Guselkumab 2-Year Data Shows Positive Results for Plaque Psoriasis Patients

New longer-term data from the open-label extension of the VOYAGE 1 guselkumab (Tremfya) trial demonstrates consistent rates of skin clearance among patients with moderate to severe plaque psoriasis, presented by Janseen Research and Development.

The data shows consistent skin clearance rates with Tremfya through week 100 among patients with moderate to severe plaque psoriasis receiving the subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody.

“These data show the rates of skin clearance with guselkumab were consistent at weeks 52 and 100 with every 8-week maintenance therapy,” said Chris Griffiths, found professor of dermatology, University of Manchester, VOYAGE 1 study steering committee member. “These important new findings contribute to the scientific evidence for targeting IL-23 in the treatment of moderate to severe plaque psoriasis.”

The phase 3, randomized, double-blind, placebo and active comparator-controlled trial was designed to evaluate the efficacy and safety of Tremfya compared with the placebo and adalimumab (Humira) in adults with moderate to severe plaque psoriasis.

Patients were randomized to receive the placebo at baseline, weeks 4 and 12, followed by crossover to Tremfya at weeks 16 and 20, followed by every 8-week dosing (q8w); Tremfya 100 mg at baseline, weeks 4 and 12, followed by q8w; or adalimumab 80 mg at baseline and 40 mg at week 1, followed by every 2-week dosing through week 47 with crossover to Tremfya q8w at week 52.

The longer-term findings from the phase 3 VOYAGE 1 study were presented at the 26th European Academy of Dermatology and Venerology (EADV) Congress. Results showed that more than 80% of patients receiving Tremfya, including those initially treated with a placebo or the anti-tumor necrosis factor (TNF)-alpha agent Humira, achieved at least 90% improvement in the Psoriasis Area Severity Index (PASI 90) or near complete skin clearance, and an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 100.

Results from the open-label extension of the study showed that at week 100, 82.4% of patients initially randomized to Tremfya achieved an IGA score of 0/1 (cleared of minimal disease) and 82.1% achieved a PASI 90 score, near skin clearance.

Additionally, at week 100, 53.8% achieved an IGA score of 0 and 49% achieved a PASI 100 score.

Measures represent skin completely cleared of plaques, consistent with PASI 100 and IGA 0 results demonstrated at week 52.

Among patients initially randomized to receive Humira and transitioned to Tremfya at week 52, the proportion of patients achieving a PASI 90 score increased from 50.5% at week 52 to 81.1% at week 100. The proportion of patients who achieved PASI 100 and IGA 0 scores increased from 24% and 27.3% at week 52 to 51.6% and 55.6% at week 100.

Results among patients initially randomized to placebo and crossed over to Tremfya at weeks 16 and 20 demonstrated consistent levels of skin clearance at weeks 52 and 100.

Over the 2-year Tremfya treatment period, scores from the Psoriasis Symptoms and Signs Diary (PSSD) were consistent.

In VOYAGE 1, patients initially randomized to receive Humira and crossed over to Tremfya demonstrated substantial improvement in PSSD scores from week 48 to week 100. The proportion of patients reporting PSSD symptom scores of 0 improved from 23.1% at week 48, during Humira treatment, to 41.8% percent at week 100 during Tremfya treatment.

Adverse effects, serious adverse effects and infections per 100 patient-years of follow-up through week 100 among the placebo crossover to Tremfya group and the initial Tremfya group combined were 220.30, 6.5 and 87.77 — consistent with those through week 48, 282.12, 5.84 and 110.97.

No cases of tuberculosis, opportunistic infections or serious hypersensitivity reactions were reported.

Findings follow the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of Tremfya, and the U.S. Food and Drug Administration (FDA) approval of Tremfya in July.

VOYAGE 1 is part of a comprehensive Tremfya phase 3 clinical development program along with 2 additional phase 3 trials: VOYAGE 2 and NAVIGATE.

A press release was made available.