RESEARCH - Treatment of IA wiith MTX in clinical practice: treatment duration and incidence of adverse drug reactions

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Rheumatology 2005 44(1):61-66; doi:10.1093/rheumatology/keh512

Rheumatology Vol. 44 No. 1 © British Society for Rheumatology 2005; all

rights reserved

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PAPER

The treatment of inflammatory arthritis with methotrexate in clinical

practice: treatment duration and incidence of adverse drug reactions

A. J. Kinder, A. B. Hassell1, J. Brand1, A. Brownfield1, M. Grove1 and M. F.

Shadforth1

Leicester Royal Infirmary and 1 Staffordshire Rheumatology Centre, Haywood

Hospital, Burslem, Stoke on Trent, UK.

Correspondence to: A. B. Hassell. E-mail: andyhassell@...

Objective. To identify the proportion of patients with inflammatory

arthritis who remain on methotrexate in the medium to long term and the

incidence of side-effects in clinical practice.

Method. The study population comprised all patients with inflammatory

arthritis treated with methotrexate and monitored in clinics under the

auspices of Staffordshire Rheumatology Centre. Two clinical auditors

collected data retrospectively from the computer database used to support

monitoring of patients on disease-modifying anti-rheumatic drugs.

Information was collected on duration of treatments and reasons for stopping

treatment. For patients identified as having potentially serious

side-effects or who died whilst taking methotrexate, further information on

their outcome was collected from patients' medical notes and where

applicable post mortem reports and death registers.

Results. Between 1986 and 1999, 673 patients were treated with methotrexate,

of whom 551 had a diagnosis of rheumatoid arthritis. From the Kaplan-Meier

analysis, the probability of patients remaining on treatment 5 yr after

starting methotrexate was 0.74. Three hundred and sixteen patients stopped

methotrexate between 1986 and 1999. In 117 patients, the methotrexate was

restarted. Seventy-two patients (10.7% of all patients) stopped because of

inefficacy or patient choice or situation. Thirty-seven patients (5.5%)

stopped methotrexate due to abnormal haematology (usually low neutrophils).

Thirty-seven patients (5.5%) stopped methotrexate due to abnormalities in

liver function tests. Life-threatening side-effects were identified in 12

patients (1.8%). These included six pneumonitis, five cytopenias and one

disseminated varicella zoster. Two of these patients (0.3%) died, one from

pneumonitis and one from disseminated varicella zoster. A total of 25

patients (3.7%) died while taking methotrexate and four died (0.6%) within 3

months of stopping methotrexate. One death (0.15%) was directly attributable

to methotrexate (methotrexate pneumonitis).

Conclusion. This study has shown that methotrexate is well tolerated in

clinical practice in the medium to long term. It has produced accurate data

on the incidence of adverse effects of methotrexate in a local population in

a non-research setting. It has identified the incidence of life-threatening

side-effects to be 1.7% with one death (0.15%) directly due to methotrexate.

This information should prove useful when recommending such treatment to

patients with inflammatory arthritis.

http://rheumatology.oxfordjournals.org/cgi/content/abstract/44/1/61

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