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Shionogi Announces Publication of a New Systematic Review in CHEST Highlighting the Importance of Early, Appropriate Therapy to Improve Meaningful Outcomes Like Mortality in Patients With Severe Bacterial Infections

The results underscore the importance of providing appropriate therapy early in the course of infection to improve meaningful outcomes such as mortality and provide support for the recommended approach of early broad-spectrum empiric therapy, followed by de-escalation to targeted treatment¹

An increase in antimicrobial resistance has created a challenge: providing early appropriate therapy while limiting unnecessary antibiotic use, as antibiotics therapy may need to be initiated before the causative pathogen and its drug resistance profile are known. This means patients with severe bacterial infections often experience a delay in receiving appropriate treatment ¹

This systematic review looks at studies published after 2007 reporting the impact of delayed appropriate treatment on clinical outcomes in hospitalised adults with bacterial infections ¹

The results showed mortality was significantly lower in patients who did not experience delayed appropriate antibiotic therapy compared with those who did ¹

Business Wire 01 ottobre 202015:14

Shionogi B.V., the European subsidiary of Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announce the publication of a new systematic review in CHEST Journal, funded by Shionogi B.V, examining the effect of delayed appropriate antibiotic therapy on the outcomes of patients with severe bacterial infections.¹ The review was carried out to characterise the impact of time to effective therapy for antimicrobials and guide treatment decisions to optimise prompt appropriate antibiotic therapy for patients most at risk. The study found that mortality was significantly lower in patients receiving appropriate therapy without delay compared with those experiencing delay.¹

Severe bacterial infections requiring in-hospital treatment are associated with considerable mortality, morbidity and healthcare costs. Physicians must often initiate antibiotic therapy before the pathogen causing the infection and its drug-resistance profile are confirmed, due to the lack of rapid diagnostic techniques. However, with the growing issue of antimicrobial resistance (AMR), it is necessary to limit unnecessary antibiotic use. This makes it challenging to initiate early appropriate therapy, and as a result many patients with severe bacterial infections experience delays.¹ This systematic review provides support for the recommended approach of early broad-spectrum empiric therapy, followed by de-escalation to targeted treatment, rather than use of antibiotic escalation strategies. Results also highlight the need for increased availability of rapid techniques to determine antibiotic susceptibility to identify patients with or without drug-resistant infections. This would facilitate rapid de-escalation of broad-spectrum therapy and rapid escalation in cases where empiric therapy is not optimal for the causative pathogen.

The results from this systematic review of 37 studies showed that there was a high prevalence of delayed appropriate antibiotic therapy in hospitalised patients with severe bacterial infections, with over a quarter (27%) experiencing a delay.¹ Mortality was significantly lower in patients who did not experience delayed appropriate antibiotic therapy compared with those who did (OR 0.57 [95% CI, 0.45–0.72]).¹ Mortality was also significantly lower in the no-delay group for patients with infections caused by Gram-negative pathogens (there was no significant difference seen in patients with infections caused by Gram-positive pathogens).¹

“The results of this study highlight the need to provide appropriate therapy early in the course of infection, especially Gram-negative infections, to improve meaningful outcomes such as mortality and provides support for the recommended approach of early broad-spectrum empiric therapy, followed by de-escalation to targeted treatment,” said Evan J. Zasowski, Primary Investigator of the study.

“This is a valuable study which demonstrates the importance of early initiation of appropriate antibiotic therapy whilst ensuring proper stewardship of these drugs, in order to try and combat the threat of antimicrobial resistance.” said John Keller, CEO of Shionogi B.V, “It also underscores the need for increased availability of rapid diagnostic tests to determine antibiotic susceptibility to identify patients with or without drug-resistant infections and ensure they are given the appropriate treatment in the shortest time possible to ensure the best possible patient outcomes. We support this stewardship approach for our product cefiderocol, which has just received European Commission (EC) marketing authorisation for the treatment of infections due to aerobic Gram-negative bacteria in adults with limited treatment options.”

Antimicrobial resistance (AMR)

Antimicrobial resistance (AMR) is a major health burden which urgently needs to be addressed. In Europe about 25,000 patients die from an infection with multidrug-resistant bacteria every year.² Infections caused by carbapenem-resistant Gram-negative bacteria are often associated with a high mortality rate.³ If no action is taken, antibiotic resistance is predicted to kill 10 million people every year by 2050, at a cumulative cost to global economic output of 100 trillion USD.⁴

Shionogi’s commitment to fighting antimicrobial resistance

Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years. Shionogi is proud to be one of the few large pharmaceutical companies that continues to focus on research and development in anti-infectives. The company invests the highest proportion of its pharmaceutical revenues in relevant anti-infectives R&D compared to other large pharmaceutical companies.⁵

For more information please refer to: https://www.shionogi.com/global/en/sustainability/amr.html

About Shionogi
Shionogi & Co., Ltd. is a 142-year-old global, research driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders, cardiovascular diseases and gastroenterology. Shionogi’s research and development currently target two therapeutic areas: infectious diseases, and pain/CNS disorders.

For more information on Shionogi & Co., Ltd., please visit: https://www.shionogi.com/global/en/

Shionogi B.V. is the European headquarters of Shionogi & Co., Ltd. For more information on Shionogi B.V., please visit: www.shionogi.eu

Forward Looking Statement
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

References

¹Zasowski et al. A Systematic Review of the Effect of Delayed Appropriate Antibiotic Treatment on the Outcomes of Patients With Severe Bacterial Infections. CHEST 2020; 158(3):929-938

² European Centre for Disease Prevention and Control (ECDC). Technical Report: the bacterial challenge: time to react. 2009. Retrieved from Https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/0909_TER_The_Bacterial_Challenge_Time_to_React.pdf Last accessed September 2020

³ Perez F, et al. ‘Carbapenem-Resistant Enterobacteriaceae: A Menace to our Most Vulnerable Patients’. Cleve Clin J Med. Apr 2013; 80(4): 225–33

⁴ O’Neill J. ‘Tackling Drug-Resistant Infections Globally: Final Report and Recommendations’. Review on Antimicrobial Resistance. May 2016. https://amr-review.org/sites/default/files/160518_Final%20paper_with%20cover.pdf Last accessed September 2020

⁵ Antimicrobial Resistance Benchmark 2020. https://accesstomedicinefoundation.org/media/uploads/downloads/5e270aa36821a_Antimicrobial_Resistance_Benchmark_2020 pdf Last accessed September 2020