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      Real‐world experience of secukinumab in moderate to severe psoriasis patients in Thailand: Characteristics, effectiveness, and safety

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          Abstract

          Secukinumab demonstrated high efficacy and favorable safety profile in patients with moderate‐to‐severe plaque psoriasis (PsO) in clinical trials. However, understanding of patient characteristics and clinical outcomes in real world in Thailand is still limited. To describe patient characteristics, effectiveness and safety of secukinumab in Thai PsO patients. This retrospective study analyzed data from medical records of adult PsO patients who initiated secukinumab at 7 dermatology centers from September 2017 to April 2021. Study outcomes included patient characteristics and changes in Psoriasis Area and Severity Index (PASI) score from baseline at weeks 4 and 16 after secukinumab initiation. Adverse events were recorded. Subgroup analyses by adherence rate and completeness of loading dose were performed. Of 163 patients, the mean (SD) age was 44.0 (14.0) years. Most patients (84.7%) were previously treated with topical therapy while 62.0% and 21.5% of patients had received systemic and biologic therapy, respectively. The mean baseline PASI score was 15.4 (9.3). Overall, the mean PASI score improved by 58.0% at week 4 and 78.4% at week 16. Statistically significant differences in PASI approvement were revealed among subgroups of patients with different loading dose and adherence rate. Adverse effects were reported in 8.0% of patients. The characteristics of patients in this study were slightly different from clinical trials in terms of demographic and clinical characteristics, as well as PsO treatment. Secukinumab was effective and safe in Thai patients with PsO, especially among those with complete loading dose and a higher adherence rate.

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          Most cited references31

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          Pathophysiology, Clinical Presentation, and Treatment of Psoriasis: A Review

          Approximately 125 million people worldwide have psoriasis. Patients with psoriasis experience substantial morbidity and increased rates of inflammatory arthritis, cardiometabolic diseases, and mental health disorders.
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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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              A systematic review of worldwide epidemiology of psoriasis

              To inform the WHO Global report on psoriasis, a new comprehensive worldwide systematic review of the epidemiology of psoriasis was undertaken. The aim of this study was to systematically review the worldwide literature regarding the epidemiology of psoriasis, including prevalence and incidence, in adults and in children. A search of 15 electronic medical databases was performed. Using a rigorous systematic protocol, eligible articles were analysed. No language, regional or temporal restrictions were applied. A total of 76 study observations met all eligibility criteria and were included in the systematic review. The estimates of the prevalence of psoriasis in adults ranged from 0.51% to 11.43%, and in children from 0% to 1.37%. Psoriasis is a common disease, occurring more frequently with advancing age. Limited data on the epidemiology of psoriasis are available. The available prevalence data come from only 20 countries, meaning there are huge geographic gaps in knowledge, especially from low- and middle-income settings.
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                Author and article information

                Contributors
                natta.rama@gmail.com
                Journal
                Dermatol Ther
                Dermatol Ther
                10.1111/(ISSN)1529-8019
                DTH
                Dermatologic Therapy
                John Wiley & Sons, Inc. (Hoboken, USA )
                1396-0296
                1529-8019
                16 November 2022
                December 2022
                : 35
                : 12 ( doiID: 10.1111/dth.v35.12 )
                : e15958
                Affiliations
                [ 1 ] Division of Dermatology, Department of Medicine, Faculty of Medicine Chulalongkorn University Bangkok Thailand
                [ 2 ] Institute of Dermatology Ministry of Public Health Bangkok Thailand
                [ 3 ] Department of Dermatology, Faculty of Medicine, Siriraj Hospital Mahidol University Bangkok Thailand
                [ 4 ] Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Chiang Mai University Chiang Mai Thailand
                [ 5 ] Division of Dermatology, Department of Medicine, Srinagarind Hospital Medical School Khon Kaen University Khon Kaen Thailand
                [ 6 ] Division of Dermatology Thammasat University Pathum Thani Thailand
                [ 7 ] Novartis Bangkok Thailand
                [ 8 ] Division of Dermatology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital Mahidol University Bangkok Thailand
                Author notes
                [*] [* ] Correspondence

                Natta Rajatanavin, Division of Dermatology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, 270 Rama VI Rd., Ratchatewi, Bangkok 10400, Thailand.

                Email: natta.rama@ 123456gmail.com

                Author information
                https://orcid.org/0000-0002-2628-0894
                https://orcid.org/0000-0001-6625-6445
                Article
                DTH15958
                10.1111/dth.15958
                10078165
                36279306
                1e7cf7d5-cd5b-4edf-8203-e45b2f8f46bc
                © 2022 The Authors. Dermatologic Therapy published by Wiley Periodicals LLC.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 21 October 2022
                : 22 July 2022
                : 22 October 2022
                Page count
                Figures: 2, Tables: 7, Pages: 8, Words: 4996
                Funding
                Funded by: Novartis Thailand
                Categories
                Original Article
                Original Articles
                Custom metadata
                2.0
                December 2022
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.2.7 mode:remove_FC converted:06.04.2023

                biologics,il‐17,psoriasis,real world,secukinumab
                biologics, il‐17, psoriasis, real world, secukinumab

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