title: A multicentre randomized trial of the treatment of patients with pemphigus vulgaris with infliximab and prednisone compared with prednisone alone.
abstract: BACKGROUND
  Pemphigus vulgaris (PV) is a blistering disease and tumour necrosis factor-α has a role in its pathogenesis.
  
  
  OBJECTIVE
  To evaluate the safety of infliximab (IFX) with prednisone compared with prednisone alone in the treatment of PV. In addition, treatment response was assessed and mechanistic studies were performed.
  
  
  METHODS
  Subjects with PV who had ongoing disease activity while being maintained on prednisone were randomized to receive either IFX or placebo in addition to prednisone. Response status and immunoglobulin (Ig) G anti-desmoglein (Dsg)1 and Dsg3 antibodies were assessed at 18 and 26 weeks.
  
  
  RESULTS
  Ten subjects were randomized to each group. There were no safety signals during the course of the study. At week 18, one subject in each group had responded. At week 26, three IFX-treated subjects vs. none in the placebo group had responded (P = 0·21). At weeks 18 and 26, the median IgG anti-Dsg1 and anti-Dsg3 levels were lower in the IFX-treated patients [IgG anti-Dsg-1 (week 18, P = 0·035; week 26, P = 0·022); IgG anti-Dsg3 (week 18, P = 0·035; week, 26 P = 0·05)].
  
  
  CONCLUSIONS
  This study is limited by the relatively small sample size. There was no significant difference between study arms in the proportion of subjects with treatment-related adverse events > grade 3. IFX therapy was not shown to be effective for the treatment of patients with PV in this randomized, placebo-controlled trial, although IFX treatment may be associated with a decrease in anti-Dsg1 and Dsg3 antibodies.
authors.affiliation: Department of Dermatology, Duke Hospital South, Duke University Medical Center, Room 4044, Durham, NC, 27710, U.S.A.
authors.forename: R P
authors.initials: RP
authors.lastname: Hall
authors.forename: J
authors.initials: J
authors.lastname: Fairley
authors.forename: D
authors.initials: D
authors.lastname: Woodley
authors.forename: V P
authors.initials: VP
authors.lastname: Werth
authors.forename: D
authors.initials: D
authors.lastname: Hannah
authors.forename: R D
authors.initials: RD
authors.lastname: Streilein
authors.forename: J
authors.initials: J
authors.lastname: McKillip
authors.forename: J
authors.initials: J
authors.lastname: Okawa
authors.forename: M
authors.initials: M
authors.lastname: Rose
authors.forename: L L
authors.initials: LL
authors.lastname: Keyes-Elstein
authors.forename: A
authors.initials: A
authors.lastname: Pinckney
authors.forename: A
authors.initials: A
authors.lastname: Overington
authors.forename: J
authors.initials: J
authors.lastname: Wedgwood
authors.forename: L
authors.initials: L
authors.lastname: Ding
authors.forename: B
authors.initials: B
authors.lastname: Welch
mesh_terms: D000328:Adult; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D051183:Desmoglein 1 / Q000276:immunology; D051184:Desmoglein 3 / Q000276:immunology; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000378:metabolism; D000069285:Infliximab / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010392:Pemphigus / Q000188:drug therapy*; D011241:Prednisone / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D051183:Desmoglein 1; D051184:Desmoglein 3; D007074:Immunoglobulin G; D000069285:Infliximab; D011241:Prednisone