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61. Siliq - brodalumab - Psoriasis, moderate to severe plaque

Siliq - brodalumab - Psoriasis, moderate to severe plaque brodalumab | CADTH.ca Find the information you need brodalumab brodalumab Last Updated: July 16, 2018 Result type: Reports Project Number: SR0547-000 Product Line: Generic Name: brodalumab Brand Name: Siliq Manufacturer: Valeant Canada LP Indications: Psoriasis, moderate to severe plaque Submission Type: New Project Status: Complete Biosimilar: No Date Recommendation Issued: June 20, 2018 Recommendation Type: Reimburse with clinical (...) period ended and validation of redacted CDR review report(s) received June 13, 2018 CDEC Final Recommendation issued to applicant and drug plans June 20, 2018 CDEC Final Recommendation posted June 22, 2018 Final CDR review report(s) and patient input posted July 16, 2018 Tags dermatology, psoriasis, brodalumab; siliq; psoriases; psoriatic Files Follow us: © 2019 Canadian Agency for Drugs and Technologies in Health Get our newsletter:

2017 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

62. Tacrolimus for the Treatment of Adults with Psoriasis or Vitiligo: A Review of the Clinical and Cost-Effectiveness

Tacrolimus for the Treatment of Adults with Psoriasis or Vitiligo: A Review of the Clinical and Cost-Effectiveness Tacrolimus for the Treatment of Adults with Psoriasis or Vitiligo: A Review of the Clinical and Cost-Effectiveness | CADTH.ca Find the information you need Tacrolimus for the Treatment of Adults with Psoriasis or Vitiligo: A Review of the Clinical and Cost-Effectiveness Tacrolimus for the Treatment of Adults with Psoriasis or Vitiligo: A Review of the Clinical and Cost (...) -Effectiveness Published on: October 11, 2017 Project Number: RC0920-000 Product Line: Research Type: Drug Report Type: Summary with Critical Appraisal Result type: Report Question What is the clinical effectiveness of tacrolimus for the treatment of adults with psoriasis? What is the clinical effectiveness of tacrolimus for the treatment of adults with vitiligo? What is the cost-effectiveness of tacrolimus for the treatment of adults with psoriasis? What is the cost-effectiveness of tacrolimus

2017 Canadian Agency for Drugs and Technologies in Health - Rapid Review

63. Guselkumab (Tremfya) - Psoriasis

Guselkumab (Tremfya) - 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 5520 Send a question via our website www.ema.europa.eu/contact 14 September 2017 EMA/692068/2017 Committee for Medicinal Products for Human Use (CHMP) Assessment report Tremfya International non-proprietary name: guselkumab Procedure No. EMEA/H/C/004271/0000 Note Assessment report as adopted by the CHMP (...) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Pharmaceutical form(s): Solution for injection (injection) Strength(s): 100 mg Route(s) of administration: Subcutaneous use Packaging: pre-filled syringe (glass) Package size(s): 1 pre-filled syringe Assessment report EMA/692068/2017 Page 3/148 Table of contents 1. Background information on the procedure 8 1.1. Submission of the dossier 8 2. Scientific discussion 10 2.1. Problem statement 10 2.1.1

2017 European Medicines Agency - EPARs

64. Adalimumab (Cyltezo) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

Adalimumab (Cyltezo) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis 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 (...) of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Medicinal product no longer authorised Assessment report EMA/CHMP/750187/2017 Page 8/115 Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1) and to improve physical function. Psoriasis Cyltezo is indicated

2017 European Medicines Agency - EPARs

65. 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

66. 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

67. 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

68. 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

69. Infliximab for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, ulcerative colitis and Crohn's disease

Infliximab for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, ulcerative colitis and Crohn's disease '); } else { document.write(' '); } ACE | Infliximab for the treatment of rheumatoid arthritis ankylosing spondylitis psoriatic arthritis plaque psoriasis ulcerative colitis and crohns disease Search > > Infliximab for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, ulcerative colitis (...) and Crohn's disease - Infliximab for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, ulcerative colitis and Crohn's disease Published on 1 March 2018 Guidance Recommendation The Ministry of Health’s Drug Advisory Committee has recommended: Infliximab biosimilar (Remsima) 100mg vial for the treatment of: Adults with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, chronic plaque psoriasis, ulcerative

2018 Appropriate Care Guides, Agency for Care Effectiveness (Singapore)

70. Etanercept (Lifmior) - rheumatoid arthritis, certain forms of juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis

Etanercept (Lifmior) - rheumatoid arthritis, certain forms of 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 17 July 2017 EMA/114647/2016 Corr.1 Committee for Medicinal Products for Human Use (CHMP) Assessment (...) report LIFMIOR International non-proprietary name: etanercept Procedure No. EMEA/H/C/004167/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/114647/2017 Page 2/19 Table of contents 1. Background information on the procedure 4 1.1. Submission of the dossier 4 Rheumatoid arthritis 4 Juvenile idiopathic arthritis 4 Psoriatic arthritis 4 Ankylosing spondylitis (AS) 5 Plaque psoriasis 5 Paediatric plaque psoriasis

2017 European Medicines Agency - EPARs

71. Brodalumab (Siliq) - To treat adults with moderate-to-severe plaque psoriasis

Brodalumab (Siliq) - To treat adults with moderate-to-severe plaque psoriasis Siliq (brodalumab) U.S. Department of Health and Human Services Search FDA Submit search Siliq (brodalumab) Siliq Company: Valeant Pharmaceuticals Application No.: 761032 Approval Date: 02/15/2017 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) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) Date created

2017 FDA - Drug Approval Package

72. Feasibility and Utility of the Psoriasis Symptom Inventory (PSI) in Clinical Care Settings: A Study from the International Psoriasis Council. Full Text available with Trip Pro

Feasibility and Utility of the Psoriasis Symptom Inventory (PSI) in Clinical Care Settings: A Study from the International Psoriasis Council. The Psoriasis Symptom Inventory (PSI) is a patient-reported outcome measure designed to assess psoriasis signs and symptoms.The aim was to assess the usefulness of the PSI in enhancing patient care in the clinical setting.Eight dermatology clinics in six countries enrolled adults representing the full spectrum of psoriasis severity who regularly received (...) care at the clinic. Patients were administered the eight-item PSI (score range 0-32; higher scores indicate greater severity) while waiting for the physician; the physician conducted a static physician global assessment (sPGA) and estimated psoriasis-affected body surface area (BSA) at the same visit. Physicians completed a brief questionnaire after each patient visit, and were interviewed about the PSI after all patients were seen.The clinics enrolled 278 patients; mean [standard deviation (SD

2019 American journal of clinical dermatology

73. The association of scalp psoriasis with overall psoriasis severity and koebnerization in children: cross-sectional findings from the Dutch ChildCAPTURE registry. (Abstract)

The association of scalp psoriasis with overall psoriasis severity and koebnerization in children: cross-sectional findings from the Dutch ChildCAPTURE registry. Scalp psoriasis can be a physical and psychological burden for patients irrespective of overall psoriasis severity and is difficult to treat. Studies on scalp psoriasis in children and potential associations with clinical characteristics are sparse. In children, the scalp is commonly reported as the initial site of presentation (...) and scalp psoriasis tends to develop more frequently in girls than in boys. One multicenter study reported scalp psoriasis more frequently in severe psoriasis versus moderate psoriasis but the finding did not reach statistical significance. This article is protected by copyright. All rights reserved.This article is protected by copyright. All rights reserved.

2019 British Journal of Dermatology

74. Psoriasis and liver fibrosis: an investigation using transient elastography in Tunisian patients with psoriasis. (Abstract)

Psoriasis and liver fibrosis: an investigation using transient elastography in Tunisian patients with psoriasis. We investigated the prevalence of liver fibrosis in psoriatic patients and evaluated the factors associated with liver fibrosis in this population. We enrolled 112 patients with psoriasis aged of 18 years or older. We excluded pregnant women, patients with known liver diseases, heavy alcohol drinkers and regular users of hepatotoxic medications other than methotrexate. Psoriasis (...) was defined as severe in following conditions: PASI≥10, or generalized pustular, erythrodermic or arthropathic psoriasis, or requirement of a systemic medication. Anthropometric measurements were performed. This article is protected by copyright. All rights reserved.This article is protected by copyright. All rights reserved.

2019 British Journal of Dermatology

75. The top ten research priorities for psoriasis in the UK; results of a James Lind Alliance psoriasis priority setting partnership. Full Text available with Trip Pro

The top ten research priorities for psoriasis in the UK; results of a James Lind Alliance psoriasis priority setting partnership. Psoriasis is an immune-mediated inflammatory skin disease, with a prevalence of 0·09% to 11·4%, which affects approximately two million people in the U.K.1,2 It has a significant psychological and social impact on affected individuals, is associated with co-morbidities such as depression, cardiovascular disease and inflammatory arthritis, and confers a substantial (...) economic burden on the National Health Service.1-3 Access to appropriate care that addresses the high health-care burden and complex interlinked physical, psychological and social needs of those who have psoriasis is often poor. This article is protected by copyright. All rights reserved.This article is protected by copyright. All rights reserved.

2019 British Journal of Dermatology

76. Absolute and Relative Psoriasis Area and Severity Indices (PASI) for Comparison of the Efficacy of Ixekizumab to Etanercept and Placebo in Patients with Moderate-to-severe Plaque Psoriasis: An Integrated Analysis of UNCOVER-2 and UNCOVER-3 Outcomes. Full Text available with Trip Pro

Absolute and Relative Psoriasis Area and Severity Indices (PASI) for Comparison of the Efficacy of Ixekizumab to Etanercept and Placebo in Patients with Moderate-to-severe Plaque Psoriasis: An Integrated Analysis of UNCOVER-2 and UNCOVER-3 Outcomes. Treatment goals defined by the absolute Psoriasis Area and Severity Index (PASI) scores offer certain advantages in the clinical setting. In order to investigate potential treatment targets, this study evaluated absolute PASI outcomes relative (...) to other measures of response using data from two randomized clinical trials of patients with moderate-to-severe psoriasis treated with ixekizumab, etanercept, or placebo (n=2,567). Response was assessed throughout 12 weeks as the proportion of patients achieving absolute PASI band cut-offs who also reached established response criteria. Most PASI band ≤2 responders also achieved PASI 90 (70.1-100%), static Physician's Global Assessment (0,1) (91.3-96.1%), Dermatology Life Quality Index (0,1) (63.0

2019 Acta Dermato-Venereologica

77. Re-Categorization of Psoriasis Severity: Delphi Consensus from the International Psoriasis Council. Full Text available with Trip Pro

Re-Categorization of Psoriasis Severity: Delphi Consensus from the International Psoriasis Council. Psoriasis severity categories have been important tools for clinicians to use in treatment decisions as well as to determine eligibility criteria for clinical studies. However, due to the heterogeneity of severity classifications and their lack of consideration for the impact of psoriasis involvement of special areas or past treatment history, patients may be mis-categorized, which can lead (...) to under-treatment of psoriasis.To develop a consensus statement on the classification of psoriasis severity.A modified Delphi approach was developed by the International Psoriasis Council to define psoriasis severity.After completion of the exercise, seven severity definitions were preferentially ranked. This most preferred statement rejects the mild, moderate and severe categories in favor of a dichotomous definition: Psoriasis patients should be classified as either candidates for topical therapy

2019 Journal of American Academy of Dermatology

78. Secukinumab demonstrates improvements in absolute and relative psoriasis area severity indices in moderate-to-severe plaque psoriasis: results from a European, multicentric, retrospective, real-world study. Full Text available with Trip Pro

Secukinumab demonstrates improvements in absolute and relative psoriasis area severity indices in moderate-to-severe plaque psoriasis: results from a European, multicentric, retrospective, real-world study. Objective: This European, multicentric, retrospective study aimed to collect data on secukinumab effectiveness in a real-world setting. Research design and methods: All psoriatic patients starting secukinumab between January 2016 and February 2017 in 11 European centers were followed until (...) February 2018 and retrospectively evaluated. Main outcome measures: Secukinumab effectiveness was assessed by relative improvement from baseline of the Psoriasis Area Severity Index (PASI) and absolute PASI score modifications throughout 52 weeks of therapy. Additionally measures assessing effectiveness were used, including improvements of body surface area (BSA) and Dermatology Life Quality Index (DLQI). Results: Out of the 330 patients with potentially 52-week treatment duration, naïve to biologics

2019 Journal of Dermatological Treatment

79. Characterization of insufficient responders to anti-tumor necrosis factor therapies in patients with moderate to severe psoriasis: real-world data from the US Corrona Psoriasis Registry. Full Text available with Trip Pro

Characterization of insufficient responders to anti-tumor necrosis factor therapies in patients with moderate to severe psoriasis: real-world data from the US Corrona Psoriasis Registry. Objective: Biologic therapies have dramatically changed the management of moderate to severe psoriasis; however, few US real-world studies characterize the unmet needs of patients who do not respond to biologic therapies. This study examined the characteristics at enrollment of patients with moderate to severe (...) psoriasis who had insufficient responses to anti-tumor necrosis factor therapies (anti-TNFs). Methods: Patients enrolled in the Corrona Psoriasis Registry from April 2015 to June 2018 who initiated an anti-TNF at enrollment were stratified on the basis of body surface area (BSA) improvement to <3% or a 75% improvement from enrollment to the 6-month follow-up visit (response versus insufficient response). Patient demographics and disease characteristics were described at enrollment, and changes

2019 Journal of Dermatological Treatment

80. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy. Full Text available with Trip Pro

Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy. Psoriasis is a chronic inflammatory disease involving multiple organ systems and affecting approximately 3.2% of the world's population. In this section of the guidelines of care for psoriasis, we will focus the discussion on ultraviolet (UV) light-based therapies, which include narrowband and broadband UVB, UVA in conjunction (...) with photosensitizing agents, targeted UVB treatments such as with an excimer laser, and several other modalities and variations of these core phototherapies, including newer applications of pulsed dye lasers, intense pulse light, and light-emitting electrodes. We will provide an in-depth, evidence-based discussion of efficacy and safety for each treatment modality and provide recommendations and guidance for the use of these therapies alone or in conjunction with other topical and/or systemic psoriasis

2019 Journal of American Academy of Dermatology

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