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61. 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

62. 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

63. Pimecrolimus for the Treatment of Adults with Atopic Dermatitis, Seborrheic Dermatitis, or Psoriasis: A Review of Clinical and Cost-Effectiveness

Pimecrolimus for the Treatment of Adults with Atopic Dermatitis, Seborrheic Dermatitis, or Psoriasis: A Review of Clinical and Cost-Effectiveness Pimecrolimus for the Treatment of Adults with Atopic Dermatitis, Seborrheic Dermatitis, or Psoriasis: A Review of Clinical and Cost-Effectiveness | CADTH.ca Find the information you need Pimecrolimus for the Treatment of Adults with Atopic Dermatitis, Seborrheic Dermatitis, or Psoriasis: A Review of Clinical and Cost-Effectiveness Pimecrolimus (...) for the Treatment of Adults with Atopic Dermatitis, Seborrheic Dermatitis, or Psoriasis: A Review of Clinical and Cost-Effectiveness Published on: September 25, 2017 Project Number: RC0919-000 Product Line: Research Type: Drug Report Type: Summary with Critical Appraisal Result type: Report Question What is the clinical effectiveness of pimecrolimus for the treatment of adults with atopic dermatitis? What is the clinical effectiveness of pimecrolimus for the treatment of adults with seborrheic dermatitis? What

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

64. 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

65. Brodalumab (Kyntheum) - plaque psoriasis

Brodalumab (Kyntheum) - 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. 18 May 2017 EMA/381484/2017 Committee for Medicinal Products for Human Use (CHMP) Assessment report Kyntheum International non-proprietary (...) Kirin KLH Keyhole Limpet Hemocyanin LLOQ lower limit of quantification Assessment report EMA/381484/2017 Page 5/135 M750, M751 Surrogate antibodies against mouse IL-17RA MACE Major adverse cardiovascular event NOAEL No observed adverse effect level NOEL No observed effect level NRI Non-responder imputation PASI Psoriasis Area and Severity Index PASI 75 75% improvement in the Psoriasis Area and Severity Index PASI 90 90% improvement in the Psoriasis Area and Severity Index PASI 100 100% improvement

2017 European Medicines Agency - EPARs

66. Tremfya - guselkumab - Psoriasis, moderate to severe plaque

Tremfya - guselkumab - Psoriasis, moderate to severe plaque guselkumab | CADTH.ca Find the information you need guselkumab guselkumab Last Updated: April 5, 2018 Result type: Reports Project Number: SR0530-000 Product Line: Generic Name: guselkumab Brand Name: Tremfya Manufacturer: Janssen Inc. Indications: Psoriasis, moderate to severe plaque Submission Type: New Project Status: Complete Biosimilar: No Date Recommendation Issued: February 21, 2018 Recommendation Type: Reimburse with clinical

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

67. 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

68. 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

69. 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

70. Dimethyl fumarate (Skilarence) for the treatment of plaque psoriasis in adults

Dimethyl fumarate (Skilarence) for the treatment of plaque psoriasis in adults Dimethyl fumarate (Skilarence®) for the treatment of plaque psoriasis in adults | Report | National Health Care Institute You are here: Dimethyl fumarate (Skilarence®) for the treatment of plaque psoriasis in adults Search within English part of National Health Care Institute Search Dimethyl fumarate (Skilarence®) for the treatment of plaque psoriasis in adults The Minister of Health, Welfare and Sport (WVS) asked

2018 National Health Care Institute (Zorginstituut Nederland)

71. 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)

72. Development of the Psoriasis Symptoms Scale (PSS) in patients with moderate-to-severe psoriasis: qualitative and quantitative analyses. (Abstract)

Development of the Psoriasis Symptoms Scale (PSS) in patients with moderate-to-severe psoriasis: qualitative and quantitative analyses. Background: Psoriasis is a chronic inflammatory skin disease. Objective: To establish content validity and assess psychometric properties of the Psoriasis Symptoms Scale (PSS) in patients with moderate-to-severe psoriasis (Ps). Methods: The PSS is an eight-item patient-completed questionnaire assessing symptoms (itch, pain, stinging, burning), signs (redness

2019 Journal of Dermatological Treatment

73. 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)

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 PubMed abstract

74. 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

75. 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

76. The top ten research priorities for psoriasis in the UK; results of a James Lind Alliance psoriasis priority setting partnership. (Full text)

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 PubMed abstract

77. Psoriasis treat to target: defining outcomes in psoriasis using data from a real-world, population-based cohort study (the British Association of Dermatologists Biologics and Immunomodulators Register, BADBIR). (Full text)

Psoriasis treat to target: defining outcomes in psoriasis using data from a real-world, population-based cohort study (the British Association of Dermatologists Biologics and Immunomodulators Register, BADBIR). The 'treat to target' paradigm improves outcomes and reduces costs in chronic disease management but is not yet established in psoriasis.To identify treatment targets in psoriasis using two common measures of disease activity: Psoriasis Area and Severity Index (PASI) and Physician's (...) Global Assessment (PGA).Data from a multicentre longitudinal U.K. cohort of patients with psoriasis receiving systemic or biologic therapies (British Association of Dermatologists Biologics and Immunomodulators Register, BADBIR) were used to identify absolute PASI thresholds for 90% (PASI 90) and 75% (PASI 75) improvements in baseline disease activity, using receiver operating characteristic curves. The relationship between PGA (clear, almost clear, mild, moderate, moderate-severe, severe) and PASI

2019 British Journal of Dermatology PubMed abstract

78. Quality of Life in Psoriasis Vulgaris: Use of the ItchyQoL Question-naire in a Secukinumab Phase III Trial in Patients with Psoriasis Vulgaris. (Full text)

Quality of Life in Psoriasis Vulgaris: Use of the ItchyQoL Question-naire in a Secukinumab Phase III Trial in Patients with Psoriasis Vulgaris. Chronic pruritus is a bothersome symptom in psoriasis vulgaris and can profoundly reduce quality of life (QoL). In this exploratory analysis of the PSORITUS study, the impact of pruritus on QoL in 130 subjects with moderate-to-severe psoriasis was assessed using the ItchyQoL questionnaire. The majority of patients (n = 127) had to scratch their itchy (...) questionnaire as a validated tool responsive to treatment for detailed insights into chronic pruritus in patients with psoriasis.

2019 Acta Dermato-Venereologica PubMed abstract

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)

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 PubMed abstract

80. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy. (Full text)

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 PubMed abstract

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