FDA alert

First Oral Treatment Approved to Treat Moderate, Severe Crohn Disease

Jessica Ganga

The FDA has approved upadacitinib to treat adults with moderate-to-severe Crohn disease. Upadacitinib is the first oral treatment approved by the FDA to treat this disease. The FDA has previously approved upadacitinib for several other conditions including moderate-to-severe rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis.

The approval follows two randomized induction trials that evaluated the efficacy and safety of the oral treatment. In total, 857 patients with moderately to severely active Crohn disease were randomized 2:1 and received 45 mg of treatment or placebo once a day for 12 weeks. At the last week of treatment, a greater proportion of patients who received upadacitinib achieved clinical remission compared to those who received placebo.

Further, a greater proportion of patients who received treatment “demonstrated improvement in intestinal inflammation as assessed by colonoscopy,” according to the press release.

Additionally, 343 patients participated in a study to assess upadacitinib as a maintenance treatment. Participants in the trial responded to 12 weeks of the treatment once daily. Patients received a maintenance regimen of 15 to 30 mg or placebo once daily for 52 weeks. At week 52, a great proportion of participants who received treatment achieved clinical remission when compared to those who received placebo. Additionally, those who received treatment, demonstrated improvement in intestinal inflammation, which was assessed by colonoscopy.

Based on the studies, patients should start treatment with 45 mg of upadacitinib once daily for 12 weeks. Following the initial treatment, the recommended maintenance dosage is 15 mg once a day. For patients with refractory, severe, or extensive Crohn disease, a 30 mg once daily dose may be considered.

The common adverse events included upper respiratory tract infections, anemia, fever, acne, herpes zoster, and headache



FDA approves first oral treatment for moderately to severely active Crohn disease. News release. US Food and Drug Administration; May 18, 2023. Accessed May 25, 2023.