Cefiderocol effective against treatment-resistant bacteria, studies find
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WASHINGTON — Several studies showcase strong efficacy of cefiderocol against treatment-resistant Pseudomonas aeruginosa and Acinetobacter baumannii both in the U.S. and abroad, according to data presented at IDWeek.
“As a research-driven organization with a deep history in infectious disease, we believe that continuing to evaluate the clinical utility of our medicines is in the best interest of the patients we serve,” Simon Portsmouth, MD, executive medical director at Shionogi, told Healio. “We continue to study [cefiderocol]” — the first and only siderophore cephalosporin antibiotic for the treatment of serious gram-negative infections — “to deepen our understanding of how it performs in real-world settings against treatment-resistant gram-negative bacterial infections.”
At IDWeek, several studies showing new real-world evidence of cefiderocol’s efficacy against difficult-to-treat gram-negative bacterial infections were presented.
Data from the PROVE study, an ongoing international retrospective study assessing real-world outcomes and safety of cefiderocol in hospitalized patients with gram-negative bacterial infections using chart reviews to pull existing medical records of patients given a first-time prescription of cefiderocol, showed that the treatment achieved clinical cure in 63% of patients with A. baumannii infections 96% of which were resistant to carbapenems — and 63% of patients with P. aeruginosa infections — 97% of which were carbapenem resistant.
Data from an analysis of early-use experience, which included compassionate use where patients had limited treatment options, also showed high efficacy, with 80% of patients treated with cefiderocol reporting clinical cure for difficult-to-treat gram-negative infections, including P. aeruginosa and A. baumannii. According to the study, adverse event (AE) data were reported for 53 patients, 13 of whom reported AEs and 40 who did not.
In vitro data were also assessed and presented at IDWeek. According to data from SENTRY — an antimicrobial surveillance program that monitors highly resistant bacteria and antimicrobial resistance patterns globally — cefiderocol demonstrated in vitro activity against more than 96% of all the tested difficult-to-treat resistant gram-negative pathogens from Israel and Turkey, and more than 92% of all the tested difficult-to-treat gram-negative pathogens from the U.S.
Portsmouth noted, however, that this in vitro activity “does not necessarily correlate with clinical efficacy.”
Finally, safety and tolerability data were presented, and according to Portsmouth, these data were “generally consistent” with the safety profile of cefiderocol in previous clinical studies. According to the data presented, in a cohort of 220 patients treated with cefiderocol for either A. baumannii or P. aeruginosa, 79% of patients survived and 21% of patients died within 30 days of starting treatment. Additionally, five patients had adverse drug reactions — two of which were classified as rashes, one an increase in liver function tests and two diarrhea. One patient who was treated with cefiderocol experienced interstitial nephritis, which was considered a severe adverse drug reaction.
“As the increasing threat of antimicrobial resistance continues to be recognized, it is important to show strong activity against resistant pathogens that the WHO deems to be high priority,” Portsmouth said. “[Cefiderocol] continues to demonstrate its important role in improving outcomes in patients infected with highly resistant pathogens.”
References:
- Henriksen AB, et al. In vitro activity of cefiderocol against difficult-to-treat resistance European gram-negative bacterial pathogens from the multi-national sentinel surveillance study, SENTRY in 2020 and 2021. Presented at: IDWeek; Oct. 19-23, 2022. Washington. (hybrid meeting).
- Marcella P, et al. Real-world experience of cefiderocol with Pseudomonas aeruginosa in the PROVE (retrospective cefiderocol chart review) study. Presented at: IDWeek; Oct. 19-23, 2022. Washington. (hybrid meeting).
- Viale P, et al. Systematic review of the early use experience of ciderocol in real world practice. Presented at: IDWeek; Oct. 19-23, 2022. Washington. (hybrid meeting).
- Yamano Y, et al. In vitro antibacterial activity of cefiderocol against difficult-to-treat resistant gram-negative pathogens in United States from SENTRY antimicrobial surveillance program in 2020/2021. Presented at: IDWeek; Oct. 19-23, 2022. Washington. (hybrid meeting).
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