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      Effectiveness and Safety of Secukinumab for Psoriasis in a Real-World Clinical Setting in the Asia-Pacific and Middle East Regions: Results from the REALIA Study

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          Abstract

          Introduction

          Secukinumab has demonstrated sustained long-term efficacy with a favourable safety profile in various manifestations of psoriatic disease. We investigated effectiveness and safety of secukinumab, other biologics and conventional systemic therapies in patients with chronic plaque psoriasis in a real-world setting.

          Methods

          REALIA was a non-interventional, multicentre, prospective, parallel group study. Eligible patients were ≥ 18 years old with chronic plaque psoriasis commencing a new treatment with a biologic agent or conventional systemic therapies.

          Results

          At baseline, 541 patients were divided into three cohorts based on treatment initiated: conventional systemics (173), secukinumab (184) and other biologics (184). A significantly higher proportion of patients achieved almost clear to clear skin based on physician’s judgement in secukinumab versus conventional systemics at month 3 (64.7% versus 22.8%, P < 0.001) and month 6 (61.8% versus 20.8%, P < 0.001). At month 12, clear to almost clear skin was achieved by 52.1% of the patients in secukinumab versus 35.8% in conventional systemics ( P = 0.066). The proportion of patients achieving Psoriasis Area Severity Index (PASI) 90 on conventional systemics, secukinumab and other biologics was 18.8%, 59.7% and 40.0% at month 3 and 35.3%, 60.8% and 50.0% at month 12, respectively. Secukinumab patients showed significantly higher change in PASI total score from baseline versus conventional systemics at month 3 {least squares [LS] mean [standard error (SE)]: −14.49 [0.648] versus −8.48 [1.149], P < 0.001} and numerically higher [LS mean (SE): −13.60 (0.475) versus −10.84 (1.733), P = 0.122] at month 12. The proportion of patients with Dermatology Life Quality Index 0/1 score on conventional systemics, secukinumab and other biologics was 22.6%, 65.0% and 41.6% at month 3 and 32.0%, 63.5% and 41.3% at month 12, respectively. Safety profile was comparable across cohorts.

          Conclusions

          Secukinumab is effective and well tolerated in patients with chronic plaque psoriasis in a real-world setting in an Asia-Pacific and Middle East population, and these results are in agreement with clinical outcomes of secukinumab reported in randomised clinical trials.

          Trial registration number

          170803-001645.

          Supplementary Information

          The online version contains supplementary material available at 10.1007/s13555-021-00675-w.

          Related collections

          Most cited references28

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          Global epidemiology of psoriasis: a systematic review of incidence and prevalence.

          The worldwide incidence and prevalence of psoriasis is poorly understood. To better understand this, we performed a systematic review of published population-based studies on the incidence and prevalence of psoriasis. Three electronic databases were searched from their inception dates to July 2011. A total of 385 papers were critically appraised; 53 studies reported on the prevalence and incidence of psoriasis in the general population. The prevalence in children ranged from 0% (Taiwan) to 2.1% (Italy), and in adults it varied from 0.91% (United States) to 8.5% (Norway). In children, the incidence estimate reported (United States) was 40.8/100,000 person-years. In adults, it varied from 78.9/100,000 person-years (United States) to 230/100,000 person-years (Italy). The data indicated that the occurrence of psoriasis varied according to age and geographic region, being more frequent in countries more distant from the equator. Prevalence estimates also varied in relation to demographic characteristics in that studies confined to adults reported higher estimates of psoriasis compared with those involving all age groups. Studies on the prevalence and incidence of psoriasis have contributed to a better understanding of the burden of the disease. However, further research is required to fill existing gaps in understanding the epidemiology of psoriasis and trends in incidence over time.
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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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              National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study

              Abstract Objective To systematically review and provide information on the incidence of psoriasis and quantify global, regional, and country specific estimates of its prevalence. Design Systematic review and meta-analysis. Data sources Medline, Embase, Web of Science, SciELO, Korean Journal Databases, Russian Science Citation Index, WPRIM, SaudiMedLit, Informit, IndMed, and HERDIN were searched systematically from their inception dates to October 2019. Methods Studies were included if they reported on the incidence or prevalence of psoriasis in the general population. Incidence data were summarised descriptively, whereas bayesian hierarchical models were fitted to estimate the global, regional, and country specific prevalence of psoriasis. Results 41 164 records were identified and 168 studies met the inclusion criteria. In adults, the incidence of psoriasis varied from 30.3 per 100 000 person years (95% confidence interval 26.6 to 34.1) in Taiwan to 321.0 per 100 000 person years in Italy. The prevalence of psoriasis varied from 0.14% (95% uncertainty interval 0.05% to 0.40%) in east Asia to 1.99% (0.64% to 6.60%) in Australasia. The prevalence of psoriasis was also high in western Europe (1.92%, 1.07% to 3.46%), central Europe (1.83%, 0.62% to 5.32%), North America (1.50%, 0.63% to 3.60%), and high income southern Latin America (1.10%, 0.36% to 2.96%). Conclusions Eighty one per cent of the countries of the world lack information on the epidemiology of psoriasis. The disease occurs more frequently in adults than in children. Psoriasis is unequally distributed across geographical regions; it is more frequent in high income countries and in regions with older populations. The estimates provided can help guide countries and the international community when making public health decisions on the appropriate management of psoriasis and assessing its natural history over time. Systematic review registration PROSPERO CRD42019160817.
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                Author and article information

                Contributors
                huang3764@yahoo.com.tw
                Journal
                Dermatol Ther (Heidelb)
                Dermatol Ther (Heidelb)
                Dermatology and Therapy
                Springer Healthcare (Cheshire )
                2193-8210
                2190-9172
                17 January 2022
                17 January 2022
                February 2022
                : 12
                : 2
                : 511-527
                Affiliations
                [1 ]GRID grid.512291.c, Skin Health Institute, ; Carlton, Victoria Australia
                [2 ]GRID grid.412094.a, ISNI 0000 0004 0572 7815, National Taiwan University Hospital, ; Taipei, Taiwan
                [3 ]Northern Dermatology, Chermside, Queensland Australia
                [4 ]GRID grid.415310.2, ISNI 0000 0001 2191 4301, King Faisal Specialist Hospital and Research Centre, ; Riyadh, Saudi Arabia
                [5 ]GRID grid.416659.9, ISNI 0000 0004 1773 3761, Saint George Hospital University Medical Center, ; Beirut, Lebanon
                [6 ]Mediclinic, Al-Noor Hospital, Abu Dhabi, United Arab Emirates
                [7 ]GRID grid.7269.a, ISNI 0000 0004 0621 1570, Department of Dermatology and Venereology, Faculty of Medicine, , Ain Shams University, ; Cairo, Egypt
                [8 ]GRID grid.496862.7, ISNI 0000 0004 0544 6263, Novartis Ireland Ltd, ; Dublin, Ireland
                [9 ]GRID grid.419481.1, ISNI 0000 0001 1515 9979, Novartis Pharma AG, ; Basel, Switzerland
                [10 ]Chang Gung Memorial Hospital Linkou and Chang Gung University, Tao-yuan, Taiwan
                Article
                675
                10.1007/s13555-021-00675-w
                8850524
                35038128
                5a45504a-b552-4851-b5ac-09ff85391e71
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 10 November 2021
                : 24 December 2021
                Funding
                Funded by: Novartis Pharma AG
                Categories
                Original Research
                Custom metadata
                © The Author(s) 2022

                Dermatology
                biologics,psoriasis,real-world,safety,secukinumab
                Dermatology
                biologics, psoriasis, real-world, safety, secukinumab

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