INTRODUCTION & OBJECTIVES: Secukinumab, a fully human monoclonal antibody (mAb) that selectively targets IL-17A, is highly efficacious in the treatment of moderate to severe plaque psoriasis, with early onset, a sustained effect, and a favorable safety profile. We explored the relationship between patient-reported pain, itching, and scaling and secukinumab skin clearance as measured by the Psoriasis Area and Severity Index (PASI).
MATERIALS & METHODS: The CLEAR study was a phase 3b study that compared secukinumab and ustekinumab in adults with moderate to severe plaque psoriasis. Data to week 16 data were included in the analysis. Pain, itching, scaling (0-10 numerical rating scales with higher scores indicative of greater severity) and PASI were evaluated at baseline and Weeks 1, 2, 3, 4, 8, 12, and 16 for secukinumab 300 mg. PASI response levels were defined as 75-89 and 90-100. The effect of skin clearance on pain, itching, and scaling was evaluated using ANCOVA and the percentage of patients reporting complete symptom relief (a score of 0 post baseline) was compared using Pearson Chi-square statistics.
RESULTS: Pain, itching, and scaling data were analyzed for 310 patients (PASI 90-100/PASI 75-89 at Week 16: n=264/46; baseline mean (SD) pain=4.0(3.2)/4.1(3.2), itching=6.4(2.7)/6.0(2.9), scaling=6.6(2.6)/6.3(2.8)). Improvements from baseline to Week 16 in pain, itching, and scaling for PASI 90-100 responders were significantly higher compared to PASI 75-89 responders (Least Square Mean Improvements PASI 90-100/PASI 75-89: pain=3.5 vs. 2.5, itching=5.4 vs. 4.3, scaling=6.1 vs. 4.7; all P< 0.0001). A significantly higher percentage of patients achieving PASI 90-100 reported complete relief from pain (76% vs. 47%), itching (57% vs. 27%), and scaling (72% vs. 22%) at Week 16 than those achieving PASI 75-89 (all P< 0.01). Similar trends were observed for evaluations at Weeks 4-12 (all P< 0.05 for mean improvements and percentage reporting complete relief).
CONCLUSIONS: In patients treated with secukinumab 300 mg, higher levels of skin clearance translated into greater improvements in patient-reported psoriasis-related pain, itching, and scaling.