UCERIS Efficacy | UCERIS (budesonide) Extended Release Tablets

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

Patients beginning the CORE studies had^1,5 :

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 presentation^1,6:

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 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

NEXT: Safety

INDICATION

UCERIS^® (budesonide) extended release tablets are a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

IMPORTANT SAFETY INFORMATION—UCERIS extended release tablets

UCERIS extended release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of UCERIS tablets. Anaphylactic reactions have occurred with other budesonide formulations
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
Care is needed in patients who are transferred from glucocorticosteroid treatment with higher systemic effects to glucocorticosteroids with lower systemic effects, such as UCERIS tablets, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients. Taper patients slowly from systemic corticosteroids if transferring to UCERIS tablets
Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Glucocorticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. More serious or even fatal courses of chickenpox or measles can occur in susceptible patients
Caution should be taken in patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where glucocorticosteroids may have unwanted effects
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%)
Concomitant use of inhibitors of Cytochrome P450 3A4 (such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, and erythromycin) should be avoided. Advise patients to also avoid ingestion of grapefruit and grapefruit juice, which are known to inhibit CYP3A4, when taking UCERIS tablets
Since the dissolution of the coating of UCERIS tablets is pH dependent, the release properties and uptake of the compound may be altered when UCERIS tablets are used after treatment with gastric acid-reducing agents (eg, PPIs, H2-blockers, and antacids)
There are no adequate and well-controlled studies in pregnant women. Budesonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Budesonide is secreted in human milk. A decision should be made whether to discontinue nursing or to discontinue UCERIS tablets, taking into account the clinical importance of UCERIS tablets to the mother
Patients with moderate to severe liver disease should be monitored for increased signs and/or symptoms of hypercorticism. Discontinuing the use of UCERIS tablets should be considered in these patients

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information for UCERIS extended release tablets.

Salix Product Information Call Center
Phone: 1-800-321-4576
Email: salixmc@dlss.com

Delivering combined clinical and endoscopic remission: A closer look

A typical moderate UC disease presentation1,6:

SELECTED IMPORTANT SAFETY INFORMATION

A typical moderate UC disease presentation^1,6: