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1. Risankizumab for treating moderate to severe plaque psoriasis

Risankizumab for treating moderate to severe plaque psoriasis Risankizumab for treating moder Risankizumab for treating moderate to ate to se sev vere plaque psoriasis ere plaque psoriasis T echnology appraisal guidance Published: 21 August 2019 www.nice.org.uk/guidance/ta596 © 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. Risankizumab for treating moderate to severe plaque psoriasis (TA596) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 13Contents Contents 1 Recommendations 4 2 Information about

2019 National Institute for Health and Clinical Excellence - Technology Appraisals

2. 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

3. 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

4. WITHDRAWN: Antistreptococcal interventions for guttate and chronic plaque psoriasis. Full Text available with Trip Pro

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

5. Guselkumab for treating moderate to severe plaque psoriasis

Guselkumab for treating moderate to severe plaque psoriasis Guselkumab for treating moder Guselkumab for treating moderate to ate to se sev vere plaque psoriasis ere plaque psoriasis T echnology appraisal guidance Published: 13 June 2018 nice.org.uk/guidance/ta521 © 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 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. Guselkumab for treating moderate to severe plaque psoriasis (TA521) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 14Contents Contents 1 Recommendations 4 2 Information about guselkumab 6 3

2018 National Institute for Health and Clinical Excellence - Technology Appraisals

6. Brodalumab for treating moderate to severe plaque psoriasis

Brodalumab for treating moderate to severe plaque psoriasis Brodalumab for treating moder Brodalumab for treating moderate to ate to se sev vere plaque psoriasis ere plaque psoriasis T echnology appraisal guidance Published: 21 March 2018 nice.org.uk/guidance/ta511 © 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. Brodalumab for treating moderate to severe plaque psoriasis (TA511) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 20Contents Contents 1 Recommendations 4 2 Information about brodalumab 6 3

2018 National Institute for Health and Clinical Excellence - Technology Appraisals

7. 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)

8. 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)

9. 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)

10. Antistreptococcal interventions for guttate and chronic plaque psoriasis. Full Text available with Trip Pro

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

11. Risankizumab (plaque psoriasis) - Addendum to Commission A19-41

Risankizumab (plaque psoriasis) - Addendum to Commission A19-41 1 Translation of addendum A19-87 Risankizumab (Plaque-Psoriasis) – Addendum zum Auftrag A19-41 (Version 1.0; Status: 30 October 2019). 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 30 October 2019 1.0 Commission: A19-87 Version: Status: IQWiG Reports – Commission No. A19-87 Risankizumab (...) (plaque psoriasis) – Addendum to Commission A19-41 1 Addendum A19-87 Version 1.0 Risankizumab – Addendum to Commission A19-41 30 October 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Risankizumab (plaque psoriasis) – Addendum to Commission A19-41 Commissioning agency Federal Joint Committee Commission awarded on 7 October 2019 Internal Commission No. A19-87 Address of publisher Institut für

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Tildrakizumab (plaque psoriasis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Tildrakizumab (Plaque-Psoriasis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 February 2019). Please note: This document was translated by an external translator and 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. A18-78 Tildrakizumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-78 Version 1.0 Tildrakizumab (plaque psoriasis) 13 February 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Tildrakizumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

Risankizumab (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 Risankizumab (Plaque-Psoriasis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 29 August 2019). 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. A19-41 (...) Risankizumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-41 Version 1.0 Risankizumab (plaque psoriasis) 29 August 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Risankizumab (plaque psoriasis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 2 May

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

14. Certolizumab pegol (Cimzia) - Psoriasis, moderate to severe plaque

Certolizumab pegol (Cimzia) - Psoriasis, moderate to severe plaque certolizumab pegol | CADTH.ca Find the information you need certolizumab pegol certolizumab pegol Last Updated: October 3, 2019 Result type: Reports Project Number: SR0587-000 Product Line: Generic Name: certolizumab pegol Brand Name: Cimzia Manufacturer: UCB Canada Inc. Indications: Psoriasis, moderate to severe plaque Manufacturer Requested Reimbursement Criteria 1 : For the treatment of adult patients with moderate to severe (...) plaque psoriasis who are candidates for systemic therapy. Submission Type: New Indication Project Status: Active Biosimilar: No Fee Schedule: Schedule A The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable. Key Milestones 2 Call for patient input posted October 15, 2018 Patient group input closed December 03, 2018 Clarification: - Patient

2019 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

15. Risankizumab (Skyrizi) - patients with moderate to severe plaque psoriasis

Risankizumab (Skyrizi) - patients with moderate to severe plaque psoriasis Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved

2019 Health Canada - Drug and Health Product Register

16. 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

17. 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)

18. 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

19. 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

20. 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

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