In this study, physicians from the Mayo Clinic, Rochester, evaluated the short- and long-term safety of infliximab in patients with Crohn’s disease in clinical practice.
The team reviewed the medical records of 500 consecutive patients treated with infliximab at the Mayo Clinic.
They determined the likelihood of a causal relationship to infliximab for each adverse event by calculating an intrinsic likelihood score.
The physicians determined that the 500 patients received a median of 3 infusions and had a median follow-up of 17 months.
Of these patients, 9% experienced a serious adverse event, of which 6% were related to infliximab.
|4% experienced acute infusion reactions.|
The team found that 4% experienced acute infusion reactions.
While serum sickness-like disease occurred in 19 of 500 patients. This was attributed to infliximab in 14.
In addition, 3 patients developed drug-induced lupus, and 1 developed a new demyelination disorder.
Overall, 48 patients had an infectious event, of which 41 were attributed to infliximab.
Furthermore, 20 patients had a serious infection. Of these, 2 had fatal sepsis, 8 had pneumonia, 6 had viral infections, 2 had abdominal abscesses requiring surgery, 1 had arm cellulitis, and 1 histoplasmosis.
The team found that 9 patients developed a malignant disorder. It is possible that 3 of these cases were related to infliximab.
In total, 10 deaths occurred. In 5 of these patients, the events leading to death may have been related to infliximab.
Dr Jean-Frederic Colombel's team concluded, "Short- and long-term infliximab therapy is generally well tolerated".
"However, clinicians must be vigilant for the occurrence of infrequent but serious events, including serum sickness-like reaction, opportunistic infection and sepsis, and autoimmune disorders".