Background Tumour necrosis factor α (TNFα) is a proinflammatory cytokine involved in the pathogenesis of Sjögren’s syndrome (SS), and blockade of TNFα may reduce the activity of the disease.

Objectives This study evaluated the safety and potential efficacy of infliximab, a chimeric human-mouse anti-TNFα monoclonal antibody, in patients with active primary SS.

Methods This was a monocentre, open-label pilot study. Sixteen patients with active primary SS (ESR > 25 mm/h and hyperIgG) received three infusions of 3 mg/kg infliximab (at weeks 0, 2 and 6). Standard clinical assessment, complete ophtalmological testing and functional evaluation.

Results All the patients completed the study. There was a statistically significant improvement in all clinical and functional parameters. They included global assessments (p < 0.01) for patient global assessment, patient pain, physician global assessment, erythrocyte sedimentation rate (p < 0.05), salivary flow rate (p < 0.001), Schirmer I test (p < 0.01), lissamine green staining (p < 0.05), tender joint count (p < 0.01), fatigue score (p < 0.001), dry eyes and dry mouth (p < 0.01). This clinical benefit was observed at week 2 and was maintained throughout the study and the 2 months follow-up period. The treatment was well tolerated in all patients and no significant adverse events were seen. No lupus-like syndrome and no anti-dsDNA antibodies were observed.

Conclusion In patients with active primary SS, a loading dose regimen of three infusions of infliximab provided a fast and significant clinical benefit without major adverse reaction. It was possible to maintain statistically significant improvement up to 8 weeks after the third infusion.