Infliximab in patients with primary Sjogren's syndrome - A pilot study

Objective. Tumor necrosis factor alpha (TNF alpha) is a proinflammatory cyt okine involved in the pathogenesis of Sjogren's syndrome (SS), and blockade of TNF alpha may reduce the activity of the disease. The purpose of this s tudy was to evaluate the safety and potential efficacy of infliximab, a chi meric human-mouse anti-TNF alpha monoclonal antibody, in patients with acti ve primary SS. Methods. This was a single-center, open-label pilot study. Sixteen patients with active primary SS received 3 infusions of infliximab (3 mg/kg) at 0, 2, and 6 weeks. Standard clinical assessment, complete ophthalmologic testi ng, and functional evaluation of salivary flow were performed at baseline a nd at weeks 2, 6, 10, and 14. Results. All patients completed the study. There was statistically signific ant improvement in all clinical and functional parameters, including global assessments (patient's global assessment, patient's assessment of pain and fatigue, physician's global assessment), erythrocyte sedimentation rate, s alivary flow rate, the Schirmer I test, tender joint count, fatigue score, and dry eyes and dry mouth. This clinical benefit was observed at week 2 an d was maintained throughout the study and the 2-month followup period. The treatment was well tolerated in all patients, and no significant adverse ev ents were seen. No lupus-like syndrome was observed, and no anti-double-str anded DNA anti-bodies were observed that were attributable to infliximab th erapy. Conclusion. In patients with active primary SS, a loading-dose regimen of 3 infusions of infliximab provided a fast and significant clinical benefit w ithout major adverse reactions. It was possible to maintain statistically s ignificant improvement for up to 8 weeks after the third infusion.