CRESEMBA® in Invasive Aspergillosis

Prescribing information is available at the bottom of this page.

The SECURE trial was undergone to compare the efficacy and safety of intravenous and oral formulations of isavuconazole to voriconazole for the primary treatment of invasive aspergillosis.

Please click here to view the SECURE clinical trial summary.

SECURE Study Design

Primary endpoint2

Efficacy:

  • All-cause mortality from first dose of study drug to Day 42 in the ITT population

Secondary endpoints

Efficacy:

  • Overall response at end of treatment in the mITT population

Other Secondary endpoints:

  • All-cause mortality form first dose of study drug to day 84

  • Overall clinical, mycological and radiological responses on Day 42, 84 and end of treatment

  • Safety

  • Tolerability

* Hepatic dysfunction (bilirubin ≥3 × ULN, alanine transaminase or aspartate transaminase ≥5 × ULN, cirrhosis or chronic hepatic failure), or moderate-to-severe renal dysfunction (calculated creatinine clearance <50 mL/min). As assessed by the data review committee. ITT, intention-to-treat; IV, intravenous; mITT, modified intention-to-treat; PO, orally; q8h, every 8 hours; q12h, every 12 hours; q24h

References

  1. CRESEMBA Summary of Product Characteristics.
  2. Maertens JA, Raad II, Marr KA, et al. Isavuconazole versus voricanazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE); a phase 3, randomised-controlled, non-inferiority trial. Lancet. 2016;387(10020):760–769.
  3. Mullane M, et al. Safety and Outcomes in Invasive Aspergillosis Patients with Renal vs. No Renal Impairment Treated with Isavuconazole: Experience from the SECURE (Randomised) and VITAL Trials. Poster EV0932 presented at the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2015, Copenhagen, Denmark.

In the SECURE trial, CRESEMBA® demonstrated comparable efficacy to voriconazole in invasive aspergillosis*2. This allows you to prescribe CRESEMBA with confidence in your aspergillosis patients.

Efficacy data in invasive aspergillosis

*The non-inferiority margin was 10% for adjusted treatment differences between CRESEMBA and voriconazole; an upper 95% CI less than 10% suggests that CRESEMBA is non-inferior to voriconazole.)

References

  1. CRESEMBA Summary of Product Characteristics.
  2. Maertens JA, Raad II, Marr KA, et al. Isavuconazole versus voricanazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentuous fungi (SECURE); a phase 3, randomised-controlled, non-inferiority trial. Lancet. 2016;387(10020):760–769.
  3. Mullane M, et al. Safety and Outcomes in Invasive Aspergillosis Patients with Renal vs. No Renal Impairment Treated with Isavuconazole: Experience from the SECURE (Randomised) and VITAL Trials. Poster EV0932 presented at the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2015, Copenhagen, Denmark.

In the SECURE trial, CRESEMBA® demonstrated survival comparable to voriconazole throughout the study2*.  

Survival data in invasive aspergillosis

*Patients were censored on the day of their last known survival status, represented by the circles. Figure shows data for ITT population. CI – confidence interval; EOT – end of treatment; ITT – intention-to-treat; mITT – modified intention-to-treat.

References

  1. CRESEMBA Summary of Product Characteristics.
  2. Maertens JA, Raad II, Marr KA, et al. Isavuconazole versus voricanazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentuous fungi (SECURE); a phase 3, randomised-controlled, non-inferiority trial. Lancet. 2016;387(10020):760–769.
  3. Mullane M, et al. Safety and Outcomes in Invasive Aspergillosis Patients with Renal vs. No Renal Impairment Treated with Isavuconazole: Experience from the SECURE (Randomised) and VITAL Trials. Poster EV0932 presented at the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2015, Copenhagen, Denmark.

In the SECURE trial, CRESEMBA® demonstrated significantly fewer AEs vs. voriconazole2. This means that with fewer discontinuations than voriconazole, CRESEMBA could give your patients a better chance of tolerating treatment2. CRESEMBA specifically showed significantly reduced hepatic, eye and skin toxicity vs. voriconzaole2

Toxicity data in invasive aspergillosis

Significantly different TEAEs in invasive aspergillosis

References
  1. CRESEMBA Summary of Product Characteristics.
  2. Maertens JA, Raad II, Marr KA, et al. Isavuconazole versus voricanazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentuous fungi (SECURE); a phase 3, randomised-controlled, non-inferiority trial. Lancet. 2016;387(10020):760–769.
  3. Mullane M, et al. Safety and Outcomes in Invasive Aspergillosis Patients with Renal vs. No Renal Impairment Treated with Isavuconazole: Experience from the SECURE (Randomised) and VITAL Trials. Poster EV0932 presented at the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2015, Copenhagen, Denmark.

CRESEMBA® is efficacious and well tolerated in patients with renal impairment31. Rates of treatment success and study drug-related TEAEs were similar between patients with an without renal impairment3

 

In a pooled analysis from the SECURE and VITAL trials, safety and outcomes were reported in invasive aspergillosis patients with renal vs. no repairment treatment with CRESEMBA.CRESEMBA® in patients with renal impairment
CRESEMBA does not contain cyclodextrin, which is often associated with nephrotoxicity.

References
  1. CRESEMBA Summary of Product Characteristics.
  2. Maertens JA, Raad II, Marr KA, et al. Isavuconazole versus voricanazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentuous fungi (SECURE); a phase 3, randomised-controlled, non-inferiority trial. Lancet. 2016;387(10020):760–769.
  3. Mullane M, et al. Safety and Outcomes in Invasive Aspergillosis Patients with Renal vs. No Renal Impairment Treated with Isavuconazole: Experience from the SECURE (Randomised) and VITAL Trials. Poster EV0932 presented at the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2015, Copenhagen, Denmark.

Prescribing Information

This includes legal category, basic NHS cost and a link to SPC. Please click each relevant SPC link to be directed to EMC website.

 
Cresemba® (isavuconazole)
Cresemba® 100mg hard capsules – SPC
Legal Category: POM. Basic NHS Cost:14 caps pack £599.28
Cresemba® 200mg powder for concentrate for solution for infusion – SPC
Legal Category: POM Basic NHS Cost: 1 vial pack £297.84

 

Vfend® (Voriconazole)
Vfend® 50mg filmed tablets – SPC
Legal Category: POM. Basic NHS Cost: 28 tabs £275.68
Vfend® 200mg filmed tablets – SPC
Legal Category: POM. Basic NHS Cost: 28 tabs £1102.74
Vfend® 200mg powder for solution for infusion – SPC
Legal Category: POM. Basic NHS Cost: 1 vial £77.14
Vfend® 40mg/ml Powder for oral suspension – SPC
Legal Category: POM Basic NHS Cost: 75ml £551.37

PP-CRB-GBR-0805.  October 2020