FDA Approves RINVOQ (upadacitinib) Once Daily for Adults with Moderately to Severely Active Crohn's Disease

Recently, AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF inhibitors. This is the seventh indication for RINVOQ in the fields of gastroenterology, dermatology, and rheumatology to receive FDA approval. In the field of gastroenterology, RINVOQ is now approved in the United States for the treatment of ulcerative colitis and Crohn's disease.

This approval is supported by data from two induction studies (U-EXCEED and U-EXCEL) and the U-ENDURE maintenance study. Compared with the placebo group, the FDA-assessed co-primary endpoints and key secondary endpoints in the induction study for RINVOQ 45 mg and in the maintenance study for RINVOQ 15 mg and 30 mg were statistically significant.

Endoscopic Response: In two induction studies, 34% and 46% of patients receiving RINVOQ 45 mg achieved endoscopic response at week 12 (defined as a >50% reduction from baseline in the Simplified Endoscopic Score for Crohn's Disease [SES-CD], or for patients with isolated ileal disease and a baseline SES-CD score of 4, at least a 2-point reduction from baseline), compared to 3% and 13% of patients receiving placebo. In the maintenance study, 28% and 41% of patients receiving RINVOQ 15 mg and 30 mg, respectively, achieved endoscopic response at week 52, compared to 7% of patients receiving placebo.

Clinical RemissionIn two induction studies, 36% and 46% of patients receiving RINVOQ 45 mg achieved clinical remission (defined as Crohn's Disease Activity Index [CDAI] < 150) at week 12, compared to 18% and 23% of patients receiving placebo. Additionally, in the maintenance study, 42% and 55% of patients receiving RINVOQ 15 mg and 30 mg, respectively, achieved clinical remission at week 52, compared to 14% of patients receiving placebo.

Rapid Clinical Response and Steroid-Free Clinical Remission

In U-EXCEED and U-EXCEL, a clinical response based on CDAI was observed as early as two weeks, with a greater proportion of patients receiving RINVOQ achieving a clinical response at week 2 compared to placebo.

This is the first approved drug for moderate to severe Crohn's disease that requires steroid tapering during the induction phase of a clinical program, with the regimen beginning steroid tapering at week 4. Compared to the placebo group (11% and 13%, respectively), more patients treated with RINVOQ in the U-EXCEED and U-EXCEL groups achieved steroid-free clinical remission at week 12 (defined as discontinuation of steroids and achieving clinical remission based on CDAI [CDAI less than 150]), with rates of 30% and 40%, respectively. In U-ENDURE, the percentages of patients receiving RINVOQ 15 mg and 30 mg who achieved steroid-free remission (defined as no steroid use in the previous 90 days up to week 52 and achieving clinical remission) were higher (42% and 53%, respectively) compared to those receiving placebo (14%).

RINVOQ Safety

Overall, the safety profile observed in Crohn's disease patients treated with RINVOQ is consistent with the known safety profile of RINVOQ for other indications.

Editor: Liuli

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