Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE)

BackgroundSecukinumab is a fully human anti-interleukin-17A monoclonal antibody. ObjectiveDetermine the efficacy, safety and usability of secukinumab administered via autoinjector/pen. MethodsThis phase III trial randomized subjects with moderate to severe plaque psoriasis to secukinumab 300 mg, 150mg or placebo self-injection once weekly to Week 4, then every 4weeks. Co-primary end points at Week 12 were 75% improvement in Psoriasis Area and Severity Index (PASI 75) and clear/almost clear skin by investigator's global assessment 2011 modified version (IGA mod 2011 0/1). Secondary end points included autoinjector usability, assessed by successful, hazard-free self-injection and subject-reported acceptability on Self-Injection Assessment Questionnaire. ResultsWeek 12 PASI 75 and IGA mod 2011 0/1 responses were superior with secukinumab 300mg (86.7% and 73.3%, respectively) and 150mg (71.7% and 53.3%, respectively) vs. placebo (3.3% and 0%, respectively) (P<0.0001 for all). All subjects successfully self-administered treatment at Week 1, without critical use-related hazards. Subject acceptability of autoinjector was high throughout 12weeks. Adverse events were higher with secukinumab (300mg, 70.0%; 150mg, 63.9%) vs. placebo (54.1%), with differences largely driven by mild/moderate nasopharyngitis. ConclusionSecukinumab delivered by autoinjector/pen is efficacious, well-tolerated and associated with high usability in moderate to severe plaque psoriasis.