Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial

Andrew Blauvelt; Kim A Papp; Christopher E M Griffiths; Bruce Randazzo; Yasmine Wasfi; Yaung-Kaung Shen; Shu Li; Alexa B Kimball

doi:10.1016/j.jaad.2016.11.041

Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasisCitation formats

External authors:
Andrew Blauvelt
Kim A Papp
Bruce Randazzo
Yasmine Wasfi
Yaung-Kaung Shen
Shu Li
Alexa B Kimball

Standard

Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis : Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. / Blauvelt, Andrew; Papp, Kim A; Griffiths, Christopher E M; Randazzo, Bruce; Wasfi, Yasmine; Shen, Yaung-Kaung; Li, Shu; Kimball, Alexa B.

In: Journal of the American Academy of Dermatology, 2017.

Research output: Contribution to journal › Article › peer-review

Harvard

Blauvelt, A, Papp, KA, Griffiths, CEM, Randazzo, B, Wasfi, Y, Shen, Y-K, Li, S & Kimball, AB 2017, 'Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial', Journal of the American Academy of Dermatology. https://doi.org/10.1016/j.jaad.2016.11.041

APA

Blauvelt, A., Papp, K. A., Griffiths, C. E. M., Randazzo, B., Wasfi, Y., Shen, Y-K., Li, S., & Kimball, A. B. (2017). Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. Journal of the American Academy of Dermatology. https://doi.org/10.1016/j.jaad.2016.11.041

Vancouver

Blauvelt A, Papp KA, Griffiths CEM, Randazzo B, Wasfi Y, Shen Y-K et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. Journal of the American Academy of Dermatology. 2017. https://doi.org/10.1016/j.jaad.2016.11.041

Author

Blauvelt, Andrew ; Papp, Kim A ; Griffiths, Christopher E M ; Randazzo, Bruce ; Wasfi, Yasmine ; Shen, Yaung-Kaung ; Li, Shu ; Kimball, Alexa B. / Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis : Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. In: Journal of the American Academy of Dermatology. 2017.

Bibtex

@article{0cd0eb79f9c3498ab01bcfb7718d3bda,

title = "Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial",

abstract = "BACKGROUND: Guselkumab, an interleukin-23 blocker, was superior to adalimumab in treating moderate to severe psoriasis in a phase II trial.OBJECTIVES: We sought to compare efficacy and safety of guselkumab with adalimumab and placebo in patients with psoriasis treated for 1 year.METHODS: Patients were randomized to guselkumab 100 mg (weeks 0 and 4, then every 8 weeks; n = 329); placebo→guselkumab (weeks 0, 4, and 12 then guselkumab at weeks 16 and 20, then every 8 weeks; n = 174); or adalimumab (80 mg week 0, 40 mg week 1, then 40 mg every 2 weeks through week 47; n = 334). Physician-reported outcomes (Investigator Global Assessment, Psoriasis Area and Severity Index [PASI]), patient-reported outcomes (Dermatology Life Quality Index, Psoriasis Symptoms and Signs Diary), and safety were evaluated through week 48.RESULTS: Guselkumab was superior (P < .001) to placebo at week 16 (85.1% vs 6.9% [Investigator Global Assessment score of 0/1 (cleared/minimal)] and 73.3% vs 2.9% [90% or greater improvement in PASI score from baseline (PASI 90)]). Guselkumab was also superior (P < .001) to adalimumab for Investigator Global Assessment 0/1 and PASI 90 at week 16 (85.1% vs 65.9% and 73.3% vs 49.7%), week 24 (84.2% vs 61.7% and 80.2% vs 53.0%), and week 48 (80.5% vs 55.4% and 76.3% vs 47.9%). Furthermore, guselkumab significantly improved patient-reported outcomes through week 48. Adverse event rates were comparable between treatments.LIMITATIONS: Analyses were limited to 48 weeks.CONCLUSIONS: Guselkumab demonstrated superior efficacy compared with adalimumab and was well tolerated in patients with psoriasis through 1 year.",

author = "Andrew Blauvelt and Papp, {Kim A} and Griffiths, {Christopher E M} and Bruce Randazzo and Yasmine Wasfi and Yaung-Kaung Shen and Shu Li and Kimball, {Alexa B}",

year = "2017",

doi = "10.1016/j.jaad.2016.11.041",

language = "English",

journal = "Journal of the American Academy of Dermatology",

issn = "0190-9622",

publisher = "Mosby, Incorporated",

}

RIS

TY - JOUR

T1 - Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis

T2 - Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial

AU - Blauvelt, Andrew

AU - Papp, Kim A

AU - Griffiths, Christopher E M

AU - Randazzo, Bruce

AU - Wasfi, Yasmine

AU - Shen, Yaung-Kaung

AU - Li, Shu

AU - Kimball, Alexa B

PY - 2017

Y1 - 2017

N2 - BACKGROUND: Guselkumab, an interleukin-23 blocker, was superior to adalimumab in treating moderate to severe psoriasis in a phase II trial.OBJECTIVES: We sought to compare efficacy and safety of guselkumab with adalimumab and placebo in patients with psoriasis treated for 1 year.METHODS: Patients were randomized to guselkumab 100 mg (weeks 0 and 4, then every 8 weeks; n = 329); placebo→guselkumab (weeks 0, 4, and 12 then guselkumab at weeks 16 and 20, then every 8 weeks; n = 174); or adalimumab (80 mg week 0, 40 mg week 1, then 40 mg every 2 weeks through week 47; n = 334). Physician-reported outcomes (Investigator Global Assessment, Psoriasis Area and Severity Index [PASI]), patient-reported outcomes (Dermatology Life Quality Index, Psoriasis Symptoms and Signs Diary), and safety were evaluated through week 48.RESULTS: Guselkumab was superior (P < .001) to placebo at week 16 (85.1% vs 6.9% [Investigator Global Assessment score of 0/1 (cleared/minimal)] and 73.3% vs 2.9% [90% or greater improvement in PASI score from baseline (PASI 90)]). Guselkumab was also superior (P < .001) to adalimumab for Investigator Global Assessment 0/1 and PASI 90 at week 16 (85.1% vs 65.9% and 73.3% vs 49.7%), week 24 (84.2% vs 61.7% and 80.2% vs 53.0%), and week 48 (80.5% vs 55.4% and 76.3% vs 47.9%). Furthermore, guselkumab significantly improved patient-reported outcomes through week 48. Adverse event rates were comparable between treatments.LIMITATIONS: Analyses were limited to 48 weeks.CONCLUSIONS: Guselkumab demonstrated superior efficacy compared with adalimumab and was well tolerated in patients with psoriasis through 1 year.

AB - BACKGROUND: Guselkumab, an interleukin-23 blocker, was superior to adalimumab in treating moderate to severe psoriasis in a phase II trial.OBJECTIVES: We sought to compare efficacy and safety of guselkumab with adalimumab and placebo in patients with psoriasis treated for 1 year.METHODS: Patients were randomized to guselkumab 100 mg (weeks 0 and 4, then every 8 weeks; n = 329); placebo→guselkumab (weeks 0, 4, and 12 then guselkumab at weeks 16 and 20, then every 8 weeks; n = 174); or adalimumab (80 mg week 0, 40 mg week 1, then 40 mg every 2 weeks through week 47; n = 334). Physician-reported outcomes (Investigator Global Assessment, Psoriasis Area and Severity Index [PASI]), patient-reported outcomes (Dermatology Life Quality Index, Psoriasis Symptoms and Signs Diary), and safety were evaluated through week 48.RESULTS: Guselkumab was superior (P < .001) to placebo at week 16 (85.1% vs 6.9% [Investigator Global Assessment score of 0/1 (cleared/minimal)] and 73.3% vs 2.9% [90% or greater improvement in PASI score from baseline (PASI 90)]). Guselkumab was also superior (P < .001) to adalimumab for Investigator Global Assessment 0/1 and PASI 90 at week 16 (85.1% vs 65.9% and 73.3% vs 49.7%), week 24 (84.2% vs 61.7% and 80.2% vs 53.0%), and week 48 (80.5% vs 55.4% and 76.3% vs 47.9%). Furthermore, guselkumab significantly improved patient-reported outcomes through week 48. Adverse event rates were comparable between treatments.LIMITATIONS: Analyses were limited to 48 weeks.CONCLUSIONS: Guselkumab demonstrated superior efficacy compared with adalimumab and was well tolerated in patients with psoriasis through 1 year.

U2 - 10.1016/j.jaad.2016.11.041

DO - 10.1016/j.jaad.2016.11.041

M3 - Article

C2 - 28057360

JO - Journal of the American Academy of Dermatology

JF - Journal of the American Academy of Dermatology

SN - 0190-9622

ER -