Risks and benefits of infliximab for the treatment of Crohn's disease.
OBJECTIVE
Infliximab is effective for the treatment of active Crohn's disease. However, rare but serious complications related to infliximab therapy including lymphoma, sepsis, and death have been reported. The purpose of this study was to analyze the risks and benefits of infliximab for the treatment of Crohn's disease with the goal of providing data to aid both physicians and patients in the process of making a decision about treatment.


METHODS
A decision analytic model was constructed to determine the risks and benefits of infliximab when compared with standard therapy. The analysis simulated 2 cohorts of 100,000 patients each, with one arm receiving infliximab while the other remained on standard therapy.


RESULTS
Model results showed that in 100,000 patients at 1 year, infliximab will lead to 12,216 more patients in remission, 4255 fewer surgeries, and 33 fewer deaths from flares of disease. This is at the cost of 201 more lymphomas and 249 more deaths related to complications from infliximab. Overall, the infliximab strategy resulted in more quality-adjusted life years (QALYs/patient) than the standard therapy strategy (.77 QALYs/patient vs .75 QALYs/patient).


CONCLUSIONS
Despite an increased risk of lymphoma and death associated with use of infliximab, the substantial clinical improvement and fewer surgeries as a result of infliximab result in an increase in QALYs. In properly selected patients, the benefits of infliximab could outweigh its risks. These data should help guide decision making and the informed consent process when considering the use of infliximab for the treatment of Crohn's disease.
Siegel
Corey A
CA
Section of Gastroenterology and Hepatology, Inflammatory Bowel Disease Center, Dartmouth-Hitchcock Medical Center, Dartmouth Medical School, Lebanon, New Hampshire, USA.
Hur
Chin
C
Korzenik
Joshua R
JR
Gazelle
G Scott
GS
Sands
Bruce E
BE
D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D015331:Cohort Studies; D003424:Crohn Disease / Q000188:drug therapy* / Q000401:mortality; D003661:Decision Support Techniques; D013505:Digestive System Surgical Procedures / Q000706:statistics & numerical data; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab; D008223:Lymphoma / Q000209:etiology / Q000401:mortality; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D018570:Risk Assessment; D018805:Sepsis / Q000209:etiology / Q000401:mortality
D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab