FDA approves first pill to treat moderate to severe Crohn’s disease

By Cara Murez

HealthDay Reporter

FRIDAY, May 19, 2023 (HealthDay News) — Patients with Crohn’s disease have a new treatment option after the US Food and Drug Administration (FDA) approved a pill called Rinvoq ( upadacitinib).

Rinvoq is designed to treat adults with moderately to severely active Crohn’s disease who have not been successful with TNF (tumor necrosis factor) blockers. The daily pill is the first oral treatment for this group of patients.

Crohn’s disease is a chronic inflammatory bowel disease. It causes inflammation anywhere in the digestive tract, typically affecting the small intestine and the beginning of the large intestine. Common symptoms include diarrhea, cramps, stomach pain, and weight loss.

The drug was previously approved for several other conditions, including eczema, rheumatoid arthritis, psoriatic arthritis and ulcerative colitis, according to the website of pharmaceutical company AbbVie.

Researchers evaluated its safety and efficacy in two randomized trials in 857 patients with the disease. Participants received 45 mg of Rinvoq or a placebo daily for 12 weeks.

More patients treated with the drug achieved remission than those treated with placebo, the FDA said in a news release. In addition, more people treated with the drug had improved intestinal inflammation, which was evaluated with a colonoscopy.

The FDA also evaluated Rinvoq as a maintenance treatment, evaluating 343 patients who had responded to 12 weeks of medication. This group received either 15 mg or 30 mg once daily or a placebo for one year. More of those who received the maintenance treatment achieved remission and reduced intestinal inflammation than those who received the placebo.

Side effects of the drug were upper respiratory tract infections, anemia, fever, acne, shingles, and headache.

Use of the drug with other Janus kinase (JAK) inhibitors, biologic therapies for Crohn’s disease, or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Risks include serious infections, death, cancer, major adverse cardiovascular events, and thrombosis (blood clots).

Patients should take Rinvoq 45 mg once daily for 12 weeks and then start on a 15 mg maintenance dose. A higher maintenance dose of 30 mg may be considered for patients with refractory, severe, or extensive Crohn’s disease, according to the FDA.

More information

The US National Institutes of Health has more about Crohn’s disease.

SOURCE: US Food and Drug Administration, news release, May 18, 2023