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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. Alternative tumour necrosis factor inhibitors (TNFi) or abatacept or rituximab following failure of initial TNFi in rheumatoid arthritis: the SWITCH RCT

Alternative tumour necrosis factor inhibitors (TNFi) or abatacept or rituximab following failure of initial TNFi in rheumatoid arthritis: the SWITCH RCT Alternative tumour necrosis factor inhibitors (TNFi) or abatacept or rituximab following failure of initial TNFi in rheumatoid arthritis: the SWITCH RCT 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

2018 NIHR HTA programme

3. Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for the treatment of rheumatoid arthritis not previously treated with disease-modifying antirheumatic drugs and after the failure of conventional disease-modifyin

Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for the treatment of rheumatoid arthritis not previously treated with disease-modifying antirheumatic drugs and after the failure of conventional disease-modifyin Adalimumab, etanercept, infliximab,certolizumab pegol, golimumab, tocilizumab and abatacept for the treatment of rheumatoid arthritis not previously treated with disease-modifying antirheumatic drugs and after the failure of conventional

2016 NIHR HTA programme

4. The clinical effectiveness and cost-effectiveness of abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis: a systematic review and economic evaluation

The clinical effectiveness and cost-effectiveness of abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis: a systematic review and economic evaluation The clinical effectiveness and cost-effectiveness of abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis: a systematic review and economic evaluation Journals Library An error occurred retrieving content to display, please try again. >> >> >> Page Not Found Page

2016 NIHR HTA programme

5. Comparative effectiveness of rituximab, abatacept, and tocilizumab in adults with rheumatoid arthritis and inadequate response to TNF inhibitors: prospective cohort study. (PubMed)

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

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2019 BMJ

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

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

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

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

8. 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 (PubMed)

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

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2017 Rheumatology and therapy

9. Randomized Clinical Trial Design to Assess Abatacept in Resistant Nephrotic Syndrome (PubMed)

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

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2017 Kidney international reports

10. Abatacept monotherapy compared with abatacept plus disease-modifying anti-rheumatic drugs in rheumatoid arthritis patients: data from the ORA registry (PubMed)

Abatacept monotherapy compared with abatacept plus disease-modifying anti-rheumatic drugs in rheumatoid arthritis patients: data from the ORA registry Retention rate, efficacy, and safety of abatacept (ABA) was compared between patients with rheumatoid arthritis receiving ABA as monotherapy to those in combination ABA + conventional synthetic DMARD (csDMARD).The patients were obtained from the ORA registry. The retention rate was analysed in two ways: (1) therapeutic strategy retention

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2016 Arthritis research & therapy

11. Abatacept as rescue immunosuppression after calcineurin inhibitor treatment failure in renal transplantation. (PubMed)

Abatacept as rescue immunosuppression after calcineurin inhibitor treatment failure in renal transplantation. A majority of kidney transplant recipients receive calcineurin inhibitor-based immunosuppression. However, some do not tolerate calcineurin inhibitors and require other immunosuppressive strategies. Until recently, alternative approaches have been associated with inferior outcomes, but recent methods have effectively utilized belatacept in calcineurin inhibitor-intolerant patients (...) . Though promising, belatacept uptake has been limited by higher acute rejection rates, unavailability due to production shortages, and logistical challenges as a result of intravenous infusion requirements. Interestingly, its predecessor abatacept is clinically available in subcutaneous formulation to treat autoimmune disorders but has not been used in clinical transplantation. Here we report on a series of 9 calcineurin inhibitor-intolerant transplant recipients converted to abatacept early after

2019 American Journal of Transplantation

12. Timing of Abatacept Before Elective Arthroplasty and Risk of Post-operative Outcomes. (PubMed)

Timing of Abatacept Before Elective Arthroplasty and Risk of Post-operative Outcomes. Guidelines recommend holding biologic therapies before hip and knee arthroplasty, yet evidence to inform optimal timing is limited. We aimed to determine whether holding abatacept infusions is associated with lower risk of adverse post-operative outcomes.This retrospective cohort study using U.S. Medicare and Truven MarketScan administrative data from 2006-September 2015 evaluated adults with RA who received (...) intravenous abatacept (precisely dated in claims data) within 6 months of elective primary or revision hip or knee arthroplasty. Propensity weighted analyses using inverse probability weights compared the risk of 30-day hospitalized infection and 1-year prosthetic joint infection (PJI) between patients with different abatacept stop timing (time between last infusion and surgery). Secondary analyses evaluated non-urinary hospitalized infection and 30-day readmission.After 1939 surgeries among 1780 patients

2019 Arthritis care & research

13. Effect of CTLA4-Ig (abatacept) treatment on T cells and B cells in peripheral blood of patients with polymyositis and dermatomyositis. (PubMed)

Effect of CTLA4-Ig (abatacept) treatment on T cells and B cells in peripheral blood of patients with polymyositis and dermatomyositis. We aimed to evaluate in vivo effects of abatacept on phenotypes of T and B cells in the circulation of myositis patients in a sub-study of the ARTEMIS trial. Twelve patients with paired frozen PBMCs before and after 6-month abatacept treatment were included in this sub-study where mass cytometry (CyTOF) was chosen as a technology to be tested for its utility

2019 Scandinavian journal of immunology

14. Malignant Neoplasms in Patients With Rheumatoid Arthritis Treated With Tumor Necrosis Factor Inhibitors, Tocilizumab, Abatacept, or Rituximab in Clinical Practice: A Nationwide Cohort Study From Sweden

Malignant Neoplasms in Patients With Rheumatoid Arthritis Treated With Tumor Necrosis Factor Inhibitors, Tocilizumab, Abatacept, or Rituximab in Clinical Practice: A Nationwide Cohort Study From Sweden Considering the widespread and increasing use of biological immunomodulators (biological disease-modifying antirheumatic drugs [bDMARDs]) to treat chronic inflammatory conditions, and the concern that immunomodulation may alter cancer risk and progression, the limited available data on use (...) of these therapies as used in clinical practice and cancer risks are a concern.To assess the risk of incident malignant neoplasms in patients with rheumatoid arthritis (RA) treated with bDMARDs.This was a national register-based prospective cohort study of the public health care system in Sweden from 2006 to 2015. Cohorts of patients with RA initiating treatment with tocilizumab (n = 1798), abatacept (n = 2021), and rituximab (n = 3586), a tumor necrosis factor inhibitor (TNFi) as first-ever (n = 10 782

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2017 EvidenceUpdates

15. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis

Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis To assess the efficacy and safety of abatacept, a selective T-cell costimulation modulator, in a phase III study in psoriatic arthritis (PsA).This study randomised patients (1:1) with active PsA (~60% with prior exposure to a tumour necrosis factor inhibitor) to blinded weekly subcutaneous abatacept 125 mg (n=213) or placebo (n=211) for 24 weeks (...) , followed by open-label subcutaneous abatacept. Patients without ≥20% improvement in joint counts at week 16 were switched to open-label abatacept. The primary end point was the proportion of patients with ≥20% improvement in the American College of Rheumatology (ACR20) criteria at week 24.Abatacept significantly increased ACR20 response versus placebo at week 24 (39.4% vs 22.3%; p<0.001). Although abatacept numerically increased Health Assessment Questionnaire-Disability Index response rates (reduction

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2017 EvidenceUpdates

16. Abatacept initiation in rheumatoid arthritis and the risk of serious infection: A population-based cohort study. (PubMed)

Abatacept initiation in rheumatoid arthritis and the risk of serious infection: A population-based cohort study. To assess whether abatacept as initial biologic disease-modifying antirheumatic drug (DMARD) in the treatment of rheumatoid arthritis is associated with an increased risk of serious infections, including bone and joint, gastrointestinal, respiratory tract, skin and soft tissue, and urinary tract, when compared with other biologic DMARDs.We performed a population-based cohort study (...) among patients newly-treated with biologic DMARDs within the US-based Truven MarketScan® population and Supplemental US Medicare from 2007 to 2014. Cox proportional hazards models were used to estimate adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) of serious infections requiring hospitalisation associated with initiation of abatacept, compared with initiation of other bDMARDs, after controlling for age and deciles of the propensity score.The cohort included 5,752 patients who

2019 Seminars in arthritis and rheumatism

17. Intravenous abatacept in Japanese patients with polyarticular-course juvenile idiopathic arthritis: results from a phase III open-label study. (PubMed)

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

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2019 Pediatric Rheumatology

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

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

19. Abatacept modulates CD80 and CD86 expression and memory formation in human B-cells. (PubMed)

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

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2019 Journal of Autoimmunity

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

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

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