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

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

卷:82

Article

Reich, Kristian^1,2  Griffiths, Christopher E. M.³  Gordon, Kenneth B.⁴  Papp, Kim A.⁵  Song, Michael⁶  Randazzo, Bruce^6,7  Li, Shu⁶  Shen, Yaung-Kaung⁶  Han, Chenglong⁶  Kimball, Alexa B.⁸  Armstrong, April W.⁹  Foley, Peter^10,11  Blauvelt, Andrew¹² 

[1] Univ Med Ctr Hamburg Eppendorf, Translat Res Inflammatory Skin Dis, Inst Hlth Serv Res Dermatol & Nursing, Martinistr 52, D-20246 Hamburg, Germany

[2] Skinflammat Ctr, Hamburg, Germany

[3] Univ Manchester, Manchester NIHR Biomed Res Ctr, Dermatol Ctr, Salford Royal Hosp, Manchester, Lancs, England

[4] Med Coll Wisconsin, Milwaukee, WI 53226 USA

[5] K Papp Clin Res & Prob Res Inc, Waterloo, ON, Canada

[6] Janssen Res & Dev LLC, Spring House, PA USA

[7] Univ Penn, Sch Med, Dept Dermatol, Philadelphia, PA 19104 USA

[8] Harvard Med Sch, Dept Dermatol, Boston, MA 02115 USA

[9] Univ Southern Calif, Los Angeles, CA 90007 USA

[10] Univ Melbourne, St Vincents Hosp Melbourne, Carlton, Vic, Australia

[11] Skin & Canc Fdn Inc, Prob Med Res, Carlton, Vic, Australia

[12] Oregon Med Res Ctr, Portland, OR USA

关键词: adalimumab;    efficacy;    guselkumab;    long-term;    psoriasis;    safety;    VOYAGE 1;    VOYAGE 2;   

DOI  :  10.1016/j.jaad.2019.11.040

来源: Elsevier

【 摘 要 】

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.

【 授权许可】

Free