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

Daniel Mikol, M. Lopez-Bresnahan, S. Taraskiewicz, P. Chang, J. Rangnow, Mary Angelopoulos, Richard Arazi, Fern Arlen, Paul Ash, Lilly Atalla, William Au, Donald W. Ayres, Khurram Bashir, Ann Bass, Jacqueline Bernard, Christopher Bever, Gary Birnbaurn, Richard Blanck, Susan K. Blue, Andrew BlumenfeldRichard Bodziner, Thor E. Borresen, Michael Bowman, David W. Brandes, Staley A. Brod, Paul Brownstone, James D. Burkholder, Robert Cain, Dominic Cardelli, Mark C. Cascione, Bruce Cleeremans, Stuart Cook, Joanna Cooper, Patricia Coyle, Anne H. Cross, Thomas J. Curfman, Neil Dahlquist, Terry P. Detrich, Vithalbhai D. Dhaduk, Richard A. Dickson, Dennis W. Dietrich, Bhupesh Dihenia, Peter B. Dunne, Charles L. Echols, Lawrence Eilender, Stanton B. Elias, Michael A. Epstein, Nordeli Estronza, Geoffrey A. Eubank, Edward Fox, Stuart Fox, Robert C. Frere, John Gambin, James E. Garrison, Annmarie Gaskin, Suzanne K. Gazda, John Gilroy, David Ginsburg, Ugo Goetzl, Eugene Gosy, Phillip M. Green, Wayne Greene, Jeffrey L. Gross, Joseph B. Guarnaccia, Mark Gudesblatt, Mathews W. Gwynn, Ghazala Hayat, Larry Hollenbeck, W. David Honeycutt, Philip S. Hsu, Bruce Hughes, Barrie J. Hurwitz, Walter G. Husar, Daniel H. Jacobs, Alan K. Jacobs, Riaz A. Janjua, Douglas R. Jeffrey, Jay Kaner, Lloyd Kasper, Michael D. Kaufman, Leslie Kelman, Bhupendra O. Khatri, Peter Kinkel, Stephen Kirzinger, Mariko Kita, Robert L. Knobler, Oldrich J. Kolar, H. Stephen Kott, Ivan R. Landen, Thomas Leist, Nancy Lellelid, Jeffrey R. Levin, Kenneth Levin, William Likosky, Heidi Loganbill, Fred D. Lublin, Sylvia Lucas, Leo Maher, Raul N. Mandler

Research output: Contribution to journalArticlepeer-review

55 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)585-591
Number of pages7
JournalMultiple Sclerosis
Volume11
Issue number5
DOIs
StatePublished - Oct 2005

Keywords

  • Autoinjector
  • Compliance
  • Injection site reactions
  • Side effets

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