Rinvoq Now Approved for Crohn’s Disease

Rinvoq (upadacitinib) is a prescription JAK inhibitor that works by blocking pro-inflammatory signaling within cells. In the past, Rinvoq was approved for indications like rheumatoid arthritis, active psoriatic arthritis and ankylosing spondylitis, and moderate-to-severe ulcerative colitis. More recently, reports Healio, the U.S. Food and Drug Administration (FDA) approved Rinvoq for the treatment of adults with moderate-to-severe Crohn’s disease. In particular, this treatment is indicated for patients who cannot use TNF inhibitors or poorly responded to TNF inhibitor treatment.

Rinvoq was approved based on data from the U-EXCEED, U-EXCEL, and U-ENDURE studies. Through these studies, researchers sought to determine the drug’s safety, efficacy, and tolerability. Some of the findings from these studies show that:

  • Rinvoq was able to induce corticosteroid-free remission by 2 weeks in some patients.
  • This treatment has the ability to repair mucosal and intestinal damage and reduces the risk of further damage.
  • By week 12 of the first two studies, 34% and 46% of patients (respectively) showed some response to treatment. This was significantly higher than those receiving the placebo by 31% and 33% respectively. Patients receiving 15 or 30mg saw similar beneficial responses to treatment compared to placebo.
  • Similarly, 15, 30, and 45mg Rinvoq contributed to heightened remission as opposed to placebo. In fact, by the 52nd week of the study, 55% of people receiving 30mg Rinvoq had gone into remission.
  • While Rinvoq was found to be relatively safe, some patients experienced serious side effects such as an increased risk of death or cardiovascular issues, allergic reactions, and infections. These risks are increased in older patients with comorbidities.

About Crohn’s Disease

Crohn’s disease is an inflammatory bowel disease (IBD) characterized by chronic digestive tract inflammation. While any part of the digestive tract can be affected, Crohn’s most often impacts the colon and ileum. Because the inflammation can spread deep into tissues, it can cause severe and sometimes debilitating pain. While doctors don’t know the exact cause of Crohn’s disease, they have identified risk factors: being younger than 30, being Caucasian or of Ashkenazi Jewish descent, smoking, living in an industrialized area, and having a family history of IBD.

People living with Crohn’s disease may experience periods with no symptoms, as well as “flares” (periods of symptoms). Some common symptoms associated with this condition may include:

  • Persistent diarrhea
  • Unintentional weight loss
  • Appetite loss
  • Fatigue
  • Bowel urgency
  • Feeling like the bowels have not been completely emptied
  • Abdominal and rectal pain
  • Bloody stool
  • Anal pain or drainage
  • Mouth sores

Outside of Rinvoq, other treatment options include nutritional therapy, anti-diarrheal medication, anti-inflammatory therapies, antibiotics, and surgery.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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