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. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

EXPRESS‐II 2007.

Study characteristics
Methods RCT, placebo‐controlled, double‐blind trial
Date of study: not stated
Location: 63 centres in Europe, USA, Canada
Participants Randomised: 835 participants (mean age 44 years, 551 male)
Inclusion criteria

  • Participants with moderate‐severe psoriasis

  • PASI ≥ 12, BSA ≥ 10

  • No history of serious infection, lymphoproliferative disease, or active TB


Exclusion criteria

  • Had received biologics

  • Had an active infection

  • Had past history of malignant tumours


Dropouts and withdrawals

  • 62/835 (7.4%)

  • Inflximab 5 mg/kg (17) (AE (12), other (4), lost to follow‐up (1))

  • Infliximab 3 mg/kg (21) (AE (13), other (7), low effect (1))

  • Placebo (24) (AE (4), other (9), lost to follow‐up (1), low effect (10))
Interventions Intervention
A. Infliximab (n = 313), IV, 3 mg/kg, weeks 0, 2, 6; 10 weeks
Control intervention
B. Infliximab (n = 314), IV, 5 mg/kg, weeks 0, 2, 6; 10 weeks
C. Placebo (n = 208), IV, weeks 0, 2, 6; 10 weeks
Outcomes Assessments at 10 weeks
Primary outcomes of the trial

  • PASI 75


Secondary outcomes of the trial

  • PASI 50/90

  • DLQIAE

  • PGA
Notes Funding (p 31. e1) by Centocor, Inc, Malvern, Penn, and Schering‐Plough, Kenilworth, NJ.
Declarations of interest (appendix): "Dr Menter has received consulting, research, and/or speaking support from Abbott Laboratories, Allergan Inc, Allermed, Amgen Inc, Astralis Inc, Berlex Inc, Biogen Idec Inc, Centocor Inc, Cephalon, Collagenex Pharmaceuticals, CombinatoRx, Connetics Corp, Corixa Corporation, Dermik Laboratories, Doak Dermatologics, Dow, Ferndale Laboratories Inc, Fujisawa Healthcare Inc, Galderma, Genentech Inc, Genzyme, GlaxoSmithKline, Ligand Pharmaceuticals, Medicis, Med‐Immune Inc, Novartis Pharmaceuticals, Otsuka Pharmaceutical Inc, Protein Design Labs, QLT USA, Regeneration Pharma AG, Roche Laboratories, Serono, Sinclair, Synta Pharma, Thermosurgery, 3M Pharmaceuticals, Vertex, XOMA, and Zars Inc. Dr Feldman has received consulting, research, and/or speaking support from Amgen, Centocor, and Biogen. Dr Papp's support is as follows: Abbott: Investigator, Consultant; Amgen: Investigator, Consultant, Speaker, Advisory Boards; Centocor: Investigator, Consultant, Speaker, Senior Medical Officer for Canada (non‐compensatory), Advisory Boards; Genentech: Investigator, Consultant, Speaker, Senior Medical Officer for Canada (non‐compensatory), Advisory Boards; Serono: Investigator, Consultant, Speaker, Advisory Boards; Schering: Investigatory, Consultant, Speaker, Advisory Boards; and Wyeth: Speaker, Advisory Boards. Dr Weinstein has received consulting, research, and/or speaking support from Allergan, Amgen, Centocor, Biogen, Genentech, Valeant, Collagenex, CombinatoRx, Fujisawa, Abbott, and QLT. Dr Gottlieb has received research support from and/or is a consultant and/or speaker for Amgen, Inc, BiogenIdec, Inc, Centocor, Inc, Genentech, Inc, Abbott Labs, Ligand Pharmaceuticals, Inc, Beiersdorf, Inc, Fujisawa Healthcare, Inc, Celgene Corp, Bristol Myers Squibb, Inc, Warner Chilcott, Paradigm, Wyeth Pharmaceuticals, Schering‐Plough Corp, Eisai, Roche, Sankyo, Medarex, Kemia, Celera, TEVA, Actelion, and Amarill. At the time of the study, Dr Gottlieb was affiliated with the Clinical Research Center, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick, NJ. Dr Guzzo, Dr Dooley, Ms Li, and Ms Arnold are employees of Centocor, Inc. Mr Evans was an employee of Centocor, Inc at the time this study was conducted and is currently an employee of Scios, Inc."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote (p 31; e2): "Randomizations were performed by ClinPhone (Lawrenceville, NJ), allocating patients using a minimization algorithm with a biased coin assignment by means of an interactive voice response system"
Comment: probably done
Allocation concealment (selection bias) Low risk Quote (p 31; e2): "Randomizations were performed by ClinPhone (Lawrenceville, NJ), allocating patients using a minimization algorithm with a biased coin assignment by means of an interactive voice response system" "Patients, investigators, and all study staff except pharmacists were blinded to treatment assignments"
Comment: probably done
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote (p 31. e2): "Patients, investigators, and all study staff except pharmacists were blinded to treatment assignments... to receive IFX 3 mg/Kg or 5mg/Kg or placebo"
Comment: probably done
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote (p 31. e2): "Patients, investigators, and all study staff except pharmacists were blinded to treatment assignments... to receive IFX 3 mg/Kg or 5mg/Kg or placebo"
Comment: placebo‐controlled, probably done
Incomplete outcome data (attrition bias)
All outcomes Low risk 835 included / 835 analysed
Quote (p 31.e3/4): "For patients who discontinued... these patients were considered as not meeting the respective end‐points regardless of the observed data"
Comment: ITT
Selective reporting (reporting bias) Unclear risk Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported