J R Korzenik1, B K Dieckgraefe. 1. Department of Internal Medicine, Inflammatory Bowel Disease Center, Gastrointestinal Unit, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA. jkorzenik@partners.org
Abstract
BACKGROUND: Immunodeficiency syndromes associated with a Crohn's-like illness suggest innate immune defects may lead to Crohn's disease. Anecdotal cases using haemopoietic colony-stimulating factors report improvement in intestinal disease associated with these syndromes. AIM: To test the safety and efficacy of recombinant human granulocyte colony-stimulating factor in active Crohn's disease. METHODS: In an open-labelled 12-week trial, patients with a Crohn's Disease Activity Index between 220 and 450 were treated with recombinant human granulocyte colony-stimulating factor (filgrastim, Neupogen). Concomitant immunosuppressants were prohibited except prednisone < or =20 mg/day. Patient's received recombinant human granulocyte colony-stimulating factor 300 mcg daily subcutaneously adjusted to achieve an absolute neutrophil count between 25 and 35 x 10(9)/L. RESULTS: Twenty patients were enrolled with a mean initial Crohn's Disease Activity Index of 307 (range: 234-428). Fifteen patients (75%) completed 8 weeks; 13 patients (65%) completed 12 weeks with the mean Crohn's Disease Activity Index for patients continuing through those times of 196 (range: 36-343) and 162 (range: 20-308), respectively. At week 12, 11 patients (55%) demonstrated a decrease of at least 70 points; five (25%) achieved a sustained remission. The mean decrease was statistically significant at each assessment time-point. Three of four patients with fistulae had a positive response. Adverse effects included bone pain, mostly mild resolving with continued treatment. One patient was hospitalized with a viral-like syndrome but it is uncertain if this was treatment related. CONCLUSION: Recombinant human granulocyte colony-stimulating factor is safe and potentially effective therapy for active Crohn's disease.
BACKGROUND:Immunodeficiency syndromes associated with a Crohn's-like illness suggest innate immune defects may lead to Crohn's disease. Anecdotal cases using haemopoietic colony-stimulating factors report improvement in intestinal disease associated with these syndromes. AIM: To test the safety and efficacy of recombinant humangranulocyte colony-stimulating factor in active Crohn's disease. METHODS: In an open-labelled 12-week trial, patients with a Crohn's Disease Activity Index between 220 and 450 were treated with recombinant humangranulocyte colony-stimulating factor (filgrastim, Neupogen). Concomitant immunosuppressants were prohibited except prednisone < or =20 mg/day. Patient's received recombinant humangranulocyte colony-stimulating factor 300 mcg daily subcutaneously adjusted to achieve an absolute neutrophil count between 25 and 35 x 10(9)/L. RESULTS: Twenty patients were enrolled with a mean initial Crohn's Disease Activity Index of 307 (range: 234-428). Fifteen patients (75%) completed 8 weeks; 13 patients (65%) completed 12 weeks with the mean Crohn's Disease Activity Index for patients continuing through those times of 196 (range: 36-343) and 162 (range: 20-308), respectively. At week 12, 11 patients (55%) demonstrated a decrease of at least 70 points; five (25%) achieved a sustained remission. The mean decrease was statistically significant at each assessment time-point. Three of four patients with fistulae had a positive response. Adverse effects included bone pain, mostly mild resolving with continued treatment. One patient was hospitalized with a viral-like syndrome but it is uncertain if this was treatment related. CONCLUSION: Recombinant humangranulocyte colony-stimulating factor is safe and potentially effective therapy for active Crohn's disease.
Authors: M J Haller; M A Atkinson; C H Wasserfall; T M Brusko; C E Mathews; M Hulme; M Cintron; J Shuster; K McGrail; A Posgai; D Schatz Journal: Clin Exp Immunol Date: 2015-12-07 Impact factor: 4.330
Authors: P J Mannon; F Leon; I J Fuss; B A Walter; M Begnami; M Quezado; Z Yang; C Yi; C Groden; J Friend; R L Hornung; M Brown; S Gurprasad; B Kelsall; W Strober Journal: Clin Exp Immunol Date: 2008-12-15 Impact factor: 4.330