Artigo de Periódico
Phase II randomized, placebo-controlled trial of M. vaccae-derived protein (PVAC®) for the treatment of psoriasis
Fecha
2006Registro en:
0264-410X
v.24, n.23
Autor
Martins Netto, Eduardo
Takahashi, Denise
Oliveira, Maria de Fátima Santos Paim de
Barbosa, Paulo José Bastos
Ferraz, Neide
Paixão, Ariene
Oyafuso, Luiza Keiko
Bortoletto, Cecília
Matos, Denise
Paixão, Maurício
Silva, Anete Olivieri Pessoa da
Badaró, Roberto José da Silva
Martins Netto, Eduardo
Takahashi, Denise
Oliveira, Maria de Fátima Santos Paim de
Barbosa, Paulo José Bastos
Ferraz, Neide
Paixão, Ariene
Oyafuso, Luiza Keiko
Bortoletto, Cecília
Matos, Denise
Paixão, Maurício
Silva, Anete Olivieri Pessoa da
Badaró, Roberto José da Silva
Institución
Resumen
The treatment effect against psoriasis of an antigen (delipidated, deglycolipidated form of M. vaccae-PVAC) was investigated. One hundred and sixty-five patients were enrolled in three arms (50 or 15 μg or placebo), each receiving a total of two intradermal injections (days 0 and 21). At week 12, a 75% decrease in psoriasis area and severity index was similar among the studied groups (13, 9 and 18%, p = 0.429). The overall incidence of adverse events was significantly higher in the PVAC treated groups when compared to placebo (98.2, 87.3 and 70.9%; p < 0.001) largely due to local reactions that were limited for the most part to grades 1 and 2 in severity and were self-limiting. Despite its overall safety, PVAC was not clearly indicated to be superior to placebo in the treatment of psoriasis in this study.