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21. Cyclosporine for Moderate to Severe Plaque Psoriasis in Adults: A Review of Clinical Effectiveness and Safety

Cyclosporine for Moderate to Severe Plaque Psoriasis in Adults: A Review of Clinical Effectiveness and Safety Cyclosporine for Moderate to Severe Plaque Psoriasis in Adults: A Review of Clinical Effectiveness and Safety | CADTH.ca Find the information you need Cyclosporine for Moderate to Severe Plaque Psoriasis in Adults: A Review of Clinical Effectiveness and Safety Cyclosporine for Moderate to Severe Plaque Psoriasis in Adults: A Review of Clinical Effectiveness and Safety Last updated (...) : April 3, 2018 Project Number: RC0979-000 Product Line: Research Type: Drug Report Type: Summary with Critical Appraisal Result type: Report Question What is the clinical effectiveness of cyclosporine for moderate to severe plaque psoriasis in adults? What is the short and long-term safety of cyclosporine for moderate to severe plaque psoriasis in adults? Key Message Three systematic reviews, two randomized-controlled trials (RCTs), and nine non-randomized studies of safety outcomes formed

2018 Canadian Agency for Drugs and Technologies in Health - Rapid Review

22. Skyrizi - risankizumab - Psoriasis, moderate to severe plaque

Skyrizi - risankizumab - Psoriasis, moderate to severe plaque risankizumab | CADTH.ca Find the information you need risankizumab risankizumab Last Updated: June 24, 2019 Result type: Reports Project Number: SR0583-000 Product Line: Generic Name: risankizumab Brand Name: Skyrizi Manufacturer: AbbVie Corporation Indications: Psoriasis, moderate to severe plaque Manufacturer Requested Reimbursement Criteria 1 : Reimburse in a manner similar to other biologics for the treatment of moderate (...) -to-severe plaque psoriasis. Treatment should be discontinued if a response (PASI75) to treatment with risankizumab has not been demonstrated after 16 weeks. Submission Type: New Project Status: Complete Biosimilar: No Companion Diagnostics: No Date Recommendation Issued: May 28, 2019 Recommendation Type: Reimburse with clinical criteria and/or conditions Fee Schedule: Schedule A The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH

2018 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

23. 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

24. 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

25. Risankizumab (Skyrizi) - plaque psoriasis

Risankizumab (Skyrizi) - plaque psoriasis 1 Published 07 October 2019 1 SMC2196 risankizumab 75mg solution for injection in pre-filled syringe (Skyrizi®) AbbVie Ltd 06 September 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 risankizumab (Skyrizi ® ) is accepted for restricted (...) use within NHSScotland. Indication under review: for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SMC restriction: for 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. Risankizumab was superior to placebo, a tumour necrosis factor antagonist, and an interleukin 12/23 antagonist in improving

2019 Scottish Medicines Consortium

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

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

27. Secukinumab (plaque psoriasis) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

Secukinumab (plaque psoriasis) - Benefit assessment according to §35a Social Code Book V (new scientific findings) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Secukinumab (Plaque-Psoriasis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 May 2017). 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. A17-08 Secukinumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V 1 (new scientific findings) Extract of dossier assessment A17-08 Version 1.0 Secukinumab (plaque psoriasis) 30 May 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Secukinumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

28. Ixekizumab (plaque psoriasis) - Addendum to Commission A17-07

Ixekizumab (plaque psoriasis) - Addendum to Commission A17-07 1 Translation of addendum A17-30 Ixekizumab (Plaque Psoriasis) – Addendum zum Auftrag A17-07 (Version 1.0; Status: 28 July 2017). 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 28 July 2017 1.0 Commission: A17-30 Version: Status: IQWiG Reports – Commission No. A17-30 Ixekizumab (plaque (...) psoriasis) – Addendum to Commission A17-07 1 Addendum A17-30 Version 1.0 Ixekizumab – Addendum to Commission A17-07 28 July 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ixekizumab (plaque psoriasis) – Addendum to Commission A17-07 Commissioning agency: Federal Joint Committee Commission awarded on: 11 July 2017 Internal Commission No.: A17-30 Address of publisher: Institut für Qualität und

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

29. [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.

30. 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.

31. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Full Text available with Trip Pro

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

2017 Cochrane

32. 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. Full Text available with Trip Pro

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

2018 PLoS ONE

33. Fractal analysis of plaque border, a novel method for the quantification of atherosclerotic plaque contour irregularity, is associated with pro-atherogenic plasma lipid profile in subjects with non-obstructive carotid stenoses. Full Text available with Trip Pro

Fractal analysis of plaque border, a novel method for the quantification of atherosclerotic plaque contour irregularity, is associated with pro-atherogenic plasma lipid profile in subjects with non-obstructive carotid stenoses. Plaque border irregularity is a known imaging characteristic of vulnerable plaques, but its evaluation heavily relies on subjective evaluation and operator expertise. Aim of the present work is to propose a novel fractal-analysis based method for the quantification (...) of atherosclerotic plaque border irregularity and assess its relation with cardiovascular risk factors.Forty-two asymptomatic subjects with carotid stenosis underwent ultrasound evaluation and assessment of cardiovascular risk factors. Total, low-density lipoprotein (LDL), high-density lipoprotein (HDL) plasma cholesterol and triglycerides concentrations were measured for each subject. Fractal analysis was performed in all the carotid segments affected by atherosclerosis, i.e. 147 segments. The resulting fractal

2018 PLoS ONE

34. 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

35. Guselkumab (Tremfya) - Treatment of moderate to severe plaque psoriasis

Guselkumab (Tremfya) - Treatment of moderate to severe plaque psoriasis Published 11 June 2018 1 guselkumab 100mg solution for injection (Tremfya ® ) SMC No 1340/18 Janssen 4 May 2018 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 NHS Scotland. The advice is summarised as follows: ADVICE: following a full submission guselkumab (Tremfya ® ) is accepted for restricted (...) use within NHS Scotland. Indication under review: Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SMC restriction: for 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. In two phase III studies, guselkumab was superior to a TNF inhibitor in improving symptoms of moderate to severe plaque psoriasis

2018 Scottish Medicines Consortium

36. Brodalumab (Kyntheum) - for the treatment of moderate to severe plaque psoriasis

Brodalumab (Kyntheum) - for the treatment of moderate to severe plaque psoriasis Published 7 May 2018 1 Re-Submission brodalumab 210mg solution for injection in pre-filled syringe (Kyntheum ® ) SMC No 1283/17 Leo Laboratories Ltd 6 April 2018 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 NHS Scotland. The advice is summarised as follows: ADVICE: following (...) a resubmission brodalumab (Kyntheum ® ) is accepted for restricted use within NHS Scotland. Indication under review: for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. SMC restriction: for 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. Brodalumab was superior to placebo and to an alternative interleukin

2018 Scottish Medicines Consortium

37. Etanercept (Erelzi) - rheumatoid arthritis, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis

Etanercept (Erelzi) - rheumatoid arthritis, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 21 April 2017 EMA (...) with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Assessment report EMA/CHMP/302222/2017 Page 7/81 Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). Plaque psoriasis

2017 European Medicines Agency - EPARs

38. Dimethyl fumarate (Skilarence) - plaque psoriasis

Dimethyl fumarate (Skilarence) - plaque psoriasis 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 21 April 2017 EMA/412737/2017 Committee for Medicinal Products for Human Use (CHMP) Assessment report Skilarence International non (...) to the centralised procedure was agreed upon by the EMA/CHMP on 21 May 2015. The eligibility to the centralised procedure under Article 3(2)(b) of Regulation (EC) No 726/2004 was based on demonstration of interest of patients at Community level. The applicant applied for the following indication: treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy. The legal basis for this application refers to: Article 8(3) of Directive 2001/83/EC - complete and independent

2017 European Medicines Agency - EPARs

39. Guselkumab (Tremfya) - For the treatment of adult patients with moderate-to-severe plaque psoriasis

Guselkumab (Tremfya) - For the treatment of adult patients with moderate-to-severe plaque psoriasis TREMFYA (guselkumab) Injection U.S. Department of Health and Human Services Search FDA Submit search TREMFYA (guselkumab) Injection TREMFYA Company: Janssen Biotech, Inc. Application No.: 761061 Approval Date: 07/13/2017 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) Date created

2017 FDA - Drug Approval Package

40. Dimethyl fumarate (Skilarence) - plaque psoriasis

Dimethyl fumarate (Skilarence) - plaque psoriasis Published 9 April 2018 1 dimethyl fumarate 30mg and 120mg gastro-resistant tablets (Skilarence ® ) SMC No 1313/18 Almirall Limited 9 March 2018 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 NHS Scotland. The advice is summarised as follows: ADVICE: following a full submission dimethyl fumarate (Skilarence ® (...) ) is accepted for restricted use within NHS Scotland. Indication under review: for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy. SMC restriction: for use in patients in whom other non-biologic systemic treatments (methotrexate, ciclosporin and acitretin) are not appropriate or have failed and who are considered unsuitable for biologic therapy given their current disease state or personal preference. In a 16 week, double-blind, phase III study, dimethyl

2018 Scottish Medicines Consortium

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