Efficacy and Safety of Eravacycline in Obese Patients: A Post Hoc Analysis of Pooled Data From the IGNITE1 and IGNITE4 Clinical Trials.

BACKGROUND

The increasing prevalence of obesity worldwide merits an examination of the efficacy and safety profiles of agents dosed by weight.

METHODS

Data for patients (n = 1037) were obtained from the pooled IGNITE1 and IGNITE4 randomized double-blind trials in which patients with complicated intra-abdominal infections received eravacycline 1 mg/kg (actual body weight [ABW]) every 12 hours or comparator (ertapenem 1 g every 24 hours or meropenem 1 g every 8 hours) intravenously. This post hoc analysis evaluated clinical cure rates, adverse events, and drug discontinuation rates stratified by body mass index (BMI) categories of BMI >40 kg/m2 (Obese, Class III), BMI 35-39.9 kg/m2 (Obese, Class II), BMI 30-34.9 kg/m2 (Obese, Class I), BMI 25-29.9 kg/m2 (Overweight), BMI 18.5-24.9 kg/m2 (Healthy weight), and BMI <18.5 kg/m2 (Underweight).

RESULTS

Clinical cure rates were high across BMI categories and ranged from 82% to 94% in the eravacycline group and 88.5%-100% in the comparator group. Similar cure rates were observed among eravacycline-treated healthy weight (126/134; 94%), overweight (127/146; 87%), and obese (BMI ≥30 kg/m2; 110/129; 85.3%) patients. In the comparator group, a similar proportion of patients demonstrated clinical response (healthy weight [132/145; 91%], overweight [130/144; 90.3%], and obese [115/129; 89.1%]). Of the treatment-emergent adverse events that occurred in eravacycline-treated obese patients, a larger proportion were gastrointestinal-related (ie, nausea and vomiting); however, discontinuation rates were low and similar between eravacycline and carbapenems.

CONCLUSIONS

This post hoc analysis demonstrates the therapeutic utility and acceptable safety profile of eravacycline dosed by ABW in obese patients (BMI ≥30 kg/m2).