Dalbavancin Efficacy Examined for ABSSSI in Diabetics, Nondiabetics
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SAN DIEGO—Diabetes does not affect dalbavancin clinical response rates in patients with acute bacterial skin and skin structure Infection (ABSSSI), according to authors of a post-hoc analysis of data from a double-blind, phase 3 clinical trial, reported at IDWeek 2017.
ABSSSIs are frequently seen among patients with diabetes and are associated with an increased risk of complications, reported study co-author Michael Nowak, PharmD, of Allergan, Jersey City, NJ.
Dalbavancin is a long-acting lipoglycopeptide effective against the gram-positive bacteria responsible for ABSSSI, including methicillin-resistant Staphylococcus aureus (MRSA). Dalbavancin has “demonstrated activity in ABSSSI with single-dose administration,” Dr Nowak noted.
The authors studied adult patients with ABSSSI “involving deeper soft tissue or requiring significant surgical intervention, defined as major abscess, cellulitis, and traumatic wound/surgical site infection.”
Patients were randomized 1:1 to receive single-dose (1500mg) or 2-dose dalbavancin (1000mg on Day 1 and 500mg on Day 8).
The primary study endpoint was ≥20% reduction in erythema at 48–72 hours. In the post-hoc analysis, improved lesion size and improved “signs and symptoms” at Days 14 and 28 were defined as clinical success.
“There were 76/698 (10.9%) participants with diabetes and 622/698 (89.1%) participants without diabetes,” noted Dr. Nowak. “Participants with diabetes were more likely to be older or obese, and had higher rates of cellulitis, while participants without diabetes had higher rates of abscess.”
Clinical response at 48–72 hours after treatment with single-dose or 2-dose dalbavancin was 76.3% in patients with diabetes vs. 83.6% in patients without diabetes. At Day 14 (end of treatment), clinical success was observed with single-dose or 2-dose dalbavancin in 84.4% of patients with diabetes and 89.4% of patients without diabetes. Clinical success on Day 28 (final visit) was seen with dalbavancin in 89.5% of patients with diabetes and 92.7% of patients without diabetes.
Drug-related adverse events were observed in 20 patients with diabetes and 119 patients without diabetes, Dr. Nowak reported.
The findings suggest dalbavancin had similar efficacy as a single-dose or 2-dose regimen in patients with or without diabetes, "despite these patients having higher C-reactive protein levels and white blood cell counts," concluded Dr. Nowak.
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Nowak M, Rappo U, Gonzales PL, Chen J, McGregor JS, Bryowsky J, Talan D. Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Patients with Diabetes Mellitus. Poster presented at IDWeek; October 4–8, 2017; San Diego, CA. IDWeek.org.