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Abatacept

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81. Orencia (abatacept) - moderate to severe active rheumatoid arthritis

Orencia (abatacept) - moderate to severe active rheumatoid arthritis HAS - Medical, Economic and Public Health Assessment Division 1/21 The legally binding text is the original French version T TR RA AN NS SP PA AR RE EN NC CY Y C CO OM MM MI IT TT TE EE E Opinion 4 December 2013 ORENCIA 125 mg, solution for injection pre-filled syringe (glass) with needle guard device – 125 mg/ml B/1 (CIP: 34009 268 842 0 8) B/4 (CIP: 34009 268 843 7 6) Applicant: BRISTOL-MYERS SQUIBB INN abatacept ATC code (...) methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor. A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.” HAS - Medical, Economic and Public Health Assessment Division 2/21 Actual Benefit The actual benefit of the proprietary medicinal product ORENCIA solution for subcutaneous injection is substantial in moderate to severe active rheumatoid arthritis in adult patients who

2014 Haute Autorite de sante

82. Abatacept monotherapy compared with abatacept plus disease-modifying anti-rheumatic drugs in rheumatoid arthritis patients: data from the ORA registry Full Text available with Trip Pro

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

2016 Arthritis research & therapy

83. Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept. Full Text available with Trip Pro

Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept. Patients with rheumatoid arthritis (RA), including those treated with biologics, are at increased risk of some vaccine-preventable infections. We evaluated the antibody response to standard 23-valent pneumococcal polysaccharide vaccine (PPSV23) and the 2011-2012 trivalent seasonal influenza vaccine in adults with RA receiving subcutaneous (SC) abatacept and background disease (...) -modifying anti-rheumatic drugs (DMARDs).Two multicenter, open-label sub-studies enrolled patients from the ACQUIRE (pneumococcal and influenza) and ATTUNE (pneumococcal) studies at any point during their SC abatacept treatment cycle following completion of ≥3 months' SC abatacept. All patients received fixed-dose abatacept 125 mg/week with background DMARDs. A pre-vaccination blood sample was taken, and after 28 ± 3 days a final post-vaccination sample was collected. The primary endpoint

2017 BMC musculoskeletal disorders Controlled trial quality: uncertain

84. Real-world predictors of 12–month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study Full Text available with Trip Pro

Real-world predictors of 12–month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study An understanding of real-world predictors of abatacept retention is limited. We analysed retention rates and predictors of abatacept retention in biologic-naïve and biologic-failure patients in a 12-month interim analysis of the 2-yearAbataCepTIn rOutiNe clinical practice (ACTION) study.ACTION was an international, observational study of patients (...) with moderate-to-severe rheumatoid arthritis (RA) who initiated intravenous abatacept. In this 12-month interim analysis, crude abatacept retention rates, predictors of retention and European League Against Rheumatism (EULAR) response were evaluated in both biologic-naïve and biologic-failure patients. Retention by rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) status was also assessed, in patients with or without baseline radiographic erosions, and by body mass index (BMI).Overall, 2350

2017 RMD open

85. Abatacept in the treatment of adult dermatomyositis and polymyositis: a randomised, phase IIb treatment delayed-start trial. (Abstract)

Abatacept in the treatment of adult dermatomyositis and polymyositis: a randomised, phase IIb treatment delayed-start trial. To study the effects of abatacept on disease activity and on muscle biopsy features of adult patients with dermatomyositis (DM) or polymyositis (PM).Twenty patients with DM (n=9) or PM (n=11) with refractory disease were enrolled in a randomised treatment delayed-start trial to receive either immediate active treatment with intravenous abatacept or a 3 month delayed-start (...) responders after active treatment but only one (11%) patient in the delayed treatment arm. Eight adverse events (AEs) were regarded as related to the drug, four mild and four moderate, and three serious AEs, none related to the drug. There was a significant increase in regulatory T cells (Tregs), whereas other markers were unchanged in repeated muscle biopsies.In this pilot study, treatment of patients with DM and PM with abatacept resulted in lower disease activity in nearly half of the patients

2017 Annals of the Rheumatic Diseases Controlled trial quality: uncertain

86. Effect of Anticitrullinated Protein Antibody Status on Response to Abatacept or Antitumor Necrosis Factor-α Therapy in Patients with Rheumatoid Arthritis: A US National Observational Study. Full Text available with Trip Pro

Effect of Anticitrullinated Protein Antibody Status on Response to Abatacept or Antitumor Necrosis Factor-α Therapy in Patients with Rheumatoid Arthritis: A US National Observational Study. Assess whether baseline anticyclic citrullinated peptide antibodies (anti-CCP) status is associated with treatment response in patients with rheumatoid arthritis (RA) initiating abatacept (ABA) or a tumor necrosis factor-α inhibitor (TNFi).Using the Corrona RA registry, patients were identified who initiated

2017 Journal of Rheumatology

87. Baseline autoantibodies preferentially impact abatacept efficacy in patients with rheumatoid arthritis who are biologic naïve: 6-month results from a real-world, international, prospective study Full Text available with Trip Pro

Baseline autoantibodies preferentially impact abatacept efficacy in patients with rheumatoid arthritis who are biologic naïve: 6-month results from a real-world, international, prospective study To determine the impact of baseline rheumatoid factor (RF) and anticyclic citrullinated peptide (anti-CCP) status on the clinical efficacy of intravenous abatacept in biologic-naïve patients with rheumatoid arthritis (RA) enrolled in the real-world ACTION study.Clinical outcomes (European League (...) is associated with greater efficacy of intravenous abatacept than seronegative status.NCT02109666.

2017 RMD open

88. A window of opportunity for abatacept in RA: is disease duration an independent predictor of low disease activity/remission in clinical practice? Full Text available with Trip Pro

A window of opportunity for abatacept in RA: is disease duration an independent predictor of low disease activity/remission in clinical practice? The objective of the study was to examine whether disease duration independently predicts treatment response among biologic-naïve patients with rheumatoid arthritis (RA) initiating abatacept in clinical practice. Using the Corrona RA registry (February 2006-January 2015), biologic-naïve patients with RA initiating abatacept with 12-month (±3 months (...) were performed to examine the relationship between disease duration and response to abatacept. There were 281 biologic-naïve patients with RA initiating abatacept (disease duration 0-2 years, n = 107; 3-5 years, n = 45; 6-10 years, n = 50; >10 years, n = 79). Increased disease duration was associated with older age (p = 0.047), and the median number of prior conventional disease-modifying antirheumatic drugs used was lowest in the 0- to 2-year duration group (p < 0.001). Mean ΔCDAI (SE) ranged from

2017 Clinical rheumatology

89. Re-administration of abatacept for the control of articular symptoms of rheumatoid arthritis during anti-tuberculous therapy Full Text available with Trip Pro

Re-administration of abatacept for the control of articular symptoms of rheumatoid arthritis during anti-tuberculous therapy This case report describes the re-administration of abatacept to successfully reduce the articularsymptoms of a patient with rheumatoid arthritisduring the intensive phase of anti-tuberculous therapy. A 75-year-old man developed active pulmonary tuberculosis during the administration of abatacept for rheumatoid arthritis. The patient experienced a paradoxical reaction (...) and exacerbation of rheumatoid arthritis that caused us to discontinue the abatacept. Later re-administration of abatacept along with anti-tuberculosis treatment led to well-controlled rheumatoid arthritis without exacerbation of the tuberculosis. This case shows that re-administration of abatacept may be much safer than TNF inhibitor to treat patients who are infected with mycobacteria during thetreatment of immunological diseases such asrheumatoid arthritiswith biological agents.

2017 Respiratory Medicine Case Reports

90. A case of acute respiratory failure in a rheumatoid arthritis patient after the administration of abatacept Full Text available with Trip Pro

A case of acute respiratory failure in a rheumatoid arthritis patient after the administration of abatacept Drug-induced pulmonary disease is an important consideration in the differential diagnosis of patients with rheumatoid arthritis (RA) who present with respiratory symptoms. We report a patient with RA who developed acute respiratory failure two weeks after the administration of abatacept. The clinical findings were consistent with drug-induced acute respiratory failure, most likely acute (...) eosinophilic pneumonia. Pulse steroid was administered at 1000 mg/kg/day in the emergency department. Chest X-ray and arterial blood gas values revealed significant improvement on the second day of hospitalization. However, in the second week, the patient's fever rose up to 40°C, procalcitonin level increased to 15 ng/mL (<0.5 ng/mL is normal), and the patient died because of sepsis in the fourth week. This is the second report of respiratory failure, after the abatacept administration in the literature

2016 European journal of rheumatology

91. Impact of gender on the response and tolerance to abatacept in patients with rheumatoid arthritis: results from the ‘ORA’ registry Full Text available with Trip Pro

Impact of gender on the response and tolerance to abatacept in patients with rheumatoid arthritis: results from the ‘ORA’ registry The impact of gender on the response and tolerance to abatacept was assessed in a large prospective cohort during 2 years of follow-up.From the 1017 patients included in the Orencia and Rheumatoid Arthritis registry, disease activity was assessed at baseline, 6, 12 and 24 months. The relationship between the European League Against Rheumatism (EULAR) response (...) , the tender joint count score and the patient global assessment remained higher in women (p=0.001, 0.04 and 0.06, respectively). Drug retention and safety were comparable.In this large daily practice cohort of established rheumatoid arthritis treated with abatacept, women achieved similar remission and EULAR response than men despite higher disease activity and tender joint count during the treatment course.

2017 RMD open

92. Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis Full Text available with Trip Pro

Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis This post hoc analysis of ACQUIRE (NCT00559585) explored the effect of baseline body mass index (BMI) on the pharmacokinetics of and clinical response to subcutaneous (SC) or intravenous (IV) abatacept in patients with rheumatoid arthritis (RA). ACQUIRE was a phase 3b, 6-month, double-blind, double-dummy study in which patients with RA were randomized (1:1) to SC (fixed - dose (...) ; 125 mg/week) or IV (weight-tiered; ~ 10 mg/kg/month) abatacept plus methotrexate. In this analysis, minimum abatacept plasma concentration (Cmin) was measured at 3 and 6 months, and clinical remission over 6 months was assessed by Disease Activity Score 28 (C-reactive protein; DAS28 [CRP], < 2.6), Simplified Disease Activity Index (SDAI, ≤ 3.3), and Clinical Disease Activity Index (CDAI, ≤ 2.8). Data were stratified by baseline BMI (underweight/normal, < 25 kg/m2; overweight, 25 to < 30 kg/m2

2017 Clinical rheumatology Controlled trial quality: uncertain

93. Interleukin-10-producing LAG3+ regulatory T cells are associated with disease activity and abatacept treatment in rheumatoid arthritis Full Text available with Trip Pro

Interleukin-10-producing LAG3+ regulatory T cells are associated with disease activity and abatacept treatment in rheumatoid arthritis Regulatory T cells (Tregs) play a role in the suppression of inflammation in autoimmune diseases, and lymphocyte activation gene 3 (LAG3) was reported as a marker of interleukin (IL)-10-producing Tregs. We aimed to clarify the function of human IL-10-producing CD4+CD25-LAG3+ T cells (LAG3+ Tregs) and their association with rheumatoid arthritis (RA).LAG3+ Tregs (...) of human peripheral blood mononuclear cells (PBMCs) were cultured with B cells and follicular helper T cells to examine antibody suppression effects. The frequency of LAG3+ Tregs was evaluated in peripheral blood samples from 101 healthy donors and 85 patients with RA. In patients treated with abatacept, PBMC samples were analyzed before and after treatment. Naive CD4+ T cells were sorted and cultured in the presence of abatacept, followed by flow cytometric analysis and function assays.LAG3+ Tregs

2017 Arthritis research & therapy

94. Pre-silencing of genes involved in the electron transport chain (ETC) pathway is associated with responsiveness to abatacept in rheumatoid arthritis Full Text available with Trip Pro

Pre-silencing of genes involved in the electron transport chain (ETC) pathway is associated with responsiveness to abatacept in rheumatoid arthritis In the current context of personalized medicine, one of the major challenges in the management of rheumatoid arthritis (RA) is to identify biomarkers that predict drug responsiveness. From the European APPRAISE trial, our main objective was to identify a gene expression profile associated with responsiveness to abatacept (ABA) + methotrexate (MTX

2017 Arthritis research & therapy

95. Cost per response for abatacept versus adalimumab in rheumatoid arthritis by ACPA subgroups in Germany, Italy, Spain, US and Canada Full Text available with Trip Pro

Cost per response for abatacept versus adalimumab in rheumatoid arthritis by ACPA subgroups in Germany, Italy, Spain, US and Canada Rheumatoid arthritis (RA) is a chronic inflammatory disorder leading to disability and reduced quality of life. Effective treatment with biologic DMARDs poses a significant economic burden. The Abatacept versus Adalimumab Comparison in Biologic-Naïve RA Subjects with Background Methotrexate (AMPLE) trial was a head-to-head, randomized study comparing abatacept (...) in serum anti-citrullinated protein antibody (ACPA)-positive patients, with increasing efficacy across ACPA quartile levels. The aim of this study was to evaluate the cost per response accrued using abatacept versus adalimumab in ACPA-positive and ACPA-negative patients with RA from the health care perspective in Germany, Italy, Spain, the US and Canada. A cost-consequence analysis (CCA) was designed to compare the monthly costs per responding patient/patient in remission. Efficacy, safety and resource

2017 Rheumatology international Controlled trial quality: uncertain

96. Abatacept reduces synovial regulatory T-cell expression in patients with psoriatic arthritis Full Text available with Trip Pro

Abatacept reduces synovial regulatory T-cell expression in patients with psoriatic arthritis The aim was to study changes in immunohistochemical expression markers of synovial and skin inflammation, clinical outcomes and magnetic resonance imaging (MRI) scores with abatacept treatment in patients with psoriatic arthritis (PsA).Biological-treatment-naïve PsA patients with active disease including synovitis of a knee were enrolled in this single-centre, crossover study. Patients were randomised (...) to receive intravenous abatacept 3 mg/kg of body weight or placebo infusion on day 1, 15 and 29; thereafter abatacept 10 mg/kg of body weight was administered every 28 days for 5 months. Clinical data were collected at each visit. Synovial biopsy of the involved knee was obtained at baseline and 2 and 6 months. MRI of the same knee and skin biopsy was performed prior to arthroscopy.Fifteen patients were recruited. Significant improvements in the joint-related measures were observed; 90% were European

2017 Arthritis research & therapy Controlled trial quality: uncertain

97. Mean cost per number needed to treat with tocilizumab plus methotrexate versus abatacept plus methotrexate in the treatment of rheumatoid arthritis in patients previously treated with methotrexate Full Text available with Trip Pro

Mean cost per number needed to treat with tocilizumab plus methotrexate versus abatacept plus methotrexate in the treatment of rheumatoid arthritis in patients previously treated with methotrexate Biological disease-modifying antirheumatic drugs are particularly recommended for use in patients who are poor responders, are intolerant to conventional disease-modifying antirheumatic drugs (cDMARDs), or in whom continued treatment with cDMARDs is deemed inappropriate. We estimated the efficacy (...) and treatment costs associated with the use of tocilizumab (TCZ) plus methotrexate (Mtx) versus abatacept (ABT) plus Mtx in the treatment of rheumatoid arthritis (RA) in patients previously treated with Mtx.Clinical data from a Technology Appraisal Guidance published in January 2016 by the National Institute for Health and Care Excellence were used. Pharmacoeconomic comparison between biological agents was carried out to estimate the respective cost for the number needed to treat (NNT) compared to cDMARDs

2017 ClinicoEconomics and Outcomes Research: CEOR

98. Identification of biomarkers of response to abatacept in patients with SLE using deconvolution of whole blood transcriptomic data from a phase IIb clinical trial Full Text available with Trip Pro

Identification of biomarkers of response to abatacept in patients with SLE using deconvolution of whole blood transcriptomic data from a phase IIb clinical trial To characterise patients with active SLE based on pretreatment gene expression-defined peripheral immune cell patterns and identify clusters enriched for potential responders to abatacept treatment.This post hoc analysis used baseline peripheral whole blood transcriptomic data from patients in a phase IIb trial of intravenous abatacept (...) (~10 mg/kg/month). Cell-specific genes were used with a published deconvolution algorithm to identify immune cell proportions in patient samples, and unsupervised consensus clustering was generated. Efficacy data were re-analysed.Patient data (n=144: abatacept: n=98; placebo: n=46) were grouped into four main clusters (C) by predominant characteristic cells: C1-neutrophils; C2-cytotoxic T cells, B-cell receptor-ligated B cells, monocytes, IgG memory B cells, activated T helper cells; C3-plasma

2017 Lupus science & medicine Controlled trial quality: uncertain

99. Unsuccessful Treatment with Abatacept in Recurrent Focal Segmental Glomerulosclerosis after Kidney Transplantation Full Text available with Trip Pro

Unsuccessful Treatment with Abatacept in Recurrent Focal Segmental Glomerulosclerosis after Kidney Transplantation Recurrence of focal segmental glomerulosclerosis (FSGS) after renal transplantation occurs in up to 20-50% of FSGS patients and is associated with inferior allograft survival. Treatment of both primary FSGS as well as recurrent FSGS after transplantation with plasma exchange and immunosuppression is often unsuccessful and remains a major challenge as the disease still leads to end (...) -stage renal disease and decreased graft survival. Previous case reports have described patients with recurrent FSGS who were successfully treated with a B7-1 inhibitor (abatacept) inducing partial or complete remission. The rational basis for believing in abatacept as a new therapeutic drug for the treatment of FSGS is the study by Yu et al. [N Engl J Med 2013;369: 2416-2423] showing B7-1 in immunostainings of the podocytes. The authors speculated that B7-1 immunostaining of renal biopsies might

2017 Case Reports in Nephrology and Dialysis

100. Interference of the T Cell and Antigen-Presenting Cell Costimulatory Pathway Using CTLA4-Ig (Abatacept) Prevents Staphylococcal Enterotoxin B Pathology Full Text available with Trip Pro

Interference of the T Cell and Antigen-Presenting Cell Costimulatory Pathway Using CTLA4-Ig (Abatacept) Prevents Staphylococcal Enterotoxin B Pathology Staphylococcal enterotoxin B (SEB) is a bacterial superantigen that binds the receptors in the APC/T cell synapse and causes increased proliferation of T cells and a cytokine storm syndrome in vivo. Exposure to the toxin can be lethal and cause significant pathology in humans. The lack of effective therapies for SEB exposure remains an area (...) of concern, particularly in scenarios of acute mass casualties. We hypothesized that blockade of the T cell costimulatory signal by the CTLA4-Ig synthetic protein (abatacept) could prevent SEB-dependent pathology. In this article, we demonstrate mice treated with a single dose of abatacept 8 h post SEB exposure had reduced pathology compared with control SEB-exposed mice. SEB-exposed mice showed significant reductions in body weight between days 4 and 9, whereas mice exposed to SEB and also treated

2017 The Journal of Immunology Author Choice

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