RESEARCH - Factors associated with toxicity, final dose, and efficacy of MTX in patients with RA

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Ann Rheum Dis. 2003 May;62(5):423-6.

Factors associated with toxicity, final dose, and efficacy of

methotrexate in patients with rheumatoid arthritis.

Hoekstra M, van Ede AE, Haagsma CJ, van de Laar MA, Huizinga TW,

Kruijsen MW, Laan RF.

Department of Rheumatology, Medisch Spectrum Twente, Enschede, The

Netherlands. mhoekstra@...

OBJECTIVE: To study factors associated with toxicity, final dose, and

efficacy of methotrexate (MTX) in patients with rheumatoid arthritis

(RA). METHODS: Data were used from a randomised clinical 48 week trial

on 411 patients with RA all treated with MTX, comparing folates and

placebo. Logistic regression was used to study the relation between

baseline variables and various dependent factors, including

hepatotoxicity (alanine aminotransferase >/=3 x upper limit of normal),

MTX withdrawal, final MTX dose >/=15 mg/week, and MTX efficacy. RESULTS:

Addition of folates to MTX treatment was strongly related to the lack of

hepatotoxicity. Next to this, high body mass index was related to the

occurrence of hepatotoxicity. Prior gastrointestinal (GI) events and

younger age were related to the adverse event, diarrhoea. Hepatotoxicity

and GI adverse events were the main reason for MTX withdrawal, which in

turn was associated with the absence of folate supplementation, body

mass index, prior GI events, and female sex. Renal function (creatinine

clearance >/=50 ml/min) was not associated with toxicity. Reaching a

final dose of MTX of >/=15 mg/week was related to folate supplementation

and the absence of prior GI events. Efficacy of MTX treatment was

associated with low disease activity at baseline, male sex, use of

non-steroidal anti-inflammatory drugs (NSAIDs), and lower creatinine

clearance.

CONCLUSIONS: MTX toxicity, final dose, and efficacy are influenced by

folate supplementation. Baseline characteristics predicting the outcome

of MTX treatment are mainly prior GI events, body mass index, sex, use

of NSAIDs, and creatinine clearance.

PMID: 12695153

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstra\

ct & list_uids=12695153 & itool=iconabstr

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