The FDA has approved the first pill to treat moderate to severe Crohn’s disease
Written by Cara Murez
Health Day reporter
FRIDAY, May 19, 2023 (HealthDay News) — Crohn’s disease patients have a new treatment option after the U.S. Food and Drug Administration approved a pill called Rinvoq (upadacitinib).
Rinvoq is used to treat adults with moderately to severely active Crohn’s disease who have not had success with TNF (tumor necrosis factor) blockers. The daily tablet is the first oral treatment for the patient group.
Crohn’s is a chronic inflammatory bowel disease. It causes inflammation in any part of the digestive system, typically affecting the small intestine and the beginning of the large intestine. Common symptoms include diarrhea, cramps, stomach pain, and weight loss.
According to drugmaker AbbVie’s website, the drug has previously been approved for a number of other conditions, including eczema, rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.
Researchers evaluated its safety and effectiveness in two randomized trials involving 857 patients with the disease. Participants received 45 mg of Rinvoq or a placebo daily for 12 weeks.
According to the FDA statement, more patients treated with the drug achieved remission than those treated with a placebo. In addition, more people treated with the drug improved bowel inflammation, which was assessed by colonoscopy.
The FDA also evaluated Rinvoq as a maintenance treatment, evaluating 343 patients who responded to 12 weeks of the drug. This group received either 15 mg or 30 mg or a placebo once daily for one year. More people receiving maintenance treatment achieved remission and reduced intestinal inflammation than those taking placebo.
Side effects of the drug included upper respiratory tract infections, anemia, fever, acne, herpes zoster, and headache.
The drug is not recommended for use with other Janus kinase (JAK) inhibitors, biologic therapies for Crohn’s disease, or strong immunosuppressants, including azathioprine and cyclosporine.
Risks include serious infections, death, cancer, serious cardiovascular events, and thrombosis (blood clot).
Patients should take 45 mg of Rinvoq once daily for 12 weeks and then start on a maintenance dose of 15 mg. According to the FDA, a higher maintenance dose of 30 mg may be considered in patients with refractory, severe, or extensive Crohn’s disease.
The US National Institutes of Health has more coverage of Crohn’s disease.
SOURCE: US Food and Drug Administration, press release, May 18, 2023