Early Clinical Response With Omadacycline vs Moxifloxacin in CABP
The OPTIC study evaluated noninferiority of omadacycline to moxifloxacin.
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SAN DIEGO — Regardless of disease severity, according to Pneumonia Outcomes Research Team (PORT) risk class, patients with community-acquired bacterial pneumonia (CABP) experienced a comparable early clinical response (ECR) and posttherapy clinical response (PTCR) when treated with omadacycline or moxifloxacin, according to research presented at the American Thoracic Society 2018 International Meeting, held May 18-23, 2018, in San Diego, California.
The noninferiority of omadacycline to moxifloxacin was demonstrated in the phase 3, randomized, double-blind OPTIC (Omadacycline for Pneumonia Treatment in the Community; ClinicalTrials.gov Identifier: NCT02531438) study (N=774). ECR, a primary outcome for patients with CABP established by the US Food and Drug Administration (FDA), can vary according to the patient's disease severity at the time of hospitalization.
For this analysis, study authors evaluated ECR (72-120 hours after first dose) in the OPTIC study by PORT risk class; a secondary objective was PTCR (5-10 days after last dose). ECR was defined as "survival, no receipt of rescue antibacterial therapy and improvement in at least 2 of 4 CABP symptoms (cough, sputum production, pleuritic chest pain, dyspnea) without deterioration in any of these 4 symptoms," stated lead author Julio A. Ramirez, MD, FACP, from the University of Louisville, Kentucky. PTCR was defined as survival with resolution of signs and symptoms of the infection to the extent that further antibacterial therapy was not needed.
Of the intent-to-treat population, the PORT risk class breakdown was as follows: class II (14.2% of the omadacycline group and 13.9% of the moxifloxacin group), class III (58.8% and 55.7%, respectively), and class IV (26.4% and 29.6%, respectively). Baseline radiology confirmed pulmonary infiltrates with multilobar infiltrates present in 24.1% of patients who received omadacycline and 29.1% of patients who received moxifloxacin; unilateral or bilateral pleural effusions were also confirmed.
Overall, the clinical success rates of both ECR and PTCR were "high and similar" between the 2 treatment groups across PORT risk class subgroups, Dr Ramirez added. The majority of patients in both study groups (75%-80%) met the FDA-defined end point of ECR: class II (75.4% of the omadacycline group vs 73.2% of the moxifloxacin group), class III (84.1% vs 86.6%, respectively), and class IV (77.5% vs 80.2%, respectively). PTCR was seen in 80 to 90% of patients in both study arms.
Dr Ramirez noted, "In clinical practice, reaching ECR is likely to translate into an early switch from intravenous to oral antibiotics and early hospital discharge."
Disclosures: Several researchers report financial relationships with Paratek Pharmaceuticals.
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Ramirez JA, Garrity-Ryan L, Eckburg B, et al. Early clinical response of omadacycline versus moxifloxacin in the treatment of community-acquired bacterial pneumonia by PORT risk class: results from the OPTIC study. Presented at: American Thoracic Society 2018 International Conference; May 18-23, 2018; San Diego, CA. Abstract 4458.