

Studies that include the stringent endpoint of endoscopic remission as the definition of remission, like the CORE studies, have been found to have lower placebo response rates.4
The CORE studies for UCERIS tablets used a three-pronged approach—CORE investigators conducted the trial using 3 key elements1,5 :
- They selected a patient population that mirrors active mild to moderate ulcerative colitis patients
- They included 2 different measures of remission—clinical plus endoscopic
- Finally, they raised the importance of mucosal appearance by using the Endoscopic Index (EI) in addition to the Ulcerative Colitis Disease Activity Index (UCDAI)
- In clinical studies, the most common adverse reactions of UCERIS tablets (occurring in ≥2% of UCERIS patients and at a higher incidence than placebo) were headache (11%), nausea (5%), decreased blood cortisol (4%), upper abdominal pain (4%), fatigue (3%), flatulence (2%), abdominal distension (2%), acne (2%), urinary tract infection (2%), arthralgia (2%), and constipation (2%)
Delivering combined clinical and endoscopic remission: A closer look
The efficacy of UCERIS tablets was assessed in two randomized, double-blind, placebo-controlled studies. The studies were conducted in a total of 970 adult patients with active, mild to moderate ulcerative colitis (UC).1,5
Patients beginning the CORE studies had1,5 :
- Active, mild to moderate UC (UCDAI score between 4 and 10)
- A median baseline UCDAI score of 7, representing moderate UC†
- No concomitant UC treatment on entering the studies and through completion
A typical moderate UC disease presentation1,6:
- 4 to 6 stools per day
- Obvious blood in stool
- A mucosa with mild friability on endoscopy
- Moderate disease activity based on physician' s evaluation
Study design: Two randomized, double-blind, placebo-controlled studies were conducted in a total of 970 adult patients with active, mild to moderate UC (UCDAI: ≥4 and ≤10 at entry). The primary endpoint was induction of combined clinical and endoscopic remission (defined as a UCDAI score of ≤1, with subscores of 0 for both rectal bleeding and stool frequency, normal mucosa with no friability on endoscopy, and a ≥1-point reduction in the EI score) after 8 weeks of treatment.1,5
†UCDAI is a four-component scale (total score of 0 to 12) that is composed of clinical assessments of stool frequency, rectal bleeding, mucosal appearance, and physician' s rating of disease activity, with subscores of 0—3 for each component.6
‡EI is a four-component scale (total score of 0 to 12) composed of granulation, vascular pattern, vulnerability of mucosa, and mucosal damage.7
The CORE studies utilized a combined primary endpoint, requiring both clinical and endoscopic remission at week 8.
- UCDAI score of ≤1, with subscores of 0 for both rectal bleeding and stool frequency1
- Normal mucosa (with no evidence of friability) by endoscopy5
- ≥1-point reduction in the Rachmilewitz EI score, which measures clinical assessment of mucosal condition1,7‡
SELECTED IMPORTANT SAFETY INFORMATION
- UCERIS extended release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of UCERIS
- When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Since UCERIS tablets are a glucocorticosteroid, general warnings concerning glucocorticoids should be followed