Study D9422C00002 was an open-label, un-comparative study designed to evaluate Entocort 6 mg once daily as maintenance treatment in 50 pediatric patients (children and adolescents aged 5 to 17 years) with a diagnosis of mild to moderate Crohn's disease of the ileum and/or ascending colon who were in clinical remission (PCDAI ≤10). Treatment consisted of a 12-week maintenance treatment phase of 6 mg once daily, a 2-week taper phase to 3 mg once daily. The median duration of treatment exposure of Entocort was days (range: 11 days to 135 days). Most patients remained in the clinical remission stage, as there were no major changes in the mean PCDAI composite score or IMPACT 3 score. Mean (SD) PCDAI was () at baseline and () after 12 weeks of maintenance treatment with Entocort 6 mg daily. At the same points in time the mean IMPACT3 score was () and (), respectively. AEs were observed at a similar frequency and severity as seen in adults, and were mostly related to Crohn's disease, puberty and possible GCS related side effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every 6 hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenocortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, Prednisone, and prednisolone, are considered to be short acting (producing adrenocortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.