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

AbstractObjectives: 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.Materials and methods: 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 Inje...