Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in the Obese Population. (4th October 2017) - Georgiades, Benjamin
Abstract: Background: Dalbavancin is a lipoglycopeptide with activity against Gram-positive pathogens responsible for ABSSSI, including methicillin-resistant Staphylococcus aureus (MRSA), and is FDA-approved as a single- or two-dose regimen. The objective of this study was to assess efficacy and safety of dalbavancin for the treatment of ABSSSI among overweight and obese patients. Methods: This was a subanalysis of a previously published randomized, double-blind, phase 3 trial of 698 patients with ABSSSI, defined as major abscess, cellulitis, or traumatic wound/surgical site infection and an area of erythema ≥75 cm 2 . Patients were randomized 1:1 to receive dalbavancin 1500 mg intravenously (IV) as a single dose or as two doses: 1000 mg on Day 1 and 500 mg on Day 8. The primary outcome measure was clinical response at 48–72 hours, defined as ≥20% reduction in infection-associated erythema. Clinical success (resolution or improvement in all signs and symptoms; no further antibiotic treatment needed) was assessed at Days 14 and 28. Safety was assessed at every visit. Results: There were 237 patients with normal weight (BMI <25), 221 patients who were overweight (BMI 25 to <30), and 240 patients who were obese (119 with BMI 30 to <35; 60 with BMI 35 to <40; 61 with BMI ≥40). Rates of diabetes, hypertension, SIRS, and cellulitis were higher in obese patients (Figure 1). Clinical success rates at end-of-treatment visit and final visit were similar between normal weight, overweight, or obese patient groups (Figure 2). Study drug-related treatment-emergent adverse events (TEAEs) were observed in 7.2% of normal weight patients, 4.6% of overweight patients, and as follows in obese patients: 7.6% (BMI 30 to <35), 11.7% (BMI 35 to <40), and 13.1% (BMI ≥ 40 kg/m 2 ). Rates of serious TEAEs were similar between groups, ranging from 0 to 3.3% among BMI groups. Rates of TEAEs were also similar to those reported for dalbavancin in previous phase 3 trials. Conclusion: Dalbavancin is effective and well tolerated in overweight and obese patients. Disclosures: B. Georgiades, Allergan plc: Employee, Salary. U. Rappo, Allergan plc: Employee and Shareholder, Salary. P. L. Gonzalez, Allergan plc: Employee and Shareholder, Salary. J. S. McGregor, Allergan plc: Employee, Salary. J. Chen, Allergan plc: Employee, Salary