Andreas Pinter1, Sascha Gerdes2, Charis Papavassilis3, Maximilian Reinhardt4. 1. a Department of Dermatology, Venereology and Allergology , University Hospital Frankfurt , Frankfurt am Main , Germany. 2. b Psoriasis-Center, Department of Dermatology , University Medical Center Schleswig-Holstein , Kiel , Germany. 3. c Novartis Pharma AG , Basel , Switzerland. 4. d Novartis Pharma GmbH , Nürnberg , Germany.
Abstract
Background: Secukinumab is a fully human monoclonal antibody that neutralizes interleukin-17A (IL-17A), a key cytokine involved in the development of psoriasis. Here, we characterized secukinumab treatment-responder profiles and identified baseline factors affecting response. Methods: Pooled phase 3 data from moderate to severe plaque psoriasis patients treated with secukinumab for 16 weeks (FIXTURE [NCT01358578], ERASURE [NCT01365455], and CLEAR [NCT02074982]) were analyzed to characterize responder groups, identifying factors associated with treatment response, and to evaluate early response kinetics as a biomarker for treatment response. Etanercept and ustekinumab were evaluated as comparators. Results: Patients treated with secukinumab 300 mg (n = 867), ustekinumab 45/90 mg (n = 318), and etanercept 50 mg (n = 298) were evaluated. For secukinumab 300 mg, more patients were in higher responder groups than etanercept and ustekinumab. In higher response groups, fewer patients had previous systemic or biologic treatment, metabolic syndrome, hypertension, diabetes, and fewer were current smokers. Mean body weight, waist circumference, and BMI decreased as response level increased. Early onset of response (PASI50 at Week 4 or 8) correlated with sustained efficacy at Week 16. Conclusions: Baseline factors, including weight and cardiometabolic status, were associated with response to secukinumab. Early onset of response may indicate treatment efficacy later on.
Background: Secukinumab is a fully human monoclonal antibody that neutralizes interleukin-17A (IL-17A), a key cytokine involved in the development of psoriasis. Here, we characterized secukinumab treatment-responder profiles and identified baseline factors affecting response. Methods: Pooled phase 3 data from moderate to severe plaque psoriasispatients treated with secukinumab for 16 weeks (FIXTURE [NCT01358578], ERASURE [NCT01365455], and CLEAR [NCT02074982]) were analyzed to characterize responder groups, identifying factors associated with treatment response, and to evaluate early response kinetics as a biomarker for treatment response. Etanercept and ustekinumab were evaluated as comparators. Results:Patients treated with secukinumab 300 mg (n = 867), ustekinumab 45/90 mg (n = 318), and etanercept 50 mg (n = 298) were evaluated. For secukinumab 300 mg, more patients were in higher responder groups than etanercept and ustekinumab. In higher response groups, fewer patients had previous systemic or biologic treatment, metabolic syndrome, hypertension, diabetes, and fewer were current smokers. Mean body weight, waist circumference, and BMI decreased as response level increased. Early onset of response (PASI50 at Week 4 or 8) correlated with sustained efficacy at Week 16. Conclusions: Baseline factors, including weight and cardiometabolic status, were associated with response to secukinumab. Early onset of response may indicate treatment efficacy later on.
Entities:
Keywords:
IL-17A; Secukinumab; baseline factors; psoriasis; responder groups
Authors: Nikolai Loft; Alexander Egeberg; Mads Kirchheiner Rasmussen; Lars Erik Bryld; Christoffer V Nissen; Tomas Norman Dam; Kawa Khaled Ajgeiy; Lars Iversen; Lone Skov Journal: Acta Derm Venereol Date: 2021-01-04 Impact factor: 3.875
Authors: P Hampton; A Halliday; M Aassi; S Subramanian; M Jain; C E M Griffiths Journal: J Eur Acad Dermatol Venereol Date: 2021-02-09 Impact factor: 6.166
Authors: A P Fernandez; E Dauden; S Gerdes; M G Lebwohl; M A Menter; C L Leonardi; M Gooderham; K Gebauer; Y Tada; J P Lacour; L Bianchi; A Egeberg; I Pau-Charles; A M Mendelsohn; S J Rozzo; N N Mehta Journal: J Eur Acad Dermatol Venereol Date: 2022-06-25 Impact factor: 9.228