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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. 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

6. Methotrexate for psoriatic arthritis. (PubMed)

Methotrexate for psoriatic arthritis. Psoriatic arthritis is an inflammatory disease associated with joint damage, impaired function, pain, and reduced quality of life. Methotrexate is a disease-modifying anti-rheumatic drug (DMARD) commonly prescribed to alleviate symptoms, attenuate disease activity, and prevent progression of disease.To assess the benefits and harms of methotrexate for psoriatic arthritis in adults.We searched CENTRAL, MEDLINE, Embase, the WHO International Clinical Trials (...) Registry Platform, and www.clinicaltrials.gov for relevant records. We searched all databases from inception to 29 January 2018. We handsearched included articles for additional records and contacted study authors for additional unpublished data. We applied no language restrictions.We included all randomised controlled trials (RCTs) and quasi-RCTs that compared methotrexate versus placebo, or versus another DMARD, for adults with psoriatic arthritis. We reported on the following major outcomes: disease

2019 Cochrane

7. 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)

8. 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)

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

13. 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

14. Certolizumab pegol and secukinumab for treating active psoriatic arthritis following inadequate response to disease-modifying antirheumatic drugs: a systematic review and economic evaluation

Certolizumab pegol and secukinumab for treating active psoriatic arthritis following inadequate response to disease-modifying antirheumatic drugs: a systematic review and economic evaluation Certolizumab pegol and secukinumab for treating active psoriatic arthritis following inadequate response to disease-modifying antirheumatic drugs: a systematic review and economic evaluation Journals Library An error occurred retrieving content to display, please try again. >> >> >> Page Not Found Page (...) not found (404) Sorry - the page you requested could not be found. Please choose a page from the navigation or try a website search above to find the information you need. >> >> >> >> Issue {{metadata .Issue }} Toolkit 1)"> 0)"> 1)"> {{metadata.Title}} {{metadata.Headline}} In active psoriatic arthritis, certolizumab and secukinumab had some incremental cost-effectiveness ratios of £20,000-£30,000 per QALY, depending on psoriasis severity and the previous treatments used. {{author}} {{($index

2017 NIHR HTA programme

15. 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

16. Treating Psoriatic Arthritis to Target: Defining Psoriatic Arthritis Disease Activity Score (PASDAS) That Reflects State Of Minimal Disease Activity (MDA). (PubMed)

Treating Psoriatic Arthritis to Target: Defining Psoriatic Arthritis Disease Activity Score (PASDAS) That Reflects State Of Minimal Disease Activity (MDA). PASDAS is a composite disease activity measure (range 0-10) for psoriatic arthritis (PsA). We aimed to validate a cutoff value of PsA Disease Activity Score (PASDAS) that defines minimal disease activity (MDA) state, as well as validate previously defined PASDAS cutoffs for low and high disease activity.Patients were prospectively recruited

2019 Journal of Rheumatology

17. Certolizumab pegol and secukinumab for treating active psoriatic arthritis following inadequate response to disease-modifying antirheumatic drugs: a systematic review and economic evaluation

Certolizumab pegol and secukinumab for treating active psoriatic arthritis following inadequate response to disease-modifying antirheumatic drugs: a systematic review and economic evaluation Certolizumab pegol and secukinumab for treating active psoriatic arthritis following inadequate response to disease-modifying antirheumatic drugs: a systematic review and economic evaluation Certolizumab pegol and secukinumab for treating active psoriatic arthritis following inadequate response to disease (...) L. Certolizumab pegol and secukinumab for treating active psoriatic arthritis following inadequate response to disease-modifying antirheumatic drugs: a systematic review and economic evaluation. Health Technology Assessment 2017; 21(56) Authors' objectives To determine the clinical effectiveness and cost-effectiveness of CZP and SEC for treating active PsA in adults in whom DMARDs have been inadequately effective. Authors' conclusions SEC and CZP may be an effective use of NHS resources

2018 Health Technology Assessment (HTA) Database.

18. Psoriatic Arthritis and Burden of Disease: Patient Perspectives from the Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey (PubMed)

Psoriatic Arthritis and Burden of Disease: Patient Perspectives from the Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey Psoriatic arthritis (PsA) is underdiagnosed and has a substantial impact on quality of life, disability, and work productivity. The population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey examined the impact of PsA on patients' activities of daily living and unmet treatment needs.This large

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2016 Rheumatology and therapy

19. Severity of fatigue in people with rheumatoid arthritis, psoriatic arthritis and spondyloarthritis - Results of a cross-sectional study. (PubMed)

Severity of fatigue in people with rheumatoid arthritis, psoriatic arthritis and spondyloarthritis - Results of a cross-sectional study. Despite improvements in treatment for rheumatoid arthritis (RA), psoriatic arthritis (PsA) and spondyloarthritis (axSpA), several key unmet needs remain, such as fatigue. The objective of this study was to describe the severity of fatigue, disease characteristics and socioeconomic factors in people with RA, PsA and axSpA.The study was designed as a cross

2019 PLoS ONE

20. Influence of Axial Involvement on Clinical Characteristics of Psoriatic Arthritis: Analysis from the Corrona Psoriatic Arthritis/Spondyloarthritis Registry. (PubMed)

Influence of Axial Involvement on Clinical Characteristics of Psoriatic Arthritis: Analysis from the Corrona Psoriatic Arthritis/Spondyloarthritis Registry. We analyzed the characteristics of patients with psoriatic arthritis (PsA) with and without axial involvement in the US-based Corrona Psoriatic Arthritis/Spondyloarthritis Registry.All patients were included who had PsA and data on axial involvement, defined as physician-reported presence of spinal involvement at enrollment

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2018 Journal of Rheumatology

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