Enbrel in Sjogren's syndrome: a 12-week clinical trial

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Arthritis Rheum. 2004 Jul;50(7):2240-5.

Etanercept in Sjogren's syndrome: a twelve-week randomized,

double-blind, placebo-controlled pilot clinical trial.

Sankar V, Brennan MT, Kok MR, Leakan RA, JA, Manny J, Baum BJ,

Pillemer SR.

National Institutes of Health, Bethesda, land, USA.

sankarv@...

OBJECTIVE: To assess the safety and potential efficacy of etanercept in

the treatment of Sjogren's syndrome (SS). METHODS: This pilot study was

a 12-week randomized, double-blind, placebo-controlled trial of

etanercept, with 14 subjects in each group. Patients received 25 mg of

etanercept or placebo (vehicle) by twice-weekly subcutaneous injection.

Patients met the American-European Consensus Group criteria for SS. The

primary outcome required at least 20% improvement from baseline values

for at least 2 of the following 3 domains: subjective or objective

measures of dry mouth, subjective or objective measures of dry eyes, and

IgG level or erythrocyte sedimentation rate (ESR). RESULTS: Of the 14

patients taking etanercept, 11 had primary SS and 3 had SS secondary to

rheumatoid arthritis. Baseline measures did not differ between the 2

groups. Three etanercept-treated patients and 1 placebo-treated patient

did not complete the trial. Five etanercept-treated patients and 3

placebo-treated patients showed improvement from baseline in the primary

outcome variable at 12 weeks, but the difference was not statistically

significant. There were no significant differences between the groups

for changes in subjective measures of oral or ocular symptoms (by visual

analog scale), the IgG level, Schirmer I test result, van Bijsterveld

score, or salivary flow. At 12 weeks, the ESR had decreased in the

etanercept group compared with baseline (P = 0.004); however, the mean

reduction was only 18.6%.

CONCLUSION: We found no evidence to suggest that treatment with

etanercept at a dosage of 25 mg twice weekly for 12 weeks was clinically

efficacious in SS. A larger trial will be necessary to definitively

address the efficacy of etanercept in the treatment of SS.

PMID: 15248223

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Mayo Clinic in Rochester

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s Hopkins Medicine

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