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

By Kara Murez

HealthDay reporter

FRIDAY, May 19, 2023 (HealthDay News) — Crohn’s disease patients have a new treatment option, following U.S. Food and Drug Administration approval of a pill called Rinvoq (upadacitinib).

Rinvoq is indicated for the treatment of adults with moderately to severely active Crohn’s disease who have not had success with tumor necrosis factor (TNF) 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 in every part of the digestive tract, mostly in the small intestine and the beginning of the large intestine. Common symptoms include diarrhea, cramping, 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 pharmaceutical company AbbVie’s website.

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

More patients treated with the medication achieved remission than those treated with the placebo, the FDA said in a news release. Also, more people treated with the drug had an improvement in bowel inflammation, which was assessed with a colonoscopy.

The FDA also evaluated Rinvoq as a maintenance treatment and evaluated 343 patients who had responded to the 12-week medication. This group received 15 mg or 30 mg once a day or a placebo for a year. More of those who received the maintenance treatment achieved remission and reduced bowel inflammation than those who received the placebo.

Side effects of the medication included upper respiratory infections, anemia, fever, acne, herpes zoster, and headache.

The medicine is not recommended for use with other Janus kinase (JAK) inhibitors, biologic therapies for Crohn’s disease, or with strong immunosuppressants, including azathioprine and cyclosporine.

Risks include serious infections, death, cancer, serious cardiovascular side effects and thrombosis (blood clot).

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

More information

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

SOURCE: U.S. Food and Drug Administration press release, May 18, 2023