RESEARCH - Arava in RA: recommendations through a process of consensus

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Rheumatology (Oxford). 2005 Mar;44(3):280-6. Epub 2005 Jan 18.

Leflunomide in rheumatoid arthritis: recommendations through a process of

consensus

Department of Rheumatology, Ysbyty Gwynedd Hospital, University of Wales,

Bangor LL57 2PW, UK. peter.maddison@...

OBJECTIVES: To determine, by consensus, the optimal use of leflunomide in

rheumatoid arthritis (RA), using a multidisciplinary panel of experts and

performing meta-analyses of available data. METHODS: A multidisciplinary

panel of experts in RA was convened. Important questions, pertinent to the

use of leflunomide in the treatment of RA, were defined by consensus at an

initial meeting. Each question was allocated to subgroups of two or three

members, who worked separately to prepare a balanced opinion, based on

published literature, data from individual patients taking part in phase II

and phase III clinical trials provided by Aventis, and data from a USA-based

medical claims database (AETNA). The full group then reconvened to agree on

an overall consensus statement. Recommendations concerning efficacy and

tolerability versus comparator drugs and placebo were derived from two new

meta-analyses. RESULTS: Leflunomide was at least as effective as

sulphasalazine and methotrexate, and equally well tolerated on meta-analysis

of trial data. Overall withdrawal rates for all adverse events were similar

for all three drugs. Avoidance of the loading dose reduces 'nuisance'

side-effects (e.g. nausea), but probably delays the onset of action. Adverse

events could usually be managed by dose reduction and/or symptomatic

therapy.

CONCLUSIONS: On the basis of efficacy, safety and cost, leflunomide should

be considered in patients with RA who have failed first-line DMARD drug

therapy. In refractory cases, leflunomide may be used in combination with,

for example, methotrexate before biological agents. Therapy should be

initiated by a specialist, but repeat prescribing in general practice on a

shared care basis is acceptable using agreed protocols. Clear mechanisms are

required to monitor toxicity, with good communication between the patient

and rheumatologist to manage nuisance side-effects and avoid unnecessary

discontinuation of leflunomide.

PMID: 15657072

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

ctPlus & list_uids=15657072

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