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For Most Mild to Moderate Crohn's Patients
ENTOCORT® EC is first-line therapy1
Significantly higher clinical remission rates vs mesalamine†7
)
Data from a 16-week, randomized, double-blind, multicenter study of 182 patients with a median baseline CDAI score of 272. Adapted from Thomsen et al, N Engl J Med.7
Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score of ≤150.
†Mesalamine is not approved for the treatment of Crohn’s disease in the United States.
Clinically established efficacy profile vs prednisolone in pivotal randomized controlled trials for induction of remission in Crohn's disease2
Table 1: Clinical Improvement Rates (CDAI ≤ 150) After 8 Weeks of Treatment
| Clinical Study | ENTOCORT EC
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Placebo | Prednisolone | ||||||||||||||||||||
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ENTOCORT EC was well tolerated compared to mesalamine and prednisolone in clinical trials‡2
- Keep tolerability top of mind: a well tolerated adverse event profile vs mesalamine‡2
)
ENTOCORT EC data from a pooled analysis of 5 short-term, active disease state trials. Mesalamine data from a short-term, active disease state trial.
‡Mesalamine is not approved for the treatment of Crohn’s disease in the United States.
Clinical studies have shown that the frequency of GCS-related side effects was substantially reduced with ENTOCORT EC vs prednisolone2
**Long-term therapy is defined as induction, maintenance, and re-treatment for recurring active episodes of disease.
*For Crohn’s disease involving the ileum and/or ascending colon, ENTOCORT EC is indicated for the treatment of mild to moderate active disease (up to 8 weeks with repeated 8-week courses as necessary) and the maintenance of clinical remission of mild to moderate disease for up to an additional 3 months.
Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score of ≤150.
Important safety information
Since ENTOCORT EC® is a glucocorticosteroid (GCS), general warnings about GCSs should be followed. GCSs can reduce the response of the hypothalamus-pituitary-adrenal axis to stress. Supplementation with a systemic GCS is recommended before surgery or other stress situations. Adrenocortical function monitoring may be required in patients being transferred to ENTOCORT EC from a systemic GCS, and the dose of the systemic GCS should be reduced cautiously.
Patients on drugs that suppress the immune system are more susceptible to infections and should avoid exposure to infections such as chicken pox or measles.
Patients with moderate to severe liver disease and patients who are concomitantly taking ketoconazole or any other CYP3A4 inhibitor should be closely monitored for increased signs and/or symptoms of hypercorticism.
The adverse event profile of ENTOCORT EC in 6 mg once daily clinical trial treatment (52-week) was similar to that of 9 mg once daily clinical trial treatment (8-week). The most frequently reported adverse events in clinical trials of ENTOCORT EC were headache, respiratory infection, nausea, and symptoms of hypercorticism.
