Clinical

Bezlotoxumab may lower risk of C. difficile readmissions

 

Key clinical point: Patients treated with bezlotoxumab were less likely to experience recurrent Clostridium difficile infection.

Major finding: A total of 27 of 530 (5%) bezlotoxumab patients were readmitted within 30 days of discharge compared with 58 of 520 (11%) placebo patients.

Data source: Randomized, double-blind, placebo-controlled, multicenter, global phase 3 trials conducted from November 2011-May 2015 at 322 sites in 30 countries.

Disclosures: All investigators report employment or financial support with Merck and have individually reported financial ties to similar companies like Astellas, AstraZeneca, Pfizer, and others.


 

FROM CLINICAL INFECTIOUS DISEASES

 

Clostridium difficile infection (CDI) patients treated with bezlotoxumab were less likely to be readmitted for recurring symptoms within 30 days of discharge, according to a phase 3 trial funded by Merck.

Recurrent CDI is a burden on both patients and providers, increasing health risks with each recurrence and eating through hospital resources, according to Vimalanand S. Prabhu, PhD, associate principal scientist for Merck.

Clostridium difficile cjc2nd/Wikimedia Commons/CC ASA-3.0
“Approximately 25% of patients experience recurrent CDI. … After a first recurrence of CDI, the probability of a second recurrence is approximately 38%,” according to a study cited by Dr. Prabhu and colleagues (Clin Infect Dis. 2014 Aug 1;59[3]:345-54). “Recent model-based estimates place the 2014 economic cost of CDI at $5.4 billion in the United States, mostly attributable to hospitalization.”

In a randomized, double-blind, placebo-controlled, study of 1,050 CDI patients, a total of 27 (5%) of 530 of those given bezlotoxumab were re-hospitalized 30 days after discharge, compared with 58 (11%) of 520 patients in the placebo group (Clin Infect Dis. 2017 Aug 11. doi. 10.1093/cid/cix523).

Patients were gathered from 322 sites across 30 countries between November 2011 and May 2015.

When measuring CDI-related readmissions, the investigators found use of bezlotoxumab reduced rCDI hospitalizations by 6%, and by approximately 8% in high-risk patients, such as those over 65 years old or with severe CDI.

Bezlotoxumab works by binding to CDI toxin B, a primary cause of CDI symptoms, according to Dr. Prabhu and fellow investigators. The researchers suggested that bezlotoxumab could be a prevailing factor in fighting the rate of CDI infections, which accounted for 29,000 deaths in 2011 (N Engl J Med. 2015 Jun 11;372[24]:2368-9).

Investigators acknowledged that patients admitted for the study may be healthier than the real-world CDI population.

All investigators reported some financial involvement, whether being a full-time employee or acting as a consultant, for Merck, which funded the study. Individually, investigators reported financial ties to similar medical companies, such as Pfizer and AstraZeneca.
   Comments ()

Next Article: