This article is written live from ID Week 2017 Annual Meeting in San Diego, CA. MPR will be reporting news on the latest findings from leading experts in infectious diseases. Check back for more news from IDWeek 2017.
SAN DIEGO—Dalbavancin is “effective and well tolerated” among patients with acute bacterial skin and skin structure infection (ABSSSI) who are overweight and obese, according to a subgroup analysis of data from a randomized, double-blind, Phase 3 trial, reported at IDWeek 2017.
“Clinical success rates at end-of-treatment visit and final visit were similar between normal weight, overweight, or obese patient groups,” reported study coauthor Benjamin Georgiades, PharmD, of Allergan, Jersey City, NJ.
Dalbavancin is a lipoglycopeptide used to treat gram-positive pathogens that cause ABSSSI, including methicillin-resistant Staphylococcus aureus (MRSA). The coauthors analyzed data for 698 study participants diagnosed with ABSSSI (major abscess, cellulitis, or traumatic wound/surgical site infection and an area of erythema ≥75cm2).
Patients had been randomized 1:1 to receive intravenous single- or 2-dose dalbavancin (1500mg IV or 1000mg on Day 1 and 500mg on Day 8).
The primary study endpoint had been clinical response at 48–72 hours, defined as ≥20% reduction in infection-associated erythema, Dr. Georgiades noted. Clinical success was defined as “resolution or improvement in all signs and symptoms” at Day 14 and Day 28, and no further need for antibiotic treatment, he said.
“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),” Dr. Georgiades reported. Rates of hypertension was higher in obese patients, he noted.
Drug-related treatment-emergent adverse events (TEAEs) were seen 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),” he reported. “Rates of serious TEAEs were similar between groups, ranging from 0 to 3.3% among BMI groups,” Dr Georgiades noted.
Overall, the findings suggest dalbavancin is effective and well tolerated as a single-dose or 2-dose regimen for ABSSSI among patients who are normal weight, overweight, or obese, the authors concluded.
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Georgiades B, Rappo U, Gonzalez PL, McGregor JS, Chen J, McCarthy M. Efficacy and safety of dalbavancin for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in the obese population. Poster presented at IDWeek; October 4–8, 2017; San Diego, CA. IDWeek.org.