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 ( 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.


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.