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 elements^1,5 :

• 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

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 condition^1,7‡

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