Dendritic Cells Therapy Induces CD4+ T Memory Cells with Concomitant Profile TH1-TH17 in Responding Melanoma Patients

Abstracts period; non-serious infections occurred in 18 patients (annual rate: 3.44 infections/patient). The annual rate of days missed from work/school was 9.44 days/patient. Eighteen of 31 patients experienced adverse events (AEs) causally related to and temporally associated (72 h) with study medication (rate: 0.096 events/infusion), mostly local injection site reactions of mild or moderate intensity. Serious AEs were experienced by 4 patients (rate: 0.006 events/infusion) but none was considered related to study medication. Subcutaneous IgPro20 administered weekly at 100% of previous IVIG dose resulted in higher serum IgG levels than previous IVIG therapy, adequate control of infection rate, and no safety concerns. doi:10.1016/j.clim.2010.03.260

F.39. Health-Related Quality of Life of Patients with Primary Immunodeficiency Switching from Intravenous IgG to a New 20% Subcutaneous IgG Teresa Gonzalez Quevedo 1, Wilma Mannhardt-Laakmann 2, Ewa Bernatowska 3, Margit Serban 4, Stephen Jolles 5, Javier de Gracia 6, Bodo Grimbacher 7, Ed Wang 8, Michael Borte 9. 1 Hospitales Universitarios Virgen del Rocío, Sevilla, Spain; 2 Universitäts-Kinderklinik der Johannes Gutenberg Universität, Mainz, Germany; 3Child Health Institute, Warsaw, Poland; 4Clinica III Pediatrie Louis Turcanu, Temesvar, Romania; 5University Hospital of Wales, Cardiff, United Kingdom; 6Hospital Vall d'Hebron, Barcelona, Spain; 7 Royal Free Hospital & University College Medical School, London, United Kingdom; 8CSL Behring LLC, King of Prussia, PA; 9Municipal Hospital St. Georg, Leipzig, Germany Home administration of high concentration, low volume subcutaneous IgG (SCIG) for patients with primary immunodeficiency (PID) offers convenience and reduced healthcare costs. We present the first health-related quality of life (HRQL) assessment of IgPro20, a new SCIG therapy for patients with PID, and the broadest HRQL evaluation of switching from intravenous IgG (IVIG). Twenty-nine subjects previously on IVIG self-administered IgPro20 weekly at a dose equivalent to their previous therapy. Nineteen subjects previously on SCIG were assessed in parallel. Validated HRQL questionnaires covering generic or disease-specific treatment satisfaction aspects were completed at baseline, 12, 24 and 40 weeks. Improvements in the following domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) were observed for IVIG pre-treated patients: convenience (median score of 56 at baseline improved to 83 by study end), effectiveness (67 to 78), and overall satisfaction (71 to 79). Increases in Life Quality Index (LQI) domains by study end were observed in IVIG pre-treated patients for: treatment interference (from 58 to 92), therapy-related problems (63 to 83), therapy settings (56 to 94) and total score (70 to 89). Scores for Short-Form-36 Health Survey (adults) and most of the Child Health Questionnaire Parental-Form-50 (children) showed no major change by study end. All HRQL indices were maintained in patients pre-treated with SCIG. In conclusion, treatment with an equivalent dose of subcutaneous IgPro20 improved HRQL and treatment satisfaction in patients

S87 previously treated with IVIG. Superior satisfaction of IgPro20 over IVIG therapy is further reinforced by the positive LQI results on patients' daily activities. doi:10.1016/j.clim.2010.03.261

F.40. Dendritic Cells Therapy Induces CD4+ T Memory Cells with Concomitant Profile TH1-TH17 in Responding Melanoma Patients Lorena Salazar, Mercedes López, Claudia Durán, Gabriela Segal, Flavio Salazar-Onfray. University of Chile, ICBM, Santiago, Chile Dendritic cells (DCs), have proved to be a promising immuntherapeutical strategy againts solid cancer. We have developed a rapid protocol to generate DCs in 48 hrs, against malign melanoma. The immunization protocol resulting in two groups of patients, differentiated by their tumor-specific delayed type hypersensitivity (DTH), and correlated with their median survival, 60% of patients are DTH(+) and showing a three-fold prolonged survival compared to DTH(-) (33 and 11 months respectively). In order to asses if DCs induces an efficient immunological memory, we have determined through the expression of phosphatase kinase CD45RO the memory T cells populations (TM). We have found in PBL of DTH(+) patients an increased number of CD4TM (22.77 ± 3.04% vs 27.09 ± 1,67%), but not of CD8TM (7.14 ±0.76% vs 7.14±0.75%) postimmunotherapy. On the other hand, DTH(-) patients didn't showed differences in the induction of CD4TM (20.45 ±1.66% vs 20.66±2.45%) or CD8TM (8.22± 1.12% vs 8.30± 0.92%) after the teraphy. Despite these results, we observed an important induction of central CD4 and CD8 TM sub-population postimmunotherapy trough a high expression of CD62L, CD28 and CCR7 molecules in both DTH(+) and DTH(-) patients. To evaluate the profile of T cells induced, we evaluated the TH1, TH17 and Treg population by flow citometry, and determinated that postimmunotherapy, DTH(+) patients have a significant increase of TH1 (12.05± 2.35% vs 19.12± 2.65%, p=0,05) and TH17 (0.77 ± 0.20 vs 2.6 ± 0.56, p = 0.05) lymphocytes, while, DTH(-) patients presents a TGFβ1-TH3 regulator profile (39.01 ±1.421 vs 44.52 ±2.114, p =0.001). In conclusion, these results indicate that DCs therapy induces an efficient immunological memory, associate at pro-inflamatorie outline in DTH(+) patients. doi:10.1016/j.clim.2010.03.262

F.41. The Positive Results of Human Recombinant α-2-β-interferon Treatment on the Process of Maturation in the Pregnants with Sexual-transmitted Infections Tatyana Yaremtchuk 1, Olga Korchynska 1, Angela Misiura 1, Yuriy Petryshyn 2, Bogdan Korchynskiy 1; 1Lviv National Medical University, Lviv, Ukraine; 2Lviv Regional Clinical Perinatal Center, Lviv, Ukraine The aim of research was the increasing of effectiveness of treatment of the pregnants with obstetrical