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Secukinumab improves patient-reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo-controlled clinical trials
- Source :
- International Journal of Dermatology. 55:401-407
- Publication Year :
- 2016
- Publisher :
- Wiley, 2016.
-
Abstract
- 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.
- Subjects :
- 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
Subjects
Details
- ISSN :
- 00119059
- Volume :
- 55
- Database :
- OpenAIRE
- Journal :
- International Journal of Dermatology
- Accession number :
- edsair.doi.dedup.....8050dd5dcf65f3e0f2668eaf1dbdc466
- Full Text :
- https://doi.org/10.1111/ijd.13236