Characteristics associated with drug-induced liver injury from interferon beta in multiple sclerosis patients
2014 (English)In: Expert Opinion on Drug Safety, ISSN 1474-0338, E-ISSN 1744-764X, Vol. 13, no 10, 1305-1317 p.Article, review/survey (Refereed) Published
Objective: To identify and characterize drug-induced liver injury (DILI) associated with IFN-beta in multiple sclerosis (MS) using recommended criteria. Methods: This retrospective, mixed methods design included a cohort of IFN-beta 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-beta product, and DILI were explored in BC cohort using Cox proportional hazard analyses. Characteristics, including the time to DILI, were compared between sites. Results: In BC, 18/942 (1.9%) of IFN-beta exposed MS patients met criteria for DILI, with a trend toward an increased risk for women and those exposed to IFN-beta-1a SC (44 mcg 3 x 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). Conclusions: Approximately 1 in 50 IFN-beta exposed patients developed DILI in BC, Canada. Identification of DILI cases from diverse sources highlighted that this reaction occurs even after years of exposure.
Place, publisher, year, edition, pages
2014. Vol. 13, no 10, 1305-1317 p.
adverse drug reactions, drug-induced liver injury, IFN-beta, multiple sclerosis
Pharmacology and Toxicology Pharmaceutical Sciences
IdentifiersURN: urn:nbn:se:uu:diva-235583DOI: 10.1517/14740338.2014.947958ISI: 000342281200004OAI: oai:DiVA.org:uu-235583DiVA: diva2:761474