First oral treatment approved for moderate to severe Crohn's disease
Upadacitinib (Rinvoq) is now approved to treat adult patients with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.
The FDA has approved the first oral product to treat moderately to severely active Crohn's disease, the agency announced on May 18.
Upadacitinib (Rinvoq) is now approved to treat adult patients with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. The Janus kinase (JAK) inhibitor is also indicated to treat certain patients with other conditions, such as moderate to severe ulcerative colitis and rheumatoid arthritis.
For the new indication, patients should start with 45 mg of the drug once daily for 12 weeks, the FDA said. Following the 12-week period, the recommended maintenance dosage is 15 mg once a day. Clinicians can consider a maintenance dosage of 30 mg once daily in patients with refractory, severe, or extensive Crohn's disease.
Two randomized induction trials of 857 patients evaluated the drug's efficacy and safety. They randomized patients 2:1 to receive 45 mg of the drug or placebo once a day for 12 weeks. At week 12, a greater proportion of those treated with the drug versus placebo achieved clinical remission based on the Crohn's Disease Activity Index (CDAI) and had improvement in intestinal inflammation, as assessed by colonoscopy.
Another trial of 343 patients who responded to 12 weeks of 45 mg of upadacitinib once daily assessed the drug as a maintenance treatment. It randomized patients to receive a maintenance regimen of 15 or 30 mg or placebo once daily for 52 weeks. At week 52, a greater proportion of those treated with either maintenance regimen achieved clinical remission based on the CDAI and had improvement in intestinal inflammation compared with those who received placebo.
The most common side effects of the drug as indicated for Crohn's disease are upper respiratory tract infections, anemia, fever, acne, herpes zoster, and headache. The drug is not recommended for use in combination with other JAK inhibitors, biological therapies for Crohn's disease, or strong immunosuppressants such as azathioprine and cyclosporine. Serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis have occurred with JAK inhibitors, the FDA noted.