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      Effectiveness and safety of secukinumab for psoriasis in real-world practice: analysis of subgroups stratified by prior biologic failure or reimbursement

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          Abstract

          Background:

          Little is known about the treatment outcomes of secukinumab in clinical practice, which differ from those in clinical trials. The effectiveness of biologics may differ in psoriasis patients with previous biologics exposure. The objective of this study was to investigate the real-world effectiveness and safety of secukinumab therapy and analyze subgroups stratified by reimbursement or prior biologic failure.

          Methods:

          This retrospective multicenter study collected data from a cohort of 118 consecutive patients who received secukinumab treatment between December 2015 and March 2018. Effectiveness was evaluated by degree of improvement in the Psoriasis Area and Severity Index (PASI) scores. Adverse events and reasons for discontinuation were also recorded.

          Results:

          The mean PASI improvement rate at weeks 4, 12, 24, and 36 was 63.5%, 77.7%, 78.7%, and 76.0%, respectively. Compared with reimbursed patients, nonreimbursed patients had a significantly lower baseline PASI and a shorter mean disease duration of psoriasis; they were more frequently biologic-naïve, had used less prior traditional antipsoriatic drugs and were more likely to be treated with secukinumab 150 mg. The effectiveness of secukinumab in nonreimbursed patients was superior despite higher discontinuation rates. Compared with patients without prior biologic failure, patients with prior biologic failure had a significantly lower mean PASI improvement at weeks 12, 24, 36, and 48. The decline in response rates to secukinumab tended to be more pronounced for patients who failed ustekinumab than tumor necrosis factor-α inhibitors. Moreover, the number of prior biologic failures was associated with a decreased response rate and increased likelihood of secondary loss of effectiveness of secukinumab therapy.

          Conclusion:

          In a real-life clinical setting, the characteristics of nonreimbursed patients receiving secukinumab treatment differed from those of reimbursed patients. The PASI improvement for secukinumab was substantial but lower than that in clinical trials. The number and classes of prior biologic failures impact the treatment response to secukinumab.

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          Most cited references36

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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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            Differential Drug Survival of Biologic Therapies for the Treatment of Psoriasis: A Prospective Observational Cohort Study from the British Association of Dermatologists Biologic Interventions Register (BADBIR).

            Drug survival reflects a drug's effectiveness, safety, and tolerability. We assessed the drug survival of biologics used to treat psoriasis in a prospective national pharmacovigilance cohort (British Association of Dermatologists Biologic Interventions Register (BADBIR)). The survival rates of the first course of biologics for 3,523 biologic-naive patients with chronic plaque psoriasis were compared using survival analysis techniques and predictors of discontinuation analyzed using a multivariate Cox proportional hazards model. Data for patients on adalimumab (n=1,879), etanercept (n=1,098), infliximab (n=96), and ustekinumab (n=450) were available. The overall survival rate in the first year was 77%, falling to 53% in the third year. Multivariate analysis showed that female gender (hazard ratio (HR) 1.22; 95% confidence interval (CI): 1.09-1.37), being a current smoker (HR 1.19; 95% CI: 1.03-1.38), and a higher baseline dermatology life quality index (HR 1.01; 95% CI: 1.00-1.02) were predictors of discontinuation. Presence of psoriatic arthritis (HR 0.82; 95% CI: 0.71-0.96) was a predictor for drug survival. As compared with adalimumab, patients on etanercept (HR 1.63; 95% CI: 1.45-1.84) or infliximab (HR 1.56; 95% CI: 1.16-2.09) were more likely to discontinue therapy, whereas patients on ustekinumab were more likely to persist (HR 0.48; 95% CI: 0.37-0.62). After accounting for relevant covariates, ustekinumab had the highest first-course drug survival. The results of this study will aid clinical decision making when choosing biologic therapy for psoriasis patients.
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              • Record: found
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              • Article: not found

              Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis.

              Real-life data on newer biological and biosimilar agents for moderate-to-severe psoriasis are lacking.
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                Author and article information

                Contributors
                Journal
                Ther Adv Chronic Dis
                Ther Adv Chronic Dis
                TAJ
                sptaj
                Therapeutic Advances in Chronic Disease
                SAGE Publications (Sage UK: London, England )
                2040-6223
                2040-6231
                17 April 2019
                2019
                : 10
                : 2040622319843756
                Affiliations
                [1-2040622319843756]Department of Dermatology, Chang Gung Memorial Hospital, Linkou Branch, Taoyuan
                [2-2040622319843756]School of Medicine, College of Medicine, Chang Gung University, Taoyuan
                [3-2040622319843756]Department of Dermatology, Chang Gung Memorial Hospital, Linkou Branch, Taoyuan, No.5, Fuxing Street, Guishan Dist., Taoyuan City 333
                [4-2040622319843756]School of Medicine, College of Medicine, Chang Gung University, Taoyuan
                [5-2040622319843756]Department of Dermatology, Chang Gung Memorial Hospital, Linkou Branch, Taoyuan
                [6-2040622319843756]School of Medicine, College of Medicine, Chang Gung University, Taoyuan
                [7-2040622319843756]Department of Dermatology, Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital, Linkou, Taipei
                [8-2040622319843756]Department of Dermatology, National Taiwan University Hospital, Taipei
                [9-2040622319843756]Department of Dermatology, College of Medicine, National Taiwan University, Taipei
                [10-2040622319843756]Department of Dermatology, National Taiwan University Hospital Hsin-Chu Branch, NO.25, Lane 442, Section 1, Jingguo Road, Hsinchu City 300
                [11-2040622319843756]Department of Dermatology, National Taiwan University Hospital, Taipei
                [12-2040622319843756]Department of Dermatology, College of Medicine, National Taiwan University, Taipei
                [13-2040622319843756]Institute of Biomedical Engineering, College of Medicine and College of Engineering, National Taiwan University, Taipei
                Author notes
                [†]

                These authors contributed equally.

                Author information
                https://orcid.org/0000-0002-1498-1474
                https://orcid.org/0000-0002-0493-9707
                Article
                10.1177_2040622319843756
                10.1177/2040622319843756
                6472156
                31024679
                8ee02e8e-1e74-409a-a92f-eab620679c07
                © The Author(s), 2019

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 2 October 2018
                : 20 March 2019
                Funding
                Funded by: Chang Gung Memorial Hospital, Linkou, FundRef https://doi.org/10.13039/501100005795;
                Award ID: CMRPG2F0332 and CMRPG1F0061
                Funded by: national taiwan university hospital, FundRef https://doi.org/10.13039/501100005762;
                Award ID: 106-HCH055 and 107-HCH057
                Categories
                Original Research
                Custom metadata
                January-December 2019

                biologic failure,real-world,reimbursement,secukinumab,tumor necrosis factor-α inhibitors,ustekinumab

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