Safety and effectiveness of infliximab for inflammatory bowel diseases in clinical practice.
OBJECTIVE
Our aim was to assess the efficacy and safety of infliximab (IFX) in clinical practice in three Primary Care, Hospital Centers.


METHODS
From September 2004 to December 2008 62 patients (28 males, 34 females, mean age 30.25 years, range 15-55 years), affected by ulcerative colitis (UC) (23 pts) or by Crohn's disease (CD) (39 patients) were treated. Clinical efficacy, safety, mucosal healing and quality of life were assessed both in UC and CD.


RESULTS
A total of 746 infusions were performed. IFX was administered for a mean of 26 months (range 8-44 months). 33/39 (84.61%) pts with CD were in remission under treatment with IFX for a mean time of 19 months (range 12-44 months). Mean Crohn Disease Activity Index (CDAI) score decreased from 295 (range 258-346) to 136 (range 98-136) (p < 0.005). Inflammatory Bowel Disease Quality of Life (IBDQL) improved from 48 (at entry) to 198 (at the end of the study) (p < 0.005). 20/23 (86.95%) patients with UC were in remission under treatment with IFX for a mean of 18 months (range 8-34 months). Mean Disease Activity Index (DAI) decreased from 11 (range 9-12) to < 3 (range 2-3) (p < 0.05). Mean Mayo Subscore for Endoscopy decreased from 3 to < 1 (range 0-1). IBDQL improved from 56 (at entry) to 194 (at the end of the study) (p < 0.005). Only 5 patients (8.06%) experienced side-effects.


CONCLUSIONS
Long-term outpatients treatment with IFX seems to be safe and effective in managing patients affected by IBD in clinical practice.
Tursi
A
A
Division of Gastroenterology, "Michele Sarcone" Hospital, Terlizzi, Bari, Italy. antotursi@tiscali.it
Elisei
W
W
Brandimarte
G
G
Giorgetti
G
G
Penna
A
A
Castrignano
V
V
D000293:Adolescent; D000328:Adult; D000553:Ambulatory Care; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy / Q000473:pathology; D003424:Crohn Disease / Q000188:drug therapy / Q000473:pathology; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab