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FDA approves Rinvoq as first pill to treat moderate-to-severe Crohn's disease

Posted at 3:35 PM, May 22, 2023
and last updated 2023-05-22 18:20:13-04

(WXYZ) — A new drug has been approved by the Food and Drug Administration to treat moderate-to-severe Crohn's disease. It’s called Rinvoq, a pill that adults can take daily.

The data looks pretty good, and I am very hopeful that this new treatment will help some patients because Crohn’s can be a painful and debilitating disease, and it’s not curable.

If you have Crohn’s, it means you have chronic inflammatory bowel disease. Patients have inflammation of the lining of the digestive tract. And any part of the small or large intestine can be involved. Unfortunately, the disease can have a huge impact on a person’s life. Common symptoms include diarrhea, fever, fatigue, cramping, stomach pain, blood in the stool, mouth sores and weight loss.

Now, there are treatments that help manage Crohn's. However, this particular drug is for adults that have not had success with other preapproved drugs called TNF blockers. The FDA gave the green light for Rinvoq after looking at two randomized trials.

They included 857 patients with moderately to severely active Crohn’s disease. Over 12 weeks, participants were given either 45 mg of Rinvoq or a placebo. And researchers found that more patients treated with the new drug had clinical remission compared to the placebo group.

On top of that, Rinvoq was found to be safe to take as a maintenance treatment at a lower dose for a longer period of time.

The most common side effects noted by the FDA were upper respiratory tract infections, anemia, fever, acne, headache and herpes zoster — otherwise known as shingles.

Patients who take Rinvoq can not use it with other Janus kinase inhibitors, biological therapies for Crohn’s disease or with strong immunosuppressants. And while Rinvoq has been newly approved for Crohn’s, it was already approved for other health conditions.

I want to mention that patients considering this drug for Crohn's should be aware that serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis have occurred with Janus kinase inhibitors inhibitors such as Rinvoq.

While this is concerning, I’ve treated many patients suffering from Crohn’s who are desperate to get relief. So I strongly advise those with Crohn’s to talk to their doctor. With the right therapies, this disease can be managed, and patients can experience healing of inflammation and long-term remission.