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Psoriatic Arthritis

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

Adalimumab (Idacio) - Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Hidradenitis Suppurativa, Colitis, Ulcerative, Crohn Disease EMA/85985/2019 EMEA/H/C/004475 Idacio (adalimumab) An overview of Idacio and why it is authorised in the EU What is Idacio and what is it used for? Idacio is a medicine that acts on the immune system (the body’s natural defences) and is used to treat the following conditions: • plaque (...) psoriasis (a disease causing red, scaly patches on the skin); • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints); • rheumatoid arthritis (a disease causing inflammation of the joints); • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when there are clear signs of inflammation but X-ray does not show disease; • polyarticular juvenile idiopathic arthritis and active enthesitis-related

2019 European Medicines Agency - EPARs

2. 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 (...) of the Psoriasis Area and Severity Index (PASI) score PBMC Peripheral blood mononuclear cells PC Process characterisation PD Pharmacodynamics PETG Polyethylene tetraphthalate copolymer PFS Pre-filled syringe Ph. Eur. European Pharmacopoeia PK Pharmacokinetics PP Process parameters PPS Per-protocol analysis set PPso Plaque Psoriasis PsA Psoriatic Arthritis PsO; Ps Psoriasis p.v. Paravenous PV Process validation R2 adj Adjusted correlation coefficient RA Rheumatoid Arthritis RGA Reporter Gene Assay s.c

2018 European Medicines Agency - EPARs

3. Adalimumab (Hyrimoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Papulosquamous Skin Diseases, Hidradenitis Suppurativa, Ankylosing Spondylitis, Uveitis

Adalimumab (Hyrimoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Papulosquamous Skin Diseases, Hidradenitis Suppurativa, Ankylosing Spondylitis, Uveitis 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how (...) an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Hyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Hyrimoz is indicated for the treatment of active and progressive psoriatic arthritis

2018 European Medicines Agency - EPARs

4. 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 (...) patients who have responded inadequately to conventional therapy. Psoriatic arthritis Zessly is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Zessly should be administered • in combination with methotrexate • or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated Infliximab has been shown to improve physical function in patients with psoriatic

2018 European Medicines Agency - EPARs

5. 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 (...) years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Etanercept has not been studied in children aged less than 2 years

2017 European Medicines Agency - EPARs

6. 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 (...) with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS Cyltezo is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. Psoriatic arthritis Cyltezo is indicated for the treatment

2017 European Medicines Agency - EPARs

7. 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

8. Abatacept for treating psoriatic arthritis after DMARDs (terminated appraisal)

Abatacept for treating psoriatic arthritis after DMARDs (terminated appraisal) Abatacept for treating psoriatic arthritis Abatacept for treating psoriatic arthritis after DMARDs (terminated appr after DMARDs (terminated appraisal) aisal) T echnology appraisal guidance Published: 13 March 2019 nice.org.uk/guidance/ta568 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Contents Contents Advice 3 Information 3 Abatacept (...) for treating psoriatic arthritis after DMARDs (terminated appraisal) (TA568) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 3Advice Advice NICE is unable to make a recommendation about the use in the NHS of abatacept for treating psoriatic arthritis after disease modifying anti-rheumatic drugs (DMARDs) because Bristol–Myers Squibb Pharmaceuticals Ltd did not provide an evidence submission. The company has confirmed

2019 National Institute for Health and Clinical Excellence - Technology Appraisals

9. Tofacitinib for treating active psoriatic arthritis after inadequate response to DMARDs

Tofacitinib for treating active psoriatic arthritis after inadequate response to DMARDs T T ofacitinib for treating activ ofacitinib for treating active psoriatic e psoriatic arthritis after inadequate response to arthritis after inadequate response to DMARDs DMARDs T echnology appraisal guidance Published: 3 October 2018 nice.org.uk/guidance/ta543 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our (...) 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. T ofacitinib for treating active psoriatic arthritis after inadequate response to DMARDs (TA543) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk

2018 National Institute for Health and Clinical Excellence - Technology Appraisals

10. Ixekizumab for treating active psoriatic arthritis after inadequate response to DMARDs

Ixekizumab for treating active psoriatic arthritis after inadequate response to DMARDs Ix Ixekizumab for treating activ ekizumab for treating active psoriatic e psoriatic arthritis after inadequate response to arthritis after inadequate response to DMARDs DMARDs T echnology appraisal guidance Published: 8 August 2018 nice.org.uk/guidance/ta537 © 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 (...) , 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. Ixekizumab for treating active psoriatic arthritis after inadequate response to DMARDs (TA537) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice

2018 National Institute for Health and Clinical Excellence - Technology Appraisals

11. Ixekizumab (psoriatic arthritis) - Benefit assessment according to §35a Social Code Book V

Ixekizumab (psoriatic arthritis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Ixekizumab (Psoriasis Arthritis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 May 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. A18-14 Ixekizumab (...) (psoriatic arthritis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-14 Version 1.0 Ixekizumab (psoriatic arthritis) 30 May 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ixekizumab (psoriatic arthritis) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 20 February 2018

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

12. Ixekizumab (psoriatic arthritis) - Addendum to Commission A18-14

Ixekizumab (psoriatic arthritis) - Addendum to Commission A18-14 1 Translation of addendum A18-47 Ixekizumab (Psoriasis Arthritis) – Addendum zum Auftrag A18-14 (Version 1.0; Status: 26 July 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 July 2018 1.0 Commission: A18-47 Version: Status: IQWiG Reports – Commission No. A18-47 Ixekizumab (...) (psoriatic arthritis) – Addendum to Commission A18-14 1 Addendum A18-47 Version 1.0 Ixekizumab – Addendum to Commission A18-14 26 July 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Ixekizumab (psoriatic arthritis) – Addendum to Commission A18-14 Commissioning agency: Federal Joint Committee Commission awarded on: 9 July 2018 Internal Commission No.: A18-47 Address of publisher: Institut für

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

13. Tofacitinib (psoriatic arthritis) - Benefit assessment according to §35a Social Code Book V

Tofacitinib (psoriatic arthritis) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Tofacitinib (Psoriasis Arthritis) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 28 November 2018). 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. A18-51 Tofacitinib (psoriatic arthritis) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-51 Version 1.0 Tofacitinib (psoriatic arthritis) 28 November 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Tofacitinib (psoriatic arthritis) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

14. 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)

15. Psoriatic arthritis

Psoriatic arthritis Psoriatic arthritis - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Psoriatic arthritis Last reviewed: February 2019 Last updated: March 2018 Summary Polyarticular psoriatic arthritis distinguished from rheumatoid arthritis by the presence of dactylitis and the absence of anticyclic citrullinated peptide antibodies. Non-steroidal anti-inflammatory drugs (NSAIDs) usually sufficient to treat limited (...) disease. Patients with progressive peripheral arthritis (polyarthritis, joint erosions) or oligoarthritis refractory to NSAIDs and/or intra-articular corticosteroids require disease-modifying antirheumatic disease therapy (e.g., methotrexate) early in the disease course. Tumour necrosis factor (TNF)-alpha inhibitors may be considered as second-line therapy for most disease manifestations. Definition Psoriatic arthritis is a chronic inflammatory joint disease associated with psoriasis

2018 BMJ Best Practice

16. Taltz - ixekizumab - Arthritis, psoriatic

Taltz - ixekizumab - Arthritis, psoriatic ixekizumab | CADTH.ca Find the information you need ixekizumab ixekizumab Last Updated: August 31, 2018 Result type: Reports Project Number: SR0558-000 Product Line: Generic Name: ixekizumab Brand Name: Taltz Manufacturer: Eli Lilly Canada Inc. Indications: Arthritis, psoriatic Manufacturer Requested Reimbursement Criteria 1 : To be reimbursed for the treatment of adult patients with active psoriatic arthritis (PsA), used alone or in combination

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

19. Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs

Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs Certolizumab pegol and secukinumab for Certolizumab pegol and secukinumab for treating activ treating active psoriatic arthritis after e psoriatic arthritis after inadequate response to DMARDs inadequate response to DMARDs T echnology appraisal guidance Published: 24 May 2017 nice.org.uk/guidance/ta445 © NICE 2018. All rights reserved. Subject to Notice of rights (https (...) to have due regard to the need 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. Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs (TA445) © NICE 2018. All rights

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

20. Apremilast for treating active psoriatic arthritis

Apremilast for treating active psoriatic arthritis Apremilast for treating activ Apremilast for treating active psoriatic e psoriatic arthritis arthritis T echnology appraisal guidance Published: 22 February 2017 nice.org.uk/guidance/ta433 © 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, arrived at after careful (...) 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. Apremilast for treating active psoriatic arthritis (TA433) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 31Contents Contents 1 Recommendations 4 2 The technology 5 3 Evidence 6 4 Committee discussion 7 Clinical need and practice 7

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

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