This site contains promotional information intended only for healthcare professionals resident in the United Kingdom
Menu
Close
Example of description text sitting alongside header
Example of description text sitting alongside header
Menu
Close
Example of description text sitting alongside header
Example of description text sitting alongside header
Menu
Close
Adverse event reporting can be found at the bottom of the page
Menu
Close
Invasive fungal infections in solid organ transplant recipients
Invasive fungal infections and chronic obstructive pulmonary disease
Information on how to access prescribing information and adverse event reporting can be found towards the bottom of the page.
SECURE was a phase 3 trial comparing CRESEMBA® and voriconazole for the primary treatment of invasive mould disease caused by Aspergillus species and other filamentous fungi.1
SECURE: the pivotal phase 3 trial for CRESEMBA® in invasive aspergillosis1
Key exclusion criteria: hepatic dysfunction or moderate-to-severe renal dysfunctiona
Primary efficacy endpoint: all-cause mortality at day 42 (ITT population)
Key secondary endpoint: overall response at the end of treatment (mITT population)
Other secondary endpoints
All-cause mortality at Day 42 (ITT population) was comparable with CRESEMBA® and voriconazole: 19% vs 20% (adjusted treatment difference: –1.0%; 95% CI: –7.8, 5.7).1
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.1
Response rates
DRC-assessed response at end of treatment (mITT)
Adapted from reference 1.
Treatment success was defined as a complete or partial response, as assessed by a data review committee. 31 CRESEMBA® patients and 29 voriconazole patients were assumed not to have achieved success because they had no imaging after baseline.
Survival
Adapted from reference 1.
Drug-related AEs were significantly reduced with CRESEMBA® vs voriconazole (p<0.001).1 More specifically, CRESEMBA® showed reduced hepatic, eye and skin toxicity.1 With fewer discontinuations than voriconazole, CRESEMBA® could give your patients a better chance of tolerating treatment.1
| AEs and treatment discontinuations in the SECURE trial1 | |||
| CRESEMBA® (n=257) | Voriconazole (n=259) |
p value | |
|---|---|---|---|
| Any TEAE | 96% | 98% | 0.122 |
| Drug-related AEs | 42% | 60% | <0.001 |
| AEs leading to discontinuation | 14% | 23% | - |
| Drug-related AEs leading to discontinuation | 8% | 14% | - |
| Drug-related AEs that were reduced with CRESEMBA® vs voriconazole1 | |||
| CRESEMBA® (n=257) | Voriconazole (n=259) |
p value | |
|---|---|---|---|
| Skin and subcutaneous tissue disorders | 33% | 42% | 0.037 |
| Eye disorders | 15% | 27% | 0.002 |
| Hepatobiliary disorders | 9% | 16% | 0.016 |
The response rates, survival rates and safety profile of CRESEMBA® allow you to prescribe with confidence for your patients with invasive aspergillosis.1
Prescribing Information:
Click here for CRESEMBA® (isavuconazole) and Vfend (voriconazole) prescribing information
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
This site is intended only for healthcare professionals resident in the United Kingdom. If you are a member of the public wishing to access information on a specific medicine, please visit www.medicines.org.uk/emc
This website is brought to you by Pfizer Limited, a company registered in England
and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent, CT13 9NJ
Copyright © 2024 Pfizer Limited. All rights reserved.
VAT registration number GB201048427
These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.
I confirm that I am a healthcare professional* resident in the United Kingdom.
If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.
*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
PP-UNP-GBR-7812. January 2024