Background: Secukinumab is highly efficacious in the treatment of moderate to severe plaque psoriasis, with fast onset, a sustained effect, and a favorable safety profile. CLEAR is a phase 3b study comparing the efficacy/safety of secukinumab versus ustekinumab, an anti-IL-12/23 mAb, in adults with moderate to severe plaque psoriasis. This analysis examined the treatment effect on psoriasis-related pain, itching, and scaling.
Methods: This analysis used baseline to Week 16 data for patients aged ≥ 18 years randomized 1:1 to subcutaneous treatment arms (secukinumab 300 mg and ustekinumab 45 mg or 90 mg according to body weight at baseline). Psoriasis-related pain, itching, and scaling over the last 24 hours were assessed using a 0-10 numerical rating scale with higher scores indicating greater severity. Mean treatment difference at Week 16 was examined via analyses of covariance adjusting for geographical region, body weight stratum, and baseline score. The percentage of subjects reporting complete relief of symptoms (score = 0) was compared between treatment arms. Time to complete relief was computed as the period from randomization to the Week when a symptom score of 0 occurred. Median time to complete symptom relief was compared between treatment arms using Kaplan-Meier methods with a log-rank test.
Results: The full analysis set included 336 subjects randomized to secukinumab 300 mg and 339 subjects to ustekinumab. Mean changes from baseline to Week 16 for pain, itching, and scaling were significantly greater for secukinumab (–3.3, –5.0, and –5.7) than for ustekinumab (–2.8, –4.6, and –5.2; all p < 0.05). Significantly more secukinumab-treated subjects achieved complete pain (80.3% vs. 69.7%), itching (64.0% vs. 52.2%), and scaling (74.4% vs. 56.1%) relief by Week 16 than ustekinumab-treated subjects (all p < 0.05). The median time to complete itching (12 vs. 16 Weeks) and scaling relief (8 vs. 16 Weeks) was significantly faster for secukinumab than for ustekinumab (both p < 0.001). The median time to pain relief was 8 Weeks for both treatment arms, but the Kaplan-Meier curves were statistically different, and the log rank test favored secukinumab (p = 0.0056).
Conclusion: Secukinumab 300 mg alleviates patient-reported, psoriasis-related pain, itching, and scaling significantly faster and better than ustekinumab.
