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A post hoc and subpopulation analysis of the MODIFY trials showed that taking bezlotoxumab (MERCK) , a monoclonal antibody that neutralizes Clostridium difficile toxin B, led to lower recurrence of C. difficile infection and fewer hospital readmissions among European patients compared with placebo, according to study data presented at ECCMID 2016.
MODIFY I and II were global phase 3 trials that demonstrated the safety and efficacy of a single 10 mg/kg IV dose of bezlotoxumab (Merck) to decrease C. difficile recurrence when paired with standard antibiotic therapy. While initial antibiotic treatment for C. difficile is often successful, up to 35% of patients experience a recurrence of the infection, with each recurrence increasing the risk for future recurrences.
In the post hoc analysis, researchers studied a subset of European patients from the MODIFY trials who received standard antibiotic treatment plus either bezlotoxumab (n = 313) or placebo (n = 293).
Analysis showed that the recurrence of C. difficile in the bezlotoxumab group was 15% vs. 24.2% in the placebo group (difference, –9.2%; 95% CI, –15.6 to –2.9). These rates were consistent with those observed in the overall group of patients in the MODIFY trials, according to the researchers. Further, just 4.5% of European patients in the bezlotoxumab group experienced hospital readmission associated with C. difficile infection compared with 13.3% in the placebo group (difference, –8.8%; 95% CI, –13.9 to –4). All-cause hospital readmissions were 23% in the bezlotoxumab group and 26.6% in the placebo group (difference, –3.5%; 95% CI –11 to 3.9).
Results of two other post hoc analyses of the MODIFY trials also were presented at ECCMID 2016.
In one, researchers showed that giving bezlotoxumab to patients receiving standard antibiotic care was effective through 12 weeks in key subpopulations at high risk for C. difficile recurrence and/or C. difficile infection-related adverse outcomes, including those aged 65 years and older, those with at least one C. difficile infection within the previous 6 months, and those who were immunocompromised.
Another post hoc analysis showed that the magnitude of reduction in rates of C. difficile recurrence in patients taking bezlotoxumab compared with placebo was greater when diagnosis was made using enzyme immunoassays for toxin detection (–12.8%; 95% CI –18.5 to –7) rather than PCR (–6.5%; 95% CI –12.8 to –0.3). The results were clinically meaningful no matter the testing method, the researchers said. – by Gerard Gallagher
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