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Treatment with upadacitinib was associated with significant clinical remission and endoscopic response in patients with moderate to severe Crohn disease, according to positive topline results from the phase 3 U-EXCEED induction study.
The randomized, double-blind, placebo-controlled U-EXCEED induction study (ClinicalTrials.gov Identifier: NCT03345836) evaluated the efficacy and safety of upadacitinib in adults with moderately to severely active Crohn disease with inadequate response to or intolerance to biologic therapy. Over 60% of the study participants had previously failed 2 or more biologic therapies. Patients were randomly assigned 2:1 to receive upadacitinib 45mg or placebo once daily as induction treatment for 12 weeks.
Results showed that at week 12, a significantly greater proportion of patients treated with upadacitinib achieved clinical remission per Crohn Disease Activity Index (CDAI) compared with those treated with placebo (39% vs 21%, respectively; P <.0001). Similarly, 40% of patients treated with upadacitinib achieved clinical remission as measured by patient-reported symptoms of stool frequency/abdominal pain (SF/AP) at week 12 compared with 14% of the placebo group (P <.0001). Endoscopic response was achieved by 35% of the upadacitinib arm vs 4% of the placebo arm (P <.0001).
Among patients who were receiving corticosteroids at baseline, a significantly higher proportion of patients in the upadacitinib arm achieved steroid-free clinical remission per CDAI and per SF/AP at week 12 compared with placebo. Treatment with upadacitinib also led to a significantly higher proportion of patients achieving early symptom improvement measured by CR-100 (defined as reduction of CDAI 100 points or greater from baseline) at week 2 and clinical remission at week 4 vs placebo. The safety profile of upadacitinib 45mg was consistent with that observed in previous studies across indications.
Upadacitinib, a Janus kinase (JAK) inhibitor, is currently marketed under the brand name Rinvoq® and is approved for the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to tumor necrosis factor blockers.
Reference
Upadacitinib (Rinvoq®) achieved primary and key secondary endpoints in first phase 3 induction study in patients with Crohn’s disease. News release. AbbVie. Accessed December 6, 2021. https://www.prnewswire.com/news-releases/upadacitinib-rinvoq-achieved-primary-and-key-secondary-endpoints-in-first-phase-3-induction-study-in-patients-with-crohns-disease-301437612.html.
