Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study

<b>Objectives:</b> Guselkumab, an interleukin-23 antagonist, is approved for self-administration with the UltraSafe Plus™ syringe to treat moderate-to-severe plaque-type psoriasis. We evaluated the efficacy, safety, pharmacokinetics, and acceptability of guselkumab administered using a novel patient-controlled injector (One-Press) in psoriasis patients. <b>Materials and methods:</b> This Phase 3, multicentre, double-blind, placebo-controlled study (ORION, Clinicaltrials.gov identifier-NCT02905331) randomized adults with moderate-to-severe psoriasis (4:1) to guselkumab 100 mg at Weeks 0/4/12/20/28 or placebo at Weeks 0/4/12 with crossover to guselkumab 100 mg at Weeks 16/20/28. Week 16 co-primary endpoints were the proportions of patients achieving Investigator Global Assessment (IGA) cleared/minimal (IGA 0/1) and Psoriasis Area and Severity Index 90% improvement (PASI90) responses. One-Press usability/acceptability was evaluated using the Self-Injection Assessment Questionnaire (SIAQ) and Patient-Controlled Injection Device Questionnaire. Final assessments occurred at Week 40. <b>Results:</b> At Week 16, significantly higher proportions of guselkumab-treated (<i>N</i> = 62) than placebo-treated (<i>N</i> = 16) patients achieved IGA 0/1 (80.6% vs. 0.0%, <i>p</i> &lt; .001) and PASI90 (75.8% vs. 0.0%, <i>p</i> &lt; .001) responses. Adverse events were comparable between treatments. SIAQ results demonstrated 99% (68/69) of patients were satisfied/very satisfied with One-Press at Week 28. <b>Conclusions:</b> Guselkumab administered using the One-Press patient-controlled injector was efficacious and well-tolerated in moderate-to-severe psoriasis patients, consistent with previously reported Phase-3 studies of guselkumab administered using UltraSafe Plus. One-Press was highly acceptable to patients.