A prospective open-label trial of Remicade in patients with severe exacerbation of Crohn's disease requiring hospitalization: a comparison with outcomes previously observed in patients receiving intravenous hydrocortisone.
OBJECTIVE
To evaluate treatment response to intravenous (IV) infliximab (IFX) as a first-line therapy in patients hospitalized for severe Crohn's disease and compare it with our earlier data using IV hydrocortisone.


METHODS
Seventeen cases received IFX (5 mg/kg) and were matched for the same goal of therapy to those who had received hydrocortisone (300 mg/d). The Crohn's and Colitis Foundation of America-International Organization of Inflammatory Bowel Disease (CCFA-IOIBD) score was obtained for the IFX-treated cases on admission and daily and the Crohn's disease activity index (CDAI) score weekly throughout the hospitalization and compared with those who received hydrocortisone. Discharge was guided by the same criteria in both groups.


RESULTS
For the IFX group, the admission mean CCFA-IOIBD score was 13.5 (+/-4.4). Eight of 17 patients achieved a clinical response with a mean score of 4 (+/-1.5), representing a >or=50% reduction from baseline to discharge. The mean admission score for the hydrocortisone group was 17.75 (+/-7.1) with 13 of 16 achieving a mean score of 4.5 (+/-2.3). The mean discharge score for the 17 IFX patients was 6.9 (+/-3) and for the hydrocortisone group was 5.9 (+/-3.2). Median length of hospitalization for the IFX patients was 4 days (range 1 to 9) and 7.5 (5 to 15) days for the hydrocortisone group (P<0.001).


CONCLUSIONS
IFX therapy was an effective first-line agent in patients with severe Crohn's disease who require hospitalization and therefore a primary treatment option. Most patients receiving IFX can anticipate a briefer hospitalization than with IV hydrocortisone. Failure of an early response can provide an opportunity to consider an alternate form of therapy sooner with IFX than with hydrocortisone.
Department of Gastroenterology, Lenox Hill Hospital, and New York University School of Medicine, New York, NY 10021, USA.
Jyoti K
JK
Bhatia
Burton I
BI
Korelitz
Georgia
G
Panagopoulos
Efrat
E
Lobel
Felice
F
Mirsky
Keith
K
Sultan
William
W
DiSanti
Alexander
A
Chun
Gregory
G
Keenan
Khalid
K
Mamun
D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D003424:Crohn Disease / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006760:Hospitalization; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage*; D000069285:Infliximab; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000069285:Infliximab; D006854:Hydrocortisone