Secukinumab, a drug currently in clinical trials for treatment of psoriasis, has been shown to clear psoriasis for a full year, findings presented at the European Academy of Dermatology and Venereology indicate.
To evaluate the safety, efficacy, and usability of secukinumab administered via autionjector/pen, Carle Paul, MD, of the Paul Sabatier University in Toulouse, France, and colleagues conducted a phase III randomized trial.
Patients with moderate to severe plaque psoriasis were randomized to receive secukinumab 300 mg, 150 mg, or placebo self-injection one weekly to Week 4, then every four weeks. Co-primary end points at Week 12 were ≥75% improvement in Psoriasis Area and Severity Index (PASI 75) and clear-to-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.
Week 12 PASI 75 and IGA mod 2011 0/1 responses were superior with secukinumab 300 mg (86.7% and 73.3%, respectively) and 150 mg (71.7% and 53.3%, respectively) versus 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 12 weeks. Adverse events were higher with secukinumab (300 mg, 70.0%; 150 mg, 63.9%) versus placebo (54.1%), with differences largely driven by mild or moderate nasopharyngitis.
“Secukinumab delivered by autoinjector/pen is efficacious, well-tolerated and associated with high usability in moderate to severe plaque psoriasis,” concluded the researchers.