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1. Tildrakizumab for treating moderate to severe plaque psoriasis

Tildrakizumab for treating moderate to severe plaque psoriasis Tildr Tildrakizumab for treating moder akizumab for treating moderate to ate to se sev vere plaque psoriasis ere plaque psoriasis T echnology appraisal guidance Published: 17 April 2019 nice.org.uk/guidance/ta575 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guidance represent (...) inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Tildrakizumab for treating moderate to severe plaque psoriasis (TA575) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 24Contents Contents 1 Recommendations 4 2 Information about

2019 National Institute for Health and Clinical Excellence - Technology Appraisals

2. Certolizumab pegol for treating moderate to severe plaque psoriasis

Certolizumab pegol for treating moderate to severe plaque psoriasis Certolizumab pegol for treating Certolizumab pegol for treating moder moderate to se ate to sev vere plaque psoriasis ere plaque psoriasis T echnology appraisal guidance Published: 17 April 2019 nice.org.uk/guidance/ta574 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guidance (...) inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Certolizumab pegol for treating moderate to severe plaque psoriasis (TA574) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 25Contents Contents 1 Recommendations 4 2 Information

2019 National Institute for Health and Clinical Excellence - Technology Appraisals

3. WITHDRAWN: Antistreptococcal interventions for guttate and chronic plaque psoriasis. (PubMed)

WITHDRAWN: Antistreptococcal interventions for guttate and chronic plaque psoriasis. Guttate psoriasis is a distinctive acute form of psoriasis which characteristically occurs in children and young adults. It is closely associated with preceding streptococcal sore throat or tonsillitis. Some authorities have claimed that ordinary (chronic plaque) psoriasis may also be made worse by infection at distant sites. Although many dermatologists have recommended using antibiotics for guttate psoriasis (...) in particular, it is not clear whether they influence the course of either form of psoriasis. Some dermatologists have also recommended tonsillectomy for psoriasis in patients with recurrent streptococcal sore throat.To assess the evidence for effectiveness of antistreptococcal interventions including antibiotics and tonsillectomy in the management of acute guttate and chronic plaque psoriasis.We searched the Cochrane Clinical Trials Register (Cochrane Library, Issue 3, 1999), Medline (1966- September 1999

2019 Cochrane

4. Antistreptococcal interventions for guttate and chronic plaque psoriasis. (PubMed)

Antistreptococcal interventions for guttate and chronic plaque psoriasis. Psoriasis is a chronic skin disease that affects approximately two per cent of the general population. Plaque psoriasis is the most common form: it usually appears as raised, red patches of inflamed skin, covered with silvery white scales. The patches often occur in a symmetrical pattern. Guttate psoriasis is a particular form of psoriasis with widespread, small erythematosquamous lesions. Streptococcal infection (...) is suspected to be a triggering factor for the onset of guttate psoriasis, and flare-up of chronic plaque psoriasis. The previous Cochrane Review on this topic was published in 2000; it required an update because antistreptococcal treatment continues to be used to treat psoriasis, especially for the acute form of guttate psoriasis.To assess the effects of antistreptococcal interventions for guttate and chronic plaque psoriasis.We searched Cochrane Skin Specialised Register, Cochrane Register of Studies

2019 Cochrane

5. Guselkumab (plaque psoriasis) - Benefit assessment according to §35a Social Code Book V

Guselkumab (plaque psoriasis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Guselkumab (Plaque-Psoriasis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 February 2018). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A17-60 Guselkumab (...) (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-60 Version 1.0 Guselkumab (plaque psoriasis) 27 February 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Guselkumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 23 November 2017

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

6. Guselkumab (plaque psoriasis) - Addendum to Commission A17-60

Guselkumab (plaque psoriasis) - Addendum to Commission A17-60 1 Translation of addendum A18-24 Guselkumab (Plaque-Psoriasis) – Addendum zum Auftrag A17-60 (Version 1.0; Status: 27 April 2018). Please note: This translation is provided as a service by IQWiG to English- language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 27 April 2018 1.0 Commission: A18-24 Version: Status: IQWiG Reports – Commission No. A18-24 Guselkumab (plaque (...) psoriasis) – Addendum to Commission A17-60 1 Addendum A18-24 Version 1.0 Guselkumab – Addendum to Commission A17-60 27 April 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Guselkumab (plaque psoriasis) – Addendum to Commission A17-60 Commissioning agency: Federal Joint Committee Commission awarded on: 9 April 2018 Internal Commission No.: A18-24 Address of publisher: Institut für Qualität und

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

7. Brodalumab (plaque psoriasis) - Addendum to Commission A17-42

Brodalumab (plaque psoriasis) - Addendum to Commission A17-42 1 Translation of addendum A18-02 Brodalumab (Plaque-Psoriasis) – Addendum zum Auftrag A17-42 (Version 1.0; Status: 26 January 2018). Please note: This translation is provided as a service by IQWiG to English- language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 26 January 2018 1.0 Commission: A18-02 Version: Status: IQWiG Reports – Commission No. A18-02 Brodalumab (...) (plaque psoriasis) – Addendum to Commission A17-42 1 Addendum A18-02 Version 1.0 Brodalumab – Addendum to Commission A17-42 26 January 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Brodalumab (plaque psoriasis) – Addendum to Commission A17-42 Commissioning agency: Federal Joint Committee Commission awarded on: 8 January 2018 Internal Commission No.: A18-02 Address of publisher: Institut

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

8. Risankizumab rzaa (Skyrizi) - To treat moderate-to-severe plaque psoriasis

Risankizumab rzaa (Skyrizi) - To treat moderate-to-severe plaque psoriasis Drug Approval Package: Skyrizi U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: Skyrizi Company: AbbVie, Inc. Application Number: 761105 Approval Date: 04/23/2019 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF) FDA Application Review Files (PDF) (PDF) (PDF) (PDF) (PDF

2019 FDA - Drug Approval Package

9. Certolizumab pegol (Cimzia) - the treatment of moderate to severe plaque psoriasis

Certolizumab pegol (Cimzia) - the treatment of moderate to severe plaque psoriasis 1 Published 08 April 2019 1 SMC2132 certolizumab pegol 200mg solution for injection in pre-filled syringe and pen (Cimzia®) UCB Pharma Ltd 8 March 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission (...) certolizumab pegol (Cimzia ® ) is accepted for restricted use within NHSScotland. Indication under review: the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy SMC restriction: patients who have failed to respond to standard systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contra- indication to these treatments. Certolizumab pegol has shown a similar reduction in the signs and symptoms of psoriasis

2019 Scottish Medicines Consortium

10. Tildrakizumab (Ilumetri) - treatment of adults with moderate to severe plaque psoriasis

Tildrakizumab (Ilumetri) - treatment of adults with moderate to severe plaque psoriasis Published 12 August 2019 1 SMC2167 tildrakizumab 100mg solution for injection in pre- filled syringe (Ilumetri®) Almirall Limited 5 July 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission (...) tildrakizumab (Ilumetri ® ) is accepted for restricted use within NHSScotland. Indication under review: The treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. SMC restriction: for use in patients who have failed to respond to conventional systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contraindication to these treatments. Tildrakizumab was superior to placebo in improving the signs and symptoms

2019 Scottish Medicines Consortium

11. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. (PubMed)

Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Psoriasis is an immune-mediated disease for which some people have a genetic predisposition. The condition manifests in inflammatory effects on either the skin or joints, or both, and it has a major impact on quality of life. Although there is currently no cure for psoriasis, various treatment strategies allow sustained control of disease signs and symptoms. Several randomised controlled trials (RCTs (...) of age) with moderate to severe plaque psoriasis or psoriatic arthritis whose skin had been clinically diagnosed with moderate to severe psoriasis, at any stage of treatment, in comparison to placebo or another active agent.Three groups of two review authors independently undertook study selection, data extraction, 'Risk of bias' assessment, and analyses. We synthesised the data using pair-wise and network meta-analysis (NMA) to compare the treatments of interest and rank them according

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2017 Cochrane

12. No Association between Thrombin Generation and Intra-Plaque Haemorrhage in Symptomatic Carotid Atherosclerotic Plaques: The Plaque at RISK (PARISK) Study. (PubMed)

No Association between Thrombin Generation and Intra-Plaque Haemorrhage in Symptomatic Carotid Atherosclerotic Plaques: The Plaque at RISK (PARISK) Study.  Carotid atherosclerosis is an important cause of stroke. Intra-plaque haemorrhage (IPH) on magnetic resonance imaging (MRI) increases stroke risk. Development of IPH is only partly understood. Thrombin is an essential enzyme in haemostasis. Experimental animal studies have shown conflicting results on the relation between thrombin and plaque (...) vulnerability. We hypothesize that decreased thrombin generation (TG) is associated with IPH and plaque vulnerability. This article investigates whether TG is associated with IPH and other features of plaque vulnerability in stroke patients. Recently symptomatic stroke patients underwent carotid MRI and blood sampling. MRI plaque features include plaque burden, presence of IPH, amount of lipid-rich necrotic core (LRNC), calcified tissue and fibrous tissue (% of total wall volume). TG was assessed

2018 Thrombosis and haemostasis

13. Co-localization of plaque macrophages with calcification is associated with a more vulnerable plaque phenotype and a greater calcification burden in coronary target segments as determined by OCT. (PubMed)

Co-localization of plaque macrophages with calcification is associated with a more vulnerable plaque phenotype and a greater calcification burden in coronary target segments as determined by OCT. The presence of plaque macrophages and microcalcifications are acknowledged features of plaque vulnerability. Experimental data suggest that microcalcifications promote inflammation and macrophages foster microcalcifications. However, co-localization of plaque macrophages and calcification (ColocCaMa (...) ) in coronary segments and its impact on plaque phenotype and lesion vulnerability is unexplored.Plaque morphology including ColocCaMa of calcified coronary target segments in patients with stable coronary artery disease (n = 116) was analyzed using optical coherence tomography (OCT) prior to coronary intervention. Therefore we considered macrophages co-localized with calcification if their distance in an OCT frame was <100μm and OCT-defined microcalcifications with a calcium arc <22.5°.ColocCaMa

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2018 PLoS ONE

14. Impact of combined plaque structural stress and wall shear stress on coronary plaque progression, regression, and changes in composition. (PubMed)

Impact of combined plaque structural stress and wall shear stress on coronary plaque progression, regression, and changes in composition. The focal distribution of atherosclerotic plaques suggests that local biomechanical factors may influence plaque development.We studied 40 patients at baseline and over 12 months by virtual-histology intravascular ultrasound and bi-plane coronary angiography. We calculated plaque structural stress (PSS), defined as the mean of the maximum principal stress (...) at the peri-luminal region, and wall shear stress (WSS), defined as the parallel frictional force exerted by blood flow on the endothelial surface, in areas undergoing progression or regression. Changes in plaque area, plaque burden (PB), necrotic core (NC), fibrous tissue (FT), fibrofatty tissue, and dense calcium were calculated for each co-registered frame. A total of 4029 co-registered frames were generated. In areas with progression, high PSS was associated with larger increases in NC and small

2019 European Heart Journal

15. [Brodalumab (plaque psoriasis) - benefit assessment according to õ35a Social Code Book V]

[Brodalumab (plaque psoriasis) - benefit assessment according to õ35a Social Code Book V] Brodalumab (Plaque-Psoriasis): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17-42; version 1.1 [Brodalumab (plaque psoriasis) – benefit assessment according to §35a Social Code Book V] Brodalumab (Plaque-Psoriasis): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17-42; version 1.1 [Brodalumab (plaque psoriasis) – benefit assessment according to §35a Social Code Book V (...) ] Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Brodalumab (Plaque-Psoriasis): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17-42; version 1.1. [Brodalumab (plaque psoriasis) – benefit assessment

2018 Health Technology Assessment (HTA) Database.

16. Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation

Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation Duarte A, Mebrahtu T, Goncalves P S, Harden M, Murphy R, Palmer S, Woolacott (...) N, Rodgers M & Rothery C. Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Duarte A, Mebrahtu T, Goncalves P S, Harden M, Murphy R, Palmer S, Woolacott N, Rodgers M & Rothery C.. Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people: systematic review and economic evaluation. Health Technology

2018 Health Technology Assessment (HTA) Database.

17. Targeted Immunomodulators for the Treatment of Moderate-to-Severe Plaque Psoriasis: Effectiveness and Value

Targeted Immunomodulators for the Treatment of Moderate-to-Severe Plaque Psoriasis: Effectiveness and Value ©Institute for Clinical and Economic Review, 2018 Targeted Immunomodulators for the Treatment of Moderate-to-Severe Plaque Psoriasis: Effectiveness and Value Condition Update Evidence Report June 12, 2018 Prepared for: ©Institute for Clinical and Economic Review, 2018 Page i Evidence Report: Targeted Immunomodulators for Plaque Psoriasis | Condition Update ICER Staff/Consultants (...) Immunomodulators for Plaque Psoriasis | Condition Update About ICER The Institute for Clinical and Economic Review (ICER) is an independent non-profit research organization that evaluates medical evidence and convenes public deliberative bodies to help stakeholders interpret and apply evidence to improve patient outcomes and control costs. The funding for this report comes from government grants and non-profit foundations, with the largest single funder being the Laura and John Arnold Foundation. No funding

2018 California Technology Assessment Forum

18. Targeted Immunomodulators for the Treatment of Moderate-to-Severe Plaque Psoriasis: Effectiveness and Value

Targeted Immunomodulators for the Treatment of Moderate-to-Severe Plaque Psoriasis: Effectiveness and Value ©Institute for Clinical and Economic Review, 2018 Targeted Immunomodulators for the Treatment of Moderate-to-Severe Plaque Psoriasis: Effectiveness and Value Condition Update Final Evidence Report August 03, 2018 Prepared for: ©Institute for Clinical and Economic Review, 2018 Page i Final Evidence Report: Plaque Psoriasis Condition Update ICER Staff/Consultants University of Washington (...) ii Final Evidence Report: Plaque Psoriasis Condition Update About ICER The Institute for Clinical and Economic Review (ICER) is an independent non-profit research organization that evaluates medical evidence and convenes public deliberative bodies to help stakeholders interpret and apply evidence to improve patient outcomes and control costs. The funding for this report comes from government grants and non-profit foundations, with the largest single funder being the Laura and John Arnold

2018 California Technology Assessment Forum

19. A novel workflow combining plaque imaging, plaque and plasma proteomics identifies biomarkers of human coronary atherosclerotic plaque disruption (PubMed)

A novel workflow combining plaque imaging, plaque and plasma proteomics identifies biomarkers of human coronary atherosclerotic plaque disruption Atherosclerotic plaque rupture is the culprit event which underpins most acute vascular syndromes such as acute myocardial infarction. Novel biomarkers of plaque rupture could improve biological understanding and clinical management of patients presenting with possible acute vascular syndromes but such biomarker(s) remain elusive. Investigation (...) of biomarkers in the context of de novo plaque rupture in humans is confounded by the inability to attribute the plaque rupture as the source of biomarker release, as plaque ruptures are typically associated with prompt down-stream events of myocardial necrosis and systemic inflammation.We developed a novel approach to identify potential biomarkers of plaque rupture by integrating plaque imaging, using optical coherence tomography, with both plaque and plasma proteomic analysis in a human model

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2017 Clinical proteomics

20. [Secukinumab (plaque psoriasis) - addendum to Commission A17-08]

[Secukinumab (plaque psoriasis) - addendum to Commission A17-08] Secukinumab (Plaque-Psoriasis): Addendum zum Auftrag A17-08; Auftrag A17-31 [Secukinumab (plaque psoriasis) - addendum to Commission A17-08] Secukinumab (Plaque-Psoriasis): Addendum zum Auftrag A17-08; Auftrag A17-31 [Secukinumab (plaque psoriasis) - addendum to Commission A17-08] Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Record Status This is a bibliographic record of a published health technology (...) assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Secukinumab (Plaque-Psoriasis): Addendum zum Auftrag A17-08; Auftrag A17-31. [Secukinumab (plaque psoriasis) - addendum to Commission A17-08] Cologne: Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). IQWiG-Berichte 529. 2017 Final publication URL Indexing Status Subject indexing

2017 Health Technology Assessment (HTA) Database.

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