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Abatacept

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1. 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

2. Overall infection risk in rheumatoid arthritis during treatment with abatacept, rituximab and tocilizumab; an observational cohort study Full Text available with Trip Pro

Overall infection risk in rheumatoid arthritis during treatment with abatacept, rituximab and tocilizumab; an observational cohort study Overall Infection Risk in Rheumatoid Arthritis During Treatment With Abatacept, Rituximab and Tocilizumab; An Observational Cohort Study - PubMed This site needs JavaScript to work properly. Please enable it to take advantage of the complete set of features! Welcome to the new PubMed. For legacy PubMed go to . Clipboard, Search History, and several other (...) characters Choose a collection: Unable to load your collection due to an error Add Cancel Add to My Bibliography My Bibliography Unable to load your delegates due to an error Add Cancel Actions Cite Share Permalink Copy Page navigation Rheumatology (Oxford) Actions 2019 Nov 25 [Online ahead of print] Overall Infection Risk in Rheumatoid Arthritis During Treatment With Abatacept, Rituximab and Tocilizumab; An Observational Cohort Study , , , , , , , Affiliations Expand Affiliations 1 DANBIO and Copenhagen

2020 EvidenceUpdates

3. Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis

Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis Abatacept, adalimumab, etanercept and Abatacept, adalimumab, etanercept and tocilizumab for treating juv tocilizumab for treating juvenile enile idiopathic arthritis idiopathic arthritis T echnology appraisal guidance Published: 16 December 2015 nice.org.uk/guidance/ta373 © NICE 2019. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y (...) 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. Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis (TA373) © NICE 2019. All rights reserved. Subject to Notice of rights (https

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

4. Risk of serious infections in patients with rheumatoid arthritis treated in routine care with abatacept, rituximab and tocilizumab in Denmark and Sweden (Abstract)

Risk of serious infections in patients with rheumatoid arthritis treated in routine care with abatacept, rituximab and tocilizumab in Denmark and Sweden To estimate (1) crude and age-and gender-adjusted incidence rates (IRs) of serious infections (SI) and (2) relative risks (RR) of SI in patients with rheumatoid arthritis (RA) initiating treatment with abatacept, rituximab or tocilizumab in routine care.This is an observational cohort study conducted in parallel in Denmark and Sweden including (...) patients with RA in Denmark (DANBIO) and Sweden (Anti-Rheumatic Treatment in Sweden Register/Swedish Rheumatology Quality Register) who started abatacept/rituximab/tocilizumab in 2010-2015. Patients could contribute to more than one treatment course. Incident SI (hospitalisations listing infection) and potential confounders were identified through linkage to national registries. Age- and gender-adjusted IRs of SI per 100 person years and additionally adjusted RRs of SI during 0-12 and 0-24 months since

2019 EvidenceUpdates

5. 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 (...) according to 1987 American College of Rheumatology criteria, enrolled in one of the three French Society of Rheumatology registries; who had no severe cardiovascular disease, active or severe infections, or severe immunodeficiency, with follow-up of at least 24 months.Initiation of intravenous rituximab, abatacept, or tocilizumab for rheumatoid arthritis.The primary outcome was drug retention without failure at 24 months. Failure was defined as all cause death; discontinuation of rituximab, abatacept

2019 BMJ

6. 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

7. Abatacept for treating rheumatoid arthritis after the failure of conventional disease-modifying anti-rheumatic drugs (rapid review of technology appraisal guidance&#160

Abatacept for treating rheumatoid arthritis after the failure of conventional disease-modifying anti-rheumatic drugs (rapid review of technology appraisal guidance  Abatacept for treating rheumatoid arthritis after the failure of conventional disease-modifying anti-rheumatic drugs | Guidance | NICE Abatacept for treating rheumatoid arthritis after the failure of conventional disease-modifying anti-rheumatic drugs Technology appraisal guidance [TA280] Published date: 24 April 2013 Guidance

2013 National Institute for Health and Clinical Excellence - Technology Appraisals

8. Abatacept for psoriatic arthritis - second line

Abatacept for psoriatic arthritis - second line Abatacept for psoriatic arthritis – second line Abatacept for psoriatic arthritis – second line 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. Abatacept for psoriatic arthritis – second line. Birmingham: NIHR Horizon Scanning Research&Intelligence Centre. Horizon Scanning Review. 2015 (...) Authors' objectives Psoriatic arthritis occurs when the joints are affected in people who already have psoriasis (a skin condition that causes itchy red, flaky, scaly patches of skin). People with psoriatic arthritis often feel pain and experience stiffness in joints, for example, in the hands, feet, knees, neck, spine and elbows. Abatacept is a new drug for the treatment of psoriatic arthritis which is injected under skin. Studies are currently underway to see how well the drug works and whether

2015 Health Technology Assessment (HTA) Database.

9. Abatacept (Orencia) - polyarticular juvenile idiopathic arthritis

Abatacept (Orencia) - polyarticular juvenile idiopathic arthritis All Wales Medicines Strategy Group (AWMSG) - abatacept (Orencia) | | Appraisal information Search and reports abatacept (Orencia®) Reference No. 2 Publication date: 27/02/2014 Last review date: 17/02/2017 Appraisal information abatacept (Orencia®) 250 mg powder for concentrate for solution for infusion Company: Bristol-Myers Squibb Pharmaceuticals Ltd BNF category: Musculoskeletal and joint diseases NMG meeting date: 27/11/2013 (...) AWMSG meeting date: 15/01/2014 Submission Type: Full Submission Status: Superseded Advice No: 0114 Ratification by Welsh Government: 26/02/2014 Current Progress Submission received NMG meeting AWMSG meeting Ratification by Welsh Government AWMSG advice AWMSG ADVICE SUPERSEDED BY NICE GUIDANCE (TA373) NICE GUIDANCE ISSUED DECEMBER 2015 (Refer to NICE website for full guidance on NICE recommendations, including any specific restrictions on the use of the technology) Abatacept (Orencia®) is recommended

2014 All Wales Medicines Strategy Group

10. Improvements in Fatigue in 1536 Patients with Rheumatoid Arthritis and Correlation with Other Treatment Outcomes: A Post Hoc Analysis of Three Randomized Controlled Trials of Abatacept Full Text available with Trip Pro

Improvements in Fatigue in 1536 Patients with Rheumatoid Arthritis and Correlation with Other Treatment Outcomes: A Post Hoc Analysis of Three Randomized Controlled Trials of Abatacept A post hoc analysis of three randomized controlled trials of abatacept in rheumatoid arthritis (RA) was conducted to explore the effect of abatacept on fatigue in RA and its correlation with other outcomes.In this analysis of AGREE (early RA) and AIM and ATTAIN (established RA), changes in baseline fatigue (0-100 (...) with abatacept were 28.9 (1.7), 25.3 (1.2), and 21.9 (1.6) in AGREE, AIM, and ATTAIN, respectively, with corresponding decreases of 16.0, 13.7, and 13.4 at day 29. Most patients (67.8%; 624/920) reported improvements ≥MCID in fatigue with abatacept at day 169; 79.2% (671/847) and 57.8% (388/671) reported improvements ≥MCID in pain and sleep, respectively; 18.9% (158/836) were in DAS28 (CRP) remission. Agreement between improvement in fatigue and other outcomes was low (kappa range 0.30-0.51 [pain], 0.14-0.26

2017 Rheumatology and therapy Controlled trial quality: uncertain

11. Randomized Clinical Trial Design to Assess Abatacept in Resistant Nephrotic Syndrome Full Text available with Trip Pro

Randomized Clinical Trial Design to Assess Abatacept in Resistant Nephrotic Syndrome Treatment-resistant nephrotic syndrome is a rare form of glomerular disease that occurs in children and adults. No Food and Drug Administration-approved treatments consistently achieve remission of proteinuria and preservation of kidney function. CD80 (B7-1) can be expressed on injured podocytes, and administration of abatacept (modified CTLA4-Ig based on a natural ligand to CD80) has been associated (...) with sustained normalization of urinary protein excretion and maintenance of glomerular filtration rate in experimental and clinical settings.In this report, we describe the rationale for and design of a randomized, placebo-controlled, clinical trial of abatacept in patients with treatment-resistant nephrotic syndrome caused by focal segmental glomerulosclerosis or minimal change disease. The design is a hybrid of a parallel-group and crossover design (switchover) with the primary objectives assessed

2017 Kidney international reports Controlled trial quality: uncertain

12. Therapeutic trials of biologics in primary biliary cholangitis: An open label study of abatacept and review of the literature. (Abstract)

Therapeutic trials of biologics in primary biliary cholangitis: An open label study of abatacept and review of the literature. Primary biliary cholangitis (PBC) is a classic autoimmune disease in which humoral, cytotoxic, and innate immune responses have been implicated with the specific targeting of a mitochondrial antigen. The mainstay of treatment remains the bile acid ursodeoxycholic acid (UDCA). Corticosteroids may have some benefits, but to date, clinical trials of biologics targeting B (...) cells and IL-12/23 have not shown any efficacy. Because activated T cells target the intrahepatic bile ducts in PBC and pre-clinical models suggested that blocking CD80/CD86 with CTLA-4 Ig might have therapeutic benefit in PBC, we performed an open-label trial to determine if CTLA-4 Ig (abatacept) is safe and potentially efficacious in PBC patients with an incomplete response to UDCA. PBC patients with an alkaline phosphatase (ALP) > 1.67 × the upper limit of normal after 6 months on UDCA treatment

2019 Journal of Autoimmunity

13. Abatacept modulates CD80 and CD86 expression and memory formation in human B-cells. Full Text available with Trip Pro

Abatacept modulates CD80 and CD86 expression and memory formation in human B-cells. Cytotoxic T lymphocyte antigen-4 (CTLA-4) limits T-cell activation and is expressed on T-regulatory cells. Human CTLA-4 deficiency results in severe immune dysregulation. Abatacept (CTLA-4 Ig) is approved for the treatment of rheumatoid arthritis (RA) and its mechanism of action is attributed to effects on T-cells. It is known that CTLA-4 modulates the expression of its ligands CD80 and CD86 on antigen (...) presenting cells (APC) by transendocytosis. As B-cells express CD80/CD86 and function as APC, we hypothesize that B-cells are a direct target of abatacept.To investigate direct effects of abatacept on human B-lymphocytes in vitro and in RA patients.The effect of abatacept on healthy donor B-cells' phenotype, activation and CD80/CD86 expression was studied in vitro. Nine abatacept-treated RA patients were studied. Seven of these were followed up to 24 months, and two up to 12 months only and treatment

2019 Journal of Autoimmunity

14. Comparative safety of abatacept in rheumatoid arthritis with COPD: A real-world population-based observational study. (Abstract)

Comparative safety of abatacept in rheumatoid arthritis with COPD: A real-world population-based observational study. The ASSURE randomized trial of abatacept safety in rheumatoid arthritis (RA) reported more frequent respiratory adverse events with abatacept among the subgroup of 54 patients with chronic obstructive pulmonary disease (COPD), leading to a label warning. We assessed the risk of adverse respiratory events associated with abatacept, compared with other biologic DMARDs (bDMARDs (...) ), among patients with RA and COPD in a real-world observational setting.We formed a prevalent new-user cohort of patients with RA and COPD treated with bDMARDs within the US-based MarketScan databases from 2007 to 2014. Abatacept users were matched on time-conditional propensity scores to users of other bDMARDs. Adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) of adverse respiratory events comparing abatacept with other bDMARDs were estimated using the Cox model.The cohort included 1807

2019 Seminars in arthritis and rheumatism

15. Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study. Full Text available with Trip Pro

Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study. To investigate efficacy and safety of intravenous abatacept in Japanese patients with active polyarticular-course juvenile idiopathic arthritis (pJIA).In this phase III, open-label, multicenter, single-arm study, patients with pJIA aged 4-17 years who failed ≥1 biologic or methotrexate received weight-tiered (< 75 kg: 10 mg/kg; 75-100 kg: 750 mg; > 100 (...)  kg: 1000 mg) intravenous abatacept at Weeks 0, 2, 4, and every 4 weeks thereafter. The study comprised a short-term period (16 weeks) and ongoing long-term period. Primary endpoint: Week 16 JIA-American College of Rheumatology criteria 30 (JIA-ACR30) response rate. Secondary endpoints/outcomes included Week 16 JIA-ACR50/70/90 response and inactive disease rates, Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), pharmacokinetics, safety, and immunogenicity. Proportions

2019 Pediatric Rheumatology

16. Does Abatacept Increase Postoperative Adverse Events in Rheumatoid Arthritis Compared with Conventional Synthetic Disease-modifying Drugs? (Abstract)

Does Abatacept Increase Postoperative Adverse Events in Rheumatoid Arthritis Compared with Conventional Synthetic Disease-modifying Drugs? The aim of this study was to investigate whether abatacept (ABT) causes more adverse events than conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) after orthopedic surgery in patients with rheumatoid arthritis (RA).A retrospective multicenter nested case-control study was performed in 18 institutions. Patients receiving ABT (ABT group

2019 Journal of Rheumatology

17. Body mass index and treatment response to subcutaneous abatacept in patients with psoriatic arthritis: a Full Text available with Trip Pro

Body mass index and treatment response to subcutaneous abatacept in patients with psoriatic arthritis: a This post hoc analysis of the phase III Active PSoriaTic Arthritis RAndomizEd TriAl (ASTRAEA) evaluated the effect of baseline body mass index (BMI) on subsequent response to subcutaneous (SC) abatacept in patients with psoriatic arthritis (PsA).In ASTRAEA, patients with active PsA were randomised (1:1) to receive blinded weekly SC abatacept 125 mg or placebo for 24 weeks. Treatment response (...) ; obese, >30 kg/m2) and compared in univariate and multivariate models.Of 212/213 and 210/211 patients with baseline BMI data in the abatacept and placebo groups, respectively, 15% and 19% were underweight/normal, 36% and 27% were overweight, and 49% and 54% were obese. After adjusting for baseline characteristics, there were no significant differences for any outcome measure at week 24 with abatacept in the overweight or obese versus underweight/normal subgroup. In the placebo group, patients

2019 RMD open Controlled trial quality: predicted high

18. Arthritis prevention in the pre-clinical phase of RA with abatacept (the APIPPRA study): a multi-centre, randomised, double-blind, parallel-group, placebo-controlled clinical trial protocol. Full Text available with Trip Pro

Arthritis prevention in the pre-clinical phase of RA with abatacept (the APIPPRA study): a multi-centre, randomised, double-blind, parallel-group, placebo-controlled clinical trial protocol. We present a study protocol for a multi-centre, randomised, double-blind, parallel-group, placebo-controlled trial that seeks to test the feasibility, acceptability and effectiveness of a 52-week period of treatment with the first-in-class co-stimulatory blocker abatacept for preventing or delaying (...) of investigational medicinal product, either abatacept or placebo treatment over the course of a 52-week period. Participants were followed up for a further 52 weeks. The primary endpoint was defined as the time to development of at least three swollen joints or to the fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA using swollen but not tender joints, whichever endpoint was met first. In either case, swollen joints were

2019 Trials Controlled trial quality: predicted high

19. Efficacy and safety profile of intravenous tocilizumab versus intravenous abatacept in treating female Saudi Arabian patients with active moderate-to-severe rheumatoid arthritis. (Abstract)

Efficacy and safety profile of intravenous tocilizumab versus intravenous abatacept in treating female Saudi Arabian patients with active moderate-to-severe rheumatoid arthritis. To compare the efficacy and safety of tocilizumab with those of abatacept in patients with active rheumatoid arthritis not responding to anti-tumor necrosis factor therapy.A prospective, open-label study was carried out on adult females with moderate-to-severe rheumatoid arthritis. Patients were randomly assigned (...) to receive either intravenous tocilizumab or abatacept treatment. History taking, clinical examination, and laboratory evaluation were done at baseline and during a 24-week period of follow-up. Disease activity was calculated using the DAS28-ESR score. The incidence of accompanying adverse events was evaluated and all statistical analyses were performed by InStat.One hundred thirty-two patients were enrolled and classified randomly into the tocilizumab (n = 68) and abatacept (n = 64) groups. By week 24

2019 Clinical rheumatology Controlled trial quality: uncertain

20. Re-treatment with abatacept plus methotrexate for disease flare after complete treatment withdrawal in patients with early rheumatoid arthritis: 2-year results from the AVERT study. Full Text available with Trip Pro

Re-treatment with abatacept plus methotrexate for disease flare after complete treatment withdrawal in patients with early rheumatoid arthritis: 2-year results from the AVERT study. To complete reporting of outcomes after total withdrawal of all rheumatoid arthritis (RA) therapy and re-treatment after flare in Assessing Very Early Rheumatoid arthritis Treatment study (NCT01142726).Patients with early RA were initially randomised to double-blind, weekly subcutaneous abatacept plus methotrexate (...) , or abatacept or methotrexate monotherapy. At month 12, patients with Disease Activity Score (DAS)28 C reactive protein (CRP) <3.2 had all RA treatments rapidly withdrawn and were observed for ≤12 months or until flare. After ≥3 months' withdrawal, patients with protocol-defined RA flare received open-label abatacept plus methotrexate for 6 months (re-treatment).Proportion of patients in DAS28-CRP-defined remission remained numerically higher in original abatacept plus methotrexate and abatacept arms versus

2019 RMD open Controlled trial quality: uncertain

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