Efficacy of Anidulafungin in 504 Patients with Invasive Candidiasis (IC) From a Pooled Clinical Trial Database

Ref ID: 18759

Author:

B. Kullberg, MD – Professor of Medicine1, U. Conte, PharmD – Clinician 2, H. Schlamm, MD – Medical Development Lead 2, P. Biswas, PhD – Statistician 2, R. Swanson, PhD – Clinical Development Lead 2, M. Ruhnke, MD – Professor of Medicine 3;

Author address:

1Radboud Univ. Nijmegen Med. Ctr., Nijmegen, Netherlands, 2Pfizer Inc., New York, NY, 3Charité Univ.smedizin, Berlin, Germany.

Full conference title:

52nd Annual ICAAC

Date: 9 September 2014

Abstract:

Background: The recent completion of 4 similar prospective, open-label, non-comparative studies in the USA, Canada, Latin America, Europe and Asia allowed us to create a large database of patients treated with anidulafungin and enabled us to assess efficacy in IC, including neutropenic patients, patients with deep tissue candidiasis, and patients with non-albicans Candida spp. infection, including C parapsilosis. Methods: Data from patients with microbiologically-confirmed IC enrolled in these studies were pooled. Each patient was initially treated with IV anidulafungin with an option to step down to oral azole. Total treatment duration was ≥ 14 d. Global response (based on clinical and microbiologic response) was assessed at end of IV anidulafungin therapy and end of all antifungal therapy (primary endpoint). Results: 504 patients (mean age 57.6 yrs) were included. Mean APACHE II score was 15; 35 (6.9%) were neutropenic, 105 (20.8%) had deep tissue candidiasis , 278 (55.2%) had non-albicans Candida, including 69 (13.7%) with C parapsilosis. Mean duration of anidulafungin treatment was 11.6 d; step down to oral azole occurred in 232 (46.0%) patients; mean duration of all antifungal therapy was 16.5 d. Rate of successful global response and all-cause mortality is shown below:
Conclusions: In this large database of patients with IC, response to treatment with anidulafungin was consistent with those reported in published studies, and support the results observed in the anidulafungin registrational trial. In addition, this database enabled us to generate valuable data regarding the use of anidulafungin to treat IC in neutropenic patients, patients with deep tissue infection and patients with C parapsilosis infection.

Abstract Number: M-1229

Conference Year: 2012

Link to conference website: NULL

New link: NULL

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