Lefamulin a safe, effective alternative to moxifloxacin for unilobar, multilobar pneumonia
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In a pooled analysis of the LEAP 1 and LEAP 2 trials, lefamulin was safe and its efficacy was comparable to that of moxifloxacin in patients with unilobar and multilobar community-acquired bacterial pneumonia.
“Various studies have found that pneumonia with multilobar infiltration is associated with several decreased clinical outcomes including higher mortality,” Thomas M. File, MD, MS, FCCP, chair of the infectious disease division at Summa Health, Akron, Ohio, said during a virtual presentation at the CHEST Annual Meeting. “Lefamulin is the first pleuromutilin antibiotic approved for IV and oral use in adults with community-acquired bacterial pneumonia based on the results of two noninferiority phase 3 trials compared to moxifloxacin.”
To investigate the efficacy and safety of lefamulin (Xenleta, Nabriva Therapeutics) in patients with community-acquired bacterial pneumonia who have or are at risk for severe pneumonia, the researchers analyzed pooled data from the LEAP 1 and LEAP 2 trials based on the presence of unilobar vs. multilobar infiltrates.
In LEAP 1, 551 adults with PORT risk class III to V were randomly assigned to IV lefamulin 150 mg every 12 hours for 5 to 7 days or moxifloxacin 400 mg every 24 hours for 7 days with optional IV to oral switch. In LEAP 2, 738 adults with PORT risk class II to IV were randomly assigned to oral lefamulin 600 mg every 12 hours for 5 days or moxifloxacin 400 mg every 24 hours for 7 days.
For the post hoc pooled analysis, the researchers evaluated efficacy outcomes based on the primary endpoints of early clinical response and investigator assessment of clinical response at test of cure. Endpoints were assessed in all randomized patients with at least one baseline pathogen.
Among patients randomized to lefamulin or moxifloxacin, 69% had unilobar infiltrates and 31% had multilobar infiltrates.
Patients with multilobar pneumonia were more likely than those with unilobar pneumonia to be aged older than 65 years, have a PORT risk score of IV or V, and have a history of asthma, COPD or smoking. Streptococcus pneumoniae was the most frequently identified baseline pathogen overall, File said.
Patients assigned lefamulin or moxifloxacin had high and similar success rates for early clinical response, File said. In those with unilobar infiltrates, early clinical response was 92% in the lefamulin group and 94% in the moxifloxacin group, and in those with multilobar infiltrates the rate was 85% and 90%, respectively.
Investigator assessment of clinical response was also similar. In those with unilobar infiltrates, the rate was 86% in the lefamulin group and 89% in the moxifloxacin group, and in those with multilobar infiltrates the rate was 77% and 80%, respectively.
The most common treatment-emergent adverse events were gastrointestinal related and rates were similar in the lefamulin and moxifloxacin groups and in those with unilobar and multilobar infiltrates, File said.
“Based on the data shown here and elsewhere in outpatients and nonsevere inpatients with community-acquired bacterial pneumonia, lefamulin would fit well into these treatment recommendations as an alternative to fluoroquinolones,” File said.