An open-labelled study of granulocyte colony-stimulating factor in the treatment of 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.


OBJECTIVE
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.


CONCLUSIONS
Recombinant human granulocyte colony-stimulating factor is safe and potentially effective therapy for active Crohn's disease.
Korzenik
J R
JR
Department of Internal Medicine, Inflammatory Bowel Disease Center, Gastrointestinal Unit, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA. jkorzenik@partners.org
Dieckgraefe
B K
BK
D000328:Adult; D003424:Crohn Disease / Q000150:complications / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D000069585:Filgrastim; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011994:Recombinant Proteins; D012003:Rectal Fistula / Q000188:drug therapy / Q000209:etiology; D012720:Severity of Illness Index; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim