Notes
Outline
Anti-TNF-a Strategies in CHF:
Data from Randomized, Controlled Clinical Trials

Arthritis Advisory Committee

March 4, 2003
Ellis F. Unger, M.D.
Office of Therapeutics Research and Review (OTRR)
Center for Biologics Evaluation and Research (CBER)
U.S. Food and Drug Administration (US FDA)
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"10 cases:"
10 cases:
6 received infliximab & 4 received etanercept
Median ejection fraction = 20%
(range 10 to 45%, n=9)
3 with underlying risk factors for CHF
After discontinuation of TNF antagonists and HF treatment:
3 reported complete resolution of CHF
6 reported improvement
1 reported death
"Significant overlap between CHF and..."
Significant overlap between CHF and RA in the general population, to a lesser extent CHF & Crohn’s Disease
Data from RCT’s in the CHF population raise concerns about the safety of Infliximab and Etanercept.
Post-marketing data raise concern regarding new-onset CHF.
CBER plans comprehensive analyses of the RCT databases of all 3 TNF-blockers.
Specific language for labeling is under discussion.