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?

K, Bentaberry F, Dumoulin C, Miremont-Salamé G, Haramburu F,

Dehais J, Schaeverbeke T.

Département de Pharmacologie, Université 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

http://www.ncbi.nlm.nih.gov/pubmed/16845649

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