FDA Approves Abbvie’s Medication for Crohn’s Disease in Adults

On May 18, 2023, the United States Food and Drug Administration (FDA) approved RINVOQ, manufactured by Abbvie, as a once-daily treatment for adults with moderate or severely active Crohn’s disease (CD). The medication provides an additional treatment option for individuals who have not experienced successful relief from other treatments.  

RINVOQ (upadacitinib) is a selective Janus kinase (JAK) inhibitor that has previously been used to mediate inflammatory responses for patients with eczema, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondylarthritis, and ulcerative colitis. The drug has a higher affinity for JAK-1 than other JAK inhibitors.  

Based on the historical ability to mediate inflammatory disorders, researchers began to explore JAK as a treatment for CD. After launching two induction studies, U-EXCEED and U-EXCEL, and one maintenance study, U-ENDURE, researchers evaluated the endoscopic response and clinical remission after using RINVOQ.  

Each of these studies was a phase 3, double-blind, placebo-controlled study evaluating varying doses of RINVOQ. The induction studies evaluated a 45 mg dose of the drug, while the maintenance study assessed 15 and 30 mg doses.  

According to the press release from Abbvie, an endoscopic response is defined as a reduction in Simplified Endoscopic Score for CD (SES-CD) by at least 50%. In the U-EXCEED trial, 34% of those taking 45 mg of RINVOQ had achieved an endoscopic response by 12 weeks, compared to 3% of participants receiving the placebo.  

Additionally, U-EXCEL data showed that 46% of participants on 45 mg of RINVOQ and only 13% of participants taking the placebo had achieved an endoscopic response by 12 weeks.  

Throughout the maintenance trial, 28% of patients taking 15 mg of RINVOQ had reached the desired endoscopic response within one year. In addition, 41% of patients on 30 mg of RINVOQ had an endoscopic response at one year. Comparatively, only 7% of placebo participants had an endoscopic response after a year.   

Regarding clinical remission, 36% and 46% of participants treated with 45 mg of RINVOQ in the U-EXCEED and U-EXCEL studies, respectively, achieved clinical remission, defined as a Crohn’s disease activity index (CDAI) of less than 150. The proportion of patients achieving clinical remission on the placebo was much lower, at 18% and 23%, respectively.  

In the longitudinal maintenance study, 42% and 55% of patients on 15and 30 mg, respectively, achieved clinical remission. Meanwhile, only 14% of placebo patients had similarly favorable outcomes.  

Although the drug has proven effective and generally safe, some side effect risks include serious infections, blood clots, immune system complications, and allergic reactions. The drug is only recommended for patients who did not have success with one or more TNF blockers.  

"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," said Thomas Hudson, MD, senior vice president of research and development, chief scientific officer, AbbVie, in the press release. “We’re pleased that RINVOQ may provide this relief and is now available to treat Crohn's disease."