This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Mikol, D Search for Related Content PubMed PubMed Citation Articles by Mikol, D Social Bookmarking                   What's this?

A randomized, multicentre, open-label, parallel-group trial of the tolerability of interferon beta-1a (Rebif®) administered by autoinjection or manual injection in relapsing-remitting multiple sclerosis

University of Michigan, Ann Arbor, MI, USA, dmiko{at}umich.edu

M Lopez-Bresnahan

Serono Inc, Rockland, MA, USA

S Taraskiewicz

Serono Inc, Rockland, MA, USA

P Chang

Serono Inc, Rockland, MA, USA

J Rangnow

Serono Inc, Rockland, MA, USA

Rebiject^TM Study Group

Injection site reactions (ISRs) are a common side effect of subcutaneous interferon beta therapy, particularly during initiation of therapy. Retrospective analysis of two clinical trials showed that patients using an autoinjector experienced fewer ISRs than patients administering interferon beta manually. This randomized, open-label trial compared the occurrence of ISRs in relapsing-remitting multiple sclerosis patients subcutaneously injecting interferon beta-1a manually or with autoinjector. In total, 1825 patients (autoinjector, 932; manual injection, 893) were included in the intention-to-treat analysis. Significantly fewer patients using the autoinjector experienced ISRs, based on physician assessment, compared with manual injection (78.7% versus 85.4%; p<0.001). There was no statistical difference on primary study endpoint: number of patients experiencing moderate to severe ISRs after 12 weeks’ therapy (25.3% versus 23.2%, P=0.449). The patient-reported proportion of any ISR during the treatment period was significantly greater for the manual injection group (71.8% versus 66.1%; p<0.001). The decreased incidence of ISRs with the autoinjector compared to manual injection seen in this short-term study, coupled with ease of use of the autoinjector, suggest that it could improve compliance, and therefore therapeutic outcomes in some patients.

Key Words: autoinjector • compliance • injection site reactions • side effects

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

				K. Baum, C. O'Leary, F. Coret Ferrer, E. Klimova, L. Prochazkova, J. Bugge, and for the BRIGHT Study Group Comparison of injection site pain and injection site reactions in relapsing-remitting multiple sclerosis patients treated with interferon beta-1a or 1b Multiple Sclerosis, November 1, 2007; 13(9): 1153 - 1160. [Abstract] [PDF]