Impact of obesity on clinical outcomes in patients treated with ceftobiprole: results from Phase 3 clinical trials.

Abstract

Background: Ceftobiprole was non-inferior to comparators for the treatment of Staphylococcus aureus bloodstream infection (bacteraemia) (SAB), acute bacterial skin and skin structure infection (ABSSSI), and community-acquired bacterial pneumonia (CABP), leading to regulatory approval for these indications. Whether dosing should be modified for patients with obesity is unknown.

Objectives: This post hoc analysis evaluated the relationship of obesity and clinical outcomes in patients treated with ceftobiprole for SAB, ABSSSI or CABP.

Methods: Efficacy and safety outcomes were assessed based on BMI from three registrational clinical trials that evaluated ceftobiprole against comparators.

Results: Overall, 1641 patients were included from the three Phase 3 clinical trials (802 ceftobiprole; 839 comparators). When stratifying by BMI, ceftobiprole had similar outcomes to the overall ceftobiprole population (80.4%) including patients with obesity (BMI = 30-40 kg/m2) (81.7%). Severe obesity (BMI ≥ 40 kg/m2) was associated with decreased clinical cure rates overall (68.2%) compared with the overall ceftobiprole population, and this was especially noted in the clinically evaluable patient population with CABP receiving ceftobiprole (66.7% in severe obesity versus 86.6% overall). This was also seen in the comparator group (33.3% in severe obesity versus 87.4% overall). However, the number of patients with severe obesity was low in the CABP trial. The safety profile was similar between treatment groups in all studies and not influenced by BMI.

Conclusions: This analysis further supports the efficacy and safety of ceftobiprole at current recommended doses in obese patients with SAB, ABSSSI or CABP.