Study for Janssen Pharmaceuticals’ Severe Plaque Psoriasis Treatment Provides Optimization Insight

On September 8, Janssen Pharmaceutical Companies announced new data from their ongoing Phase 3b GUIDE study of TREMFYA (guselkumab). The goal of the study was the evaluation of whether the severe plaque psoriasis treatment could maintain control of the disease. The study met its 68-week primary endpoint.

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TREMFYA’s Interaction with Severe Plaque Psoriasis

Severe plaque psoriasis (Pso) is the most common kind of psoriasis, a disease responsible for itchy rashes. Without a cure, the chronic condition causes the appearance of dry, itchy, raised skin patches (plaques) covered with scales. Pso appears on the elbows, knees, lower back, and scalp. Around 125 million people worldwide live with Pso.

An issue with a patient’s immune system is the current theory of the disease’s cause. Doctors believe that some genetic disposition causes skin cells’ overactive growth. 

Though there is no cure for Pso, treatments for managing symptoms are available. One example is Cosentyx (secukinumab). Developed by Novartis, Cosentyx selectively inhibits the interaction between 17A (IL-17A) cytokine and its receptor. This cytokine in the immune system is responsible for inflammatory response, thereby lessening Pso’s effects.

Janssen’s TREMFYA functions similarly, although it inhibits the interaction between interleukin (IL)-23 and its receptor. However, the lessening of the body’s inflammatory response is much the same. 

Although having already gained United States Food and Drug Administration (FDA) approval, as well as others worldwide, a Phase 3 study evaluated further therapeutic strategies for TREMFYA.

Phase 3b Study Further Emphasizes Effectiveness. 

GUIDE is a Phase 3b study aimed at determining whether super responders (SRs) receiving TREMFYA maintained disease control until week 68 with 16-week dosing intervals. Conducted alongside two trials testing the treatment’s efficacy and safety, VOYAGE 1 and 2, GUIDE achieved its primary endpoint.

The 16-week dosing interval demonstrated a disease control rate of 92.6% as compared to the approved 8-week interval’s 91.9% rate. 

On the results, Kilian Eyerich, M.D., Professor and Medical Director, Department of Dermatology, Medical Center – University of Freiburg in Breisgau, Germany, said, “These new results suggest patients who receive treatment soon after disease onset may see higher rates of psoriasis clearance and in the future we hope that dosing-interval flexibility could be a consideration that would allow this patient population to have a therapy strategy tailored to them.”

The data found by the clinical trial provides insight to researchers on how to best optimize severe plaque psoriasis treatment in the future. 

Author

Max Heirich