RESEARCH - Peripheral neuropathy associated with Arava: is there a risk patient profile?

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Pharmacoepidemiol Drug Saf. 2007 Jan;16(1):74-8.

Peripheral neuropathy associated with leflunomide: is there a risk patient

profile?

Departement de Pharmacologie, Universite Victor Segalen, Bordeaux cedex,

France.

PURPOSE: (i) To monitor the potential clinical neurotoxic symptoms in

patients treated with leflunomide in daily practice and (ii) to describe the

characteristics of patients presenting with this peripheral nervous system

symptoms. METHOD: All patients treated with leflunomide between May 2000 and

April 2003 and followed in the rheumatology department of the University

Hospital participated in the study. Data concerning treatment patterns with

leflunomide, demographic and disease characteristics were obtained from

clinical charts. Neuropathy was diagnosed with nerve conduction study (NCS).

Cases of neuropathy were described and then compared to other patients using

univariate analyses. RESULTS: One hundred and thirteen patients were

included in the study. M/F sex ratio was 0.45. Mean age at start of

treatment was 55.6 years (range = 27-81). During the study period, eight

incident cases of peripheral neuropathy and two cases of worsening of

preexisting neuropathy were reported (incidence: 9.8%). Compared with other

patients, neuropathy cases were older (69 vs. 54 years, p = 0.0006), more

often diabetic (30% vs. 2.9%, p = 0.009) and more often treated with

potentially neurotoxic drugs (20% vs. 1.9%, p = 0.039). At least one risk

factor (potentially neurotoxic drug or diabetes) was found in 50% of

patients with neuropathy versus 4% of patients without neuropathy (56% PPV,

96% NPV).

CONCLUSION: Cases of toxic neuropathy have been observed during treatment of

rheumatoid arthritis with leflunomide. Their occurrence seems to be

associated with known risk factors. Careful monitoring of the patient's

neurological status during leflunomide treatment is therefore mandatory.

Copyright © 2006 Wiley & Sons, Ltd.

PMID: 16845649

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