Enbrel in the treatment of patients with primary Sjogren's syndrome

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J Rheumatol. 2004 Jan;31(1):96-101.

Etanercept in the treatment of patients with primary Sjogren's syndrome:

a pilot study.

Zandbelt MM, de Wilde P, van Damme P, Hoyng CB, van de Putte L, van den

Hoogen F.

Department of Rheumatology, University Medical Center St. Radboud,

Nijmegen, The Netherlands.

OBJECTIVE: This pilot study evaluated the effect of anti-tumor necrosis

factor-a antiinflammatory treatment with etanercept (Enbrel®) on

sicca, systemic, and histological signs in patients with primary

Sjogren's syndrome (SS). METHODS: Fifteen patients with well defined

primary SS were treated with 25 mg etanercept subcutaneously twice per

week during 12 weeks, with followup visits at Weeks 18 and 24.

Evaluation measures included a Multidimensional Fatigue Inventory (MFI)

questionnaire, serological monitoring, salivary flow tests, Schirmer

test, rose bengal cornea staining, and tear film breakup time. A

sublabial minor salivary gland biopsy was performed at baseline and at

Week 12 and lymphocytic focus score and percentage IgA-containing plasma

cells (IgA%) were assessed. RESULTS: No increase of salivary or

lachrymal gland function was observed in any participant. In 4 patients

a decrease of fatigue complaints was noted, which was also reflected by

decreased scores in the MFI questionnaire. Reduced erythrocyte

sedimentation rate was observed in 3 of 4 patients with reduced fatigue.

No significant change of lymphocyte focus score or IgA% was observed. A

repeated treatment up to 26 weeks showed the same results.

CONCLUSION: A 12-week or prolonged treatment of etanercept 25 mg twice

weekly did not appear to reduce sicca symptoms and signs in SS. However,

etanercept treatment may be beneficial in a small subgroup of SS

patients with severe fatigue. Etanercept 25 mg twice weekly did not

affect minor salivary gland biopsy results.

PMID: 14705226

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