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Zinplava may prevent recurrent C. difficile infection in patients with IBD
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A single infusion of Zinplava was associated with a reduced incidence of recurrent Clostridium difficile infection in patients with inflammatory bowel disease, according to a post hoc analysis of the MODIFY trials presented at the European Congress of Clinical Microbiology and Infectious Diseases.
However, the researchers noted that the results should be interpreted with caution due to the small sample size in the study.
Ciaran P. Kelly
Zinplava (bezlotoxumab [bezlo]; Merck), “is a human monoclonal antibody that neutralizes C. difficile toxin B and reduces recurrence of C. difficile infection (CDI),” Ciaran P. Kelly, MD, professor of medicine at Harvard Medical School, director of gastroenterology fellowship training and director of the Celiac Center at Beth Israel Deaconess Medical Center, told Healio Gastroenterology. “In this study we evaluated 44 patients with both IBD and CDI in the MODIFY phase 3 trials of bezlo in CDI recurrence (rCDI).”
As Healio.com previously reported, the MODIFY trials showed that one 10 mg/kg IV infusion of bezlotoxumab was superior for prevention of rCDI compared with placebo.
IBD patients have higher rates of CDI, often lack common risk factors, and frequently have severe and recurrent CDI episodes, “and there is no clear consensus on how to treat these patients,” Kelly and colleagues wrote.
In this post hoc analysis they evaluated CDI-related outcomes through 12 weeks among a subset of IBD patients enrolled in the MODIFY trials, who were permitted to participate if investigators attributed their symptoms to CDI rather than their IBD. Of the 44 IBD patients, 23 had ulcerative colitis, 18 had Crohn’s disease, three had unclassified IBD, and the mean IBD duration was 8.8 years.
They found that the patients with IBD were younger (mean age, 50.3 vs. 63.5; proportion aged older than 65 years, 27.3% vs. 53.5%), were more likely to be outpatients (54.5% vs. 32%), and were more often immunocompromised (40.9% vs. 21.1%) compared with the trial’s modified intention to treat population (mITT) without IBD. In addition, a lower percentage of IBD patients achieved clinical cure with bezlotoxumab compared with the mITT population.
IBD patients who received bezlotoxumab were less likely to achieve initial clinical cure compared with IBD patients who did not receive bezlotoxumab (53.6% vs. 81.3%; difference, –27.7; 95% CI, –51.1 to 2.3). Further, IBD patients showed higher rates of rCDI in both the placebo and the bezlotoxumab groups compared with the mITT population, but a higher percentage of IBD patients in the placebo group had rCDI compared with IBD patients who received bezlotoxumab (53.8% vs. 26.7%).
A single infusion of bezlotoxumab yielded a 27.2% absolute reduction in the incidence of rCDI in IBD patients, and a 50% relative reduction.
Most recurrences in IBD patients who did not receive bezlotoxumab occurred within 4 weeks after infusion, while most recurrences in IBD patients who did receive bezlotoxumab occurred after 4 weeks following infusion.Three of the IBD patients who received placebo were hospitalized, and one died, while no IBD patients who received bezlotoxumab were hospitalized.
“The efficacy of bezlo in preventing rCDI may extend to patients with IBD, but additional data are needed due to our small cohort size,” Kelly said. “CDI is an increasingly problematic complication of IBD and is associated with poor outcomes including prolonged hospitalization, higher colectomy rates and frequent episodes of rCDI. Thus, new therapies such as bezlo, that may avoid rCDI in IBD patients would be welcome.” – by Adam Leitenberger
Reference:
Wilcox MH, et al. Abstract #EV0301. Presented at: 27th European Congress of Clinical Microbiology and Infectious Diseases; April 22-25; Vienna, Austria.
Disclosures: Some of the researchers report financial relationships with Merck.