RESEARCH - Arava of limited value in Sjogren's syndrome

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Leflunomide of Limited Value in Sjogren's Syndrome

NEW YORK (Reuters Health) Aug 27 - In patients with primary Sjogren's

syndrome, the immunomodulatory drug leflunomide has a " fairly acceptable "

safety profile but only modest efficacy, suggest results of a phase II pilot

study.

" A need remains for an easy-to-administer, cost-effective and well-tolerated

treatment for Sjogren's syndrome, " note Dr. J. M. van Woerkom and colleagues

from University Medical Center, Utrecht, the Netherlands in the August issue

of the ls of the Rheumatic Disease.

They investigated the safety and efficacy of leflunomide (20 mg/daily) for

this purpose in 15 patients with early and active primary Sjogren's

syndrome.

After 24 weeks, leflunomide was associated with a decrease in general

fatigue and an increase in physical functioning. Modest improvement in dry

eyes and mouth were observed on objective tests but visual analogue scale

values regarding dryness of eyes and mouth remained unchanged. Three

patients had " an impressive " improvement in leukocytoclastic vasculitis.

Several adverse effects were observed, mainly stomach discomfort (including

diarrhea) and hair loss. Five patients developed lupus-like skin lesions,

causing one patient to withdrawal from the study. The other four responded

well to topical corticosteroids.

Two patients with pre-existing hypertension required an increase in their

anti-hypertensive medications. In two patients, increased alanine

aminotransferase levels were noted; the levels normalized with a reduction

in the leflunomide dose.

Dr. van Woerkom and colleagues conclude that while the safety profile " seems

fairly acceptable, the observed indications for efficacy were modest and may

be doubtful in justifying a randomized controlled trial of leflunomide in

primary Sjogren's syndrome. "

Ann Rheum Dis 2007;66:1026-1032.

http://www.medscape.com/viewarticle/562080

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