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An open‐labelled study of granulocyte colony‐stimulating factor in the treatment of active Crohn's disease
Author(s) -
Korzenik J. R.,
Dieckgraefe B. K.
Publication year - 2005
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2005.02287.x
Subject(s) - medicine , crohn's disease , granulocyte colony stimulating factor , filgrastim , adverse effect , gastroenterology , prednisone , concomitant , immunology , surgery , disease , chemotherapy
Summary 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 ≤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 × 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.