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Randomized Controlled Trial
. 2016 Jun;67(6):544-51.
doi: 10.1097/FJC.0000000000000378.

Interleukin-1 Blockade in Acute Decompensated Heart Failure: A Randomized, Double-Blinded, Placebo-Controlled Pilot Study

Benjamin W Van Tassell  1 , Nayef A Abouzaki, Claudia Oddi Erdle, Salvatore Carbone, Cory R Trankle, Ryan D Melchior, Jeremy S Turlington, Clinton J Thurber, Sanah Christopher, Dave L Dixon, Daniel T Fronk, Christopher S Thomas, Scott W Rose, Leo F Buckley, Charles A Dinarello, Giuseppe Biondi-Zoccai, Antonio Abbate
Affiliations
Randomized Controlled Trial

Interleukin-1 Blockade in Acute Decompensated Heart Failure: A Randomized, Double-Blinded, Placebo-Controlled Pilot Study

Benjamin W Van Tassell et al. J Cardiovasc Pharmacol. 2016 Jun.

Abstract

Background: Heart failure is an inflammatory disease. Patients with acute decompensated heart failure (ADHF) exhibit significant inflammatory activity on admission. We hypothesized that Interleukin-1 blockade, with anakinra (Kineret, Swedish Orphan Biovitrum), would quench the acute inflammatory response in patients with ADHF.

Methods: We randomized 30 patients with ADHF, reduced left ventricular ejection fraction (<40%), and elevated C reactive protein (CRP) levels (≥5 mg/L) to either anakinra 100 mg twice daily for 3 days followed by once daily for 11 days or matching placebo, in a 1:1 double blinded fashion. We measured daily CRP plasma levels using a high-sensitivity assay during hospitalization and then again at 14 days and evaluated the area-under-the-curve and interval changes (delta).

Results: Treatment with anakinra was well tolerated. At 72 hours, anakinra reduced CRP by 61% versus baseline, compared with a 6% reduction among patients receiving placebo (P = 0.004 anakinra vs. placebo).

Conclusions: Interleukin-1 blockade with anakinra reduces the systemic inflammatory response in patients with ADHF. Further studies are warranted to determine whether this anti-inflammatory effect translates into improved clinical outcomes.

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Figures

Figure 1
Figure 1
Flow chart for patient enrollment in study
Figure 2
Figure 2
C-reactive protein (CRP) values for patients randomized to anakinra (panel A) versus placebo (panel B) during the first 72 hours of hospitalization. Boxes indicate median and interquartile ranges. Panel C shows normalized CRP and median relative changes throughout 14 days of treatment. Error bars represent interquartile range. Shaded area represents AUC for normalized CRP values. *P<0.05 and **P<0.01 for anakinra versus placebo for normalized CRP values. Panel D shows individual patient changes in CRP (%) from baseline to 72 hours.
Figure 3
Figure 3
C-reactive protein values for patients randomized to anakinra versus placebo at 14-day follow-up visit. Dashed line represents upper limit of normal value for CRP (2 mg/L). **P<0.01 (anakinra versus placebo)
See this image and copyright information in PMC

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