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


CONCLUSIONS
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.
Hengstman
G J D
GJ
Neuromuscular Centre Nijmegen, Department of Neurology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. g.hengstman@neuro.umcn.nl
De Bleecker
J L
JL
Feist
E
E
Vissing
J
J
Denton
C P
CP
Manoussakis
M N
MN
Slott Jensen
H
H
van Engelen
B G M
BG
van den Hoogen
F H J
FH
D000293:Adolescent; D000328:Adult; D000368:Aged; D000906:Antibodies / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D002097:C-Reactive Protein / Q000378:metabolism; D003882:Dermatomyositis / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005069:Evaluation Studies as Topic; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D017285:Polymyositis / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000276:immunology*
D000906:Antibodies; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D002097:C-Reactive Protein; D008727:Methotrexate