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21. Dimethyl fumarate (psoriasis) - Benefit assessment according to §35a Social Code Book V

Dimethyl fumarate (psoriasis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Dimethylfumarat (Psoriasis vulgaris) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 December 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. A17-49 (...) Dimethyl fumarate (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-49 Version 1.0 Dimethyl fumarate (plaque psoriasis) 22 December 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Dimethyl fumarate (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

22. Psoriasis

Psoriasis Psoriasis - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Psoriasis Last reviewed: February 2019 Last updated: January 2019 Summary Lesions are red, inflamed, silvery-white scaly, and circumscribed papules and plaques; often affecting elbows, knees, extensor limbs, and scalp, and, less commonly, nails, ear, and umbilical region. Typically lifelong, with a fluctuating course of exacerbations and remission (...) of lesions, which may be aggravated by genetic, infectious, emotional, and environmental factors. Diagnosis is usually clinical. Mild or limited psoriasis is treated with topical corticosteroids and/or vitamin D analogues. Moderate to severe and/or extensive psoriasis may require phototherapy, and systemic agents such as oral retinoids, methotrexate, biological agents, ciclosporin or apremilast. Definition Psoriasis is a chronic inflammatory skin disease characterised by erythematous, circumscribed scaly

2018 BMJ Best Practice

23. Brodalumab (plaque psoriasis) ? Benefit assessment according to §35a Social Code Book V

Brodalumab (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 Brodalumab (Plaque-Psoriasis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.1; Status: 1 December 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. A17-42 Brodalumab (...) (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-42 Version 1.1 Brodalumab (plaque psoriasis) 1 December 2017 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) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 1 September 2017

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

24. Latin American Clinical Practice Guidelines on the Systemic Treatment of Psoriasis SOLAPSO - Sociedad Latinoamericana de Psoriasis (Latin American Psoriasis Society). Full Text available with Trip Pro

Latin American Clinical Practice Guidelines on the Systemic Treatment of Psoriasis SOLAPSO - Sociedad Latinoamericana de Psoriasis (Latin American Psoriasis Society). This Clinical Practice Guideline on the systemic treatment of Psoriasis includes the recommendations elaborated by a panel of experts from the Latin American Psoriasis Society SOLAPSO, who assessed the quality of the available evidence using the GRADE system and the PICO process to guide the literature search. To answer each (...) question, the experts discussed the results of randomized controlled trials, observational studies and metanalysis evaluating the interventions identified (non-biologics, biologics and phototherapy) in different populations of patients with moderate to severe plaque-psoriasis, which was summarized in Tables ad-hoc. The main end-points considered to assess efficacy were PASI 50, 75, 90 and 100, PGA 0-1 and significant improvement of health-related quality of life. Specific adverse events, either severe

2019 International Journal of Dermatology

25. Utilization of the validated Psoriasis Epidemiology Screening Tool (PEST) to identify signs and symptoms of psoriatic arthritis among those with psoriasis: a cross-sectional analysis from the US-based Corrona Psoriasis Registry. Full Text available with Trip Pro

Utilization of the validated Psoriasis Epidemiology Screening Tool (PEST) to identify signs and symptoms of psoriatic arthritis among those with psoriasis: a cross-sectional analysis from the US-based Corrona Psoriasis Registry. Despite increasing awareness of the disease, rates of undiagnosed psoriatic arthritis (PsA) are high in patients with psoriasis (PsO). The validated Psoriasis Epidemiology Screening Tool (PEST) is a five-item questionnaire developed to help identify PsA at an early

2019 Journal of the European Academy of Dermatology and Venereology

26. Observational study on Swedish plaque psoriasis patients receiving narrowband-UVB treatment show decreased S100A8/A9 protein and gene expression levels in lesional psoriasis skin but no effect on S100A8/A9 protein levels in serum. Full Text available with Trip Pro

Observational study on Swedish plaque psoriasis patients receiving narrowband-UVB treatment show decreased S100A8/A9 protein and gene expression levels in lesional psoriasis skin but no effect on S100A8/A9 protein levels in serum. S100A8 and S100A9 proteins are highly upregulated in patients with psoriasis and have been proposed as potential biomarkers for psoriasis. The present study was designed to analyze the effect of narrowband ultraviolet B therapy on these proteins. S100A8, S100A9 gene (...) expression and S100A8/A9 heterocomplex protein levels were analyzed in lesional and non-lesional skin before and after narrowband-UVB treatment in patients with chronic plaque type psoriasis. In addition, disease severity was measured by psoriasis area and severity index (PASI) and serum protein levels of S100A8/A9 were repeatedly analyzed. Narrowband-UVB treatment significantly reduced S100A8, S100A9 gene expression and S100A8/A9 protein levels in lesional skin while serum levels showed no significant

2019 PLoS ONE

27. 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

28. 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

29. Tildrakizumab (Ilumetri) - plaque psoriasis

Tildrakizumab (Ilumetri) - plaque psoriasis Ilumetri | European Medicines Agency Search Search Menu Ilumetri tildrakizumab Table of contents Authorised This medicine is authorised for use in the European Union. Overview Ilumetri is a medicine that acts on the immune system and is used to treat plaque psoriasis, a disease causing red, scaly patches on the skin. It is used in adults with moderate to severe disease for whom treatments applied to the skin are not suitable. Ilumetri contains (...) the tildrakizumab. Expand section Collapse section How is Ilumetri used? Ilumetri can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating plaque psoriasis. Ilumetri is available as a solution in pre-filled syringes for injection under the skin. The recommended dose is one 100 mg injection, followed by a further dose after 4 weeks and then an injection every 12 weeks. The dose may be increased to 200 mg in certain patients, for example

2018 European Medicines Agency - EPARs

30. Adalimumab (Hefiya) - Juvenile Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

Adalimumab (Hefiya) - Juvenile Rheumatoid Arthritis, 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, 2018. Reproduction is authorised provided the source is acknowledged. 31 May 2018 EMA/CHMP/520007/2018 Committee for Medicinal (...) (cell) NKIPC Non- Key in process control Assessment report EMA/CHMP/520007/2018 Page 6/128 NKPP Non-key process parameter NMR Nuclear magnetic resonance NSD Needle safety device NZW New Zealand White OOS Out of specification PACMP Post approval change management protocol PAR Proven Acceptable Ranges PASI Psoriasis area and severity index PASI50/75/90/100 Reduction of the PASI score by 50%, 75%, 90% or more or 100% PASI50/PASI75 Reduction of 50%/75% or more of the Psoriasis Area and Severity Index

2018 European Medicines Agency - EPARs

31. Adalimumab (Halimatoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

Adalimumab (Halimatoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, 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, 2018. Reproduction is authorised provided the source is acknowledged. 31 May 2018 (...) Neutralizing antibody NK Natural Killer (cell) NKIPC Non- Key in process control Assessment report EMA/CHMP/519681/2018 Page 6/128 NKPP Non-key process parameter NMR Nuclear magnetic resonance NSD Needle safety device NZW New Zealand White OOS Out of specification PACMP Post approval change management protocol PAR Proven Acceptable Ranges PASI Psoriasis area and severity index PASI50/75/90/100 Reduction of the PASI score by 50%, 75%, 90% or more or 100% PASI50/PASI75 Reduction of 50%/75% or more

2018 European Medicines Agency - EPARs

32. Dimethyl fumarate for treating moderate to severe plaque psoriasis

Dimethyl fumarate for treating moderate to severe plaque psoriasis Dimeth Dimethyl fumar yl fumarate for treating moder ate for treating moderate ate to se to sev vere plaque psoriasis ere plaque psoriasis T echnology appraisal guidance Published: 6 September 2017 nice.org.uk/guidance/ta475 © NICE 2018. 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. Dimethyl fumarate for treating moderate to severe plaque psoriasis (TA475) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 22Contents Contents 1 Recommendations 4 2 The technology 6

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

33. Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people

Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people Adalimumab, etanercept and Adalimumab, etanercept and ustekinumab for treating plaque psoriasis ustekinumab for treating plaque psoriasis in children and y in children and young people oung people T echnology appraisal guidance Published: 12 July 2017 nice.org.uk/guidance/ta455 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice (...) to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health 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. Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people (TA455) © NICE 2018. All rights reserved. Subject to Notice of rights (https

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

36. Tildrakizumab (Ilumya) - To treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Tildrakizumab (Ilumya) - To treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy Drug Approval Package: ILUMYA (tildrakizumab-asmn) U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: ILUMYA (tildrakizumab-asmn) Company: Merck Sharp & Dohme Corporation Application Number: 761067 Approval Date: 03/20/2018 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634

2018 FDA - Drug Approval Package

37. Ixekizumab for treating moderate to severe plaque psoriasis

Ixekizumab for treating moderate to severe plaque psoriasis Ix Ixekizumab for treating moder ekizumab for treating moderate to ate to se sev vere plaque psoriasis ere plaque psoriasis T echnology appraisal guidance Published: 26 April 2017 nice.org.uk/guidance/ta442 © NICE 2018. 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 the view of NICE (...) . 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. Ixekizumab for treating moderate to severe plaque psoriasis (TA442) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 27Contents Contents 1 Recommendations 4 2 The technology 5 3 Evidence 6 4

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

38. Infliximab (Zessly) - Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Psoriasis, Ankylosing Spondylitis

Infliximab (Zessly) - Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Psoriasis, Ankylosing Spondylitis 22 March 2018 EMA/223369/2018 Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report Zessly International non-proprietary name: infliximab Procedure No. EMEA/H/C/004647/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 30 Churchill Place ? Canary Wharf ? London E14 5EU (...) arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Psoriasis Zessly is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA. The legal basis for this application refers to: Article 10(4) of Directive 2001/83/EC

2018 European Medicines Agency - EPARs

39. 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

40. 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

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