[A study of efficiacy of infliximab treatment for Crohn's disease.].
OBJECTIVE
To investigated the potential and safety of the monoclonal antibody to TNFalpha infliximab (IFX) in the treatment of active Crohn's disease (CD).


METHODS
Patients who were confirmed diagnosis of CD and were unresponsive to the conventional treatments, or recurred after surgeries, or discontinued treatment due to drug intolerance, were treated with IFX intravenously in a dose of 5 mg/kg at week 0, 2, 6 (IFX infusion continued at an interval of every 8 weeks if respond to initial dosing). Clinical assessments, including disease activity, blood biological markers and colonoscopic findings, were performed at baseline (week 0) and each week (4 weeks or later for colonoscopy) after IFX infusion were conducted until the week before 4(th) infusion from initiated.


RESULTS
Ten patients (8 male, 2 female) with mean age of 31.4 years (ranged from 15 to 65 years old) were included in the analysis. The mean subjective score from baseline to week 14 was decreased from 2.2 +/- 0.6 to 1.2 +/- 0.4 (P < 0.05). The mean Harvey-Bradshaw index was 6.6 +/- 1.6 at baseline and 2.1 +/- 1.0 at week 14. The levels of ESR, CRP, serum total protein (TP) and albumin (Alb) were significantly improved during the 14-week period. Colonoscopy showed a remarkable improvement of Crohn's Disease Endoscopic Index of Severity (CDEIS). No infusion-related reaction was observed in all patients during the treatment. Mild or transient skin itching and headache were respectively reported in two patients. Transient elevation of serum ALT and AST after 3(rd) infusion in one patient, and severe anemia including leucopenia and thrombocytopenia at week 35 after 1(st) infusion in one male patient were observed.


CONCLUSIONS
Treatment with three infusions of IFX in a dose of 5 mg/kg was effective for induction of remission for active and complex CD patients who failed to respond to conventional treatment. Long-term safety of the therapy effect was warranted in further investigations.
Zheng
Jia-Ju
JJ
Department of Gastroenterology, Affiliated Suzhou Hospital of Nanjing Medical University/Suzhou Municipal Hospital, Suzhou Institute for Digestive Disease and Natrition, Suzhou 215008, China. Email: zhengjj218@163.com.
Wang
Yu-Ming
YM
Zhu
Fan
F
Gu
Wei
W
Xing
Ye-Chen
YC
Zhou
Chun-Li
CL
Shen
Bi-Wu
BW
D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D003113:Colonoscopy; D003424:Crohn Disease / Q000188:drug therapy; D006801:Humans; D000069285:Infliximab; D012074:Remission Induction
D000911:Antibodies, Monoclonal; D000069285:Infliximab