RESEARCH - Peripheral neuropathy associated with Arava (leflunomide): 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.

Abstract

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.

PMID: 16845649

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

Not an MD

[Guest guest]

Thanks for posting this , its very helpful.

Lee

>

> 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.

>

>

> Abstract

>

> 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.

>

>

> PMID: 16845649

>

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

>

>

>

> Not an MD

>