Characteristics associated with drug-induced liver injury from interferon beta in multiple sclerosis patients. (October 2014)

• Record Type: Journal Article
• Authors: Kowalec, Kaarina; Kingwell, Elaine; Yoshida, Eric M; Marrie, Ruth Ann; Kremenchutzky, Marcelo; Campbell, Trudy L; Wadelius, Mia; Carleton, Bruce; Tremlett, Helen
• Is Part Of: Expert opinion on drug safety. Volume 13:Number 10(2014)
• Page Start: 1305
• Page End: 1317
• Publication Date: 2014-10
• Subjects: Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1517/14740338.2014.947958
• Languages: English
• ISSNs: 1474-0338

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <p> <bold> <italic>Objective:</italic> </bold> To identify and characterize drug-induced liver injury (DILI) associated with IFN-β in multiple sclerosis (MS) using recommended criteria.</p> <p> <bold> <italic>Methods:</italic> </bold> This retrospective, mixed methods design included a cohort of IFN-β exposed MS patients from British Columbia (BC), Canada and a series of DILI cases from other Canadian provinces and two adverse drug reaction (ADR) networks (USA and Sweden). Associations between sex, age and IFN-β product, and DILI were explored in BC cohort using Cox proportional hazard analyses. Characteristics, including the time to DILI, were compared between sites.</p> <p> <bold> <italic>Results:</italic> </bold> In BC, 18/942 (1.9%) of IFN-β exposed MS patients met criteria for DILI, with a trend toward an increased risk for women and those exposed to IFN-β-1a SC (44 mcg 3 × weekly) (adjusted Hazard Ratios: 3.15;95% CI:0.72 – 13.72, p = 0.13 and 6.26;95%CI:0.78 – 50.39, p = 0.08, respectively). Twenty-four additional cases were identified from other sites; the median time to DILI was comparable between BC and other Canadian cases (105 and 90 days, respectively), but longer for the ADR network cases (590 days, p = 0.006).</p> <p> <bold> <italic>Conclusions:</italic> </bold> Approximately 1 in 50 IFN-β exposed patients developed DILI in BC, Canada. Identification of DILI cases from diverse sources highlighted that this reaction occurs even after years of exposure.</p> </abstract>