title: Phase II randomized, placebo-controlled trial of M. vaccae-derived protein (PVAC) for the treatment of psoriasis.
abstract: 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.
authors.affiliation: Federal University of Bahia, Brazil. enetto@ufba.br
authors.forename: Eduardo Martins
authors.initials: EM
authors.lastname: Netto
authors.forename: Denise
authors.initials: D
authors.lastname: Takahashi
authors.forename: Maria
authors.initials: M
authors.lastname: de Fátima Paim de Oliveira
authors.forename: Paulo
authors.initials: P
authors.lastname: Barbosa
authors.forename: Neide
authors.initials: N
authors.lastname: Ferraz
authors.forename: Ariene
authors.initials: A
authors.lastname: Paixão
authors.forename: Luiza Keiko
authors.initials: LK
authors.lastname: Oyafuso
authors.forename: Cecília
authors.initials: C
authors.lastname: Bortoletto
authors.forename: Denise
authors.initials: D
authors.lastname: Matos
authors.forename: Maurício
authors.initials: M
authors.lastname: Paixão
authors.forename: Anete Olivieri Pessoa
authors.initials: AO
authors.lastname: da Silva
authors.forename: Roberto
authors.initials: R
authors.lastname: Badaro
mesh_terms: 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
chemical_list: D000942:Antigens, Bacterial; D001428:Bacterial Vaccines; D010919:Placebos; D015164:Vaccines, Inactivated