Long-Term Safety of MTX: Discontinuation is Unusual and Rarely due to Laboratory Abnormalities

August 12, 2004

Ann Rheum Dis. 2004 Jun 18 [Epub ahead of print]

Long-Term Safety of Methotrexate in Routine Clinical Care:

Discontinuation is Unusual and Rarely due to Laboratory Abnormalities.

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

Brooklyn Heights Arthritis Associates, Long Island College Hospital,

Brooklyn, New York, USA.

OBJECTIVE: To analyze patients with rheumatoid arthritis (RA) treated

with methotrexate in a weekly academic rheumatology clinic over 13 years

for continuation of courses and reasons for discontinuation. METHODS:

All 248 RA patients with analyzable longitudinal courses who took

methotrexate in standard care between 1990 and 2003 were studied.

Continuation of courses was analyzed using life tables. All abnormal and

severely abnormal, values for aspartate aminotransferase (AST)

>40U/l,>80U/l, albumin <35g/l,<30g/l, white blood cell (WBC) count <4.0

x 109/l, <3.0 x 109/l,and platelet count <150 x 109/l,<100 x 109/l, were

identified. Responses of the clinician, and subsequent laboratory values

were reviewed. RESULTS: Over 1007 person-years, the probability to

continue methotrexate over 5 years was 79% (95% Confidence Interval, CI,

72% to 84%). Severe laboratory abnormalities occurred in 2.9 per 100

person- years, specifically 0.9 for AST>80U/l, 1.1 for albumin<30g/l,

0.7 for WBC<3.0 x 109/l, and 0.3 for platelets<100 x 109/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.

CONCLUSION: Methotrexate was associated with a high rate of

continuation, and few clinically significant laboratory abnormalities.

Discontinuation was primarily due to clinical, rather than laboratory,

findings. Vigilance for methotrexate toxicity is required but

methotrexate appears among the safest therapies for RA.

PMID: 15208176

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

August 18, 2004

This sure it good to read!

> Ann Rheum Dis. 2004 Jun 18 [Epub ahead of print]

>

> Long-Term Safety of Methotrexate in Routine Clinical Care:

> Discontinuation is Unusual and Rarely due to Laboratory Abnormalities.

>

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

>

> Brooklyn Heights Arthritis Associates, Long Island College Hospital,

> Brooklyn, New York, USA.

>

> OBJECTIVE: To analyze patients with rheumatoid arthritis (RA) treated

> with methotrexate in a weekly academic rheumatology clinic over 13 years

> for continuation of courses and reasons for discontinuation. METHODS:

> All 248 RA patients with analyzable longitudinal courses who took

> methotrexate in standard care between 1990 and 2003 were studied.

> Continuation of courses was analyzed using life tables. All abnormal and

> severely abnormal, values for aspartate aminotransferase (AST)

>> >40U/l,>80U/l, albumin <35g/l,<30g/l, white blood cell (WBC) count <4.0

> x 109/l, <3.0 x 109/l,and platelet count <150 x 109/l,<100 x 109/l, were

> identified. Responses of the clinician, and subsequent laboratory values

> were reviewed. RESULTS: Over 1007 person-years, the probability to

> continue methotrexate over 5 years was 79% (95% Confidence Interval, CI,

> 72% to 84%). Severe laboratory abnormalities occurred in 2.9 per 100

> person- years, specifically 0.9 for AST>80U/l, 1.1 for albumin<30g/l,

> 0.7 for WBC<3.0 x 109/l, and 0.3 for platelets<100 x 109/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.

>

> CONCLUSION: Methotrexate was associated with a high rate of

> continuation, and few clinically significant laboratory abnormalities.

> Discontinuation was primarily due to clinical, rather than laboratory,

> findings. Vigilance for methotrexate toxicity is required but

> methotrexate appears among the safest therapies for RA.

>

> PMID: 15208176

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

>

August 18, 2004