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Maintenance of clinical response and consistent safety profile with up to 3 years of continuous treatment with guselkumab: Results from the VOYAGE 1 and VOYAGE 2 trials

Standard

Maintenance of clinical response and consistent safety profile with up to 3 years of continuous treatment with guselkumab: Results from the VOYAGE 1 and VOYAGE 2 trials. / Reich, Kristian; Griffiths, Christopher E M; Gordon, Kenneth B; Papp, Kim A; Song, Michael; Randazzo, Bruce; Li, Shu; Shen, Yaung-Kaung; Han, Chenglong; Kimball, Alexa B; Armstrong, April W; Foley, Peter; Blauvelt, Andrew.

in: J AM ACAD DERMATOL, Jahrgang 82, Nr. 4, 04.2020, S. 936-945.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Reich, K, Griffiths, CEM, Gordon, KB, Papp, KA, Song, M, Randazzo, B, Li, S, Shen, Y-K, Han, C, Kimball, AB, Armstrong, AW, Foley, P & Blauvelt, A 2020, 'Maintenance of clinical response and consistent safety profile with up to 3 years of continuous treatment with guselkumab: Results from the VOYAGE 1 and VOYAGE 2 trials', J AM ACAD DERMATOL, Jg. 82, Nr. 4, S. 936-945. https://doi.org/10.1016/j.jaad.2019.11.040

APA

Reich, K., Griffiths, C. E. M., Gordon, K. B., Papp, K. A., Song, M., Randazzo, B., Li, S., Shen, Y-K., Han, C., Kimball, A. B., Armstrong, A. W., Foley, P., & Blauvelt, A. (2020). Maintenance of clinical response and consistent safety profile with up to 3 years of continuous treatment with guselkumab: Results from the VOYAGE 1 and VOYAGE 2 trials. J AM ACAD DERMATOL, 82(4), 936-945. https://doi.org/10.1016/j.jaad.2019.11.040

Vancouver

Reich K, Griffiths CEM, Gordon KB, Papp KA, Song M, Randazzo B et al. Maintenance of clinical response and consistent safety profile with up to 3 years of continuous treatment with guselkumab: Results from the VOYAGE 1 and VOYAGE 2 trials. J AM ACAD DERMATOL. 2020 Apr;82(4):936-945. https://doi.org/10.1016/j.jaad.2019.11.040

Bibtex

@article{64119894711e4a828ec92e3271d166d7,
title = "Maintenance of clinical response and consistent safety profile with up to 3 years of continuous treatment with guselkumab: Results from the VOYAGE 1 and VOYAGE 2 trials",
abstract = "BACKGROUND: Long-term maintenance treatment is required for patients with psoriasis.OBJECTIVES: To evaluate the efficacy and safety of guselkumab in patients with moderate to severe psoriasis through 3 years of treatment.METHODS: In 2 ongoing, phase 3 trials of guselkumab (VOYAGE 1 and VOYAGE 2), the proportions of patients achieving at least 90% and 100% improvement in the Psoriasis Area and Severity Index (PASI 90 and PASI 100, respectively) and Investigator's Global Assessment (IGA) scores of 0/1 and 0 were summarized for the guselkumab group (including placebo-to-guselkumab crossover). Patients who met treatment failure rules were considered nonresponders. Safety outcomes (rates/100 patient-years [PY]) were evaluated based on data pooled across studies through week 156.RESULTS: Three-year response rates for the guselkumab group in VOYAGE 1 and VOYAGE 2, respectively, were 82.8% and 77.2% for PASI 90, 50.8% and 48.8% for PASI 100, 82.1% and 83.0% for IGA score of 0/1, and 53.1% and 52.9% for IGA score of 0. Safety event rates across studies occurred through week 156 as follows: serious adverse events, 5.68/100 PY; serious infections, 1.15/100 PY; nonmelanoma skin cancers, 0.28/100 PY; malignancies other than nonmelanoma skin cancer, 0.47/100 PY; and major adverse cardiovascular events, 0.28/100 PY. Week 156 and week 100 rates were consistent.LIMITATIONS: There was no comparator arm beyond 1 year.CONCLUSIONS: Guselkumab shows durable efficacy and a consistent safety profile in patients with moderate to severe psoriasis treated for up to 3 years.",
keywords = "Adalimumab/administration & dosage, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized/administration & dosage, Cross-Over Studies, Double-Blind Method, Female, Follow-Up Studies, Humans, Interleukin-23 Subunit p19/antagonists & inhibitors, Male, Middle Aged, Patient Reported Outcome Measures, Placebos/administration & dosage, Psoriasis/diagnosis, Severity of Illness Index, Treatment Outcome, Young Adult",
author = "Kristian Reich and Griffiths, {Christopher E M} and Gordon, {Kenneth B} and Papp, {Kim A} and Michael Song and Bruce Randazzo and Shu Li and Yaung-Kaung Shen and Chenglong Han and Kimball, {Alexa B} and Armstrong, {April W} and Peter Foley and Andrew Blauvelt",
note = "Copyright {\textcopyright} 2019 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.",
year = "2020",
month = apr,
doi = "10.1016/j.jaad.2019.11.040",
language = "English",
volume = "82",
pages = "936--945",
journal = "J AM ACAD DERMATOL",
issn = "0190-9622",
publisher = "Mosby Inc.",
number = "4",

}

RIS

TY - JOUR

T1 - Maintenance of clinical response and consistent safety profile with up to 3 years of continuous treatment with guselkumab: Results from the VOYAGE 1 and VOYAGE 2 trials

AU - Reich, Kristian

AU - Griffiths, Christopher E M

AU - Gordon, Kenneth B

AU - Papp, Kim A

AU - Song, Michael

AU - Randazzo, Bruce

AU - Li, Shu

AU - Shen, Yaung-Kaung

AU - Han, Chenglong

AU - Kimball, Alexa B

AU - Armstrong, April W

AU - Foley, Peter

AU - Blauvelt, Andrew

N1 - Copyright © 2019 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

PY - 2020/4

Y1 - 2020/4

N2 - BACKGROUND: Long-term maintenance treatment is required for patients with psoriasis.OBJECTIVES: To evaluate the efficacy and safety of guselkumab in patients with moderate to severe psoriasis through 3 years of treatment.METHODS: In 2 ongoing, phase 3 trials of guselkumab (VOYAGE 1 and VOYAGE 2), the proportions of patients achieving at least 90% and 100% improvement in the Psoriasis Area and Severity Index (PASI 90 and PASI 100, respectively) and Investigator's Global Assessment (IGA) scores of 0/1 and 0 were summarized for the guselkumab group (including placebo-to-guselkumab crossover). Patients who met treatment failure rules were considered nonresponders. Safety outcomes (rates/100 patient-years [PY]) were evaluated based on data pooled across studies through week 156.RESULTS: Three-year response rates for the guselkumab group in VOYAGE 1 and VOYAGE 2, respectively, were 82.8% and 77.2% for PASI 90, 50.8% and 48.8% for PASI 100, 82.1% and 83.0% for IGA score of 0/1, and 53.1% and 52.9% for IGA score of 0. Safety event rates across studies occurred through week 156 as follows: serious adverse events, 5.68/100 PY; serious infections, 1.15/100 PY; nonmelanoma skin cancers, 0.28/100 PY; malignancies other than nonmelanoma skin cancer, 0.47/100 PY; and major adverse cardiovascular events, 0.28/100 PY. Week 156 and week 100 rates were consistent.LIMITATIONS: There was no comparator arm beyond 1 year.CONCLUSIONS: Guselkumab shows durable efficacy and a consistent safety profile in patients with moderate to severe psoriasis treated for up to 3 years.

AB - BACKGROUND: Long-term maintenance treatment is required for patients with psoriasis.OBJECTIVES: To evaluate the efficacy and safety of guselkumab in patients with moderate to severe psoriasis through 3 years of treatment.METHODS: In 2 ongoing, phase 3 trials of guselkumab (VOYAGE 1 and VOYAGE 2), the proportions of patients achieving at least 90% and 100% improvement in the Psoriasis Area and Severity Index (PASI 90 and PASI 100, respectively) and Investigator's Global Assessment (IGA) scores of 0/1 and 0 were summarized for the guselkumab group (including placebo-to-guselkumab crossover). Patients who met treatment failure rules were considered nonresponders. Safety outcomes (rates/100 patient-years [PY]) were evaluated based on data pooled across studies through week 156.RESULTS: Three-year response rates for the guselkumab group in VOYAGE 1 and VOYAGE 2, respectively, were 82.8% and 77.2% for PASI 90, 50.8% and 48.8% for PASI 100, 82.1% and 83.0% for IGA score of 0/1, and 53.1% and 52.9% for IGA score of 0. Safety event rates across studies occurred through week 156 as follows: serious adverse events, 5.68/100 PY; serious infections, 1.15/100 PY; nonmelanoma skin cancers, 0.28/100 PY; malignancies other than nonmelanoma skin cancer, 0.47/100 PY; and major adverse cardiovascular events, 0.28/100 PY. Week 156 and week 100 rates were consistent.LIMITATIONS: There was no comparator arm beyond 1 year.CONCLUSIONS: Guselkumab shows durable efficacy and a consistent safety profile in patients with moderate to severe psoriasis treated for up to 3 years.

KW - Adalimumab/administration & dosage

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Antibodies, Monoclonal, Humanized/administration & dosage

KW - Cross-Over Studies

KW - Double-Blind Method

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Interleukin-23 Subunit p19/antagonists & inhibitors

KW - Male

KW - Middle Aged

KW - Patient Reported Outcome Measures

KW - Placebos/administration & dosage

KW - Psoriasis/diagnosis

KW - Severity of Illness Index

KW - Treatment Outcome

KW - Young Adult

U2 - 10.1016/j.jaad.2019.11.040

DO - 10.1016/j.jaad.2019.11.040

M3 - SCORING: Journal article

C2 - 31809827

VL - 82

SP - 936

EP - 945

JO - J AM ACAD DERMATOL

JF - J AM ACAD DERMATOL

SN - 0190-9622

IS - 4

ER -