Faculty Collaboration Database

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

Date

12/07/2019

Pubmed ID

31809827

DOI

10.1016/j.jaad.2019.11.040

Scopus ID

2-s2.0-85078983517 (requires institutional sign-in at Scopus site)   69 Citations

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.

Author List

Reich K, Griffiths CEM, Gordon KB, Papp KA, Song M, Randazzo B, Li S, Shen YK, Han C, Kimball AB, Armstrong AW, Foley P, Blauvelt A

Author

Kenneth Brian Gordon MD Chair, Professor in the Dermatology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adalimumab
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
Cross-Over Studies
Double-Blind Method
Female
Follow-Up Studies
Humans
Interleukin-23 Subunit p19
Male
Middle Aged
Patient Reported Outcome Measures
Placebos
Psoriasis
Severity of Illness Index
Treatment Outcome
Young Adult