Investigational Suvratoxumab May Reduce Pneumonia Risk in Ventilated Patients in the ICU: Presented at ECCMID

By Shazia Qureshi

AMSTERDAM, the Netherlands -- April 18, 2019 -- Among patients in the intensive care unit (ICU) who are mechanically ventilated and have PCR-confirmed Staphylococcus aureus in the lungs, treatment with suvratoxumab reduced the risk of developing pneumonia, researchers reported here at the 29th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

Bruno François, MD, Centre Hospitalier Universitaire de Limoges, Limoges, France, and colleagues reported that the incidence of S aureus pneumonia by day 30 -- the primary endpoints -- was observed in 17.7% of suvratoxumab-treated patients compared with 26% of patients in the placebo group. This translated to a relative risk reduction of 31.9% in favor of suvratoxumab.

Looking at all-cause pneumonia, treatment with suvratoxumab reduced the risk by 30.6% compared with placebo, and for all-cause pneumonia or death, the value was 23.1% in favour of suvratoxumab.

While Dr. François said that none of these risk reduction values reached statistical significance, they could still be seen as positive for suvratoxumab treatment.

He also mentioned that the risk reduction appeared to be a bit more positive for those aged ≤65 years, though still not statistically significant. For this subgroup, suvratoxumab treatment reduced the risk of S aureus pneumonia by 47.4%, all-cause pneumonia by 46.8%, and all-cause pneumonia or death by 31.4% compared with placebo.

Suvratoxumab, previously called MEDI4893, is a human monoclonal antibody that targets the virulent alpha toxin released by S aureus.

The phase 2 study included patients in the ICU who had to be on mechanical ventilation (and expected to remain so for at least 3 days) and showed confirmed S aureus colonisation of their lower respiratory tract, but no current diagnosis of new-onset pneumonia and no current use of antibiotics against S aureus. Patients received intravenous suvratoxumab 5,000 mg (n = 96) or placebo (n = 100).

Of the patients in the suvratoxumab arm, 90.6% had at least 1 treatment-emergent adverse event (TEAD), as did 90.0% of placebo-treated patients. Grade ≥3 TEAEs were experienced by 52.1% and 51.0%, respectively. By day 30, 15.6% of patients in the suvratoxumab group and 16.0% patients in the placebo group had died.

The duration of the patient’s stay in the ICU as well as in the hospital was found to be reduced with suvratoxumab treatment compared with placebo. For every 90 days of follow-up, the ICU stay was 2.4 days shorter and hospital stay was 3 days shorter.

Funding for this study was provided by MedImmune (owned by AstraZeneca).
[Presentation title: Efficacy and Safety Profile of Suvratoxumab, a Novel Anti-Staphylococcus aureus Monoclonal Antibody: Results of the SAATELLITE Study in Mechanically Ventilated Intensive Care Unit Patients. Abstract L0013]

To read more Conference Dispatch articles, click here.