Alentuzumabe para tratamento de pacientes com esclerose múltipla remitente recorrente com características comparáveis aos critérios de tratamento com natalizumabe conforme o estabelecido no PCDT / Alentuzumab for the treatment of patients with relapsing-remitting multiple sclerosis with characteristics comparable to the treatment criteria with natalizumab as per the established in the PCDT

INTRODUÇÃO: A esclerose múltipla (EM) pode ser definida como uma doença crônica, inflamatória, desmielinizante, neurodegenerativa e complexa, sendo caracterizada pela presença de episódios de disfunção neurológica em áreas do sistema nervoso central (cérebro, medula espinhal e nervos ópticos) separados no tempo e no espaço. A EM geralmente afeta adultos jovens, dos 20 aos 50 anos de idade, embora alguns indivíduos possam experimentar o evento desmielinizante durante a infância ou adolescência. A EM pode ser dividida em quatro variações fenotípicas: a EMRR, a EM Secundária Progressiva, a EM Primária Progressiva e a Síndrome Clinicamente Isolada. Atualmente, o Protocolo Clínico e Diretrizes Terapêuticas (PCTD) de EM conta com nove medicamentos classificados como terapias modificadoras do curso da doença (betainterferona 1a intramuscular, betainterferona 1a subcutânea, betainterferona 1b subcutânea, glatirâmer, teriflunomida, fumarato de dimetila, azatioprina, fingolimode, natalizumabe) e um para o tratamento dos surtos (metilprednisolona). O objetivo do presente relatório é analisar as evidências científicas sobre o uso do alentuzumabe para o tratamento de pacientes com EMRR a

Alemtuzumab induction in kidney transplantation: clinical results and impact on T-regulatory cells.

Alemtuzumab (ALT), a humanized monoclonal anti-CD52 antibody, was introduced in solid organ transplantation as an induction agent. ALT associated with anticalcineurins has provided a low incidence of acute rejection episodes (ARE) and potential tolerogenic properties. We analyzed the clinical outcomes and effects on peripheral Treg of renal transplant recipients treated with ALT. Six-month data on kidney alone or kidney combined with pancreas or liver patients treated with ALT and tacrolimus (TAC) in standard doses were compared with those on renal transplant recipients of similar demography who were not treated with ALT. We evaluated patient and graft survivals, ARE incidence, hematological parameters, renal function, adverse events, and CD4+CD25+FoxP3+ T cells in peripheral blood. Demographics of recipients, donors, and transplants were similar in both groups. Mean HLA mismatch was slightly greater among ALT-treated patients (3.5 vs 2.5). No combined transplantation was performed in the ALT-untreated group. Patient and graft survivals were 100% without rejection or serious infections in both groups. ALT-treated recipients showed anemia and leukopenia in 3 patients as well as severe lymphopenia in 5 recipients, who partially recovered on day 90. Final mean plasma creatinine was 1.4 mg/dL, while calculated creatinine clearance was approximately 65 mL/min in both groups. Mean Treg cell percentage was higher among ALT-treated recipients than the comparative group or healthy controls (P < .05). In conclusion, renal transplantation results obtained using ALT with rigorous immunosuppressive therapy were excellent; serious adverse events and acute rejection were absent. The effect of the increased proportion of Treg cells must be evaluated with longer observation.