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Drug Safety Evaluation

A critical appraisal of daclizumab use as emerging therapy in multiple sclerosis

, MD, , MD, , BSc & , MD (Associate Professor)
 

Abstract

Introduction: Daclizumab (DAC) is a mAb that binds to CD25, a receptor on the surface of lymphocytes for IL-2, a chemical messenger in the immune system. This prevents activation and proliferation of lymphocytes, which are involved in the immune attack in multiple sclerosis (MS).

Areas covered: In this review, we will focus on newly emerging DAC-high-yield process (HYP) therapy for MS. Based on published original articles and citable meeting abstracts, we will discuss its mode of action as well as data on efficacy and safety.

Expert opinion: DAC has been observed to have multiple (biological) effects, which may contribute to beneficial effects in immune-related disease and particularly in relapsing-remitting MS. The positive results in the clinical studies represent achievement of an important milestone in the development of DAC-HYP as a potential new treatment option for MS patients. The benefit/risk ratios of this new biological agent in MS therapy are still being evaluated. Soon, DAC-HYP might qualify as MS therapy. A safety monitoring program is recommended in the clinical practice.

Declaration of interest

F Patti has received honoraria for speaking activities from Biogen-Idec, Novartis, Bayer-Schering, Almirall, Genzyme. He served as a member of advisory boards for Novartis, Biogen-Idec and Almirall. S Messina has received honoraria for speaking activities from Biogen-Idec, Almirall and has received personal fees from Novartis, Biogen-Idec, Bayer-Schering and Genzyme. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Notes

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