676. Health-Related Quality of Life (HRQoL) as Measured by the 12-Item Medical Outcomes Study Short-Form (SF-12) Among Adults With Community-Acquired Bacterial Pneumonia (CABP) Who Received Either Lefamulin (LEF) or Moxifloxacin (MOX) in Two Phase 3 Randomized, Double-Blind, Double-Dummy Clinical Trials (LEAP 1 and 2)

BACKGROUND: Interest in patient health experience as part of a benefit–risk assessment for new drug approvals is increasing. Patient-centeredness, a key metric in the 2010 Affordable Care Act, is also a growing area of focus in healthcare. LEF, a new antibiotic in development for treating adults with CABP, was noninferior to MOX based on clinical response endpoints in LEAP 1 and 2. HRQoL was prospectively incorporated and evaluated in both studies via SF-12, a well-known survey that measures general health status in 8 domains (physical function, role limitations due to physical problems, bodily pain, general health, vitality, social function, role limitations due to emotional problems, and mental health). METHODS: An exploratory analysis evaluated HRQoL in patients who received LEF or MOX in LEAP 1 (IV-PO treatment) and LEAP 2 (PO-only treatment). SF-12 was measured at baseline (BL) and test-of-cure (TOC; 5–10 days after last study drug dose). SF-12 outcomes assessed included the 8 domains, physical component summary (PCS), and mental component summary (MCS) scores. SF-12 scores were normalized to the 2009 US population reference mean (SD) of 50 (10). A 3-point change on any scale represents a clinically meaningful difference. RESULTS: Analysis included 1,215 patients (LEF n = 607; MOX n = 608). At BL, all mean SF-12 scores in both treatment groups were well below the US reference mean, indicating a low HRQoL level, consistent with the acute illness of the study population (figure). Clinically meaningful and significant improvements from BL to TOC were observed in all domain, PCS, and MCS scores in both groups. Mean scores were close to the reference mean, indicating an average HRQoL level. No significant differences in mean score improvements from BL to TOC were seen for LEF vs. MOX. SF-12 score improvements at TOC across predefined subgroups (age, sex, number of comorbidities, study, and PORT risk class) were comparable between treatment groups. CONCLUSION: Our data indicate that adults with CABP experienced HRQoL improvements with LEF that were comparable with MOX, and treatment with either agent resulted in return to normal HRQoL. When combined with overall study results, these data suggest LEF as a potential alternative to MOX for treatment of adults with CABP. [Image: see text] DISCLOSURES: All authors: No reported disclosures.