Skip to main content
. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

Rich 2013.

Study characteristics
Methods RCT, placebo‐controlled, double‐blind trial
Date of study: July 2009 ‐ December 2010
Location: 60 centres in Portland, USA
Participants Randomised: 404 participants
Secukinimab A (66) (mean age 43 years, 53 male)
Secukinimab B (138) (mean age 44 years, 104 male)
Secukinimab C (133) (mean age 45 years, 105 male)
Placebo (67) (mean age 44 years, 44 male)
Inclusion criteria
  • Participants with moderate‐severe psoriasis

  • PASI ≥ 12, IGA ≥ 3 or BSA ≥ 10

  • Age ≥ 18 years

  • Non‐response to topical treatment

  • Non‐response to phototherapy

  • Non‐response to conventional systemic treatment


Exclusion criteria
  • Pregnancy

  • Immunosuppresion

  • Had an active infection

  • Dropouts and withdrawals

  • 24/404 (6%)

  • Secukinimab A (5): lack efficacy (2), withdrew consent (1), AE (1), other (1)

  • Secukinimab B (4): lack efficacy (1), withdrew consent (2), other (1)

  • Secukinimab C (6): withdrew consent (2), AE (3), other (1)

  • Placebo (9): lack efficacy (5), withdrew consent (2), AE (2)

Interventions Intervention
A. Secukinumab (n = 66), SC, 150 mg, week 0, 12 weeks
Control intervention
B. Secukinumab (n = 138), SC, 150 mg, weeks 0, 4, 8, 12 weeks
C. Secukinumab (n = 133), SC, 150 mg, weeks 0, 1, 2, 4, 12 weeks
D. Placebo (n = 67), SC, weeks 0, 1, 2, 4, 8, 12 weeks
Outcomes Assessments at 12 weeks
Primary outcomes of the trial
  • PASI 75


Secondary outcomes of the trial
  • PASI 75 20/28 weeks

  • IGA 12 weeks

  • PASI 90 12 weeks

Notes Funding support quote (p 402): "Novartis Pharma AG, Basel, Switzerland"
Declarations of interest (appendix): "P.R. has received honoraria for lecturing in industry‐sponsored meetings and has received research grants from pharmaceutical companies as an investigator. B.S. has consulted for Novartis and several other pharmaceutical companies; he has served on an advisory board for Novartis and several other pharmaceutical companies. D.T. has served as a speaker and served on advisory boards for Abbott, Biogen‐Idec, Janssen‐Cilag, Leo, MSD, Novartis and Pfizer. C. Paul has received honoraria from and has been a paid consultant to Abbott, Amgen, Celgene, Janssen‐Cilag, Novartis and Pierre Fabre. K.R., E.H., A.G., M.M. and C. Papavassilis are full‐time employees of, and own stock in Novartis. J.‐P.O., A.M. and R.E.S. declare no conflicts of interest."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote (p 404): “Randomization numbers were generated by the interactive response technology provider using a validated system that automated the random assignment of patients numbers to randomisation numbers”
Comment: probably done
Allocation concealment (selection bias) Low risk Quote (p 404): “Randomization numbers were generated by the interactive response technology provider using a validated system that automated the random assignment of patients numbers to randomisation numbers”
Comment: probably done
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote (p 404): “Patients, investigator staff, persons performing the assessments and data analysts were blinded to the identity of treatment from the time of randomisation until primary outcome analysis”
Comment: probably done
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote (p 404): “Patients, investigator staff, persons performing the assessment and data analysts were blinded to the identity of treatment from the time of randomisation until primary outcome analysis”
Comment: probably done
Incomplete outcome data (attrition bias)
All outcomes Low risk 404 included/404 analysed
Quote (p 405): "Following th intent‐to‐treat principle, data were analysed... Missing values were replaced using the last‐observation‐carried‐forward approach"
Comment: ITT analyses
Selective reporting (reporting bias) Low risk Comment: the protocol for the study was available on ClinicalTrials.gov (NCT00941031)
The prespecified outcomes and those mentioned in the Methods section appeared to have been reported