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1. Therapeutic monitoring of TNF-alpha inhibitors in rheumatoid arthritis

Therapeutic monitoring of TNF-alpha inhibitors in rheumatoid arthritis Ther Therapeutic monitoring of TNF-alpha apeutic monitoring of TNF-alpha inhibitors in rheumatoid arthritis inhibitors in rheumatoid arthritis Diagnostics guidance Published: 10 July 2019 www.nice.org.uk/guidance/dg36 © 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 This guidance represents the view of NICE (...) possible. Therapeutic monitoring of TNF-alpha inhibitors in rheumatoid arthritis (DG36) © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 36Contents Contents 1 Recommendations 4 2 Clinical need and practice 5 The problem addressed 5 The condition 6 The care pathways 6 3 The diagnostic tests 8 The interventions 8 The comparator 9 4 Evidence 11 Clinical effectiveness 11 Cost effectiveness 17 5 Committee discussion 25

2019 National Institute for Health and Clinical Excellence - Diagnostics Guidance

2. Clinical effectiveness and cost-effectiveness of use of therapeutic monitoring of tumour necrosis factor alpha (TNF-a) inhibitors [LISA-TRACKER© enzyme-linked immunosorbent assay (ELISA) kits, TNF-a-Blocker ELISA kits and Promonitor© ELISA kits] versus st

Clinical effectiveness and cost-effectiveness of use of therapeutic monitoring of tumour necrosis factor alpha (TNF-a) inhibitors [LISA-TRACKER© enzyme-linked immunosorbent assay (ELISA) kits, TNF-a-Blocker ELISA kits and Promonitor© ELISA kits] versus st Clinical effectiveness and cost-effectiveness of use of therapeutic monitoring of tumour necrosis factor alpha (TNF-α) inhibitors [LISA-TRACKER® enzyme-linked immunosorbent assay (ELISA) kits, TNF-α-Blocker ELISA kits and Promonitor® ELISA (...) kits] versus standard care in patients with Crohn's disease: systematic reviews and economic modelling Clinical effectiveness and cost-effectiveness of use of therapeutic monitoring of tumour necrosis factor alpha (TNF-α) inhibitors [LISA-TRACKER® enzyme-linked immunosorbent assay (ELISA) kits, TNF-α-Blocker ELISA kits and Promonitor® ELISA kits] versus standard care in patients with Crohn's disease: systematic reviews and economic modelling Freeman K, Connock M, Auguste P, Taylor-Phillips S

2016 Health Technology Assessment (HTA) Database.

3. TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis

, Merck Sharp & Dohme), and infliximab (Remicade, Merck Sharp & Dohme; Inflectra, Hospira; Remsima,Napp) inhibit the pro-inflammatory cytokine, tumour necrosis factor (TNF) -alpha. TNF-alpha inhibitors may modify the inflammatory process of the disease. Adalimumab, certolizumab pegol, golimumab and infliximab are monoclonal antibodies, and etanercept is a recombinant human TNF-receptor fusion protein. 3.2 Adalimumab, etanercept, golimumab and infliximab have marketing authorisations in the UK (...) TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis TNF-alpha inhibitors for ankylosing TNF-alpha inhibitors for ankylosing spondylitis and non-r spondylitis and non-radiogr adiographic axial aphic axial spondyloarthritis spondyloarthritis T echnology appraisal guidance Published: 1 February 2016 nice.org.uk/guidance/ta383 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

4. Therapeutic monitoring of TNF-alpha inhibitors in Crohn's disease (LISA-TRACKER ELISA kits, IDKmonitor ELISA kits, and Promonitor ELISA kits)

for Crohn's disease. TNF-alpha is a cell signalling protein that promotes inflammatory responses. Dysregulation of TNF-alpha production can contribute to inflammatory diseases, such as Crohn's disease. TNF-alpha inhibitors, such as infliximab and adalimumab, are given to people with Crohn's disease to inhibit TNF-alpha production and suppress the inflammatory response. Therapeutic monitoring of TNF-alpha inhibitors in Crohn’s disease (LISA-TRACKER ELISA kits, IDKmonitor ELISA kits, and Promonitor ELISA (...) Therapeutic monitoring of TNF-alpha inhibitors in Crohn's disease (LISA-TRACKER ELISA kits, IDKmonitor ELISA kits, and Promonitor ELISA kits) Ther Therapeutic monitoring of TNF-alpha apeutic monitoring of TNF-alpha inhibitors in Crohn inhibitors in Crohn’s disease (LISA ’s disease (LISA- - TRA TRACKER ELISA kits, IDKmonitor ELISA CKER ELISA kits, IDKmonitor ELISA kits, and Promonitor ELISA kits) kits, and Promonitor ELISA kits) Diagnostics guidance Published: 17 February 2016 nice.org.uk

2016 National Institute for Health and Clinical Excellence - Diagnostics Guidance

5. Secukinumab for active ankylosing spondylitis after treatment with non-steroidal anti-inflammatory drugs or TNF-alpha inhibitors

Secukinumab for active ankylosing spondylitis after treatment with non-steroidal anti-inflammatory drugs or TNF-alpha inhibitors Secukinumab for activ Secukinumab for active ankylosing e ankylosing spondylitis after treatment with non- spondylitis after treatment with non- steroidal anti-inflammatory drugs or steroidal anti-inflammatory drugs or TNF-alpha inhibitors TNF-alpha inhibitors T echnology appraisal guidance Published: 28 September 2016 nice.org.uk/guidance/ta407 © NICE 2018. All (...) -steroidal anti-inflammatory drugs or TNF-alpha inhibitors (TA407) © 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 The technology 5 3 Evidence 6 4 Committee discussion 7 Clinical effectiveness 7 Cost effectiveness 10 Pharmaceutical Price Regulation Scheme (PPRS) 2014 13 Summary of appraisal committee's key conclusions 13 5 Implementation 18 6 Appraisal committee members

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

6. Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor

Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor Certolizumab pegol for treating Certolizumab pegol for treating rheumatoid arthritis after inadequate rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor response to a TNF-alpha inhibitor T echnology appraisal guidance Published: 26 October 2016 nice.org.uk/guidance/ta415 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms (...) 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 for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor (TA415) © NICE 2018. All rights reserved

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

7. Gradual tapering TNF inhibitors versus conventional synthetic DMARDs after achieving controlled disease in patients with rheumatoid arthritis: first-year results of the randomised controlled TARA study Full Text available with Trip Pro

Gradual tapering TNF inhibitors versus conventional synthetic DMARDs after achieving controlled disease in patients with rheumatoid arthritis: first-year results of the randomised controlled TARA study The aim of this study is to evaluate the effectiveness of two tapering strategies after achieving controlled disease in patients with rheumatoid arthritis (RA), during 1 year of follow-up.In this multicentre single-blinded (research nurses) randomised controlled trial, patients with RA were (...) included who achieved controlled disease, defined as a Disease Activity Score (DAS) ≤ 2.4 and a Swollen Joint Count (SJC) ≤ 1, treated with both a conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and a TNF inhibitor. Eligible patients were randomised into gradual tapering csDMARDs or TNF inhibitors. Medication was tapered if the RA was still under control, by cutting the dosage into half, a quarter and thereafter it was stopped. Primary outcome was proportion of patients

2019 EvidenceUpdates

8. Comparative effectiveness of rituximab, abatacept, and tocilizumab in adults with rheumatoid arthritis and inadequate response to TNF inhibitors: prospective cohort study. Full Text available with Trip Pro

Comparative effectiveness of rituximab, abatacept, and tocilizumab in adults with rheumatoid arthritis and inadequate response to TNF inhibitors: prospective cohort study. To compare the effectiveness and safety of three non-tumour necrosis factor (TNF) α inhibitors (rituximab, abatacept, and tocilizumab) in the treatment of rheumatoid arthritis.Population based prospective study.53 university and 54 non-university clinical centres in France.3162 adults (>18 years) with rheumatoid arthritis

2019 BMJ

9. Achieving remission in psoriatic arthritis by early initiation of TNF inhibition: a double-blind, randomised, placebo-controlled trial of golimumab plus methotrexate versus placebo plus methotrexate Full Text available with Trip Pro

Achieving remission in psoriatic arthritis by early initiation of TNF inhibition: a double-blind, randomised, placebo-controlled trial of golimumab plus methotrexate versus placebo plus methotrexate Early initiation of effective treatment favours remission in rheumatoid arthritis, but it remains unknown if the same concept applies to psoriatic arthritis (PsA). Therefore, this study investigated whether the combination of golimumab plus methotrexate (MTX) as a first-line treatment is superior

2019 EvidenceUpdates

10. A Case of Recalcitrant Psoriatic Arthritis to TNF Inhibitors Improved After Administration of Secukinumab, an IL-17A Inhibitor Full Text available with Trip Pro

A Case of Recalcitrant Psoriatic Arthritis to TNF Inhibitors Improved After Administration of Secukinumab, an IL-17A Inhibitor Psoriatic arthritis (PsA) is a unique inflammatory arthritis due to the fact that patients have to deal not only with pain but also with their skin appearance, which may have a detrimental effect on their everyday lives and psychology. Treating a patient with PsA, improving both the musculoskeletal and skin symptoms is a challenge for the clinical rheumatologist (...) . In this case, we present a patient of recalcitrant PsA to tumor necrosis factor inhibitors (TNFi) who had an exceptional improvement after administration of the interleukin-17A inhibitor (IL-17Ai) secukinumab.

2017 Rheumatology and therapy

11. Examination of Patient-Reported Outcomes in Association with TNF-Inhibitor Treatment Response: Results from a US Observational Cohort Study Full Text available with Trip Pro

Examination of Patient-Reported Outcomes in Association with TNF-Inhibitor Treatment Response: Results from a US Observational Cohort Study Implementation of a treat-to-target strategy is challenging when the patient and physician prioritize different goals. This study aimed to "translate" improvements in Clinical Disease Activity Index (CDAI) to concepts that resonate with patients (such as pain, fatigue, morning stiffness) by examining the association between changes in disease activity (...) and patient-reported outcomes (PROs) in a national cohort of patients with rheumatoid arthritis (RA) initiating their first biologic treatment.Patients in the Corrona registry with moderate or high disease activity (M/HDA) (defined by a CDAI score > 10), prior use of at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD), 12-month follow-up, and initiating their first tumor necrosis factor inhibitor (TNFi) between 1 January 2006 through 1 November 2015 were identified. Patients

2018 Rheumatology and therapy

12. Interleukin-35 Inhibits TNF-α-Induced Osteoclastogenesis and Promotes Apoptosis via Shifting the Activation From TNF Receptor-Associated Death Domain (TRADD)–TRAF2 to TRADD–Fas-Associated Death Domain by JAK1/STAT1 Full Text available with Trip Pro

Interleukin-35 Inhibits TNF-α-Induced Osteoclastogenesis and Promotes Apoptosis via Shifting the Activation From TNF Receptor-Associated Death Domain (TRADD)–TRAF2 to TRADD–Fas-Associated Death Domain by JAK1/STAT1 Over-activated osteoclasts derived from myeloid or peripheral blood monocytes by inflammatory cytokines results in osteoporosis, osteoarthritis, and other bone erosion-related diseases. Interleukin 35 (IL-35) is a novel anti-inflammatory and immunosuppressive factor. This study (...) of NF-κB, MAPK, TRAF2, RIP1, Fas-associated death domain (FADD), and caspase3 was further investigated. In addition, a murine calvarial osteolysis model was established via the subcutaneous injection of TNF-α onto the calvaria, and histological analysis was subsequently performed. As a result, IL-35 inhibited TNF-α-induced osteoclast formation and bone resorption in vitro and osteolysis calvaria in vivo. NFATc1, c-fos, and TRAP were downregulated by IL-35 through the inhibition of NF-κB and MAPK

2018 Frontiers in immunology

13. Mental health, fatigue and function are associated with increased risk of disease flare following TNF inhibitor tapering in patients with rheumatoid arthritis: an exploratory analysis of data from the Optimizing TNF Tapering in RA (OPTTIRA) trial Full Text available with Trip Pro

Mental health, fatigue and function are associated with increased risk of disease flare following TNF inhibitor tapering in patients with rheumatoid arthritis: an exploratory analysis of data from the Optimizing TNF Tapering in RA (OPTTIRA) trial Tapering of anti-tumour necrosis factor (TNF) therapy appears feasible, safe and effective in selected patients with rheumatoid arthritis (RA). Depression is highly prevalent in RA and may impact on flare incidence through various mechanisms (...) . This study aims to investigate if psychological states predict flare in patients' dose tapering their anti-TNF therapy.This study is a post-hoc analysis of the Optimizing TNF Tapering in RA trial, a multicentre, randomised, open-label study investigating anti-TNF tapering in RA patients with sustained low disease activity. Patient-reported outcomes (Health Assessment Questionnaire, EuroQol 5-dimension scale, Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-F), 36-Item Short Form

2018 RMD open Controlled trial quality: uncertain

14. TNF-anti-TNF Immune Complexes Inhibit IL-12/IL-23 Secretion by Inflammatory Macrophages via an Fc-dependent Mechanism. Full Text available with Trip Pro

TNF-anti-TNF Immune Complexes Inhibit IL-12/IL-23 Secretion by Inflammatory Macrophages via an Fc-dependent Mechanism. We have recently shown that the mode of action of IgG1 anti-TNF antibodies in inflammatory bowel disease (IBD) requires Fcγ-receptor (FcR) engagement on macrophages. Here we examine the effect of Fcγ-receptor signaling by anti-TNF on macrophage IL-12/IL-23 secretion.Cytokine production by human inflammatory macrophages was assessed at the level of RNA and or protein. TNF-anti (...) , did not inhibit IL-12/L-23 secretion, suggesting that the presence of an Fc-region was not sufficient. Infliximab and adalimumab formed immune complexes with soluble TNF while etanercept did not, suggesting that FcR mediated suppression of IL-12/IL-23 required the formation of immune complexes. Indeed, non-specific IgG1 immune complexes but not uncomplexed IgG1 similarly suppressed IL-12/IL-23 secretion. Finally, infliximab significantly decreased IL-12/IL-23p40 production in myeloid cells

2018 Journal of Crohn's & colitis

15. 25(OH)D3 and 1.25(OH)2D3 inhibits TNF-α expression in human monocyte derived macrophages. Full Text available with Trip Pro

25(OH)D3 and 1.25(OH)2D3 inhibits TNF-α expression in human monocyte derived macrophages. We wanted to investigate effects of vitamin D3 (25(OH)D3 and 1.25(OH)2D3) on inflammatory cytokine expression in both activated and non-activated Mφ.Mononuclear cells, isolated from healthy donor buffy coats were cultured for a 6-day differentiation-period. Fully differentiated Mφ were pre-treated with either 25(OH)D3 or 1.25(OH)2D3 for (4, 12 or 24 hours) +/-LPS challenge for 4 hours. Gene expression (...) analyses of VDR, Cyp27b1 and pro-inflammatory markers TNF-α, IL-6, NF-κB, MCP-1, was performed using RT-quantitative PCR. TNF-α protein levels from Mφ culture media were analysed by ELISA.Both 25(OH)D3 and 1.25(OH)2D3 significantly inhibited TNF-α expression in both LPS-stimulated and unstimulated Mφ. Also, NF-κB, and to a lesser extend IL-6 and MCP-1 were inhibited. LPS up-regulated Cyp27b1 gene expression which was partly reverted by 1.25(OH)2D3.These data show anti-inflammatory effects of vitamin D3

2019 PLoS ONE

16. Cardiovascular (CV) Risk after Initiation of Abatacept versus TNF Inhibitors in Rheumatoid Arthritis Patients with and without Baseline CV Disease (Abstract)

Cardiovascular (CV) Risk after Initiation of Abatacept versus TNF Inhibitors in Rheumatoid Arthritis Patients with and without Baseline CV Disease To evaluate the cardiovascular safety of abatacept (ABA) versus tumor necrosis factor inhibitors (TNFi) in rheumatoid arthritis (RA) patients with and without underlying cardiovascular disease (CVD).We identified RA patients with and without baseline CVD who initiated ABA or TNFi by using data from 2 large US insurance claims databases: Medicare

2018 EvidenceUpdates

17. Evaluation of 12 GWAS-drawn SNPs as biomarkers of rheumatoid arthritis response to TNF inhibitors. A potential SNP association with response to etanercept. Full Text available with Trip Pro

Evaluation of 12 GWAS-drawn SNPs as biomarkers of rheumatoid arthritis response to TNF inhibitors. A potential SNP association with response to etanercept. Research in rheumatoid arthritis (RA) is increasingly focused on the discovery of biomarkers that could enable personalized treatments. The genetic biomarkers associated with the response to TNF inhibitors (TNFi) are among the most studied. They include 12 SNPs exhibiting promising results in the three largest genome-wide association studies

2019 PLoS ONE

18. S-allyl cysteine inhibits TNF-α-induced inflammation in HaCaT keratinocytes by inhibition of NF- κB-dependent gene expression via sustained ERK activation. (Abstract)

of I-κB, the inhibitor of NF-κB, revealed that SAC inhibited TNF-α-induced NF-κB activation, and PD98059 treatment reversed this effect. These results collectively suggest that SAC inhibits TNF-α-induced inflammation in HaCaT cells via a combined effect entailing the inhibition of the p38 and the JNK pathways and NF-κB pathway via the sustained activation of ERK.© 2019 John Wiley & Sons A/S . Published by John Wiley & Sons Ltd. (...) S-allyl cysteine inhibits TNF-α-induced inflammation in HaCaT keratinocytes by inhibition of NF- κB-dependent gene expression via sustained ERK activation. Tumor necrosis factor-α (TNF-α)-induced keratinocyte inflammation plays a key role in the pathogenesis of multiple inflammatory skin diseases. Here we investigated the anti-inflammatory effect of S-allyl cysteine (SAC) on TNF-α-induced HaCaT keratinocyte cells and the mechanism behind its anti-inflammatory potential. SAC was found to inhibit

2019 Experimental Dermatology

19. Masitinib for Crohn's disease, in patients intolerant or with an unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors

Masitinib for Crohn's disease, in patients intolerant or with an unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors Masitinib for Crohn's disease, in patients intolerant or with an unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors Masitinib for Crohn's disease, in patients intolerant or with an unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors NIHR HSRIC Record Status This is a bibliographic record of a published health (...) technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation NIHR HSRIC. Masitinib for Crohn's disease, in patients intolerant or with an unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors. Birmingham: NIHR Horizon Scanning Research&Intelligence Centre. Horizon Scanning Review. 2015 Authors' objectives Masitinib is intended to be used as second and subsequent line therapy for the treatment of moderately severe Crohn's disease

2015 Health Technology Assessment (HTA) Database.

20. Ursolic acid rich Ocimum sanctum L leaf extract loaded nanostructured lipid carriers ameliorate adjuvant induced arthritis in rats by inhibition of COX-1, COX-2, TNF-α and IL-1: Pharmacological and docking studies. Full Text available with Trip Pro

Ursolic acid rich Ocimum sanctum L leaf extract loaded nanostructured lipid carriers ameliorate adjuvant induced arthritis in rats by inhibition of COX-1, COX-2, TNF-α and IL-1: Pharmacological and docking studies. Ursolic acid (UA) is a promising molecule with anti-inflammatory, analgesic and potential anti-arthritic activity.This study was undertaken to make formulation and evaluation of Ocimum sanctum L. leaf extract (OLE) loaded nano-structured lipid carriers (OLE-NLCs) for improved

2018 PLoS ONE

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