Retrospective Real-World Evaluation of Outcomes in Patients with Skin and Soft Structure Infections Treated with Tedizolid in an Outpatient Setting

Abstract

Introduction: Outcomes data for patients who received tedizolid for acute bacterial skin and skin-structure infections (ABSSSIs) are scant. We provide a real-world analysis of economic and clinical outcomes following tedizolid use in the outpatient setting. Methods: This retrospective study of adults with skin infections treated with tedizolid (index period: 1 July 2014-31 May 2016) used data from the Optum Research and Impact National Benchmark databases. Results: Ninety-one patients received tedizolid for the treatment of skin infections (with complications, n = 18; without complications, n = 73). Some patients had [ 1 complication and infection site. Among patients with complications, pre-index complications during the [index date-30] through [index date ? 1] period included osteomyelitis (44.4%), septicemia (44.4%), and prosthetic joint/device/graft infection (16.7%). For the [index date-7] through [index date ? 1] period, the infection site included abscesses (55.6%) and chronic ulcers (38.9%). Mean (standard deviation [SD]) days supplied for the index tedizolid claim was 6.8 (2.3) days. Healthcare resource utilization (HCRU) during the 30-day post-index period included C 1 ambulatory visit (100.0%), C 1 emergency department (ED) visit (16.7%), and C 1 hospitalization (22.2%).

Long-Term Use of Tedizolid in Osteoarticular Infections: Benefits among Oxazolidinone Drugs

“…Tedizolid can also cause dose-related myelotoxicity [ 16 ], but at a lower rate than linezolid [ 24 ]. Safety of long-term use of tedizolid was evaluated in healthy volunteers for 21 days [ 16 ], while most of the information in patients is limited to six days of treatment in ABSSSIs [ 4 , 5 , 21 ], and there is little information with longer therapies where the appearance of thrombocytopenia and anemia was observed in 7.4 and 1.2%, respectively [ 22 ]. In our experience, tedizolid was administered a median of 29 days and was well tolerated without relevant hematologic adverse events appearing or need for withdrawn, even in cases with moderate/severe cytopenia at the start of therapy or those that were switched to tedizolid after developing linezolid myelotoxicity [ 25 ].…”

“…Despite the potential advantages of tedizolid in osteoarticular infections (higher microbiological activity, advantageous pharmacokinetic/pharmacodynamics parameters, lower myelotoxicity, and drug–drug interactions) [ 1 , 2 , 3 ], clinical data on long-term treatment are scarce [ 16 ]. Knowledge is limited to a few experimental studies [ 17 , 18 , 19 ], case reports [ 20 ] and recently some case series in which tedizolid is prescribed for different indication including osteoarticular infections [ 21 , 22 ]. Thus, in the present study, we intend to describe our multicenter experience within the Spanish Network for Research in Infectious Diseases (REIPI) with long-term use of tedizolid in a cohort of patients with osteoarticular and diabetic foot infections and focused on the efficacy and safety in monotherapy or combination.…”

Pharmacokinetics and Pharmacodynamics of Tedizolid

“…In the ESTABLISH 1 and 2 clinical trials, 200 mg/day of TDZ was non-inferior to 600 mg twice-daily dosing of LNZ in patients with ABSSSIs and was subsequently licensed for this indication [ 90 , 91 ]. Moreover, TDZ reduced skin and soft-tissue infection-related hospital admissions in out-patient settings [ 92 ]. Based on pooled PK and PD data from four clinical studies (one phase I, one phase II, and two phase III) where doses of 100–400 mg/day were investigated [ 10 , 15 , 91 , 91 , 93 , 94 ], a PK/PD model was developed to relate exposure to efficacy.…”

Expert Update on Acute Bacterial Skin and Skin Structure Infection Treatment Options in the Community Setting

“…e use of newer antimicrobial therapies and their simpli ed dosing regimens (whether it is a once daily oral dose or a one-time single infusion) can potentially improve the e ciency of healthcare in patients with ABSSSIs by helping stable patients in the community or 16 Real world analyses of some of these newer agents have also shown reduced hospital length of stay, improved patient productivity, and reduced direct costs per patient. [38][39][40][41] e cost of some of these agents may be higher up-front, but at the end of the day, the overall cost may be cheaper than a 5-to-6-day hospitalization to receive IV antimicrobial treatment. As an example, in a retrospective cohort study, patients with ABSSSIs treated with dalbavancin had reduced total direct costs per patient compared to those receiving standard of care ($2758 vs $4010, respectively, P = .105).…”