Secukinumab improves patient-reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo-controlled clinical trials

• Published in: International journal of dermatology Vol. 55; no. 4; pp. 401 - 407
• Main Authors: Strober, Bruce, Sigurgeirsson, Bárður, Popp, Georg, Sinclair, Rodney, Krell, James, Stonkus, Sigitas, Septe, Marcis, Elewski, Boni E., Gottlieb, Alice B., Zhao, Yang, Tran, Mary H., Karpov, Alexander, McLeod, Lori D., Mordin, Margaret, Papavassilis, Charis, Nyirady, Judit, Lebwohl, Mark
• Format: Journal Article
• Language: English
• Published: England Blackwell Publishing Ltd 01.04.2016
• Subjects: Adult; Antibodies, Monoclonal - therapeutic use; Antibodies, Monoclonal, Humanized; Double-Blind Method; Female; Humans; Immunologic Factors - therapeutic use; Male; Middle Aged; Pain - etiology; Patient Reported Outcome Measures; Pruritus - etiology; Psoriasis - complications; Psoriasis - drug therapy; Severity of Illness Index; Symptom Assessment
• ISSN: 0011-9059; 1365-4632
• DOI: 10.1111/ijd.13236

Background Secukinumab is a human interleukin‐17A antagonist indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The objective of this analysis was to measure the treatment response on psoriasis‐related itching, pain, and scaling via the Psoriasis Symptom Diary (PSD)©. Methods ERASURE (n = 738) and FIXTURE (n = 1306) were double‐blind, multicenter phase 3 studies in adults randomized to secukinumab (300, 150 mg, n = 1144) or placebo (n = 574) (administered at Weeks 0, 1, 2, 3, and 4, followed by dosing every 4 weeks) or a biologic active control (FIXTURE only). Patient‐reported itching, pain, and scaling were assessed during the first 12 weeks of treatment using the PSD. The results reported here are limited to subjects in the secukinumab and placebo treatment groups who completed the PSD. The proportions of subjects achieving prespecified responses (improvement:reduction of at least 2.2 points for itching, 2.2 points for pain, or 2.3 points for scaling) were compared for secukinumab versus placebo. Results Overall, 39% of subjects completed the PSD at baseline and Week 12 (n = 453 secukinumab; 225 placebo). Subjects treated with secukinumab achieved significantly greater improvements in itching, pain, and scaling at Week 12 versus placebo (all P < 0.0001) and had significantly greater proportions of itching, pain, and scaling responders at Week 12 versus placebo (all P < 0.05). Conclusion Secukinumab significantly improves patient‐reported itching, pain, and scaling in adults with moderate to severe psoriasis compared with placebo.