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

VOYAGE‐2 2017.

Study characteristics
Methods RCT, active/placebo‐controlled, double‐blind
Date of study: November 2014 ‐ May 2016
Location: 115 centres world‐wide
Participants Randomised: 992 participants (mean age 44 years, 692 male)
Inclusion criteria

  • Participants with moderate‐severe psoriasis (PASI ≥ 12, IGA ≥ 3 or BSA ≥ 10), age ≥ 18 years


Exclusion criteria

  • Had a history or current signs of a severe, progressive, or uncontrolled medical condition

  • Had current or history of malignancy, except non‐melanoma skin cancer, within 5 years

  • Patients with history or symptoms of active TB were excluded

  • Patients could not participate if they received guselkumab or adalimumab previously


Dropouts and withdrawals

  • 44/992 (4.4%); guselkumab (18), adalimumab (11), placebo group (15)

  • AEs: guselkumab (9), adalimumab (4), placebo group (2)

  • Lack of efficacy: guselkumab (0), adalimumab (2), placebo group (4)

  • Lost to follow‐up: guselkumab (3), adalimumab (2), placebo group (1)

  • Withdrawal of consent: guselkumab (1), adalimumab (0), placebo group (7)

  • Non‐compliance: guselkumab (1), adalimumab (2), placebo group (0)

  • Protocol violation: guselkumab (3), adalimumab (1), placebo group (1)

  • Others: guselkumab (1), adalimumab (0), placebo group (0)
Interventions Intervention
A. Guselkumab (n = 496), SC, 100 mg, weeks 0 and 4, then every 8 weeks
Control intervention
B. Adalimumab (n = 248), 80 mg week 0, then 40 mg week 1, and every 2 weeks
C. Placebo (n = 248)
Outcomes Assessments at 16 weeks
Primary outcomes of the trial

  • PASI 90

  • IGA clear or almost clear


Secondary outcomes of the trial

  • PASI 50/75

  • Mean DLQI score

  • NAPSI

  • Scalp‐specific IGA

  • Fingernail PGA

  • AEs
Notes Funding source:
Quote (p 1): "Supported by Janssen Research & Development, LLC."
Declarations of interest (p 1): "Dr Reich has served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Amgen, Biogen, Boehringer Ingelheim Pharma, Celgene, Covagen, Eli Lilly, Forward Pharma, GlaxoSmithKline, Janssen, Leo, Medac, Merck Sharp & Dohme, Novartis, Ocean Pharma, Pfizer, Regeneron, Takeda, UCB Pharma, and Xenoport. Dr Armstrong has served as investigator and/or advisor/consultant for AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Merck, Novartis, and Pfizer. Dr Foley has served as a consultant, investigator, speaker, and/or advisor for and/or received travel grants from 3M/iNova/Valeant, Abbott/AbbVie, Amgen, Biogen Idec, BMS, Boehringer Ingelheim, Celtaxsys, Celgene, Cutanea, Eli Lilly, Galderma, GSK/Stiefel, Janssen, LEO/Peplin, Novartis, Regeneron, Schering‐Plough/MSD, UCB, and Wyeth/Pfizer. Dr Gordon has received research support from AbbVie, Amgen, Boeringher Ingelheim, Eli Lilly, and Janssen, and consultant/ honoraria from AbbVie, Amgen, Boeringher Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, and Pfizer. Drs Song, Wasfi, Randazzo, Li, and Shen are all employees of Janssen Research & Development, LLC (subsidiary of Johnson & Johnson) and own stock in Johnson & Johnson."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote (p 3): "Patients were randomized 2:1:1 using a permuted block method at baseline to guselkumab 100 mg at weeks 0, 4, 12, and 20; placebo at weeks 0, 4, and 12, then guselkumab at weeks 16 and 20; or adalimumab 80 mg at week 0, 40 mg at week 1, and every 2 weeks thereafter through week 23 (Fig 1). Central randomization occurred using an interactive web based response system (Perceptive Informatics, East Windsor, NJ)."
Comment: clearly defined
Allocation concealment (selection bias) Low risk Quote (p 3): "Patients were randomized using a permuted block method at baseline in a 2:1:2 ratio to guselkumab 100 mg at weeks 0, 4, 12, and every 8 weeks through week 44; placebo at weeks 0, 4, and 12 followed by guselkumab 100 mg at weeks 16 and 20, and every 8 weeks through week 44; or adalimumab 80 mg at week 0, 40 mg at week 1, and 40 mg every 2 weeks through week 47. Central randomization was implemented using an interactive World Wide Web response system (Perceptive Informatics, East Windsor, NJ)."
Comment: clearly defined
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote (p 3): "double‐blind, placebo‐ and adalimumab comparator controlled study"
Comment: probably done
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote (p 3): "double‐blind, placebo‐ and adalimumab comparator controlled study"
Comment: probably done
Incomplete outcome data (attrition bias)
All outcomes Low risk Randomly assigned 992, 992 analyzed
Management of missing data: quote (p 3): "All randomized patients were included in the primary analysis and some secondary efficacy analyses according to their assigned treatment group.... Patients who discontinued treatment due to lack of efficacy or an adverse event [AE] of worsening of psoriasis, or started a protocol‐prohibited medication/therapy to improve psoriasis were considered treatment failures."
Comment: done
Selective reporting (reporting bias) Low risk Comment: the protocol for the study was available on ClinicalTrials.gov (NCT02207244)
The prespecified outcomes and those mentioned in the Methods section appeared to have been reported