The Food and Drug Administration (FDA) has approved Tremfya (guselkumab; Janssen) One-Press, a single-dose patient-controlled injector for the treatment of moderate-to-severe plaque psoriasis in adults.

Tremfya is administered by subcutaneous injection. Following physician approval and proper training, patients may use Tremfya One-Press, which provides a single dose of guselkumab 100mg, to self-inject the medication.

The approval of the patient-controlled injector was based on data from the ORION study (N=78) that evaluated the efficacy, safety, and pharmacokinetics of Tremfya administered with the One-Press injector. The co-primary endpoints were the proportion of patients who achieved an Investigator’s Global Assessment (IGA) score of 0/1 and the proportion of patients who achieved a Psoriasis Area and Severity Index (PASI) 90 response at Week 16.

Results showed that at week 16, a greater proportion of patients in the guselkumab group achieved an IGA score of 0 or 1 (81%) or a PASI 90 response (76%) vs the placebo group (0% for both). In addition, the proportion of patients who achieved an IGA score of 0 at week 16 was higher in the guselkumab group compared with the placebo group (56% vs 0%).

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With regard to injection-site reactions, the Company reports that symptoms with One-Press were mild and transient in nature. Moreover, results of a Self-Injection Assessment Questionnaire showed mean scores of 9.18 for “Satisfaction with Self Injection” (10 indicating “Very Satisfied”) and 9.24 for “Ease of Use” (10 indicating “Very Easy”).

“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,” said Laura Ferris, MD, PhD, Associate Professor, Department of Dermatology, University of Pittsburgh Medical Center.

Tremfya One-Press is available as a single-dose 100mg/mL patient-controlled injector; each One-Press injector can only be used once.

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