A Phase 3 study of upadacitinib, an ulcerative colitis treatment, met both its primary and secondary endpoints, according to an announcement from AbbVie. The trial, titled U-ACCOMPLISH, saw a third of participants reach clinical remission after eight weeks of treatment. Researchers are very excited by these results; they demonstrate the potential that upadacitinib has to improve the lives of ulcerative colitis patients.
About Ulcerative Colitis
Ulcerative colitis is a form of inflammatory bowel disease that impacts approximately 700,000 people throughout the United States. It is characterized by sores and ulcers in the large intestine, which then lead to symptoms like weight loss, nausea, anemia, cramping, joint pain, fatigue, loose bowel movements, blood in the stool, and rash. Unfortunately, there is no cure for this condition; however, treatment can lead to remission. Doctors often prescribe biologics, corticosteroids, antibiotics, immunomodulators, and aminosalicylates. In very severe cases, surgery may be necessary to remove part of or the entirety of the colon.
Data from U-ACCOMPLISH
According to the data released from AbbVie, 74% of patients receiving upadacitinib saw a clinical response by week 8, which can be compared to just 25% of the placebo group. Looking deeper into these numbers, we see that 63% off the upadacitinib-treated group reached a clinical response after only two weeks. 25% of the placebo group saw the same.
Further data includes:
- Upadacitinib-treated group saw 44% of its participants reach endoscopic improvement. Only 8% of the placebo group reached this improvement.
- 37% of the upadacitinib-treated group met histologic-endoscopic mucosal improvement, compared to 6% of the placebo group
- All ranked secondary endpoints were achieved
- Consistent safety profile with no new observable risks
- Common adverse events consisted of acne, anemia, and blood creatine phosphokinase increase.
- 3.2% of the upadacitinib group and 4.5% of the placebo group experienced a serious adverse event.
These results are very exciting to researchers, patients, and other medical professionals, as they demonstrate that upadacitinib is a viable treatment for ulcerative colitis.
Find the source article here.