Immunoadsorption apheresis (Selesorb) in the treatment of chronic hepatitis C virus-related type 2 mixed cryoglobulinemia.
In this short-term open label clinical pilot study, conducted at one center, the immune complex dextran sulphate adsorber (Selesorb) was used to treat four female patients aged 59-69 with HCV-related cryoglobulinaemia, vasculitis and/or neuropathy. The primary trial objective was to assess the clinical efficacy of the immunoadsorber. The secondary objective of the trial was to determine the safety of the adsorber and to investigate the adsorption capacity, measured as the adsorption of cryoglobulin-related immune complexes and the resulting influence on plasma components of the immune system. The patients have been submitted to treatment with the immunoadsorber, at approximately 1-3 days intervals, completing six sessions. The follow-up was one month. In the patients treated with Selesorb, we observed a statistically significant decrease in plasma of all classes of immunoglobulins (IgA: 5-28%; IgG: 14-44%; IgM: 8-38%). In two patients with peripheral neuropathy secondary to cryoglobulinemia, the symptomatology was improved. In a third patient the neurological involvement was substantially unchanged, and the same unsuccessful outcome was observed for Sjögren syndrome is concerned. Nevertheless, the two patients with lower extremity vasculitis showed an appreciable improvement. We failed to observe significant side effects directly related to the use of this immunoadsorbent.
Stefanutti
C
C
Dipartimento di Clinica e Terapia Medica Applicata, Plasmapheresis Unit, University La Sapienza of Rome, Umberto I Hospital, Viale del Policlinico, 155, 00161 Rome, Italy. plasmaferesi@tin.it
Di Giacomo
S
S
Mareri
M
M
De Lorenzo
F
F
D'Alessandri
G
G
Angelico
F
F
Bucci
A
A
Musca
A
A
Mammarella
A
A
D000368:Aged; D001781:Blood Component Removal / Q000379:methods* / Q000592:standards; D003449:Cryoglobulinemia / Q000209:etiology / Q000628:therapy*; D016264:Dextran Sulfate / Q000592:standards / Q000627:therapeutic use; D005260:Female; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000276:immunology / Q000628:therapy; D006801:Humans; D007136:Immunoglobulins / Q000097:blood / Q000187:drug effects; D007163:Immunosorbent Techniques; D007164:Immunosorbents / Q000592:standards / Q000627:therapeutic use*; D008875:Middle Aged; D010523:Peripheral Nervous System Diseases / Q000209:etiology / Q000628:therapy; D010865:Pilot Projects; D016896:Treatment Outcome; D014657:Vasculitis / Q000209:etiology / Q000628:therapy
D007136:Immunoglobulins; D007164:Immunosorbents; D016264:Dextran Sulfate