VOYAGE 1: Guselkumab yields encouraging outcomes in plaque psoriasis

At 100 weeks, more than 80% of patients with moderate to severe plaque psoriasis showed improvement after treatment with guselkumab, according to findings presented at the 26th European Academy of Dermatology and Venereology Congress.

The data were from the 2-year, open-label follow-up of the VOYAGE 1 trial. The cohort of patients treated with guselkumab (Tremfya, Janssen), an anti-interleukin-23 monoclonal antibody, included patients who had previously been treated with adalimumab (Humira, AbbVie).

Treatment response was measured using Psoriasis Area Severity Index (PASI) 90 and Investigator’s Global Assessment (IGA) 0/1 criteria. The follow-up duration was 100 weeks.

Results from week 100 showed that 82.4% of the cohort reached the IGA endpoint, while 82.1% achieved PASI 90. An IGA score of 0 occurred in 53.8% of the cohort, while 49% reached PASI 100. The researchers noted that these findings were consistent with outcomes reported in the 52-week study.

At 52 weeks, there was a 50.5% PASI 90 rate among patients treated with adalimumab. After being switched to guselkumab at week 52, 81.1% reached PASI 90 by week 100. Week 52 results also showed that 60.4% of patients treated with adalimumab reached IGA 0/1, but that after being switched to guselkumab, 84% reached IGA 0/1 by week 100.

Similar increases in PASI 90 and IGA 0/1 outcomes at week 52 and 100 occurred in patients treated with placebo initially and then switched to guselkumab.

PASI 100 was reached by 24% of patients at week 52 and 51.6% by week 100. For IGA 0, 27.3% achieved this endpoint at week 52 and 55.6% achieved it by week 100.

Patients treated with guselkumab for 100 weeks experienced consistent Psoriasis Symptoms and Signs Diary (PSSD) scores. Patients treated with adalimumab through week 48 demonstrated a 23.1% rate of PSSD scores of 0. After switching to guselkumab at 48 weeks, 41.8% of the cohort showed PSSD scores of 0 by week 100.

One-hundred week safety results showed that among patients treated continuously with guselkumab and those initially treated with placebo who then crossed over to the study drug, the adverse event rate was 220.30 per 100 patient-years of follow-up. In this same combined study group, serious adverse events occurred in 6.5 per 100 patient-years of follow-up, while infections occurred in 87.77 per 100 patient-years. These rates were consistent with those observed at 48 weeks.

“These data show the rates of skin clearance with guselkumab were consistent at weeks 52 and 100 with every 8-week maintenance therapy. These important new findings contribute to the scientific evidence for targeting [anti-interleukin]-23 in the treatment of moderate to severe plaque psoriasis,” said Chris Griffiths, MD, foundation professor of dermatology at the University of Manchester, U.K., and VOYAGE 1 study steering committee member. “Also noteworthy is that skin clearance rates in patients transitioned to guselkumab from adalimumab improved and the rates were consistent at weeks 52 and 100.” – by Rob Volansky

Reference:

Blauvelt A, et al. Two-year efficacy and safety of guselkumab for treatment of moderate-to-severe psoriasis: Phase 3 VOYAGE 1 trial. Presented at: European Academy of Dermatology and Venereology Annual Congress; September 13-17, 2017; Geneva.

Disclosure: Blauvelt reports serving as a scientific adviser and clinical study investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, Genentech, GSK, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Regeneron, Sandoz, Sanofi-Genzyme, Sun, UCB and Valeant; and as a paid speaker for Eli Lilly. Please see the study for all other authors' relevant financial disclosures.