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Adverse event reporting can be found at the bottom of the page
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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
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PP-PFE-GBR-3863. November 2021