Artikel
5 years of Secukinumab – high sustained efficacy and favorable safety in psoriasis patients with psoriatic arthritis at baseline
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Autoren
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Robert Bissonnette
- Innovaderm Research, Montreal, Kanada
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Thomas Luger
- Department of Dermatology, University of Münster, Münster
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Diamant Thaci
- Comprehensive Center for Inflammation Medicine (CCIM), University Hospital Schleswig-Holstein, Lübeck
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Darryl Toth
- Department of Geriatric and Environmental Dermatology, Probity Medical Research Windsor and XLR8 Medical Research, Windsor, Kanada
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Aude Lacombe
- Novartis Pharma AG, Basel, Switzerland
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Summer Xia
- Shanghai Novartis Trading Ltd., Shanghai, China
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Rafal Mazur
- Novartis Pharma AG, Basel, Switzerland
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Manmath Patekar
- Novartis Pharma AG, Basel, Switzerland
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Pascal Charef
- Novartis Pharma AG, Basel, Switzerland
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Marina Milutinovic
- Novartis Pharma AG, Basel, Switzerland
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Craig Leonardi
- Department of Dermatology, Saint Louis University Health Science Center, Saint Louis, USA
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Daniel Peterlik
- Novartis Pharma GmbH, Nürnberg
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Ulrich Mrowietz
- Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel
| Veröffentlicht: | 5. Februar 2019 |
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Gliederung
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Background: Secukinumab, a fully human monoclonal antibody that neutralizes IL-17A, has demonstrated sustained efficacy and favorable safety in the treatment of moderate to severe psoriasis (PsO) and psoriatic arthritis (PsA). SCULPTURE extension study (NCT01640951) is the first phase III study with an IL-17A inhibitor evaluating efficacy and safety up to 5 years of continuous treatment at approved doses.
Methods: In the SCULPTURE core study, patients that were Psoriasis Area and Severity Index (PASI) 75 responders at Week 12 continued receiving subcutaneous secukinumab 300 mg every 4 weeks until Year 1. Subsequently, patients (n = 168) entered extension phase and continued same double-blinded treatment regimen to Year 3 and open-label to Year 5 (presented previously). Here, in this subanalysis, we highlight for the first time efficacy and safety data of secukinumab 300 mg (every 4 weeks) through 5 years in PsO patients that reported concomitant PsA at Baseline (n = 33, 19.6% of core population). Efficacy data were assessed as observed and safety events were analyzed per year.
Results: Within the subset of PsO patients with PsA at Baseline PASI 50/75/90 responses at Year 1 (97.0%, 72.7% and 51.5%) were well sustained to Year 5 (95.8%, 87.5% and 66.7%). Absolute Dermatology Life Quality Index (DLQI) improved by 81.1% from 13.2 at Baseline to 2.5 at Year 5. Almost two thirds of those patients reported no impact of skin disease on their lives, i.e. DLQI 0/1 responses were 63.6% (Year 1) and 62.5% (Year 5). In addition, about one third reported improvement of functional ability, with Health Assessment Questionnaire Disability Index (HAQ-DI) responses reaching 32.0% (Year 1) and 36.4% (Year 5). The safety profile of secukinumab remained favorable, with no unexpected or cumulative safety concerns identified. Most common adverse events included nasopharyngitis, upper respiratory tract infection and gastroenteritis, similar with those reported for PsO patients in the core study and in previous phase III studies.
Conclusion: PsO patients with PsA at Baseline treated with secukinumab 300 mg every 4 weeks benefited from high levels of skin clearance and improved quality of life through 5 years. Moreover, a favorable safety profile was maintained for 5 years.
