Interleukin 10 (Tenovil) in the prevention of postoperative recurrence of Crohn's disease.
OBJECTIVE
New lesions of Crohn's disease occur early after ileal or ileocolonic resection and ileocolonic anastomosis. We performed a double blind controlled trial to evaluate the safety and tolerance of recombinant human interleukin 10 (IL-10; Tenovil) in subjects operated on for Crohn's disease. We also assessed the effect of Tenovil in preventing endoscopic recurrence 12 weeks after surgery.


METHODS
Patients with Crohn's disease who underwent curative ileal or ileocolonic resection and primary anastomosis were randomised within two weeks after surgery to receive subcutaneous Tenovil 4 microg/kg once daily (QD) (n=22) or 8 microg/kg twice weekly (TIW) (n=21), or placebo (QD or TIW) (n=22). An ileocolonoscopy was performed after 12 weeks of treatment.


RESULTS
Compliance was excellent. The most frequently observed adverse events were mild and moderate in severity and equally distributed across treatment groups. Thirty seven patients in the pooled Tenovil group and 21 patients in the pooled placebo group were evaluable by endoscopy. At 12 weeks, 11 of 21 patients (52%) in the placebo group had recurrent lesions compared with 17 of 37 patients (46%) in the Tenovil group (ns). The incidence of severe endoscopic recurrence was similar in both groups (9%).


CONCLUSIONS
Tenovil treatment for 12 consecutive weeks in patients with Crohn's disease after intestinal resection was safe and well tolerated. No evidence of prevention of endoscopic recurrence of Crohn's disease by Tenovil was observed.
Colombel
J F
JF
Gastroenterology Unit, Hopital Claude Huriez, Lille, France. jfcolombel@chru-lille.fr
Rutgeerts
P
P
Malchow
H
H
Jacyna
M
M
Nielsen
O H
OH
Rask-Madsen
J
J
Van Deventer
S
S
Ferguson
A
A
Desreumaux
P
P
Forbes
A
A
Geboes
K
K
Melani
L
L
Cohard
M
M
D000328:Adult; D017024:Chemotherapy, Adjuvant; D003113:Colonoscopy / Q000379:methods; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy* / Q000601:surgery; D004311:Double-Blind Method; D004587:Electrophoresis, Agar Gel / Q000379:methods; D005260:Female; D006400:Hematocrit; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007375:Interleukin-1 / Q000378:metabolism; D016753:Interleukin-10 / Q000378:metabolism / Q000627:therapeutic use*; D007413:Intestinal Mucosa / Q000378:metabolism; D008297:Male; D010349:Patient Compliance; D020133:Reverse Transcriptase Polymerase Chain Reaction; D055502:Secondary Prevention; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000378:metabolism
D006454:Hemoglobins; D007375:Interleukin-1; D014409:Tumor Necrosis Factor-alpha; D016753:Interleukin-10