Infliximab safety profile and long-term applicability in inflammatory bowel disease: 9-year experience in clinical practice.
BACKGROUND
Most available data on infliximab therapy come from large, short-term, pivotal RCTs and concerns about long-term safety profile still remain.


OBJECTIVE
To evaluate the long-term safety profile of infliximab in inflammatory bowel disease (IBD) in a clinical practice setting.


METHODS
Since 1999, all IBD patients treated with infliximab were registered and clinical outcomes prospectively recorded up to March 2008, loss of follow-up or patient's death. Infliximab regimens and preventive measures were in accordance with the prevalent guidelines or with the manufacturer's recommendations.


RESULTS
One hundred fifty-two patients were included (121 Crohn's disease, 24 ulcerative colitis, 7 indeterminate colitis), with a median of 5 infliximab infusions (IQR 3-8) and 87% of patients received at least three infusions. Seventy-nine per cent of them received concomitant immunomodulators and 70% were pre-medicated with hydrocortisone from the first infusion. After a median follow-up of 142 weeks, 13% presented infusion reactions, 13% viral or bacterial infections and two patients developed neoplasia. The mortality rate was 2.6% (four patients).


CONCLUSIONS
Infliximab therapy is safe when the recommended preventive measures are implemented, with a rate of serious adverse events less than 10%. No new safety signals were found.
Zabana
Y
Y
Gastroenterology Department, Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Spain.
Domènech
E
E
Mañosa
M
M
Garcia-Planella
E
E
Bernal
I
I
Cabré
E
E
Gassull
M A
MA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D003875:Drug Eruptions / Q000453:epidemiology; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006854:Hydrocortisone / Q000627:therapeutic use; D007239:Infections / Q000139:chemically induced / Q000453:epidemiology; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy* / Q000453:epidemiology; D000069285:Infliximab; D007262:Infusions, Intravenous / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000139:chemically induced / Q000453:epidemiology; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D012713:Serum Sickness / Q000139:chemically induced / Q000453:epidemiology; D016896:Treatment Outcome; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab; D006854:Hydrocortisone