Safety considerations when using anti-TNFα therapy to treat Crohn's disease.
BACKGROUND
Over the past decade, the introduction of a new class of anti-TNFα drugs has dramatically changed the approach taken to the management of Crohn's disease (CD). An increasing number of patients are receiving treatment with these advanced biological therapies, and the risk of adverse events that may be associated with their use must be carefully evaluated.


METHODS
Safety data about the three anti-TNFα drugs currently approved for use in CD patients (infliximab, adalimumab, and certolizumab pegol) is critically evaluated, including data coming from randomized clinical trials and post-marketing reports. Possible side effects of anti-TNFα agents are presented as drug-, class- and disease-specific adverse events. Management strategies to minimize the occurrence of side effects are summarized.


CONCLUSIONS
The safety profile of the three anti-TNFα drugs approved for clinical use in CD patients appears to be comparable among drugs. Data from clinical trials and a growing body of information from post-marketing surveillance indicate that anti-TNFα agents are generally safe, and that most of the observed side effects are mild and easily manageable. Nonetheless, serious short- and long-term adverse events may occur. Accurate selection of patients, careful pre-treatment evaluation, and regular follow-up during therapy could potentially reduce the rate of adverse events related to the use of anti-TNFα drugs.
"Sapienza" University of Rome, S. Andrea Hospital, Faculty of Medicine and Psychology , Rome , Italy.
Cristiano
C
Pagnini
Kristen O
KO
Arseneau
Fabio
F
Cominelli
D000068879:Adalimumab; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects*; D000068582:Certolizumab Pegol; D003424:Crohn Disease / Q000188:drug therapy*; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects*; D000069285:Infliximab; D011092:Polyethylene Glycols / Q000009:adverse effects*; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007140:Immunoglobulin Fab Fragments; D014409:Tumor Necrosis Factor-alpha; D011092:Polyethylene Glycols; D000069285:Infliximab; D000068879:Adalimumab; D000068582:Certolizumab Pegol
Crohn’s disease; adalimumab; anti-TNFα therapy; certolizumab pegol; infliximab; safety