2245. Oral 5-Day Lefamulin for Outpatient Management of Pneumonia Outcomes Research Team (PORT) Risk Class III/IV Community-Acquired Bacterial Pneumonia (CABP): Post Hoc Analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 2 Phase 3 Study

Abstract

BackgroundSite-of-care decisions (e.g., admission vs. outpatient) in CABP management can be challenging for healthcare providers. Here we describe a post hoc analysis of adults with CABP managed as outpatients in the LEAP 2 double-blind, noninferiority, Phase 3 trial.MethodsLEAP 2 compared the efficacy and safety of oral lefamulin (LEF) 600 mg every 12 hours for 5 days vs. oral moxifloxacin (MOX) 400 mg every 24 hours for 7 days in adults with PORT Risk Class II-IV. Descriptive statistics were generated to characterize demographics, baseline characteristics, efficacy, and safety outcomes in the subpopulation of outpatients in LEAP 2.ResultsOverall, 42% (310/736) of patients started treatment as outpatients (41% [151/368] LEF and 43% [159/368] MOX). Age, gender, and BMI were generally similar in both treatment groups. 44% (66/151) LEF and 40% (64/159) MOX outpatients had PORT Risk Class III or IV, and 21% in both groups (31/151 LEF and 34/159 MOX) had CURB-65 score 2 or 3. Comorbidities included smoking history (43% LEF vs. 34% MOX), hypertension (26% vs. 30%), COPD/asthma (14% vs. 18%), and diabetes mellitus (7% vs. 11%). Early clinical response (ECR) responder rates and investigator’s assessment of clinical response (IACR) success rates at the test of cure (TOC) visit were high and similar in both groups among all, PORT Risk Class III/IV, and CURB-65 score 2 or 3 outpatients (Table 1). In the PORT Risk Class III/IV subset, 86% LEF vs. 80% MOX patients were both an ECR responder and IACR success at TOC. In the CURB-65 score 2 or 3 subset, 87% LEF vs. 74% MOX patients were both an ECR responder and IACR success at TOC. Treatment-emergent adverse event (TEAE) rates were similar in both groups (Table 2). Consistent with overall study results, the difference between groups in related TEAEs was driven by gastrointestinal disorders (20% LEF vs. 5% MOX), specifically diarrhea (15% vs. 1%). Rates of TEAEs leading to discontinuation were low and similar in both groups. No LEF outpatient had an SAE or was admitted during the study, compared with 5 (3%) SAEs, including 2 deaths, in the MOX group.ConclusionThese study data suggest that PORT Risk Class III or IV patients can be effectively managed as outpatients with 5 days of oral LEF as an alternative to fluoroquinolones for the treatment of CABP. Disclosures All authors: No reported disclosures.