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 Blumenfeld; Richard 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

doi:10.1191/1352458505ms1197oa

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 Blumenfeld

Richard 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

Neurology

University of Michigan, Ann Arbor
Merck KGaA
Cook Neurological Consultants
Dakota Neurology
Four Peaks Neurology
Oregon Neurology PC
Section of Neurosurgery
University of Alabama at Birmingham
Minneapolis Clinic of Neurology Ltd.
University of Maryland, Baltimore
Minneapolis Clinic of Neurology
Neurological Services of Texas
Kaiser Permanente
Neurological Institute of Savannah
Mecklenburg Neurological Associates
Raleigh Neurology Associates
Northridge Neurological Center
University of Texas Health Science Center at Houston
Rutgers - The State University of New Jersey, New Brunswick
Inc.
Axiom Clinical Research of Florida
NervePro Research
East Bay Region Associates
Washington University St. Louis
Fort Wayne Neurological Center
Clinical Research Department
Advanced Neurology Specialists
Harbourside Medical Towers
St. Joseph's Hospital and Medical Center, Phoenix
Henry Ford Health System
Blue Ridge Research Center
Inc.
The Neuroscience Center of Northern New Jersey
East Carolina University
Saint Louis University
Bexar Diagnostic Medical Associates PA
Neurological Associates of Delaware Valley
Texas Neurosciences Institute
LTD
Millennium Neurology
Windsong Medical Park
Kalamazoo Neurology
Southern Connecticut PC
Griffin Hospital Derby
Multiple Sclerosis Center of New England
South Shore Neurologic Associates
NeuroTrials Research Inc.
Northland Neurological
Neurosurgical and Neurological Group Inc.
Ruan Neurological Clinic and Clinical Research Center
Duke University
Central Morris Neurology
Neurology Service of Orlando
The Neurology Center
Wake Forest University
Dartmouth College
Carolinas Medical Center
Headache Center of Atlanta
Marianjoy Rehabilitation Hospital
Dent Neurological Institute
Louisville Neuroscience Research Ctr.
Virginia Mason Medical Center
The KIND Clinic
Indiana Center for Multiple Sclerosis
USA
Hackley Professional Center
Thomas Jefferson University
Everett Clinic
Neurology Group of Bergen County
Minor and James Medical
Icahn School of Medicine at Mount Sinai
Swedish Headache Center
St. Francis Neuro Institute
George Washington University

Research output: Contribution to journal › Article › peer-review

58 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 language	English
Pages (from-to)	585-591
Number of pages	7
Journal	Multiple Sclerosis
Volume	11
Issue number	5
DOIs	https://doi.org/10.1191/1352458505ms1197oa
State	Published - Oct 2005

Keywords

Autoinjector
Compliance
Injection site reactions
Side effets

Access to Document

10.1191/1352458505ms1197oa

Cite this

Mikol, D., Lopez-Bresnahan, M., Taraskiewicz, S., Chang, P., Rangnow, J., Angelopoulos, M., Arazi, R., Arlen, F., Ash, P., Atalla, L., Au, W., Ayres, D. W., Bashir, K., Bass, A., Bernard, J., Bever, C., Birnbaurn, G., Blanck, R., Blue, S. K., ... Mandler, R. N. (2005). 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. Multiple Sclerosis, 11(5), 585-591. https://doi.org/10.1191/1352458505ms1197oa

@article{a38758e97d1b4535b1141cd7f207d01c,

title = "A randomized, multicentre, open-label, parallel-group trial of the tolerability of interferon beta-1a (Rebif{\textregistered}) administered by autoinjection or manual injection in relapsing-remitting multiple sclerosis",

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.",

keywords = "Autoinjector, Compliance, Injection site reactions, Side effets",

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

year = "2005",

month = oct,

doi = "10.1191/1352458505ms1197oa",

language = "English",

volume = "11",

pages = "585--591",

journal = "Multiple Sclerosis",

issn = "1352-4585",

number = "5",

}

Mikol, D, Lopez-Bresnahan, M, Taraskiewicz, S, Chang, P, Rangnow, J, Angelopoulos, M, Arazi, R, Arlen, F, Ash, P, Atalla, L, Au, W, Ayres, DW, Bashir, K, Bass, A, Bernard, J, Bever, C, Birnbaurn, G, Blanck, R, Blue, SK, Blumenfeld, A, Bodziner, R, Borresen, TE, Bowman, M, Brandes, DW, Brod, SA, Brownstone, P, Burkholder, JD, Cain, R, Cardelli, D, Cascione, MC, Cleeremans, B, Cook, S, Cooper, J, Coyle, P, Cross, AH, Curfman, TJ, Dahlquist, N, Detrich, TP, Dhaduk, VD, Dickson, RA, Dietrich, DW, Dihenia, B, Dunne, PB, Echols, CL, Eilender, L, Elias, SB, Epstein, MA, Estronza, N, Eubank, GA, Fox, E, Fox, S, Frere, RC, Gambin, J, Garrison, JE, Gaskin, A, Gazda, SK, Gilroy, J, Ginsburg, D, Goetzl, U, Gosy, E, Green, PM, Greene, W, Gross, JL, Guarnaccia, JB, Gudesblatt, M, Gwynn, MW, Hayat, G, Hollenbeck, L, Honeycutt, WD, Hsu, PS, Hughes, B, Hurwitz, BJ, Husar, WG, Jacobs, DH, Jacobs, AK, Janjua, RA, Jeffrey, DR, Kaner, J, Kasper, L, Kaufman, MD, Kelman, L, Khatri, BO, Kinkel, P, Kirzinger, S, Kita, M, Knobler, RL, Kolar, OJ, Kott, HS, Landen, IR, Leist, T, Lellelid, N, Levin, JR, Levin, K, Likosky, W, Loganbill, H, Lublin, FD, Lucas, S, Maher, L & Mandler, RN 2005, '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', Multiple Sclerosis, vol. 11, no. 5, pp. 585-591. https://doi.org/10.1191/1352458505ms1197oa

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. / Mikol, Daniel; Lopez-Bresnahan, M.; Taraskiewicz, S. et al.
In: Multiple Sclerosis, Vol. 11, No. 5, 10.2005, p. 585-591.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Mikol, Daniel

AU - Lopez-Bresnahan, M.

AU - Taraskiewicz, S.

AU - Chang, P.

AU - Rangnow, J.

AU - Angelopoulos, Mary

AU - Arazi, Richard

AU - Arlen, Fern

AU - Ash, Paul

AU - Atalla, Lilly

AU - Au, William

AU - Ayres, Donald W.

AU - Bashir, Khurram

AU - Bass, Ann

AU - Bernard, Jacqueline

AU - Bever, Christopher

AU - Birnbaurn, Gary

AU - Blanck, Richard

AU - Blue, Susan K.

AU - Blumenfeld, Andrew

AU - Bodziner, Richard

AU - Borresen, Thor E.

AU - Bowman, Michael

AU - Brandes, David W.

AU - Brod, Staley A.

AU - Brownstone, Paul

AU - Burkholder, James D.

AU - Cain, Robert

AU - Cardelli, Dominic

AU - Cascione, Mark C.

AU - Cleeremans, Bruce

AU - Cook, Stuart

AU - Cooper, Joanna

AU - Coyle, Patricia

AU - Cross, Anne H.

AU - Curfman, Thomas J.

AU - Dahlquist, Neil

AU - Detrich, Terry P.

AU - Dhaduk, Vithalbhai D.

AU - Dickson, Richard A.

AU - Dietrich, Dennis W.

AU - Dihenia, Bhupesh

AU - Dunne, Peter B.

AU - Echols, Charles L.

AU - Eilender, Lawrence

AU - Elias, Stanton B.

AU - Epstein, Michael A.

AU - Estronza, Nordeli

AU - Eubank, Geoffrey A.

AU - Fox, Edward

AU - Fox, Stuart

AU - Frere, Robert C.

AU - Gambin, John

AU - Garrison, James E.

AU - Gaskin, Annmarie

AU - Gazda, Suzanne K.

AU - Gilroy, John

AU - Ginsburg, David

AU - Goetzl, Ugo

AU - Gosy, Eugene

AU - Green, Phillip M.

AU - Greene, Wayne

AU - Gross, Jeffrey L.

AU - Guarnaccia, Joseph B.

AU - Gudesblatt, Mark

AU - Gwynn, Mathews W.

AU - Hayat, Ghazala

AU - Hollenbeck, Larry

AU - Honeycutt, W. David

AU - Hsu, Philip S.

AU - Hughes, Bruce

AU - Hurwitz, Barrie J.

AU - Husar, Walter G.

AU - Jacobs, Daniel H.

AU - Jacobs, Alan K.

AU - Janjua, Riaz A.

AU - Jeffrey, Douglas R.

AU - Kaner, Jay

AU - Kasper, Lloyd

AU - Kaufman, Michael D.

AU - Kelman, Leslie

AU - Khatri, Bhupendra O.

AU - Kinkel, Peter

AU - Kirzinger, Stephen

AU - Kita, Mariko

AU - Knobler, Robert L.

AU - Kolar, Oldrich J.

AU - Kott, H. Stephen

AU - Landen, Ivan R.

AU - Leist, Thomas

AU - Lellelid, Nancy

AU - Levin, Jeffrey R.

AU - Levin, Kenneth

AU - Likosky, William

AU - Loganbill, Heidi

AU - Lublin, Fred D.

AU - Lucas, Sylvia

AU - Maher, Leo

AU - Mandler, Raul N.

PY - 2005/10

Y1 - 2005/10

N2 - 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.

AB - 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.

KW - Autoinjector

KW - Compliance

KW - Injection site reactions

KW - Side effets

UR - https://www.scopus.com/pages/publications/25844457405

U2 - 10.1191/1352458505ms1197oa

DO - 10.1191/1352458505ms1197oa

M3 - Article

C2 - 16193898

AN - SCOPUS:25844457405

SN - 1352-4585

VL - 11

SP - 585

EP - 591

JO - Multiple Sclerosis

JF - Multiple Sclerosis

IS - 5

ER -

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

Abstract

Keywords

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