At the three-year mark, patients receiving TREMFYA® in clinical studies continue to show stably maintained PASI 90 and IGA 0/1 responses

LAS VEGAS, NV, USA I October 19, 2018 I The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new long-term data from the open-label period of the VOYAGE 1 clinical trial demonstrating that stably maintained rates of skin clearance with TREMFYA® treatment achieved from week 52 (1 year) were maintained through week 156 (3 years) among adult patients with moderate to severe plaque psoriasis. TREMFYA® is the first anti-interleukin (IL)-23 monoclonal antibody that was approved by the U.S. Food and Drug Administration (FDA) and is administered by subcutaneous injection. The findings, presented at the 37th Fall Clinical Dermatology Conference in Las Vegas, Nevada, showed nearly 83 percent of patients receiving TREMFYA® in the Phase 3 VOYAGE 1 study maintained at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90) response (near complete skin clearance), and an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 156.

“These findings are impressive as they demonstrate consistency in high rates of skin clearance with guselkumab treatment at weeks 48, 100 and 156 with every eight-week maintenance therapy,” said Andrew Blauvelt, M.D., MBA, President, Oregon Medical Research Center, and VOYAGE 1 study steering committee member.* “In the management of moderate to severe plaque psoriasis, including symptom relief as well as skin clearance, it is essential that we continue to evaluate the impact of treatments with long-term data like those presented today. The VOYAGE 1 findings help further our understanding of the long-term impact of targeting IL-23 with guselkumab in the treatment of plaque psoriasis.”

Results from the open-label extension of the VOYAGE 1 Phase 3 clinical study showed that at week 156, in the combined group of patients initially randomized to TREMFYA® or to placebo with crossover to TREMFYA® at week 16, 82.1 percent achieved an IGA score of 0/1 (cleared or minimal disease), 96.4 percent achieved a PASI 75 score, and 82.8 percent achieved a PASI 90 score.

At week 156, 53.1 percent of patients achieved an IGA score of 0 and 50.8 percent of patients achieved a PASI 100 response. These measures represent skin completely cleared of psoriasis plaques and are consistent with PASI 100 and IGA 0 results demonstrated at week 100.

Responses based on the Psoriasis Symptoms and Signs Diary (PSSD) were consistent at week 100 and week 156 as well. This tool evaluates patient-reported symptoms (i.e., itch, pain, stinging, burning and skin tightness) and signs (i.e., skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding). The percentage of patients reporting a PSSD symptom score of 0 was 40.2 at week 100 and 40.4 at week 156.

Of the 494 patients in the combined TREMFYA® and placebo crossover to TREMFYA® group, the percentages of patients reporting adverse events (AEs), serious AEs, infections, and serious infections through week 48 were 70.9 percent, 4.3 percent, 50.2 percent and 0.6 percent, respectively, and through week 100 were 80.0 percent, 9.1 percent, 61.1 percent and 1.2 percent, respectively. Among the same patient group, the percentages of events reported through week 156 were 86.2 percent, 13.4 percent, 67.8 percent and 2.2 percent respectively. No cases of active tuberculosis, opportunistic infections or serious hypersensitivity reactions were reported among TREMFYA-treated subjects.

“We are very pleased and excited by these results. The data adds to the growing body of safety and efficacy evidence with the use of TREMFYA over a three-year period,” said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. “As a part of our commitment to developing innovative therapies for chronic, immune-mediated disease like psoriasis, we have been focusing on generating long-term data so that patients and physicians can be more informed when making treatment decisions.”

About VOYAGE 1
This Phase 3, randomized, double-blind, placebo and active comparator-controlled trial was designed to evaluate the efficacy and safety of TREMFYA® compared with placebo and adalimumab in adults with moderate to severe plaque psoriasis.  Patients (n=837) were randomized to receive placebo at weeks 0, 4 and 12, followed by crossover to TREMFYA® at weeks 16 and 20 followed by every eight-week (q8w) dosing; TREMFYA® 100 mg at weeks 0, 4 and 12, followed by q8w dosing; or adalimumab 80 mg at week 0 and 40 mg at week 1, followed by every two-week dosing through week 47, with crossover to TREMFYA® q8w at week 52.

The co-primary endpoints of the study were the proportions of patients receiving TREMFYA® versus patients receiving placebo achieving IGA 0/1 (cleared/minimal disease) [73% vs 3% P<0.001 vs placebo] and PASI 90 [85% vs 7% P<0.001 vs placebo] responses at week 16.  Secondary endpoints were assessed at weeks 16, 24 and 48, with safety monitoring throughout the study. The open-label extension period started at week 52 and is currently ongoing.  Results presented to date include findings through week 156 of the study.  Through week 48, non-responder imputation rules were used for missing data while after week 48, no missing data were imputed after the application of treatment failure rules. 

VOYAGE 1 is part of a comprehensive TREMFYA® Phase 3 clinical development program that includes two additional Phase 3 trials, VOYAGE 2 and NAVIGATE

About TREMFYA® (guselkumab)
TREMFYA® is a human monoclonal antibody developed by Janssen that selectively blocks the protein interleukin (IL)-23 and is approved in the U.S., Canada, European Union, Japan and a number of other countries worldwide for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). Ongoing trials include: Phase 3 program evaluating TREMFYA in the treatment of active psoriatic arthritis, Phase 3 study evaluating the efficacy of TREMFYA compared with Cosentyx® (secukinumab) in the treatment of moderate to severe plaque psoriasis, and a Phase 3 program in Crohn’s disease.

About Psoriasis
Psoriasis is a chronic, inflammatory autoimmune disorder that results in the overproduction of skin cells, characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain. It is estimated that as many as 125 million people worldwide have psoriasis, including more than 8 million Americans and 14 million Europeans.1-7 The disease symptoms can range from mild, to moderate, to severe and disabling. It is estimated that nearly three percent of the world’s population is living with psoriasis.5

About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal  and www.twitter.com/JanssenUS. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

  1. National Psoriasis Foundation. People of All Races Overcome Psoriatic Disease. https://www.psoriasis.org/advance/features/people-of-all-races-overcome-the-challenge-of-psoriatic-diseases. Accessed January 30, 2018.
  2. National Psoriasis Foundation. Psoriasis Fact Sheet. https://www.psoriasis.org/sites/default/files/psoriasis_fact_sheet.pdf. Accessed January 30, 2018.
  3. National Psoriasis Foundation. Advocacy Toolkit. https://www.psoriasis.org/toolkit/the-burden-of-psoriatic-diseases. Accessed January 30, 2018.
  4. Augustin M, et al. Prevalence of skin lesions and need for treatment in a cohort of 90 880 workers. Br J Dermatol 2011;165:865–873.
  5. Healthline. Psoriasis by the Numbers: Facts, Statistics, and You. https://www.healthline.com/health/psoriasis/facts-statistics-infographic#prevalence. Accessed January 30, 2018.
  6. Parisi R, et al. Global Epidemiology of Psoriasis: A Systematic Review. J Invest Dermatol 2013;133:377–385.
  7. World Population statistics. Population of Europe 2014. http://www.worldpopulationstatistics.com/population-of-europe-2014. Accessed January 30, 2018.

SOURCE: Janssen