Abstract
Objectives—Growth hormone (GH) may reduce symptoms and improve growth in Crohn's Disease (CD). The effect upon mucosal inflammation is not known. We hypothesized that GH would improve both clinical and mucosal disease activity, and stimulate linear growth, in pediatric CD.
Methods—Twenty patients aged 7-18 receiving corticosteroids (CTX) for active CD were randomized to begin GH, 0.075 mg/kg/day (group A), or continue CTX alone (group B). Clinical and endoscopic disease activity were assessed after 12 weeks. Group B began GH at 12 weeks and clinical disease activity was assessed at 24 weeks. Subjects who experienced a clinical response after 12 weeks of GH therapy continued treatment for an additional 52 weeks, and linear growth was assessed.
Results—65% of patients receiving GH achieved clinical remission, compared to 20% treated with CTX alone (p=0.03). While endoscopic disease activity trended towards an improvement at week 12 in group A, this did not differ between the groups. 61% of week 12 GH responders maintained their clinical response through week 64. Mean (95th CI) height Z score on GH increased from -1.1 (-1.6,-0.6) to -0.4 (-1,0.2), p=0.004 during this 52 week extension phase. GH was well tolerated with no unexpected safety signals.