FDA Approves Self-Injection Guselkumab for Plaque Psoriasis

The US Food and Drug Administration (FDA) has approved single-dose, patient-controlled guselkumab injector (TREMFYA) for the treatment of adults with moderate to severe plaque psoriasis.

The approval makes the Janssen Pharmaceutical therapy the first of its kind marketed with the One-Press injector—a device designed to fit comfortably in the patient’s hand and hide the needle through administration.

Guselkumab was approved as a 100 mg subcutaneous injection administered once every 8 weeks, following starter doses at weeks 0 and 4. It is intended for physician-supervised use, until the care provider approves the patient for self-injection.

The FDA had approved guselkumab with the clinical evidence of a phase 3, multi-center, randomized trial (ORION), in which patient experience was evaluated at weeks 0, 4, and 12. The Self-Injection Assessment Questionnaire (SIAQ) gauged patient experience across 6 topics:

• Feelings about injections
• Self-image
• Self-confidence
• Pain
• Skin reactions

Patients’ scores were reported on scales of 0-10, with greater numbers indicating greater positive experience. Mean patient score for satisfaction with self-injection was 9.18, and mean score for ease of use was 9.24.

The other aspect of the ORION trial assessed the efficacy and safety of guselkumab administered via One-Press in patients with moderate to severe plaque psoriasis. In the double-blind, placebo-controlled study, a greater rate of treated patients an Investigator’s Global Assessment (IGA) score of 0 or 1, or a Psoriasis Area & Severity Index (PASI) 90 response at week 16 (81% and 76%, respectively) than the placebo group (0% for both endpoints). Additionally, the rate of patients who reached an IGA score 0 at week 16 was greater in the treated patient group than placebo group (56% vs 0%).

Another 50% of guselkumab-treated patients achieved a PASI 100 response at week 16, compared to none of the placebo patients. Injection-site reaction symptoms associated with the One-Press device were considered mostly mild and transient in nature.

Laura Ferris, MD, PhD, an associate professor in the Department of Dermatology, University of Pittsburgh Medical Center, expressed excitement for the latter finding, and for the implication of the therapy’s approval.

“The results of the ORION study showed the administration of TREMFYA with One-Press was safe and effective, providing patients with a new, more convenient way to inject their treatment," Ferris said in a statement regarding the approval.

The One-Press device’s role in the therapy administration was highlighted by Newman Yeilding, MD, head of Immunology Development at Janssen Research & Development.

"Patients living with plaque psoriasis often struggle with a conventional syringe when administering treatment," Yeilding said. "With the approval of One-Press, patients now have the option to self-administer TREMFYA with a novel device that is both simple and intuitive to use."