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Iclaprim safe, potentially cost-effective for ABSSSIs
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Motif Bio announced additional safety data from its REVIVE-2 trial of the investigational antibiotic iclaprim, showing that the treatment was well-tolerated in patients with acute bacterial skin and skin structure infections, or ABSSSIs. Other findings, presented at the European Congress of Clinical Microbiology and Infectious Diseases, showed that the drug could reduce the cost burden of acute kidney injury normally associated with vancomycin, which is currently the standard of care.
In the double-blind, randomized, active-controlled, multinational REVIVE-2 trial, Thomas Holland, MD, MSc-GH, assistant professor of medicine at Duke University School of Medicine, and colleagues compared iclaprim with vancomycin in 600 patients with ABSSSIs. Initial topline results were announced in October 2017.
Researchers compared the safety and efficacy of an 80-mg dose of iclaprim with a 15-mg/kg dose of vancomycin for ABSSSIs by administering the drugs intravenously every 12 hours for 5 to 14 days. Iclaprim reached both the primary and secondary endpoints, according to the study.
Holland and colleagues said early clinical response to iclaprim was noninferior to vancomycin in achieving at least a 20% reduction in lesion size 48 to 72 hours after it was administered in the intent-to-treat (ITT) population (78.3% vs. 76.7%). Additionally, iclaprim was noninferior to vancomycin at the test-of-cure visit 7 to 14 days after end of therapy in the ITT population (77.6% vs. 77.7%).
As previously reported, clinical cure was observed in 71.9% of patients in the iclaprim arm and in 70.5% of patients taking vancomycin. The rate of treatment-related adverse events was 14% for iclaprim and 12.9% for vancomycin. The company said there were no adverse events related to nephrotoxicity reported for patients treated with iclaprim, compared with two (0.7%) in patients who received vancomycin. There were no deaths in the iclaprim arm and one death in the vancomycin arm.
“Based on these findings, I believe that iclaprim has the potential to be a useful addition to the treatment armamentarium for patients with ABSSSI suspected or confirmed to be due to gram-positive pathogens, particularly those at high risk of kidney injury,” Holland said in a press release.
Cost benefits
Thomas Lodise, PharmD, PhD, professor at Albany College of Pharmacy and Health Sciences, and colleagues found that the use of iclaprim in patients with ABSSSIs could potentially reduce the costs of vancomycin-associated acute kidney injury (V-A AKI).
Using an economic model from a hospital perspective, the researchers estimated the overall incremental cost impact and potential cost savings of replacing vancomycin with iclaprim.
Based on an overall 9.2% rate of V-A AKI among patients with ABSSSI, iclaprim’s neutral acquisition price threshold was $1,210.26 per regimen ($172.89 per day) compared with vancomycin, according to the study. V-A AKI risks ranged from 9.2% to 16.7% across various subpopulations, the researchers said, and the upper end of the daily acquisition cost of iclaprim that still provided cost-savings varied between $150 and $300 a day.
“Costs associated with AKI [are] substantial,” Lodise told Infectious Disease News. “Patients who experience AKI vs. those who do not have an increased length of stay of 5 days. One in four require specialty consultations from nephrology or ID, and a small number of patients go on to require one or two sessions of acute dialysis. I think clinicians really need to do a risk vs. benefit assessment when considering using vancomycin for a patient with a skin infection.” – by Marley Ghizzone
References:
Holland T, et al. Abstract O0424. Presented at: European Congress of Clinical Microbiology and Infectious Diseases; April 21-24, 2018; Madrid.
Lodise T, et al. Abstract P0283. Presented at: European Congress of Clinical Microbiology and Infectious Diseases; April 21-24, 2018; Madrid.
Disclosures: Lodise receives grant support from Motif Bio and is a consultant for Allergan, Paratek and Motif Bio. Holland is a member of Motif’s Scientific Advisory Board.