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About CRESEMBA®About CRESEMBA®Meet CRESEMBA®CRESEMBA® in the ICUCRESEMBA® in ActionEfficacy EfficacyInvasive AspergillosisEfficacyGuidelines MucormycosisEfficacyGuidelinesSafetySafetyTolerabilityInvasive AspergillosisMucormycosis Safety ProfileSafety ProfileDosingDosingSimple DosingLinear PKs, Low Variability and TDMPractical ConsiderationsReal-world DataReal-world DataReal-world EffectivenessReal-world SafetyResourcesResourcesSummary of Prescribing InformationEventsMaterialsVideos

Standard-of-care efficacy in invasive aspergillosis1

CRESEMBA® is as efficacious as voriconazole1

  

Since the early 2000s, voriconazole established itself as the primary treatment for invasive aspergillosis, helping to dramatically improve survival rates.2,3

  

Now CRESEMBA® builds on this important milestone, combining the efficacy of voriconazole with improved safety and tolerability.1

  

The pivotal SECURE trial demonstrated that CRESEMBA® achieves survival rates comparable with voriconazole in invasive aspergillosis. Both response rates and all-cause mortality were also comparable in the two treatment groups.1

 Survival rates with CRESEMBA® and voriconazole from first day to Day 84 in the SECURE study (ITT population)1,a a. Patients were censored on the day of their last known survival status (circles).

Adapted from reference 1.

  

Study design
SECURE: the pivotal phase 3 trial for CRESEMBA® in invasive aspergilosis1
  


Double-blind, randomised-controlled, non-inferiority, multicentre international trial


Key exclusion criteria: hepatic dysfunction or moderate-to-severe renal dysfunctionb

Primary efficacy endpoint: all-cause mortality at Day 42 (ITT population)

Key secondary endpoint: overall response at the end of treatment (mITT population)

b. Hepatic dysfunction: bilirubin ≥3 x ULN, alanine transaminase or aspartate transaminase ≥5 x ULN, cirrhosis or chronic hepatic failure; moderate-to-severe renal dysfunction: calculated creatinine clearance <50 mL/min.

ITT, intention-to-treat; IV, intravenously; mITT, modified intention-to-treat; PO, per os (orally); ULN, upper limit of normal; q8h, every 8 hours; q12h, every 12 hours; q24h, every 24 hours.
 

  

Evidence suggests that CRESEMBA® has similar efficacy to liposomal amphotericin B in invasive aspergillosis4

  

While there are no head-to-head data to compare CRESEMBA® and liposomal amphotericin B in invasive aspergillosis, a network meta-analysis of four clinical trials showed the efficacy of CRESEMBA® was similar to liposomal amphotericin B:4

  

 Forest plot for the difference in outcomes between various antifungals and CRESEMBA® in invasive aspergillosis4

Adapted from reference 4.

  

  

AmB, amphotericin B; CI, confidence interval; ITT, intention-to-treat; OR, odds ratio.

Prescribing Information:
CRESEMBA® (isavuconazole)

References:Maertens JA et al. Lancet 2016;387(10020):760–769.Mercier T and Maertens J. J Antimicrob Chemother 2017;72(suppl_1):i29–i38.Patterson TF et al. Clin Infect Dis 2016;63(4):e1–e60.Herbrecht R et al. Curr Med Res Opin 2018;34(12):2187–2195.

PP-CRB-IND-0472 July 2022

  

Invasive Aspergillosis
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