FDA Approves Guselkumab One-Press Controlled Self-Injector for Plaque Psoriasis

Guselkumab (Tremfya, Janssen), a single-dose, patient controlled injector for adults with moderate-to-severe plaque psoriasis, has been approved by the FDA and is now available in the United States, according to a press release.

The first FDA-approved medication of its kind to offer the One-Press patient-controlled injector, guselkumab is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4. Designed for self-injection, the One-Press offers a controlled injection and hides the needle throughout the process.

In the phase 3, multicenter and randomized ORION study, patient experience with One-Press was assessed through a validated Self-Injection Assessment Questionnaire (SIAQ). Through this survey, patients could evaluate their experience at weeks 0, 4, and 12 on a scale of 0 to 10, with 0 being the worst and 10 the best, across 6 domains:

• Feelings about injections
• Self-image
• Self-confidence
• Pain
• Skin reactions during or after the injection
• Ease of use with the self-injection device
• Satisfaction with self-injection

The mean score for “Satisfaction with Self-Injection” was 9.18 (with 10 indicating “Very Satisfied”) and the mean score for “Ease of Use” was 9.24 (with 10 indicating “Very Easy”).

The study also evaluated efficacy and safety. A greater proportion of patients in the guselkumab group achieved an IGA score of 0 or 1 or a PASI 90 response at week 16 (81% and 76%, respectively) than in the placebo group (0% for both endpoints). The proportion of patients who achieved an IGA score of 0 at week 16 was higher in the guselkumab group compared to the placebo group (56% vs. 0%). The proportion of patients who achieved a PASI 100 response at week 16 was higher in the guselkumab group compared to the placebo group (50% vs. 0%).

Nearly 99% of patients reported a successful first injection. After 3 injections, patients still reported favorable outcomes with the device’s usability.

Guselkumab is intended for use under the guidance and supervision of a physician, and patients may self-inject with guselkumab One-Press after physician approval and proper training, according to Janssen.

References

• Janssen Announces U.S. FDA Approval of Novel TREMFYA® (guselkumab) One-Press Patient-controlled Injector for Adults with Moderate-to-Severe Plaque Psoriasis. Janssen website. https://www.janssen.com/janssen-announces-us-fda-approval-novel-tremfyar-guselkumab-one-press-patient-controlled-injector. Published Feb. 27, 2019. Accessed 27, 2019.