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

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

doi:10.1159/000114036

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

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

Department of Neurology

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.

Original language	English
Journal	European Neurology
Volume	59
Issue number	3-4
Pages (from-to)	159-63
Number of pages	5
ISSN	0014-3022
DOIs	https://doi.org/10.1159/000114036
Publication status	Published - 2008

Keywords

Adolescent
Adult
Aged
Antibodies/therapeutic use
Antirheumatic Agents/therapeutic use
C-Reactive Protein/metabolism
Dermatomyositis/drug therapy
Drug Therapy, Combination
Evaluation Studies as Topic
Female
Follow-Up Studies
Humans
Methotrexate/therapeutic use
Middle Aged
Polymyositis/drug therapy
Time Factors
Treatment Outcome
Tumor Necrosis Factor-alpha/immunology

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10.1159/000114036

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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.",

keywords = "Adolescent, Adult, Aged, Antibodies/therapeutic use, Antirheumatic Agents/therapeutic use, C-Reactive Protein/metabolism, Dermatomyositis/drug therapy, Drug Therapy, Combination, Evaluation Studies as Topic, Female, Follow-Up Studies, Humans, Methotrexate/therapeutic use, Middle Aged, Polymyositis/drug therapy, Time Factors, Treatment Outcome, Tumor Necrosis Factor-alpha/immunology",

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

year = "2008",

doi = "10.1159/000114036",

language = "English",

volume = "59",

pages = "159--63",

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 D

AU - De Bleecker, J L

AU - Feist, E

AU - Vissing, J

AU - Denton, C P

AU - Manoussakis, M N

AU - Slott Jensen, H

AU - van Engelen, B G M

AU - van den Hoogen, F H J

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.

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.

KW - Adolescent

KW - Adult

KW - Aged

KW - Antibodies/therapeutic use

KW - Antirheumatic Agents/therapeutic use

KW - C-Reactive Protein/metabolism

KW - Dermatomyositis/drug therapy

KW - Drug Therapy, Combination

KW - Evaluation Studies as Topic

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Methotrexate/therapeutic use

KW - Middle Aged

KW - Polymyositis/drug therapy

KW - Time Factors

KW - Treatment Outcome

KW - Tumor Necrosis Factor-alpha/immunology

U2 - 10.1159/000114036

DO - 10.1159/000114036

M3 - Journal article

C2 - 18230873

SN - 0014-3022

VL - 59

SP - 159

EP - 163

JO - European Neurology

JF - European Neurology

IS - 3-4

ER -

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

Abstract

Keywords

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