Phase II randomized, placebo-controlled trial of M. vaccae-derived protein (PVAC) for the treatment of psoriasis.
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 microg 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.
Netto
Eduardo Martins
EM
Federal University of Bahia, Brazil. enetto@ufba.br
Takahashi
Denise
D
de Fátima Paim de Oliveira
Maria
M
Barbosa
Paulo
P
Ferraz
Neide
N
Paixão
Ariene
A
Oyafuso
Luiza Keiko
LK
Bortoletto
Cecília
C
Matos
Denise
D
Paixão
Maurício
M
da Silva
Anete Olivieri Pessoa
AO
Badaro
Roberto
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000942:Antigens, Bacterial / Q000235:genetics / Q000627:therapeutic use; D001428:Bacterial Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016233:Immunotherapy, Active; D008297:Male; D008875:Middle Aged; D009161:Mycobacterium / Q000235:genetics / Q000276:immunology*; D010919:Placebos; D011565:Psoriasis / Q000188:drug therapy*; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000627:therapeutic use
D000942:Antigens, Bacterial; D001428:Bacterial Vaccines; D010919:Placebos; D015164:Vaccines, Inactivated