Effectiveness, side-effects and period of remission after treatment with methotrexate in localized scleroderma and related sclerotic skin diseases: an inception cohort study.
BACKGROUND
Detailed information is lacking on effectiveness of methotrexate (MTX) in sclerotic skin diseases, side-effects, and duration of remission after discontinuation.


OBJECTIVE
To determine effectiveness, side-effects and period of remission gained by use of MTX in sclerotic skin diseases.


METHODS
All patients with a sclerotic skin disease who were treated with MTX (group A) or MTX with corticosteroids (CS) (group B) between 1995 and 2007 were evaluated. Detailed information was collected on dosage and duration of MTX treatment, concomitant immunosuppressive medication and CS treatment, effectiveness, side-effects, duration of the remission period, and time until restart.


RESULTS
Fifty-eight patients (A, n = 47; B, n = 11) were evaluated. Clinical assessment revealed that 38 patients (81%) treated with MTX and 11 patients (100%) treated with MTX + CS showed improvement of sclerotic skin. After one treatment course 51% of the patients treated with MTX and 73% treated with MTX + CS reached remission status with a median follow-up time of 55 and 58 months. Patients showing relapse still responded to a second and even to a third course of MTX. Patients who showed a relapse had received a lower cumulative dose, due to a shorter period of treatment with MTX in the first course. Serious side-effects were seen in six patients (10%).


CONCLUSIONS
MTX was an effective treatment for various sclerotic skin diseases with a long period of remission and relatively low toxicity. Patients showing relapse still responded to a second and third course of MTX.
Kroft
E B M
EB
Department of Dermatology, Radboud University Medical Centre Nijmegen, St Radboud, PO Box 9101, NL-6500 HB Nijmegen, the Netherlands. i.kroft@zgt.nl
Creemers
M C W
MC
van den Hoogen
F H J
FH
Boezeman
J B M
JB
de Jong
E M G J
EM
D000293:Adolescent; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction; D012594:Scleroderma, Localized / Q000188:drug therapy*; D013997:Time Factors; D055815:Young Adult
D000964:Antimetabolites, Antineoplastic; D008727:Methotrexate