Open-label trial of anti-TNF-alpha in dermato- and polymyositis treated concomitantly with methotrexate

G.J. Hengstman; J.L. De Bleecker; E. Feist; J. Vissing; C.P. Denton; M.N. Manoussakis; Jensen H. Slott; B.G. van Engelen; F.H. van den Hoogen

Open-label trial of anti-TNF-alpha in dermato- and polymyositis treated concomitantly with methotrexate

G.J. Hengstman, J.L. De Bleecker, E. Feist, J. Vissing, C.P. Denton, M.N. Manoussakis, Jensen H. Slott, B.G. van Engelen, F.H. van den Hoogen

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Abstract

BACKGROUND/AIMS: To determine the efficacy of infliximab combined with weekly methotrexate in drug-naive recent-onset dermatomyositis and polymyositis. METHODS: A multicentre open-label controlled trial was conducted. Disease activity was assessed using patient's and physician's disease activity assessment, manual muscle testing (MMT), handheld dynamometry, and serum CK. The primary objective was to assess the efficacy using MMT after a period of 26 weeks. RESULTS: The study was terminated prematurely because of a low inclusion rate and a high drop-out rate due to disease progression and the occurrence of an infusion reaction. The few patients who did reach the primary endpoint showed improvement in all aspects studied. CONCLUSION: Infliximab combined with weekly methotrexate might be safe and well tolerated in a small subgroup of patients with drug-naive recent-onset myositis. At present, we do not advocate the use of this treatment because treatment response cannot be predicted beforehand
Udgivelsesdato: 2008

Original language	English
Journal	European Neurology
Volume	59
Issue number	3-4
Pages (from-to)	159-163
Number of pages	4
ISSN	0014-3022
Publication status	Published - 2008

Cite this

@article{2d35c9809b8c11debc73000ea68e967b,

title = "Open-label trial of anti-TNF-alpha in dermato- and polymyositis treated concomitantly with methotrexate",

abstract = "BACKGROUND/AIMS: To determine the efficacy of infliximab combined with weekly methotrexate in drug-naive recent-onset dermatomyositis and polymyositis. METHODS: A multicentre open-label controlled trial was conducted. Disease activity was assessed using patient's and physician's disease activity assessment, manual muscle testing (MMT), handheld dynamometry, and serum CK. The primary objective was to assess the efficacy using MMT after a period of 26 weeks. RESULTS: The study was terminated prematurely because of a low inclusion rate and a high drop-out rate due to disease progression and the occurrence of an infusion reaction. The few patients who did reach the primary endpoint showed improvement in all aspects studied. CONCLUSION: Infliximab combined with weekly methotrexate might be safe and well tolerated in a small subgroup of patients with drug-naive recent-onset myositis. At present, we do not advocate the use of this treatment because treatment response cannot be predicted beforehand Udgivelsesdato: 2008",

author = "G.J. Hengstman and Bleecker, {J.L. De} and E. Feist and J. Vissing and C.P. Denton and M.N. Manoussakis and Slott, {Jensen H.} and Engelen, {B.G. van} and Hoogen, {F.H. van den}",

year = "2008",

language = "English",

volume = "59",

pages = "159--163",

journal = "European Neurology",

issn = "0014-3022",

publisher = "S Karger AG",

number = "3-4",

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TY - JOUR

T1 - Open-label trial of anti-TNF-alpha in dermato- and polymyositis treated concomitantly with methotrexate

AU - Hengstman, G.J.

AU - Bleecker, J.L. De

AU - Feist, E.

AU - Vissing, J.

AU - Denton, C.P.

AU - Manoussakis, M.N.

AU - Slott, Jensen H.

AU - Engelen, B.G. van

AU - Hoogen, F.H. van den

PY - 2008

Y1 - 2008

N2 - BACKGROUND/AIMS: To determine the efficacy of infliximab combined with weekly methotrexate in drug-naive recent-onset dermatomyositis and polymyositis. METHODS: A multicentre open-label controlled trial was conducted. Disease activity was assessed using patient's and physician's disease activity assessment, manual muscle testing (MMT), handheld dynamometry, and serum CK. The primary objective was to assess the efficacy using MMT after a period of 26 weeks. RESULTS: The study was terminated prematurely because of a low inclusion rate and a high drop-out rate due to disease progression and the occurrence of an infusion reaction. The few patients who did reach the primary endpoint showed improvement in all aspects studied. CONCLUSION: Infliximab combined with weekly methotrexate might be safe and well tolerated in a small subgroup of patients with drug-naive recent-onset myositis. At present, we do not advocate the use of this treatment because treatment response cannot be predicted beforehand Udgivelsesdato: 2008

AB - BACKGROUND/AIMS: To determine the efficacy of infliximab combined with weekly methotrexate in drug-naive recent-onset dermatomyositis and polymyositis. METHODS: A multicentre open-label controlled trial was conducted. Disease activity was assessed using patient's and physician's disease activity assessment, manual muscle testing (MMT), handheld dynamometry, and serum CK. The primary objective was to assess the efficacy using MMT after a period of 26 weeks. RESULTS: The study was terminated prematurely because of a low inclusion rate and a high drop-out rate due to disease progression and the occurrence of an infusion reaction. The few patients who did reach the primary endpoint showed improvement in all aspects studied. CONCLUSION: Infliximab combined with weekly methotrexate might be safe and well tolerated in a small subgroup of patients with drug-naive recent-onset myositis. At present, we do not advocate the use of this treatment because treatment response cannot be predicted beforehand Udgivelsesdato: 2008

M3 - Journal article

SN - 0014-3022

VL - 59

SP - 159

EP - 163

JO - European Neurology

JF - European Neurology

IS - 3-4

ER -