disease who responded to upadacitinib induction treatment in the U-EXCEED or U-EXCEL induction study.
The full results will be presented at upcoming medical conferences and published in a peer-reviewed medical journal, AbbVie said.
Upadacitinib (Rinvoq) achieved clinical remission and endoscopic response at one year in phase 3 maintenance study in patients with Crohn's disease. May 11, 2022. Accessed May 11, 2022. https://news.abbvie.com/news/press-releases/upadacitinib-rinvoq-achieved-clinical-remission-and-endoscopic-response-at-one-year-in-phase-3-maintenance-study-in-patients-with-crohns-disease.htm