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

ECLIPSE 2019.

Study characteristics
Methods RCT, active‐controlled, double‐blind study
Date of study: April 2017‐ September 2018
Location: world‐wide (142 sites)
Phase 3
Participants Randomised: 1048 participants
Inclusion criteria
  • Have a diagnosis of plaque‐type psoriasis (with or without Psoriatic Arthritis (PsA)) for at least 6 months before the first administration of study drug

  • A woman of childbearing potential must have a negative urine pregnancy test at screening and at week 0 and agree to urine pregnancy testing before receiving injections

  • Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug

  • Agree not to receive a Bacille Calmette‐Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study drug

  • Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study


Exclusion criteria
  • Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic, rheumatologic, psychiatric, or metabolic disturbances

  • Has previously received guselkumab or secukinumab

  • Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

  • Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly

  • Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins


Baseline characteristics
N = 1048, mean age of 46 years and 67% men
Dropouts and withdrawals
  • 75/1048 (7.2%):


Guselkumab 100 group (27), Secukinumab 300 group (48)
  • AEs: Guselkumab 100 group (1 worsening of psoriasis and 8 other AEs ), Secukinumab 300 group (1 worsening of psoriasis and 10 other AEs )

  • Lack of perceived efficacy: Guselkumab 100 group (2), Secukinumab 300 group (7)

  • Lost to follow‐up: Guselkumab 100 group (2), Secukinumab 300 group (2)

  • Not comply with study drug:Guselkumab 100 group (2), Secukinumab 300 group (0)

  • Withdrew: Guselkumab 100 group (7), Secukinumab 300 group (19)

  • Pregnant: Guselkumab 100 group (1), Secukinumab 300 group (1)

  • Protocol violations: Guselkumab 100 group (2), Secukinumab 300 group (6)

  • Other: Guselkumab 100 group (2), Secukinumab 300 group (2)

Interventions Intervention
A. Guselkumab 100mg (TREMFYA) S.C injection plus placebo (one injection) at weeks 0, 4, 12, and every 8 weeks thereafter until week 44, n=534
Control intervention
B. Secukinumab 300mg (COSENTYX) administered as two 150mg S.C injections at weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter until week 44, n=514
Outcomes At week 48
Primary outcome
  • PASI 90


Secondary outcomes
  • PASI 75, PASI 90 (at weeks 12 and 48)

  • PASI 100 (at week 48)

  • IGA 0/1 (at week 48)

Notes Funding: Quote (p831):"This study was funded by Janssen Research & Development."
Conflict of interest: "
Quote (p838): "KR has served as an advisor and paid speaker and has participated in clinical trials for AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, Boehringer Ingelheim, Celgene, Covagen, Forward Pharma, Fresenius Medical Care, GlaxoSmithKline, Janssen, Janssen‐Cilag, Kyowa Kirin, LEO Pharma, Eli Lilly, Medac, Merck Sharp & Dohme, Novartis, Miltenyi Biotech, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharma, Takeda, UCB, Valeant, XBiotech, and Xenoport. AWA has served as a consultant, research investigator, speaker, or data safety board member for AbbVie, Boehringer Ingelheim/Parexel, Bristol‐Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, Genentech, GlaxoSmithKline, Janssen, Janssen‐Ortho, Kyowa Hakko Kirin, LEO Pharma, Menlo Therapeutics, Merck, Modernizing Medicine, Novartis Pharmaceutical Corp, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Science 37, UCB Pharma, and Valeant. RGL has served as principle investigator,
as a speaker, and on the scientific advisory board for and received compensation in the form of honoraria from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Janssen, LEO Pharma, Eli Lilly, Merck, Novartis, Pizer, Sun, and UCB Pharma. SF, BR, SL, M‐CH, and PB are all employees of Janssen Research & Development and own stock in Johnson & Johnson, of which Janssen is a subsidiary. AB has served as a scientific advisor or clinical study investigator for AbbVie, Aclaris, Allergan, Almirall, Amgen, Arena, Boehringer Ingelheim, Bristol‐Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, FLX Bio, Galderma, Genentech/Roche, GlaxoSmithKline,
Janssen, LEO Pharma, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Purdue Pharma, Regeneron, Revance, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB Pharma, Valeant, and Vidac, and as a paid speaker for Janssen, Regeneron, and Sanofi Genzyme."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote (p833): "Patients were randomly assigned (1:1) to receive either guselkumab or secukinumab. An outside vendor (Paraxel, Waltham, MA, USA) used an interactive web response system to randomly assign patients based on computer‐ generated permuted blocks."
Comment: probably done
Allocation concealment (selection bias) Low risk Quote (p833): "An outside vendor (Paraxel, Waltham, MA, USA) used an interactive web response system to randomly assign patients based on computer‐ generated permuted blocks."
Comment: probably done
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote (p832, 833):"A phase 3, multicentre, randomised, double‐blind, comparator‐controlled study (ECLIPSE)... ." "Patients, investigators, and the funder of the study were masked throughout the 56‐week database lock, with the exception of the unmasked site personnel who dispensed or administered the study agent."
Comment: unclear if the process guarented blinding of participants and personnel
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote (p832, 833):"A phase 3, multicentre, randomised, double‐blind, comparator‐controlled study (ECLIPSE)... ." "Patients, investigators, and the funder of the study were masked throughout the 56‐week database lock, with the exception of the unmasked site personnel who dispensed or administered the study agent."
Comment: unsure that the process guarented the blinding of outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Low risk Dealing with missing data:
Quote (p834, 835):" For efficacy analyses, we included all patients according to the random treatment allocation (intention‐to‐treat [ITT] population), regardless of the treatment received... Patients with missing data were considered non‐ responders (non‐responder imputation)."
Randomly assigned 1048, analysed 1048
Selective reporting (reporting bias) Low risk Comment: the protocol for the study was available on ClinicalTrials.gov (NCT03090100).
The prespecified outcomes and those mentioned in the Methods section appeared to have been reported.
Results are posted on ClinicalTrials.gov.