This article is part of the Arthritis Archives.
Dateline: October 24, 2001
Clinical Trial Halted
Centocor, the maker of Remicade (infliximab), has halted a Phase II clinical trial designed to assess its use for the treatment of congestive heart failure (CHF).
Previously FDA-approved for the treatment of rheumatoid arthritis and Crohn's disease, Remicade was being studied with the hope of expanding its indications.
150 patients with moderate to severe congestion heart failure (NYHA class III-IV) participated in the trial. The participants were treated with three infusions over a six-week period (either receiving Remicade 5 mg/kg, Remicade 10 mg/kg, or placebo). The Phase II trial was initiated because animal testing had shown potential for Remicade as a treatment for congestive heart failure.
Unfortunately, no improvement in the clinical status of the trial participants was demonstrated. A higher incidence of mortality and hospitalization for worsening heart failure occurred in the Remicade-treated patients, especially the patients treated at the higher dose of 10 mg/kg. Seven of 101 heart patients treated with Remicade died compared to zero of 49 patients taking placebo.
Warning Letters
After consulting with the U.S. Food and Drug Administration (FDA), Centocor sent warning letters to about 35,000 physicians. The letter offered doctors the following advice and guidelines:
- Do not initiate therapy in patients with congestive heart failure.
- Patients with congestive heart failure currently receiving Remicade treatment for rheumatoid arthritis or Crohn's disease should be re-evaluated.
- Treatment should be discontinued in patients whose congestive heart failure is worsening.
- Treatment discontinuation should be considered in patients with stable, concomitant congestive heart failure, especially those who have not demonstrated a significant clinical response to Remicade. If continuation is decided upon, cardiac status should be closely monitored.
Centocor plans to continue acquiring data on the Phase II trial participants over the next several weeks to "better characterize the risk" posed to patients with congestive heart failure. Immunex, the maker of Remicade's main competitor Enbrel (etanercept), faced a similar quandary last March when it tested its arthritis drug against congestive heart failure with no success.
Risks Vs. Benefits
The FDA maintains that the benefits of Remicade and Enbrel outweigh their risks despite the existing warnings which include:
- possible serious or fatal infections
- anemia
- central nervous system diseases
- possible reactivation of latent tuberculosis
Related Resources
Sources: Centocor Places Congestive Heart Failure Clinical Program On Hold, 10/22/01, PRESS RELEASE; Centocor, Important Drug Warning (Letter to Doctor), 10/18/01; Doctors Warned About Arthritis Drug, Associated Press, 10/22/01; J & J halts heart-failure trial of arthritis drug, Reuters, 10/22/01
First published: 10/24/2001
