Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies

Exclusion Criteria

• •Peripheral neurological damage of the type vascularitis-related multiplex mononeuropathy
• •Small fibers neuropathy
• •Neuropathy suspected of being related to alcohol, diabetes or post-chemotherapy
• •Chronic viral infection (HCV, HBV, HIV, etc.)
• •Prior treatment with polyvalent intravenous immunoglobulins in the 6 months preceding the study
• •Corticosteroid treatment at a dose greater than 20 mg/d of prednisone equivalent or no stable dose for at least 1 month before inclusion
• •Conventional immunosuppressant treatment with azathioprin, cyclophosphamide or mycophenolate mofetil on-going or interrupted less than one month before inclusion
• •Rituximab or other biotherapy (belimumab, tocilizumab, …) less than 6 months before the start of the study treatment
• •Immunomodulating treatment with methotrexate no stable dose for at least 2 months before inclusion
• •Hydroxychloroquine no stable dose for at least 3 months before inclusion
• •Pilocarpine hydrochloride secretagogue treatment no stable dose for at least one month before inclusion
• •Treatment with amitriptyline, clomipramine, carbamazepine, clonazepam, pregabaline, duloxetine or gabapentine if the dose has not been stable for at least one month before inclusion (possible dose reduction to be documented).
• •renal clairance \< 50 ml/mn
• •HIV seropositivity
• •HBV, or HCV viral replication
• •Contraindication to the use of IV Ig: h Hypersensitivity to the active substance or to any of the excipients; hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA; patients with hyperprolinaemia.
• •Contraindication to the use of Nacl
• •Immunization with live attenuated vaccine within 2 weeks prior to inclusion
• •Participation in a clinical study with an investigational product with an exclusion period
• •Women of child bearing potential or intends to become pregnant, unless they are using an effective method of birth control\* and a βHCG blood test negative
• •Pregnant or nursing (lactating) women
• •Patient under legal guardianship
• •Prisoners