Etanercept in the treatment of patients with primary Sjögren's syndrome: a pilot study.
OBJECTIVE
This pilot study evaluated the effect of anti-tumor necrosis factor-a antiinflammatory treatment with etanercept (Enbrel(R)) 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.


CONCLUSIONS
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.
Zandbelt
Michiel M
MM
Department of Rheumatology, University Medical Center St. Radboud, Nijmegen, The Netherlands.
de Wilde
Peter
P
van Damme
Philip
P
Hoyng
Carel B
CB
van de Putte
Leo
L
van den Hoogen
Frank
F
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy; D000068800:Etanercept; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007070:Immunoglobulin A / Q000276:immunology; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010950:Plasma Cells / Q000276:immunology; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D012470:Salivary Glands, Minor / Q000473:pathology; D012859:Sjogren's Syndrome / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology
D007070:Immunoglobulin A; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept