Zinforo® for the Treatment of cSSTI

A cephalosporin with consistent clinical cure rates in cSSTI*1-3

Adapted from Corey G, et al. Clin Infect Dis. 2010.1

*There is no experience with Zinforo® in the treatment of cSSTI in the following patient groups:4
The immunocompromised, patients with severe sepsis/septic shock, necrotising fasciitis, perirectal abscess and patients with third-degree and extensive burns. There is limited experience in treating patients with diabetic foot infections. Caution is advised when treating such patients.

cSSTI : complicated skin and soft tissue infections; CI: confidence interval;

References:
1. Corey G, Wilcox M, Talbot G, et al. Clin Infect Dis 2010; 51:641–50.
2. Corey G, Wilcox M, Talbot G, et al. J Antimicrob Chemother 2010;65(Suppl. 4):iv41–iv51.
3. Wilcox M, Corey G, Talbot G, et al. J Antimicrob Chemother 2010;65(Suppl. 4):iv53–iv65.
4. ZINFORO® (ceftaroline fosamil). Local Product Document of Ceftaroline; LPDZIN072021.

Real-world efficacy in clinical practice: An overall clinical success rate of 85% in cSSTI1

Prior antibiotic use in CAPTURE*1
Antibiotics were administered prior to Zinforo® treatment in 80% of the patients.
Clinical success rates in this group:

 
  • Patients receiving Zinforo® monotherapy: 86%
  • Patients receiving Zinforo® concurrently with other antibiotics: 84%
Rationale for Zinforo® use:
In a recent retrospective study, the most common reason for using Zinforo® was following disease progression on prior therapies3

 

Real-world efficacy in patients with comorbidities and renal insufficiency4
Overall clinical success rates for evaluable patients with cSSTI by category of renal function in the CAPTURE study*

Dosage adjustments are required in patients with moderate to severe (CrCl ≥15 mL/min to ≤50 mL/min) renal impairment and ESRD, including patients undergoing haemodialysis.5

Real-world efficacy demonstrated in obese patients with similar clinical success rates versus patients with a normal BMI in the CAPTURE study*6

Adapted from Evans J, et al. Postgrad Med. 2014.

Zinforo® is suitable for patients across a range of BMIs and need not be dosed according to weight.6
Normal BMI: 18.5 kg/m2 to ≤24.9 kg/m2; obese BMI: ≥30 kg/m2; morbidly obese BMI: ≥40 kg/m2.6

These data are real world and are, therefore, subject to potential confounding  bias usually associated with observational research.

*CAPTURE was a retrospective cohort study relating to the current treatment practice in the United States. In CAPTURE, ‘clinical success’ was defined as clinical cure with no further need for antibiotic therapy or clinical improvement with switch to oral agents at end of Zinforo® treatment. As CAPTURE is a retrospective chart review study, it has the limitations inherent to this study design.1

cSSTI: complicated skin and soft tissue infections; BMI: body mass index; CrCl: creatinine clearance; CAPTURE: The Clinical Assessment Program and TEFLARO Utilization Registry

References:
  1. Santos PD, et al. J Chemother. 2013;25(6):341-346.
  2. Stein GE, et al. Ceftaroline fosamil for treatment of cSSTI due to Staphylococcus aureus with vancomycin MICs of 1.5 to 2 mg/L: CAPTURE Study Experience.
  3. Casapao AM, et al. Antimicrob Agents Chemother. 2014;58(5):2541-2546.
  4. Maggiore C, et al. Expert Rev Clin Pharmacol. 2015;8(1):141-153.
  5. ZINFORO® (ceftaroline fosamil). Local Product Document of Ceftaroline; LPDZIN072021.
  6. Evans J, et al. Postgrad Med. 2014;126(5):128-134.

Consistent clinical cure rates in common causative pathogens of cSSTI, including MRSA1-5

Zinforo® demonstrated microbiological response and clinical cure rates at TOC (CANVAS 1 and CANVAS 2 integrated analysis).1

Microbiological response rates (ME population) at TOC:1
  • ZINFORO®: 92.3% of patients (n=432/468)
  • Vancomycin + aztreonam: 93.7% of patients (n=418/446)
Clinical cure rates against Staphylococcus aureus (ME population) at TOC:1
  • ZINFORO®: 93.1% of patients (n=352/378)
  • Vancomycin + aztreonam: 94.4% of patients (n=336/356)

CANVAS 1 and CANVAS 2 integrated analysis (ME population)*1-3

Adapted from Corey G, et al. Clin Infect Dis. 2010.

*Zinforo® does not cover against P. aeruginosa. Like all other cephalosporins, Zinforo® is not active against ESBL-producing strains.1,4

CANVAS: CeftAroliNe fosamil vs Vancomycin in Skin and skin structure infection; cSSTI: complicated skin and soft tissue infections; MRSA: Methicillin-resistant Staphylococcus aureus 

References:
  1. Corey G, Wilcox M, Talbot G, et al. Clin Infect Dis 2010; 51:641–50.
  2. Corey G, Wilcox M, Talbot G, et al. J Antimicrob Chemother 2010;65(Suppl. 4):iv41–iv51.
  3. Wilcox M, Corey G, Talbot G, et al. J Antimicrob Chemother 2010;65(Suppl. 4):iv53–iv65.
  4. Local Product Document. Zinforo® version LPDZIN072021.
  5. Friedland D, O’Neal T, Biek D, et al. Antimicrob Agents Chemother 2012; 56:2231–6.

Consistent clinical cure rates in cSSTI across infection types and in patients with comorbidities*1-5

Zinforo® demonstrated microbiological response and clinical cure rates at TOC (CANVAS 1 and CANVAS 2 integrated analysis).1

Clinical cure rates by analysis population at TOC visit1:
Clinical cure rates (ME population)1:
  • Zinforo®: 92.7% of patients (n = 434/468)
  • Vancomycin + aztreonam: 94.4% of patients (n = 421/446)
Clinical cure rates (CE population) at TOC1:
  • Zinforo®: 91.6% of patients (n = 559/610)
  • Vancomycin + aztreonam: 92.7% of patients (n = 549/592)

CANVAS 1 and CANVAS 2 integrated analysis1

Adapted from Corey G, et al. Clin Infect Dis. 2010.

*There is no experience with Zinforo® in the treatment of cSSTI in the following patient groups6:
The immunocompromised, patients with severe sepsis/septic shock, necrotising fasciitis, perirectal abscess and patients with third-degree and extensive burns. There is limited experience in treating patients with diabetic foot infections. Caution is advised when treating such patients.
Bacteraemia was present in 4% of the patients when baseline medical characteristics were assessed.1

CANVAS: CeftAroliNe fosamil vs Vancomycin in Skin and skin structure infection; cSSTI: complicated skin and soft tissue infections; TOC: test of cure.

References:
  1. Corey G, Wilcox M, Talbot G, et al. Clin Infect Dis 2010; 51:641–50.
  2. Corey G, Wilcox M, Talbot G, et al. J Antimicrob Chemother 2010;65(Suppl. 4):iv41–iv51.
  3. Wilcox M, Corey G, Talbot G, et al. J Antimicrob Chemother 2010;65(Suppl. 4):iv53–iv65.
  4. Garrison MW, Kawamura NM, Wen MM. Expert Rev Anti Infect Ther 2012; 10:1087–103.
  5. Friedland D, O’Neal T, Biek D, et al. Antimicrob Agents Chemother 2012; 56:2231–6.
  6. Local Product Document. Zinforo® version LPDZIN072021.

Zinforo® may be associated with early clinical response at Day 31

In an integrated retrospective subgroup analysis of CANVAS 1 and CANVAS 2, Zinforo® was associated with a trend towards early clinical response when compared to vancomycin + aztreonam at Day 3 (P=0.018)‡1:

Similarly, Day 3 clinical response rates associated with MRSA infections were:‡1

This analysis includes the following potential limitations1:
  • Evaluation of an end point that was not pre-specified in the original CANVAS 1 and CANVAS 2 study designs
  • Data collection that was not optimised for this outcome measure
  • A lack of a pre-specified hypothesis with the corresponding power calculations for this end point1
ZINFORO® was associated with early clinical response defined by the cessation of lesion spread and absence of fever.1
 
Greater improvement at Day 3 was seen regardless of:1
  • Age
  • Renal function status
  • Presence of fever
  • Bacteraemia
  • Prior antibiotic use
  • Infection type

Superiority cannot be concluded based on this retrospective integrated analysis because this was not a pre-planned analysis, nor was superiority seen in each individual study.

CANVAS: CeftAroliNe fosamil vs Vancomycin in Skin and skin structure infection; cSSTI: complicated skin and soft tissue infections; MRSA: Methicillin-resistant Staphylococcus aureus 

Reference:
  1. Friedland D, O’Neal T, Biek D, et al. Antimicrob Agents Chemother 2012; 56:2231–6.

PP-ZFO-IND-0279.  09 December 2021
Please click on Prescribing Information link to view safety and adverse events information of Zinforo.
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