BACKGROUND: @entity409 , manifested as liver enzyme elevations, occurs frequently in @entity1 who are treated with interferon, however, data for @entity1 with @entity15 are limited. OBJECTIVE: To retrospectively assess the safety profile of interferon-beta-1a therapy with respect to liver function during clinical trials and postmarketing surveillance in the treatment of @entity15 . @entity1 AND METHODS: Adverse effects and @entity854 were analysed from six randomised, controlled clinical trials (five of which were placebo-controlled) that assessed the use of interferon-beta-1a in @entity1 with @entity15 . Treatment data were collected for 2819 @entity1 for up to 12 months, of whom 1995 received interferon-beta-1a (337 [12%] received Avonex intramuscular therapy, and 1658 [59%] received Rebif subcutaneous therapy), and 824 (29%) received placebo. Data for 2 years were collated for 1178 @entity1 (from two studies). Total weekly interferon doses were 22-132 microg. Postmarketing surveillance data were also analysed. RESULTS: In @entity1 receiving interferon-beta-1a, there were significant elevations of @entity493 aminotransferase (ALT) levels, of all grades of severity, in up to 59% of @entity1 at 6 months, up to 64% of @entity1 at 12 months and up to 67% of @entity1 at 24 months; ALT elevations were asymptomatic and dose related. More than 50% of elevations in liver enzymes occurred during the first 3 months of treatment, and more than 75% occurred during the first 6 months. Elevated enzyme levels resolved spontaneously or with dosage adjustment. Although the overall incidence of liver enzyme elevation was high during the early months of therapy, after 2 years, the proportion of @entity1 with abnormal liver enzyme levels was 11% of those receiving Rebif 44 microg three times weekly compared with 6% of placebo-treated @entity1 . Only 0.4% of @entity1 discontinued interferon-beta-1a treatment because of hepatic adverse effects. Serious symptomatic interferon-related hepatic @entity137 occurs, but is uncommon. Concomitant medication use was not associated with increased risk. CONCLUSION: Asymptomatic @entity409 is common in @entity1 with @entity15 who are treated with interferon-beta-1a, and is dose related. Adverse effects are mainly mild and transient, with little impact on adherence to therapy, although rare serious events can occur. Regular liver function monitoring during the first 6 months is recommended.

Hepatic reactions during treatment of XXXX with interferon-beta-1a: incidence and clinical significance.

@entity1 :: ('9606', 'Species') :: ['patients', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity409 :: ('MESH:D008107', 'Disease') :: ['hepatic dysfunction', 'Hepatic dysfunction'] @entity854 :: ('MESH:D018376', 'Disease') :: ['laboratory abnormalities'] @entity493 :: ('CHEBI:16449', 'Chemical') :: ['alanine'] @entity15 :: ('MESH:D009103', 'Disease') :: ['multiple sclerosis']
@entity15 :: (MESH:D009103,Disease) :: ['multiple sclerosis']
