Tremfya (Guselkumab) Demonstrates Sustained High Efficacy and Consistent Safety Over Nearly 5 Years in Adults with Moderate to Severe Plaque Psoriasis; Now Available in China

October 16, 2020 /Bio ValleyBIOON/ -- Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced new open-label extension data from the Phase 3 VOYAGE 1 study evaluating Tremfya® (tremfya®, generic name: guselkumab) in adult patients with moderate-to-severe disease. The results demonstrated high rates of skin clearance, with no new safety signals identified over nearly five years of treatment. Notably, this is the first clinical study to evaluate an IL-23 inhibitor and demonstrate its efficacy and safety over a period of nearly five years.

At Week 252, in the combined Tremfya treatment group (patients initially randomized to Tremfya and those initially assigned to placebo who crossed over to Tremfya at Week 16), 84% of patients achieved PASI 90 response (≥90% improvement from baseline in the Psoriasis Area and Severity Index [PASI] score), and 82.4% achieved an Investigator’s Global Assessment (IGA) score of 0 or 1 (IGA 0/1: clear or almost clear skin). No new safety signals were observed during the 264-week study period.

Tremfya is the first fully human monoclonal antibody approved to selectively bind to the p19 subunit of interleukin-23 (IL-23), inhibiting its interaction with the IL-23 receptor, disrupting IL-23-mediated signaling, activation, and cytokine cascades, thereby suppressing IL-23 biological activity. IL-23 is a cytokine that plays a key role in plaque psoriasis. Currently, Tremfya has been approved in multiple countries for the treatment of moderate-to-severe plaque psoriasis. In China, Tremfya was approved by the National Medical Products Administration in December 2019 for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Dr. Chris Griffiths, from the Dermatology Centre at the University of Manchester in the United Kingdom, stated, “Patients with psoriasis face lifelong struggles due to this complex and disabling chronic disease. The data on Tremfya from the VOYAGE 1 study are the first to demonstrate that an IL-23 p19 inhibitor achieves skin clearance in the majority of patients over nearly five years of treatment, which is highly encouraging for both patients and physicians seeking long-term treatment options.”

VOYAGE 1 was a randomized, double-blind, placebo- and active-controlled Phase 3 trial that enrolled a total of 837 adult patients with moderate-to-severe plaque psoriasis.In the study, a total of 494 patients were randomized at Week 0 to either the Tremfya group (n=329) or the placebo group with crossover to Tremfya treatment at Week 16 (n=165); among them, 76.9% (380/494) continued Tremfya treatment through Week 252.

Safety findings were generally consistent with previously observed results and the current Summary of Product Characteristics. At the end of the safety assessment (264 weeks), the proportions of patients reporting at least one adverse event (AE), serious adverse event (SAE), or discontinuation due to an AE were 87.7%, 16.4%, and 6.1%, respectively, across all patients (n=774), the pooled Tremfya group (n=494), and the group initially treated with adalimumab (n=280). During the controlled period of the clinical studies, very common (≥10%) and common (≥1%) adverse events associated with Tremfya included upper respiratory tract infection, gastroenteritis, herpes simplex infection, tinea cruris infection, headache, diarrhea, urticaria, arthralgia, and injection site reactions. Uncommon adverse events (≥0.1%) included hypersensitivity, allergy, and rash.

Vice President, Janssen Research & Development,ImmunologyDr. Lloyd Miller, Therapeutic Area Leader, stated, “We are pleased to share these data, demonstrating Tremfya’s ability to help adult patients with moderate-to-severe plaque psoriasis achieve sustained clearance for nearly five years in the majority of patients. With remission as our ultimate goal, we remain committed to continuing to apply the best science and disease insights to improve therapies that enhance patients’ lives.”(Bioon.com)

Original Source: New First-in-Class Phase 3 Data Demonstrate TREMFYA (guselkumab) Maintained Skin Clearance Rates Through Nearly 5 Years of Continuous Use in Adult Patients with Moderate to Severe Plaque Psoriasis