Details

Autor(en) / Beteiligte

• Netto, Eduardo Martins
• Takahashi, Denise
• de Fátima Paim de Oliveira, Maria
• Barbosa, Paulo
• Ferraz, Neide
• Paixão, Ariene
• Oyafuso, Luiza Keiko
• Bortoletto, Cecília
• Matos, Denise
• Paixão, Maurício
• da Silva, Anete Olivieri Pessoa
• Badaro, Roberto

Titel

Phase II randomized, placebo-controlled trial of M. vaccae-derived protein (PVAC®) for the treatment of psoriasis

Ist Teil von

• Vaccine, 2006-06, Vol.24 (23), p.5056-5063

Ort / Verlag

Oxford: Elsevier Ltd

Erscheinungsjahr

2006

Quelle

MEDLINE

Beschreibungen/Notizen

• 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 15μg 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.