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Interleukin-1 blockade with RPH-104 (goflikicept) in patients with ST-segment elevation myocardial infarction
Antonio Abbate1, Benjamin Van Tassell2, Vlad Bogin3
1University of Virginia; Virginia, USA.
Insights
Goflikicept, an Interleukin-1 (IL-1) blocker, reduced systemic inflammation in ST-segment elevation myocardial infarction (STEMI) patients. Further studies are needed to confirm if this inflammation reduction leads to clinical benefits in STEMI patients.
Area of Science:
- Cardiology
- Immunology
- Pharmacology
Background:
- Systemic inflammation plays a crucial role in the pathophysiology of ST-segment elevation myocardial infarction (STEMI).
- Interleukin-1 (IL-1) is a key mediator of inflammation implicated in adverse cardiac remodeling post-MI.
Purpose of the Study:
- To evaluate the efficacy of goflikicept, an IL-1 blocker, in reducing systemic inflammation in STEMI patients.
- To assess the safety and tolerability of goflikicept in this patient population.
- To explore the impact of goflikicept on secondary biomarkers and clinical outcomes at 1 year.
Main Methods:
- A randomized, double-blinded clinical trial involving 102 STEMI patients.
- Patients received a single administration of goflikicept (80 mg or 160 mg) or placebo.
- Systemic inflammation was assessed by measuring the area-under-the-curve (AUC) for high-sensitivity C-reactive protein (hsCRP) at 28 days.
Main Results:
- Both doses of goflikicept significantly reduced the AUC for hsCRP at 28 days compared to placebo.
- No significant differences were observed between goflikicept doses.
- No significant differences were found in natriuretic peptide levels, major adverse cardiovascular events, heart failure progression, or adverse events between groups.
Conclusions:
- Goflikicept effectively reduces systemic inflammation in STEMI patients.
- The drug was well-tolerated at both tested doses.
- Larger trials are required to determine if IL-1 blockade with goflikicept translates to improved clinical outcomes in STEMI.
Abstract:
In a randomized double-blinded clinical trial of patients with ST segment elevation myocardial infarction (STEMI), goflikicept, an Interleukin-1 (IL-1) blocker, significantly reduced systemic inflammation, measured as the area-under-the-curve (AUC) for high-sensitivity C reactive protein (hsCRP) at 14 days. We report secondary analyses of biomarkers at 28 days, and cardiac function and clinical endpoints at 1 year. Patients received a single administration of goflikicept 80 mg (n=34), goflikicept 160 mg (n=34), or placebo (n=34). Both doses of goflikicept significantly reduced the AUC for hsCRP at 28 days compared with placebo, without statistically significant differences between the doses. There we no statistically significant differences between groups in the AUC for natriuretic peptides at 28 days. There were no significant differences between placebo, goflikicept 80 mg and 160 mg groups in deaths (2.9%, 2.9% and 0%), hospitalization for cardiovascular reasons (9.1%, 5.9%, and 0%), new-onset or progression of heart failure (9.1%, 5.9%, and 5.9%), and new or increased use of loop diuretics (24.2%, 14.7%, and 17.6%), nor in the number of patients with treatment emergent adverse events, with no treatment-related serious adverse events in any group. In conclusion, in patients with STEMI, IL-1 blockade with goflikicept 80 mg or 160 mg was well tolerated and associated with significant reduction of systemic inflammation. Further adequately powered studies are warranted to determine whether the reduction in systemic inflammation with goflikicept translates into a clinical benefit in patients with STEMI.
