Remicade study halted over side effects, death
Scientists in London have halted a study of the anti-inflammatory drug Remicade after several patients experienced severe adverse reactions, including one death. The scientists said that the high level of Remicade side effects they observed showed that it and similar drugs were ineffective at treating vasculitis, an inflammation of the blood vessels.
Scientists in the study were trying to determine whether Remicade could be used to treat vasculitis after an earlier study found that a similar drug, Enbrel, was ineffective at treating the condition and could cause tumors. Both Remicade and Enbrel are members of a class of drugs known as TNF blockers, which inhibit the protein that can cause vasculitis.
The nine participants in the recent study were scheduled to receive five Remicade infusions over a six-month period of time. But because of the Remicade side effects suffered by the participants, only five were able to complete the full study. The four patients who stopped their Remicade infusions suffered severe reactions, including hearing and vision loss, anemia and lupus-like reactions.
One of the patients involved in the study later died as a result of cardiac failure. Although scientists are unable to definitively say that Remicade was the cause of the patient’s death, autopsies later revealed that she had no underlying heart conditions at the time she began the study.
Although the study was halted before it could be completed, the scientists say that they saw no improvement in the vasculitis symptoms of the patients who took part. Given the risk of Remicade side effects and the drug’s ineffectiveness at treating vasculitis, the scientists concluded that Remicade should not be used in treating patients with vasculitis or other related conditions.
They also said that the results of their study seemed to indicate that TNF blockers like Remicade should not be used in the treatment of vasculitis. They pointed to four additional studies which also showed a high level of Remicade side effects among patients who were treated with the drug for vasculitis.