Study of eight cases of cancer in 426 rheumatoid arthritis patients treated with methotrexate.

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Ann Rheum Dis. 1997 Feb;56(2):97-102.

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Study of eight cases of cancer in 426 rheumatoid arthritis patients

treated with methotrexate.

Bologna C, Picot MC, nsen C, Viu P, Verdier R, Sany J.

Service d'Immuno-Rhumatologie, Federation de Rhumatologie, CHU

Lapeyronie, Montpellier, France.

OBJECTIVE: To report cancer cases in 426 rheumatoid arthritis

patients treated with methotrexate, and determine whether there was

an increased incidence of cancer compared with patients never treated

with methotrexate (rheumatoid controls) and to the whole regional

population. METHODS: The duration of methotrexate treatment was 37.4

(SD 27.9) months. This population was compared with 420 rheumatoid

arthritis controls and with a regional population of 812,344 people.

Life table analysis was performed to compare the cancer incidence in

the two rheumatoid populations. Adjustment for potentially

confounding factors was done. The indirect standardisation methods

was used to compare each rheumatoid population with the regional

population. RESULTS: Eight cases of cancer (1.88%; 4.04 cases/1000

person years) were diagnosed in the methotrexate population v six

(1.43%; 58.8 cases/1000 person years) in the rheumatoid controls. The

life table method showed a higher incidence of cancer in the

rheumatoid controls (P = 0.0001). In a multivariate analysis (

model), the only significant factor explaining this difference in the

cancer incidence was age (P = 0.02). In the regional population there

were 6418 new cases of cancer (0.79%; 2.85 cases/1000 person years).

By the indirect standardisation method, the ratio of observed cases

to expected cases of cancer in each of the rheumatoid populations was

not significantly different from 1. CONCLUSIONS: In these eight

cases, methotrexate was not found to be responsible for generating

cancers. However, because of data regarding lymphomas and

methotrexate, and because of the short follow up, especially in the

control group, longer prospective studies are warranted.

Ann Rheum Dis. 1997 Feb;56(2):97-102.

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