RESEARCH - Long term safety of MTX in routine clinical care: discontinuation is unusual

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Published Online First: 18 June 2004. doi:10.1136/ard.2004.023408

© 2005 by BMJ Publishing Group Ltd & European League Against Rheumatism

ls of the Rheumatic Diseases 2005;64:207-211

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EXTENDED REPORT

Long term safety of methotrexate in routine clinical care: discontinuation

is unusual and rarely the result of laboratory abnormalities

Y Yazici1, T Sokka2, H Kautiainen3, C Swearingen4, I Kulman5 and T Pincus4

1 Brooklyn Heights Arthritis Associates, Long Island College Hospital,

Brooklyn, New York, USA

2 Vanderbilt University, Nashville, Tennessee, and Jyväskylä Central

Hospital, Jyväskylä, Finland

3 Rheumatism Foundation Hospital, Heinola, Finland

4 Vanderbilt University, Nashville, Tennessee

5 Mount Sinai School of Medicine, New York

Correspondence to:

Dr Yusuf Yazici

515 East 72nd Street #29E, New York, NY 10021, 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 <4.0x109/l,

<3.0x109/l, and platelet count <150x109/l, <100x109/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 <3.0x109/l, and

0.3 for platelets <100x109/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.

http://ard.bmjjournals.com/cgi/content/abstract/64/2/207

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