RESEARCH - Pneumonitis associated with Arava: a profile of New Zealand and Australian reports

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Intern Med J. 2006 Mar;36(3):162-9.

Pneumonitis associated with leflunomide: a profile of New Zealand and

Australian reports.

Savage RL, Highton J, Boyd IW, Chapman P.

New Zealand Pharmacovigilance Centre, Department of Preventive and Social

Medicine, Dunedin, New Zealand.

Background: Pneumonitis has very rarely been observed in patients taking

leflunomide in clinical trials. Evidence is emerging that it is more

frequent in clinical practice. Aim: The aim of this study was to investigate

voluntary reports of suspected respiratory reactions to leflunomide held by

the New Zealand Pharmacovigilance Centre (NZPhvC) and the Australian Adverse

Drug Reactions Unit (ADRU) to ascertain if they fulfilled the criteria for

pneumonitis and to define characteristics of this reaction. Method: Reports

of respiratory adverse reactions attributed to leflunomide and received by

the NZPhvC and the ADRU were analysed to identify those that were likely to

be pneumonitis based on the criteria of Searles and McKendry. Features of

these reports were examined to provide further information about this

adverse reaction. Results: The NZPhvC and the ADRU received 14 reports

considered to be pneumonitis occurring in patients taking leflunomide. Two

case reports fulfilled the Searles and McKendry criteria for definite or

probable hypersensitivity pneumonitis. The patients in the remaining reports

had radiological evidence of pulmonary infiltrates, an acute respiratory

illness and no evidence of precipitating infection. In two cases the

patients were taking leflunomide alone; one improved when it was withdrawn.

In the other 12 cases, patients were taking leflunomide in combination with

methotrexate. In nine of these 12 patients pneumonitis occurred after

leflunomide was added to methotrexate, usually within 12-20 weeks. One of

the two patients who died had possible previous methotrexate pneumonitis.

Leflunomide washout with cholestyramine was used to treat three patients,

one with life-threatening illness, with good results.

Conclusion: This case series supports observations that leflunomide can

cause pneumonitis either as monotherapy or in combination with methotrexate.

The case histories indicate that prompt recognition is important to avoid

life-threatening disease and support the use of cholestyramine to remove

leflunomide.

PMID: 16503951

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstra\

ct & list_uids=16503951 & itool=iconabstr & query_hl=1 & itool=pubmed_DocSum

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