REUTERS

Janssen Announces New Three-Year TREMFYA Data Demonstrates Stably Maintained Rates of Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis

Originally Published by Johnson & Johnson.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced 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.”

Latest News

Flint, Michigan water plant

Ex-Michigan Governor Charged for Racist Lead Poisoning of Flint Water Supply; COVID-19 Vaccines Not Increasing in Availability; Democrats Plan to Repeal Trump Rules; and More

Former Michigan Governor formally charged for poisoning thousands of predominantly Black Flint citizens with water containing lead. In 2014, when the city of Flint was forced by the state to begin taking its water supply from the Flint river rather than using water from nearby Detroit as it had for…

NYPD under suit

NYPD Sued for Years of Racial Abuse and Use of Excessive Force; Trump Administration Approves Discrimination Against LGBTQ individuals; and More

NYPD sued by Attorney General for years of racial abuse and use of excessive force. In what’s been called a “landmark lawsuit,” The New York Times has reported that New York state Attorney General Letitia James is suing the city of New York, the mayor and the NYPD’s leaders, alleging…

Toyota Research Institute and Stanford University’s Dynamic Design Lab Study How to Improve Automotive Safety

Originally published on pressroom.toyota.com. Inspired by the Skills of Professional Drift Drivers, Research Seeks to Combine the Technology of Vehicle Automation with Artificial Intelligence Algorithms What if every driver who ran into trouble had the instinctive reflexes of a professional race car driver and the calculated foresight of a supercomputer…

Tribal elder

Loss of Tribal Elders Due to COVID-19 Decimating Indigenous Populations; Colorado Revamps Common-Law Marriage Requirements, Making Them More Friendly for LGBTQ Couples; and More

Loss of tribal elders due to COVID-19 decimating Indigenous populations. The Muscogee, Navajo, Blackfeet Nation, White Mountain Apache and Choctaw tribes are among the many communities of Indigenous people suffering irreparable losses due to the COVID-19 pandemic, New York Times reporter Jack Healy has reported. Already impacted by infection rates…

Justice for George Floyd

Officer Who Pressed Knee Into George Floyd’s Neck to Stand Trial Alone; Judge Halts Federal Execution of Lisa Montgomery, Only Woman on Death Row

Officer who pressed knee into George Floyd’s neck to stand trial alone in March. Former Minneapolis police officer Derek Chauvin — the man who can be seen on video pressing his knee into George Floyd’s neck for an excruciating 8 minutes and 46 seconds — will now stand trial alone,…

BASF Starts Global Registration for New and Environmentally Friendly Insecticide Active Ingredient

Originally published on BASF.com. BASF ranked No. 14 on The 2020 DiversityInc Top 50 Companies for Diversity list. Regulatory dossiers for Axalion™insecticide submitted in Australia and Korea Active ingredient with novel mode of action and high compatibility with beneficial insects, including pollinators First sales for Axalion-based products expected by 2023…

TIAA’s Roger Ferguson on Solving the Student Debt Crisis

CEO Roger Ferguson shares how TIAA (No. 9 on 2020 DiversityInc Top 50 Companies for Diversity list) teamed up with loan wellness platform Savi to help nonprofit workers reduce monthly student debt payments and work toward forgiveness. Watch his full talk at the link below. https://www.tiaa.org/public/foward-focus-/episode-7-your-financial-future-the-path-forward