By Cara Murez
health day reporter
FRIDAY, May 19, 2023 (HealthDay News) — Patients with Crohn’s disease have a new treatment option, following the U.S. Food and Drug Administration’s approval of a pill called Rinvoq (upadacitinib).
Rinvoq is intended for the treatment of adults with moderate to severe active Crohn’s disease who have not had success with TNF (tumor necrosis factor) inhibitors. 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 any part of the digestive tract, usually affecting the small intestine and the beginning of the large intestine. Common symptoms include diarrhea, cramps, stomach pain, and weight loss.
The drug has already been 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 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 drug achieved remission than those treated with the placebo, the FDA said in a press release. Additionally, more people treated with the drug showed improvement in 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 treatment. This group received 15 mg or 30 mg once daily or a placebo for one year. More of those on maintenance treatment achieved remission and reduced gut inflammation than those on placebo.
Side effects of the drug were upper respiratory tract infections, anemia, fever, acne, shingles, and headache.
The drug 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, major adverse cardiovascular events, and thrombosis (blood clot).
Patients should take 45 mg of Rinvoq once a day for 12 weeks and then start a maintenance dose of 15 mg. A higher maintenance dose of 30 mg may be considered for patients with refractory, severe, or extensive Crohn’s disease, according to the FDA.
The US National Institutes of Health has more on Crohn’s disease.
SOURCE: US Food and Drug Administration, press release, May 18, 2023