FDA Approves First Pill to Treat Moderate-to-Severe Crohn Disease

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

Rinvoq is meant to treat adults with moderately to severely active Crohn disease who have not had success with tumor necrosis factor blockers. The daily pill is the first oral treatment for this group of patients.

The medication 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 effectiveness in two randomized trials in 857 patients with the disease. Participants received either 45 mg of 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 medication had improvement in intestinal inflammation, which was assessed with a colonoscopy.

The FDA also assessed Rinvoq as a maintenance treatment, evaluating 343 patients who had responded to the 12 weeks of medication. This group received 15 or 30 mg once daily or a placebo for a year. More of those on the maintenance treatment achieved remission and reduced intestinal inflammation than those on the placebo. Side effects of the medication were upper respiratory tract infections, anemia, fever, acne, herpes zoster, and headache.

The drug is not recommended for use with other Janus kinase inhibitors, biological therapies for Crohn disease, or strong immunosuppressants, including azathioprine and cyclosporine. Among the risks are serious infections, death, cancer, major adverse cardiovascular events, and thrombosis.