Secukinumab improves patient-reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo-controlled clinical trials
| Autor: | Alexander Karpov, Mary H. Tran, Bárður Sigurgeirsson, Sigitas Stonkus, Yang Zhao, Alice B. Gottlieb, James Krell, Charis Papavassilis, Rodney Sinclair, Lori McLeod, Boni E. Elewski, Mark Lebwohl, Margaret Mordin, Bruce Strober, Marcis Septe, Georg Popp, Judit Nyirady |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty Pain Dermatology Antibodies Monoclonal Humanized Placebo Severity of Illness Index law.invention 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Internal medicine Psoriasis Severity of illness medicine Humans Immunologic Factors Patient Reported Outcome Measures Dosing business.industry Pruritus Antibodies Monoclonal Middle Aged medicine.disease Clinical trial 030220 oncology & carcinogenesis Physical therapy Itching Female Secukinumab Symptom Assessment medicine.symptom business |
| Zdroj: | International Journal of Dermatology. 55:401-407 |
| ISSN: | 0011-9059 |
| DOI: | 10.1111/ijd.13236 |
| Popis: | 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)(©).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.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 P0.0001) and had significantly greater proportions of itching, pain, and scaling responders at Week 12 versus placebo (all P0.05).Secukinumab significantly improves patient-reported itching, pain, and scaling in adults with moderate to severe psoriasis compared with placebo. |
| Databáze: | OpenAIRE |
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