RESEARCH - Long term safety of MTX in routine clinical care: discontinuation is unusual and rarely the result of labs

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Ann Rheum Dis. 2005 Feb;64(2):207-11. Epub 2004 Jun 18.

Long term safety of methotrexate in routine clinical care: discontinuation

is unusual and rarely the result of laboratory abnormalities.

Yazici Y, Sokka T, Kautiainen H, Swearingen C, Kulman I, Pincus T.

Brooklyn Heights Arthritis Associates, Long Island College Hospital,

Brooklyn, NY, USA. yaziciy@...

OBJECTIVE: To analyse patients with rheumatoid arthritis, treated with

methotrexate in a weekly academic rheumatology clinic over 13 years, for

continuation of courses and reasons for discontinuation. METHODS: All 248

patients with an analysable longitudinal course who took methotrexate in

standard care between 1990 and 2003 were studied. Continuation of courses

was analysed using life tables. All abnormal and severely abnormal values

for aspartate aminotransferase (AST) >40 U/l, >80 U/l, albumin <35 g/l, <30

g/l, white blood cell (WBC) count <4.0 x 10(9)/l, <3.0 x 10(9)/l, and

platelet count <150 x 10(9)/l, <100 x 10(9)/l, were identified. Responses of

the clinician and subsequent laboratory values were reviewed. RESULTS: Over

1007 person-years, the probability of continuing methotrexate over five

years was 79% (95% confidence interval, 72% to 84%). Severe laboratory

abnormalities occurred in 2.9 per 100 person-years, specifically 0.9 for AST

>80 U/l, 1.1 for albumin <30 g/l, 0.7 for WBC <3.0 x 10(9)/l, and 0.3 for

platelets <100 x 10(9)/l. No severe laboratory abnormality progressed to

further severity or clinical disease. Permanent discontinuations of

methotrexate occurred in 46 patients (19%), 26 (10% of all patients) for

adverse effects, 15 (32.6%) for inefficacy; only two discontinuations

resulted from laboratory abnormalities, both of WBC, possibly from other

sources.

CONCLUSIONS: Methotrexate was associated with a high rate of continuation,

and few clinically significant laboratory abnormalities. Discontinuation

primarily reflected clinical rather than laboratory findings. Vigilance for

methotrexate toxicity is required but methotrexate appears among the safest

treatments for rheumatoid arthritis.

PMID: 15208176

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

ct & list_uids=15208176 & itool=iconfft & query_hl=22 & itool=pubmed_DocSum

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