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
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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. / 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, Vol. 82, No. 4, 04.2020, p. 936-945.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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 -