Etanercept in the Treatment of Patients with Primary Sjögren's Syndrome: A Pilot Study

MICHIEL M. ZANDBELT, PETER C.M. de WILDE, PHILIP A. van DAMME, CAREL B. HOYNG, LEO B.A. van de PUTTE, FRANK H.J. van den HOOGEN

ABSTRACT.

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 Sjögren'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. (J Rheumatol 2004;31:96-101)

Key Indexing Terms:

SJÖGREN'S SYNDROME
SALIVARY GLAND BIOPSY
SICCA
FATIGUE
ETANERCEPT
ANTI-TUMOR NECROSIS FACTOR-ALPHA

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From the Departments of Rheumatology, Pathology, Oral and Cranio-Maxillofacial Surgery, and Ophthalmology, University Medical Center St. Radboud, Nijmegen, The Netherlands.

M.M. Zandbelt, MD; F.H.J. van den Hoogen, MD, PhD; L.B.A. van de Putte, MD, PhD, Department of Rheumatology; P.C.M. de Wilde, MD, PhD, Department of Pathology; P.A. van Damme, MD, PhD, Department of Oral and Cranio-Maxillofacial Surgery; C.B. Hoyng, MD, PhD, Department of Ophthalmology.

Address reprint requests to Dr. F.H.J. van den Hoogen, Department of Rheumatology, UMC St. Radboud Nijmegen, PO Box 9101, 6500 HB Nijmegen, The Netherlands. E-mail: F.vandenhoogen@reuma.umcn.nl

Submitted January 30, 2003; revision accepted June 5, 2003.

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