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      Secukinumab efficacy in reducing the severity and the psychosocial impact of moderate‐to‐severe psoriasis as assessed by the Simplified Psoriasis Index: results from the IPSI‐PSO study

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          Abstract

          Background

          The utility of the Simplified Psoriasis Index (SPI), a recently developed multidomain tool for assessing psoriasis, was investigated in a study assessing response to secukinumab.

          Methods

          In an open‐label, multicentre study involving 17 French centres, patients with moderate‐to‐severe plaque psoriasis received secukinumab 300 mg subcutaneously once weekly from baseline to W4, then every 4 weeks until W48. Dermatologist‐scored SPI psoriasis severity (proSPI‐s) was compared with Psoriasis Area and Severity Index (PASI). Patient self‐assessed severity (saSPI‐s) and psychosocial impact (SPI‐p) were compared with PASI and Dermatology Life Quality Index (DLQI), respectively.

          Results

          We included 120 patients (69.2% male; mean age 45.9 years; mean duration of psoriasis 21.6 years). Mean baseline scores were as follows: proSPI‐s 24.9, saSPI‐s 23.5, PASI 23.1, SPI‐p 8.2 and DLQI 13.6. Severity scores achieved by 16 weeks (proSPI‐s 2.3, saSPI‐s 2.2 and PASI 2.2) were maintained to W52. Reductions in mean psychosocial impact scores were maintained to W52 (SPI‐p and DLQI, respectively, 2.1 and 1.5 at W16; 1.5 and 1.9 at W52).

          Conclusions

          Decrease of PASI scores in response to secukinumab was closely correlated with proSPI‐s, supporting the latter's suitability for assessing response to therapy. Although the correlation between PASI and saSPI‐s was slightly weaker, patients were able to complete a valid assessment of their psoriasis independently, and thus potentially remotely. With the added benefit of psychosocial impact assessment (SPI‐p), SPI provides a valid tool enabling patients to assess their own psoriasis, remotely if necessary.

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          Most cited references21

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          Secukinumab in plaque psoriasis--results of two phase 3 trials.

          Interleukin-17A is considered to be central to the pathogenesis of psoriasis. We evaluated secukinumab, a fully human anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe plaque psoriasis. In two phase 3, double-blind, 52-week trials, ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis) and FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis), we randomly assigned 738 patients (in the ERASURE study) and 1306 patients (in the FIXTURE study) to subcutaneous secukinumab at a dose of 300 mg or 150 mg (administered once weekly for 5 weeks, then every 4 weeks), placebo, or (in the FIXTURE study only) etanercept at a dose of 50 mg (administered twice weekly for 12 weeks, then once weekly). The objective of each study was to show the superiority of secukinumab over placebo at week 12 with respect to the proportion of patients who had a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) and a score of 0 (clear) or 1 (almost clear) on a 5-point modified investigator's global assessment (coprimary end points). The proportion of patients who met the criterion for PASI 75 at week 12 was higher with each secukinumab dose than with placebo or etanercept: in the ERASURE study, the rates were 81.6% with 300 mg of secukinumab, 71.6% with 150 mg of secukinumab, and 4.5% with placebo; in the FIXTURE study, the rates were 77.1% with 300 mg of secukinumab, 67.0% with 150 mg of secukinumab, 44.0% with etanercept, and 4.9% with placebo (P<0.001 for each secukinumab dose vs. comparators). The proportion of patients with a response of 0 or 1 on the modified investigator's global assessment at week 12 was higher with each secukinumab dose than with placebo or etanercept: in the ERASURE study, the rates were 65.3% with 300 mg of secukinumab, 51.2% with 150 mg of secukinumab, and 2.4% with placebo; in the FIXTURE study, the rates were 62.5% with 300 mg of secukinumab, 51.1% with 150 mg of secukinumab, 27.2% with etanercept, and 2.8% with placebo (P<0.001 for each secukinumab dose vs. comparators). The rates of infection were higher with secukinumab than with placebo in both studies and were similar to those with etanercept. Secukinumab was effective for psoriasis in two randomized trials, validating interleukin-17A as a therapeutic target. (Funded by Novartis Pharmaceuticals; ERASURE and FIXTURE ClinicalTrials.gov numbers, NCT01365455 and NCT01358578, respectively.).
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            Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial.

            Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has shown superior efficacy to etanercept with similar safety in moderate to severe plaque psoriasis (FIXTURE study).
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              Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE).

              Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, demonstrated efficacy and safety in moderate-to-severe plaque psoriasis when administered via subcutaneous injection. Self-administration by pre-filled syringe (PFS) can offer patients clinical benefits of a drug, with increased convenience.
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                Author and article information

                Contributors
                mariealeth.richard@ap-hm.fr
                Journal
                J Eur Acad Dermatol Venereol
                J Eur Acad Dermatol Venereol
                10.1111/(ISSN)1468-3083
                JDV
                Journal of the European Academy of Dermatology and Venereology
                John Wiley and Sons Inc. (Hoboken )
                0926-9959
                1468-3083
                02 October 2020
                March 2021
                : 35
                : 3 ( doiID: 10.1111/jdv.v35.3 )
                : 677-684
                Affiliations
                [ 1 ] CEReSS‐EA 3279 Research Centre in Health Services and Quality of Life Aix Marseille University Marseille France
                [ 2 ] Department of Dermatology University Hospital Timone Marseille APHM Marseille France
                [ 3 ] Department of Dermatology University Hospital of Nice Archet‐2 Hospital Nice France
                [ 4 ] Department of Dermatology Larrey Hospital and Paul Sabatier University Toulouse France
                [ 5 ] Private Office Martigues France
                [ 6 ] Department of Dermatology Rouen University Hospital University of Rouen Normandie Rouen France
                [ 7 ] Department of Dermatology Cochin‐Tarnier Hospital Paris France
                [ 8 ] Department of Public Health University Hospital Timone Marseille APHM Marseille France
                [ 9 ] R&D, Novartis Pharma SAS Rueil‐Malmaison France
                [ 10 ] Department of Dermatology Victor Dupouy Hospital Argenteuil France
                [ 11 ] Centre for Dermatology University of Manchester Manchester UK
                Author notes
                [*] [* ] Correspondence: M.‐A. Richard. E‐mail: mariealeth.richard@ 123456ap-hm.fr

                Author information
                https://orcid.org/0000-0002-0870-9132
                https://orcid.org/0000-0001-7663-2053
                https://orcid.org/0000-0001-8171-6542
                https://orcid.org/0000-0002-5734-0255
                https://orcid.org/0000-0001-5780-1827
                Article
                JDV16893
                10.1111/jdv.16893
                7984225
                32815591
                f1f5016c-4df2-44b4-a5d8-4c033779ff43
                © 2020 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 22 April 2020
                : 09 July 2020
                Page count
                Figures: 4, Tables: 1, Pages: 8, Words: 5064
                Funding
                Funded by: Novartis Pharma France
                Categories
                Original Article
                Psoriasis
                Custom metadata
                2.0
                March 2021
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.0.0 mode:remove_FC converted:22.03.2021

                Dermatology
                Dermatology

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