Janssen Announces Significant Data from First Phase 3 of Guselkumab in Plaque Psoriasis (JNJ)

October 3, 2016 6:37 AM EDT

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Janssen Research & Development, LLC (Janssen) announced findings from the first of three pivotal Phase 3 studies evaluating guselkumab, a subcutaneously administered anti-interleukin (IL)-23 monoclonal antibody in late-stage development for the treatment of adults with moderate to severe plaque psoriasis. Data from the VOYAGE 1 trial showed significantly higher proportions of patients receiving guselkumab achieved cleared/minimal disease compared with patients receiving placebo, as defined by at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90, near complete skin clearance) and an Investigator's Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 16, the study co-primary endpoints. The VOYAGE 1 trial also included an active comparator arm evaluating guselkumab versus Humira® (adalimumab), and showed the superiority of guselkumab across major study endpoints and through 48 weeks of treatment. These data were presented for the first time at the 25th European Academy of Dermatology and Venereology (EADV) Congress and mark the first-ever results from a head-to-head study of an IL-23–targeted biologic therapy (guselkumab) compared with an anti-TNF-alpha treatment (adalimumab).

"Results from the VOYAGE 1 study showed high rates of skin clearance among patients with moderate to severe plaque psoriasis receiving guselkumab, and these responses were durable and maintained through week 48," said Andrew Blauvelt, M.D., M.B.A., President of the Oregon Medical Research Center and lead study investigator.* "Guselkumab also showed superior efficacy compared with adalimumab, with a separation in responses that was evident at week 16 and continued through the duration of the trial."

In the VOYAGE 1 study, the co-primary endpoints were met at week 16, with 85.1 percent of patients receiving guselkumab 100 mg at weeks 0 and 4 and then every eight weeks achieving cleared (IGA 0) or minimal disease (IGA 1) compared with 6.9 percent of patients receiving placebo (P < 0.001). Nearly three-quarters of patients receiving guselkumab (73.3 percent) achieved a PASI 90 response, or near complete skin clearance, compared with 2.9 percent of patients receiving placebo (P < 0.001).

All major secondary endpoints in VOYAGE 1 achieved statistical significance in comparisons of guselkumab versus adalimumab administered subcutaneously at weeks 0 (80 mg), 1 (40 mg) and then 40 mg every other week (P < 0.001 for all measures). At week 16, following three injections of guselkumab and ten injections of adalimumab, significantly higher proportions of patients receiving guselkumab achieved IGA 0/1 and PASI 90 (85.1 percent and 73.3 percent, respectively) compared with patients receiving adalimumab (65.9 percent and 49.7 percent, respectively). At week 24, the proportion of patients who achieved a PASI 90 response was significantly higher in the guselkumab group compared with the adalimumab group (80.2 percent vs. 53.0 percent, respectively). Higher levels of skin clearance among the guselkumab group continued through weeks 24 and 48, with significantly more patients receiving guselkumab achieving IGA 0/1 and PASI 90, as well as measures of full skin clearance, as indicated by a 100 percent improvement in PASI score (PASI 100) or an IGA score of 0, compared with adalimumab.

"The high and durable rates of response in skin clearance were associated with significant improvements in quality of life among patients treated with guselkumab," said Professor Chris Griffiths, Foundation Professor of Dermatology at the University of Manchester and steering committee member.* "Results from the VOYAGE 1 study show the promise of guselkumab, an IL-23 inhibitor, as a future therapeutic for plaque psoriasis, an immune-mediated disease."

The Dermatology Life Quality Index (DLQI) assessed the impact of disease and disease improvement following therapy on study participants' quality of life. At week 24, a score of 0/1, indicating no impact of psoriasis on health-related quality of life, was achieved by 60.9 percent of patients receiving guselkumab compared with 39.5 percent of patients receiving adalimumab. Guselkumab-treated patients also showed substantial improvement at week 48 with 62.5 percent scoring a DLQI of 0/1 compared with 38.9 percent of adalimumab-treated patients.

Through week 16 of the study, the placebo-controlled period, similar proportions of patients receiving placebo (49.4 percent), guselkumab (51.7 percent) and adalimumab (51.1 percent) reported at least one adverse event (AE). Serious AEs were reported in 1.7 percent of patients receiving placebo, 2.4 percent of patients receiving guselkumab and 1.8 percent of patients receiving adalimumab. Through week 48 of the study, the proportions of patients reporting at least one AE were comparable between guselkumab (73.9 percent) and adalimumab (74.5 percent); the proportions of patients reporting serious AEs were also similar for guselkumab (4.9 percent) and adalimumab (4.5 percent). Serious infections occurred in two patients receiving guselkumab and three patients receiving adalimumab. Through week 48, there was one myocardial infarction in each of the guselkumab and adalimumab treatment groups, and two solid malignancies (one prostate and one breast cancer) were reported in patients receiving guselkumab.

"We are committed to translating scientific progress into medicines for immune diseases like psoriasis where patients are (still) waiting for improved outcomes and treatment experiences," said Newman Yielding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "The results from the Phase 3 VOYAGE 1 study show marked differences in outcomes with guselkumab therapy through week 48 compared with placebo and adalimumab in the treatment of moderate to severe plaque psoriasis. We look forward to future data from the ongoing Phase 3 studies to further characterize the longer term efficacy and safety of this novel anti-IL-23 monoclonal antibody."



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