An open-label pilot study of granulocyte colony-stimulating factor for the treatment of severe endoscopic postoperative recurrence in Crohn's disease.
OBJECTIVE
Recombinant human granulocyte colony-stimulating factor (rhG-CSF) promoted healing of Crohn's disease (CD)-like intestinal lesions in chronic granulomatous disease and glycogen storage disease Ib, both characterized by defective neutrophil functions. We performed a prospective, open-label pilot study with rhG-CSF for the treatment of CD.


METHODS
Five patients with clinically inactive CD, but with severe endoscopic ileitis within 1 year after intestinal resection and ileocolonic anastomosis, received 300 microg of rhG-CSF (Filgrastim; Neupogen) subcutaneously, three times weekly for a total of 12 weeks. Safety was evaluated by assessment of clinical and laboratory data and disease activity. The primary parameter of efficacy was complete mucosal healing, as defined by the Rutgeerts score. Anti-inflammatory mediators were repeatedly measured during treatment.


RESULTS
All patients completed the protocol in clinical remission. In 1 subject transient headache resolved after halving the rhG-CSF dosage. Complete mucosal healing was observed in 2 patients: in 1 patient after 12 weeks of therapy and in 1 patient 9 months after treatment cessation. In a single patient, closure of an anovaginal and of a perianal fistula was noted. Neutrophil counts and interleukin-1 receptor antagonist and soluble tumor necrosis factor receptor p55 and p75 levels were found to be increased during drug administration.


CONCLUSIONS
rhG-CSF seems to be safe, well tolerated, and might provide efficacy in CD.
Dejaco
Clemens
C
Division of Gastroenterology and Hepatology, Department of Internal Medicine IV, University Hospital of Vienna, Vienna, Austria. clemens.dejaco@akh-wien.ac.at
Lichtenberger
Conny
C
Miehsler
Wolfgang
W
Oberhuber
Georg
G
Herbst
Friedrich
F
Vogelsang
Harald
H
Gangl
Alfred
A
Reinisch
Walter
W
D000328:Adult; D015415:Biomarkers / Q000097:blood; D003424:Crohn Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery; D016099:Endoscopy, Gastrointestinal; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007079:Ileitis / Q000175:diagnosis / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D012008:Recurrence; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D015415:Biomarkers; D016179:Granulocyte Colony-Stimulating Factor