Dalbavancin Safe, Efficacious for Skin Infections Regardless of Weight
Clinical success rates at end-of-treatment visit and final visit were similar in normal weight, overweight, and obese patients.
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Dalbavancin is efficacious and safe in obese patients with acute bacterial skin and skin structure infections (ABSSSI) regardless of weight, according to a subanalysis of a phase 3 study presented at IDWeek 2017, held from October 4-8 in San Diego, California.
Researchers evaluated the safety and efficacy of intravenous dalbavancin in 698 patients with ABSSSI, including major abscess, cellulitis, and traumatic wound or surgical site infection with an area of erythema >75 cm2. Patients either received 1 dose of intravenous dalbavancin 1500 mg or 2 doses of intravenous dalbavancin (1000 mg on day 1 and 500 mg on day 8). In this subgroup analysis, patients were categorized as normal weight (BMI <25; n =237), overweight (BMI 25 to <20; n =221), or obese (BMI >30; n = 240).
Despite higher rates of diabetes, hypertension, and cellulitis in obese patients, no difference in clinical success, considered resolution or improvement in all signs and symptoms with no further antibiotic treatment needed, was observed between the 3 weight groups at days 14 and 28.
In patients with a BMI <25, 25 to <30, 30 to <35, 35 to <40, and >40 kg/m2, drug-related treatment-emergent adverse events were reported in 7.2%, 4.6%, 7.6%, 11.7%, and 13.1% of patients, respectively. The rates of serious treatment-emergent adverse events ranged from 0% to 3.3% and were not significantly different between weight groups. The researchers also noted that the rates of treatment-emergent adverse events were comparable to data for dalbavancin from previous phase 3 trials.
The researchers explained that "dalbavancin is a lipoglycopeptide with activity against gram-positive pathogens responsible for [acute bacterial skin infections and skin structure infections], including methicillin-resistant Staphylococcus aureus (MRSA), and is FDA [US Food and Drug Administration]-approved as a single- or 2-dose regimen."
"Dalbavancin is effective and well tolerated in overweight and obese patients," the study investigators concluded.
Disclosures: With the exception of Matthew W. McCarthy, MD, all other authors are employees of Allergan plc.
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Georgiades B, Rappo U, Gonzalez PL, et al. Efficacy and safety of dalbavancin for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in the obese population. Presented at: IDWeek 2017; October 4-8, 2017; San Diego, California. Poster 256.