Positive results from a Second Phase 3 Induction Study, U-ACCOMPLISH, provides hope for another treatment option for the 1.6 million Americans currently living with ulcerative colitis. Upadacitinib (RINVOQ™) is an oral therapy (once daily, 45 mg) developed by AbbVie that is shown to improve clinical, endoscopic and histologic outcomes for patients living with ulcerative colitis. See chart below.
AbbVie announced that the study results showed that 33 percent of patients taking upadacitinib achieved the primary endpoint of clinical remission (per Adapted Mayo Score) versus 4% placebo at week 8. All ranked secondary endpoints were met and this reaffirms consistent findings from the first Phase 3 induction study, U-ACCOMPLISH, with no new safety risks observed. The clinical trial comprised of 522 randomized participants age 16 to 75 years of age.
Ulcerative colitis is considered to be a chronic inflammatory bowel disease (IBD) of the large intestine in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers. This leads to mucous being produced that causes abdominal pain and the need to empty the colon. This condition is a not well understood and believed to be the result of your immune system’s overactive response.
This news brings hope to a large population of people burdened by the disease. According to the Crohn’s & Colitis Foundation (2011) of the 1.6 million Americans currently living with ulcerative colitis, as many as 80,000 are children. This is a growing disease with 70,000 new cases of inflammatory bowel disease (IBD) diagnosed every year in the United States.
Upadacitinib expands the treatment landscape for the patients struggling to manage moderate to severe ulcerative colitis and several other immune-mediated diseases.
| U-ACCOMPLISH Efficacy Results at Week 8*,1 | ||
| Upadacitinib 45 mg, once daily (n=341) | Placebo (n=174) | |
| Clinical remission (per Adapted Mayo Score)a,† | 33% | 4% |
| Clinical response (per Adapted Mayo Score)b,† | 74% | 25% |
| Endoscopic improvementc,† | 44% | 8% |
| Histologic-endoscopic mucosal improvementd,† | 37% | 6% |
| *Primary endpoint was clinical remission (per Adapted Mayo Score). Clinical response (per Adapted Mayo Score), endoscopic improvement and histologic-endoscopic mucosal improvement were ranked secondary endpoints. Not all ranked secondary endpoints are shown. All primary and ranked secondary endpoints achieved p-values of <0.001 versus placebo. | ||
| aClinical remission (per Adapted Mayo Score) is defined as stool frequency subscore (SFS) ≤1 and not greater than baseline, rectal bleeding subscore (RBS) of 0 and endoscopic subscore ≤1. | ||
| b Clinical response (per Adapted Mayo Score) is defined as a decrease from baseline in the Adapted Mayo score ≥2 points and ≥30 percent from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1. | ||
| cEndoscopic improvement is defined as endoscopic subscore ≤1. | ||
| dHistologic-endoscopic mucosal improvement is defined as endoscopic subscore of 0 or 1 and Geboes score ≤3.1. |
