FDA Approves Upadacitinib for Adults With Moderately to Severely Active Crohn Disease


In clinical trials of patients with Crohn disease, upadacitinib demonstrated early and long-term symptom relief, as well a visible reduction of damage to the intestinal lining caused by excess inflammation.

The FDA has approved upadacitinib (Rinvoq, AbbVie) for the treatment of adult patients with moderately to severely active Crohn disease and who have shown an inadequate response or intolerance to 1 or more TNF blockers. This is the seventh FDA approval for upadacitinib, which is a JAK inhibitor indicated across serval immune-mediated inflammatory diseases, demonstrating greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.

The approval was based on findings from a trio of phase 3 clinical trials, including 2 induction studies, U-EXCEED (NCT03345836) and U-EXCEL (NCT03345849), and 1 maintenance study, U-ENDURE (NCT03345823). These trials evaluated the efficacy and safety of upadacitinib 45 mg once daily as induction therapy and upadacitinib 15 and 35 mg once daily as maintenance therapy in adults with moderately to severely active Crohn disease.

"Symptoms of moderately to severely active Crohn's disease can be disruptive and uncomfortable for patients, so relief as early as possible is key. Given the progressive nature of the disease, endoscopic response is just as important," U-EXCEL study investigator Edward V. Loftus, Jr., MD, professor of medicine in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota, said in a press release. "Based on the clinical trial results, treatment with Rinvoq shows both early and long-term symptom relief along with evidence of a visible reduction of damage to the intestinal lining caused by excess inflammation."

The topline results from the U-EXCEED and U-EXCEL induction studies were announced in December 2021 and February 2022, respectively. The topline results from the U-ENDURE maintenance study were announced in May 2022.

Across all studies, investigators found that significantly more individuals treated with upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response. Additionally, investigators observed clinical remission measured by the Crohn’s Disease Activity Index (CDAI) by patient-reported symptoms of stool frequency/abdominal pain (SF/AP).

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. 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 findings across all 3 double-blinded, multicenter, placebo-controlled, and randomized studies were generally consistent with the known safety profile of upadacitinib with no new safety risks observed. Serious adverse events related to upadacitinib include allergic reactions; an increased risk of death for those aged 50 years and older with at least 1 cardiovascular (CV) risk factor, cancer, and immune system issues; an increased risk of major CV events; blood clots; and serious infection.

"AbbVie recognizes the need for more treatment options for Crohn's disease that can help address both rapid relief of symptoms along with the visible reduction of intestinal lining damage," Thomas Hudson, MD, senior vice president of research and development, chief scientific officer, AbbVie, said in a press release. "We're pleased that Rinvoq may provide this relief and is now available to treat Crohn's disease."


U.S. FDA Approves RINVOQ® (upadacitinib) as a Once-Daily Pill for Moderately to Severely Active Crohn's Disease in Adults. AbbVie. News release. May 18, 2023. https://news.abbvie.com/news/press-releases/us-fda-approves-rinvoq-upadacitinib-as-once-daily-pill-for-moderately-to-severely-active-crohns-disease-in-adults.htm.

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