256. Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in the Obese Population
Session: Poster Abstract Session: Clinical: Skin and Soft Tissue
Thursday, October 5, 2017
Room: Poster Hall CD

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 2-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 cm2. Patients were randomized 1:1 to receive dalbavancin 1500 mg intravenously (IV) as a single dose or as 2 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/m2). 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.

 

Benjamin Georgiades, PharmD1, Urania Rappo, MD, MS, PharmD2, Pedro L. Gonzalez, MD1, Jennifer S. McGregor, RPh1, Jie Chen, PhD1 and Matthew McCarthy, MD3, (1)Allergan plc, Jersey City, NJ, (2)Allergan plc, Madison, NJ, (3)Weill Cornell/New York-Presbyterian Hospital, New York, NY

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

M. McCarthy, None

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