Evidence map›Paper›PMID 25123295›Full record

Trial reportThe British journal of dermatology2015

A multicentre randomized trial of the treatment of patients with pemphigus vulgaris with infliximab and prednisone compared with prednisone alone.

R P Hall, J Fairley, D Woodley, V P Werth, D Hannah, R D Streilein, J McKillip, J Okawa, M Rose, L L Keyes-Elstein and 5 more

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The British journal of dermatology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00283712 (A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Infliximab in Subjects With Pemphigus Vulgaris Receiving Prednisone), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00283712 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Infliximab in Subjects With Pemphigus Vulgaris Receiving Prednisone

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2006 to 2011Enrolled20ConditionsPemphigusArmsInfliximab, Placebo Comparator
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Article
  6. RemicadeBiologics : targets & therapy · 2019
    Review
  7. Emerging treatment options for the management of pemphigus vulgaris.Therapeutics and clinical risk management · 2018
    Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. [Pemphigus. Model disease for targeted therapy].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2015
    Review
  13. Article
  14. Management of pemphigus vulgaris: challenges and solutions.Clinical, cosmetic and investigational dermatology · 2015
    Review
  15. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 7 institutions in 1 country.

R P HallDepartment of Dermatology, Duke Hospital South, Duke University Medical Center, Room 4044, Durham, NC, 27710, U.S.A.
J Fairley
D Woodley
V P Werth
D Hannah
R D Streilein
J McKillip
J Okawa
M Rose
L L Keyes-Elstein
A Pinckney
A Overington
J Wedgwood
L Ding
B Welch
Duke University Hospital · USRho (United States) · USUniversity of Pennsylvania · USNational Institute of Allergy and Infectious Diseases · USUniversity of Iowa · USNational Institutes of Health · USUniversity of Southern California · US

Funding

Transplantation GroupUM2AI117870 · NIAID · RHO FEDERAL SYSTEMS DIVISION, INC. · PI DAVID, GLORIA · 2015 to 2023
$208.1M
Supplement - Inflammatory Triggers in B Cell AutoimmunityU19AI056363 · NIAID · DUKE UNIVERSITY · PI ST. CLAIR, EUGENE WILLIAM · 2003 to 2017
$35.3M
NIAID NIH HHS 5U19AI056363-7NIAID NIH HHS U19 AI056363NIAID NIH HHS UM2 AI117870
6 · The paper itself

Abstract

backgroundPemphigus vulgaris (PV) is a blistering disease and tumour necrosis factor-α has a role in its pathogenesis.

objectivesTo 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.

methodsSubjects 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.

resultsTen 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)].

conclusionsThis 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.

Indexed as

AdultDermatologic AgentsDesmoglein 1Desmoglein 3Drug Therapy, CombinationFemaleHumansImmunoglobulin GInfliximabMaleMiddle AgedPemphigusPrednisoneTreatment OutcomeYoung AdultDermatologic AgentsDesmoglein 1Desmoglein 3Immunoglobulin GInfliximabPrednisone

Identifiers

PMID25123295
PMCPMC4326612
OpenAlexW1999726300

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.