Comparison of weakness progression in inclusion body myositis during treatment with methotrexate or placebo.
We investigated whether 5 to 20mg per week oral methotrexate could slow down disease progression in 44 patients with inclusion body myositis in a randomized double-blind placebo-controlled study over 48 weeks. Mean change of quantitative muscle strength testing sum scores was the primary study outcome measure. Quantitative muscle strength testing sum scores declined in both treatment groups, -0.2% for methotrexate and -3.4% for placebo (95% confidence interval = -2.5% to +9.1% for difference). There were also no differences in manual muscle testing sum scores, activity scale scores and patients' own assessments after 48 weeks of treatment. Serum creatine kinase activity decreased significantly in the methotrexate group. We conclude that oral methotrexate did not slow down progression of muscle weakness but decreased serum creatine kinase activity.
Badrising
Umesh A
UA
Department of Neurology, Leiden University Medical Center, The Netherlands. ubadrising@lumc.nl
Maat-Schieman
Marion L C
ML
Ferrari
Michel D
MD
Zwinderman
Aeilko H
AH
Wessels
Judith A M
JA
Breedveld
Ferdinand C
FC
van Doorn
Pieter A
PA
van Engelen
Baziel G M
BG
Hoogendijk
Jessica E
JE
Höweler
Chris J
CJ
de Jager
Aeiko E
AE
Jennekens
Frans G I
FG
Koehler
Peter J
PJ
de Visser
Marianne
M
Viddeleer
Alain
A
Verschuuren
Jan J
JJ
Wintzen
Axel R
AR
D000284:Administration, Oral; D000368:Aged; D003402:Creatine Kinase / Q000097:blood; D018450:Disease Progression; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D018908:Muscle Weakness / Q000209:etiology* / Q000503:physiopathology*; D018979:Myositis, Inclusion Body / Q000150:complications* / Q000188:drug therapy*; D010919:Placebos / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D017211:Treatment Failure
D004791:Enzyme Inhibitors; D010919:Placebos; D003402:Creatine Kinase; D008727:Methotrexate