SUMMARY  

• A phase 3, randomized, double blind, placebo (PBO)-controlled  trial (ORION) that evaluated the efficacy, safety, pharmacokinetics (PK), and immunogenicity of TREMFYA One-Press in adults patients with moderate to severe plaque psoriasis (PsO).¹  
  • At week 16, the co-primary endpoints of Investigator's Global Assessment (IGA) score of 0/1 was achieved by 80.6% of patients receiving TREMFYA compared to 0% of patients receiving PBO (P<0.001), and Psoriasis Area and Severity Index (PASI) 90 was achieved by 75.8% of patients receiving TREMFYA compared to 0% of patients receiving PBO (P<0.001).
  • Similarly, higher proportions of TREMFYA-treated patients than PBO-treated patients achieved major secondary endpoints of IGA 0 (56.5% versus 0%; P<0.001) and PASI 100 (50.0% versus 0%; P<0.001) at week 16.
  • For safety through week 16, 62.9% of patients receiving TREMFYA and 68.8% of patients receiving PBO reported adverse events (AEs). All patients at all visits successfully completed self-injections with one device on the first attempt, except one patient who did not remove the cap prior to initial injection.
  • The usability and acceptability of the One-Press device was evaluated using the self-injection assessment questionnaire (SIAQ), which compared post-dose scores and comfortability with device across six domains. Post-dose scores were favorable (overall mean scores ranged from 7.63 to 9.84) and comparable between TREMFYA and PBO groups across all six domains.

CLINICAL DATa

Phase 3 Clinical Study - ORION (One-Press Injector for Adult Patients with Moderate to Severe Plaque PsO)

Ferris et al (2019)¹ evaluated the efficacy, safety, and PK of TREMFYA compared to PBO, both administered via the One-Press device in a phase 3, multicenter, double-blind, randomized trial in adult patients with moderate to severe plaque PsO.

Study Design/Methods

• Inclusion criteria:
  • Patients who are ≥18 years of age with moderate to severe plaque PsO for ≥6 months
  • IGA ≥3, PASI ≥12 and body surface area (BSA) involvement≥ 10%  
  • Candidates for systemic therapy or phototherapy
  • Willingness to self-administer study agent  
• Exclusion criteria:
  • History or current signs of severe, progressive, or uncontrolled medical condition
  • History of current malignancy (exclusive of nonmelanoma skin cancer)
• Patients were randomized in a 4:1 ratio to receive subcutaneous (SC) TREMFYA 100 mg at weeks 0, 4, 12, 20, and 28 or SC PBO at weeks 0, 4, and 12, with crossover to TREMFYA 100 mg at weeks 16, 20 and 28 via the One-Press device at the study site after receiving training on the proper use of device.
  • To maintain blinding, patients in the TREMFYA group received PBO at week 16.
  • The study agent consisted of a single-use prefilled glass syringe with a 27-gauge, half inch fixed needle containing 1 mL of a sterile solution of TREMFYA (100 mg/mL) or PBO.
• Usability and acceptability were evaluated at weeks 0, 4 ,12 and 28 using the SIAQ.
  • Patients rated their experience using One-Press device across six domains on a 5-to-6-point semantic Likert-type scale, and ratings were then transformed to scores ranging from 0 (worst experience; equivalent to rating of 1) to 10 (best experience; equivalent to rating of 5 or 6).
  • Patients also completed a questionnaire specific to the One-Press device, which indicated their agreement with each statement (‘I liked being able to inject the medication at a speed that comfortable for me,’ ‘The design of the device handle made the device easy to use,’ and ‘I was able to easily tell when the injection was finished’) on a 5-point scale (strongly disagree, disagree, neither agree or disagree, agree, or strongly agree).

Results

Patient Demographics

• A total of 85 patients were screened, 78 patients were randomized to receive TREMFYA 100 mg (n=62) or PBO (n=16). 
• Thirteen of the 16 PBO patients crossed over to TREMFYA at week 16 and 85% (66/78) randomized patients completed the study.
• At baseline, patients had longstanding PsO (mean duration:18.7 years) with extensive skin involvement (mean BSA: 19.8%).
• Disease severity was moderate to severe, with a mean PASI score of 18 and IGA scores of 3 (moderate) and 4 (severe) in 84.6% and 15.4% of patients, respectively.
• For baseline characteristics, see Table: Baseline Characteristics.

Efficacy

PBO-Controlled Period (Weeks 0-16) – TREMFYA vs PBO

• For co-primary and secondary endpoints, see Table: Co-Primary and Major Secondary Endpoints at Week 16. 

Crossover Period (Weeks 16-32) – PBO to TREMFYA

• PBO-treated patients who switched to TREMFYA at week 16 experienced notable improvement, with IGA 0/1 and PASI 90 response rates exceeding 80% at week 32.

Usability and Acceptability

• All patients across all visits successfully completed self-injections on the first attempt using one device.
• One patient did not remove the device cap prior to the initial injection attempt, which was an isolated deviation.
• Up to week 28, post-dose SIAQ scores remained consistently favorable, with overall mean scores ranging from 7.63 to 9.84. These scores were similar for both the TREMFYA and PBO groups across all six domains: feelings about injections, self-image, self-confidence, pain and skin reactions during or after the injection, ease of use of the self-injection device and satisfaction with self-injection.
• Scores related to pain and skin reactions (burning sensation, cold sensation, itching, redness, swelling, bruising or hardening at the injection site) were consistently high from week 0 (mean:9.83) to week 28 (mean:9.79), indicating patients were largely unaffected by injection-site discomfort.
• Most patients, regardless of study agent, rated the One-Press device as easy/very easy to use (87%-100%) and expressed satisfied/very satisfied (81%-100%) from weeks 0-28.
• Over 97% of patients “strongly agreed” or “agreed” that they liked injecting at a comfortable speed (97.3%), that the handle design made the device easy to use (97.3%), and that they could easily tell when the injection was complete (94.7%).

Safety

• The incidence of AEs was comparable between TREMFYA and PBO-treated patients (62.9% and 68.8%, respectively).
• The most common AEs were injection site pain (40.3% and 43.8% respectively) and injection site coldness (22.6% and 18.8% respectively).
• No cases of active tuberculosis (TB), opportunistic infections, malignancies, deaths, major adverse cardiovascular events (MACE), AEs of PsO, possible anaphylactic/serum sickness-like reactions to study agent, or suicidal ideation/behavior were reported through week 40.
• For full safety analysis set, see Table: Summary of Adverse Events Through Week 40.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 3 September 2025.