title: Immunoadsorption apheresis and immunosuppressive drug therapy in the treatment of complicated HCV-related cryoglobulinemia.
abstract: The immunosuppressive drug therapy (IDT) is not always effective to avoid the development of complications in hepatitis C virus-related cryoglobulinemia (HCV-Cr). Removal of cryoglobulins by therapeutic plasmapheresis is currently accepted. In this randomized, parallel group study, 17 male and female patients aged 43-79 years, with complicated HCV-Cr, were submitted for 12 weeks (initial immunosuppressive therapy) to IDT (alpha-interferon, pegylated-interferon alpha-2a, cyclophosphamide, methylprednisolone, prednisone, cyclosporine, ribavirin, and melphalan). Then, they were randomly assigned to two parallel groups: A # 9 patients treated by immunoadsorption apheresis (Selesorb((R))) (IA) plus IDT, and B # 8 patients submitted to IDT only, for further 12 weeks. # 187 IA aphereses were performed. No adverse reactions or complications were observed. A Clinical Score (CS) was adapted from a pre-existing scoring model to evaluate signs and symptoms inherent to the underlying immunologic disorder. The CS was calculated at baseline (CS0), after the initial immunosuppressive therapy (CS1 = 12 weeks) when patients were treated only with IDT, and at the end of the study (24 weeks) in the group A (CSA; IA plus IDT) and B (CSB; IDT only). The score did not change significantly from CS0 to CS1. However, statistically significant differences were observed between CS1 and CSA (P < 0.001), and CSA versus CSB (P = 0.03), respectively. The changes observed were favorable to the patients assigned to the IA plus IDT group (A): in most case relief of symptoms and complications have been obtained.
authors.affiliation: Department of Clinical and Medical Therapy, Plasmapheresis Unit, University of Rome 'La Sapienza', Policlinico 'Umberto I' Rome, Rome, Italy. cstefanutti@alice.it
authors.forename: Claudia
authors.initials: C
authors.lastname: Stefanutti
authors.forename: Antonio
authors.initials: A
authors.lastname: Vivenzio
authors.forename: Serafina
authors.initials: S
authors.lastname: Di Giacomo
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Labbadia
authors.forename: Fabio
authors.initials: F
authors.lastname: Mazza
authors.forename: Giovanna
authors.initials: G
authors.lastname: D'Alessandri
authors.forename: Pietro M
authors.initials: PM
authors.lastname: Ferraro
authors.forename: Cesare
authors.initials: C
authors.lastname: Masala
mesh_terms: D000328:Adult; D000368:Aged; D001781:Blood Component Removal / Q000379:methods*; D003131:Combined Modality Therapy; D003449:Cryoglobulinemia / Q000628:therapy*; D005260:Female; D006526:Hepatitis C / Q000150:complications*; D006801:Humans; D007163:Immunosorbent Techniques; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged
chemical_list: D007166:Immunosuppressive Agents