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41. Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Haploinsufficiency

Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Haploinsufficiency Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Haploinsufficiency - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached (...) the maximum number of saved studies (100). Please remove one or more studies before adding more. Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Haploinsufficiency The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our

2018 Clinical Trials

42. Abatacept for the treatment of adults with psoriatic arthritis: patient selection and perspectives Full Text available with Trip Pro

Abatacept for the treatment of adults with psoriatic arthritis: patient selection and perspectives Psoriatic arthritis (PsA) is a heterogeneous disease with several clinical subtypes including peripheral arthritis, dactylitis, enthesitis, nail disease, and axial arthritis. Nonsteroidal anti-inflammatory drugs, glucocorticoids, and conventional disease-modifying agents are used as first line in the treatment of active PsA. For moderate-to-severe PsA failing conventional therapy, antitumor (...) necrosis factor inhibitors have historically been the drugs of choice. In recent years, novel interleukin-23/interleukin-17 pathway targets such as ustekinumab and secukinumab, and phosphodiesterase-4 inhibitor apremilast have been approved for use in the United States and Europe. Two sets of recommendations for the management of PsA were published in 2016 with consideration for these newer therapies. Since then, the results from a Phase III randomized controlled trial demonstrated that abatacept has

2018 Psoriasis: Targets and Therapy Controlled trial quality: uncertain

43. Abatacept as a Therapeutic Option for Rheumatoid Vasculitis Full Text available with Trip Pro

Abatacept as a Therapeutic Option for Rheumatoid Vasculitis Abatacept is a fusion protein composed of the fragment crystallizable region (Fc region) of the immunoglobulin IgG1 fused to the extracellular domain of cytotoxic T-lymphocyte-associated protein 4. Our patient presented with lower extremity purpura in the setting of rheumatoid arthritis and common variable immunodeficiency disease. A biopsy of cutaneous lesions confirmed the etiology of rheumatoid vasculitis. Although rituximab (...) is the recommended treatment, it has the potential to exacerbate immunodeficiency. The cutaneous lesions responded well to abatacept after failure to respond to other treatment modalities. This case is the first, to our knowledge, to be reported in North America. Our case may encourage extensive clinical trials on abatacept as a treatment option.

2018 Cureus

44. Medium-vessel vasculitis presenting as multiple leg ulcers after treatment with abatacept Full Text available with Trip Pro

Medium-vessel vasculitis presenting as multiple leg ulcers after treatment with abatacept 30246135 2019 02 26 2352-5126 4 8 2018 Sep JAAD case reports JAAD Case Rep Medium-vessel vasculitis presenting as multiple leg ulcers after treatment with abatacept. 811-813 10.1016/j.jdcr.2018.06.021 Holt Melia Hernandez MH Department of Dermatology, University of Iowa Hospitals and Clinics, Iowa City, Iowa. Liu Vincent V Department of Dermatology, University of Iowa Hospitals and Clinics, Iowa City, Iowa (...) . Department of Pathology, University of Iowa Hospitals and Clinics, Iowa City, Iowa. Fairley Janet J Department of Dermatology, University of Iowa Hospitals and Clinics, Iowa City, Iowa. eng Case Reports 2018 09 14 United States JAAD Case Rep 101665210 2352-5126 Orencia Th, T helper cell abatacept adverse effects leg ulcers psoriasis psoriatic arthritis vasculitis 2018 9 25 6 0 2018 9 25 6 0 2018 9 25 6 1 epublish 30246135 10.1016/j.jdcr.2018.06.021 S2352-5126(18)30176-0 PMC6141677 RMD Open. 2016 Jul 15;2

2018 JAAD Case Reports

45. Application of nSMOL coupled with LC‐MS bioanalysis for monitoring the Fc‐fusion biopharmaceuticals Etanercept and Abatacept in human serum Full Text available with Trip Pro

Application of nSMOL coupled with LC‐MS bioanalysis for monitoring the Fc‐fusion biopharmaceuticals Etanercept and Abatacept in human serum The principle of nano-surface and molecular-orientation limited (nSMOL) proteolysis has a unique characteristic Fab-selective proteolysis for antibody bioanalysis that is independent of a variety of monoclonal antibodies by the binding antibody Fc via Protein A/G in a pore with 100 nm diameter and modified trypsin immobilization on the surface (...) on the C-terminus, and its functional domain is available to orient and interact with the reaction solution. In this report, we describe the validated LC-MS bioanalysis for monitoring Ethanercept and Abatacept using nSMOL technology. The quantitation range of Ethanercept in human serum was from 0.195 to 100 μg/mL using the signature peptide VFCTK (aa.43-47), and that of Abatacept was from 0.391 to 100 μg/mL using the signature peptide MHVAQPAVVLASSR (aa.1-14). Both proteins fulfilled the guideline

2018 Pharmacology research & perspectives

46. Subacute cutaneous lupus erythematosus and systemic lupus erythematosus associated with abatacept Full Text available with Trip Pro

Subacute cutaneous lupus erythematosus and systemic lupus erythematosus associated with abatacept 30167444 2019 02 26 2352-5126 4 7 2018 Aug JAAD case reports JAAD Case Rep Subacute cutaneous lupus erythematosus and systemic lupus erythematosus associated with abatacept. 698-700 10.1016/j.jdcr.2018.03.008 Tarazi Meera M Corporal Michael J. Crescenz VAMC, Philadelphia, Pennsylvania. Department of Dermatology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania (...) School of Medicine, Philadelphia, Pennsylvania. eng Case Reports 2018 08 16 United States JAAD Case Rep 101665210 2352-5126 ANA, antinuclear antibodies CLE, cutaneous lupus erythematosus CTLA-4, cytotoxic T-lymphocyte–associated antigen-4 HCQ, hydroxychloroquine RA, rheumatoid arthritis SCLE, subacute cutaneous lupus erythematosus SLE, systemic lupus erythematosus abatacept drug-induced lupus erythematosus subacute cutaneous lupus erythematosus systemic lupus erythematosus 2018 9 1 6 0 2018 9 1 6 0

2018 JAAD Case Reports

47. Subcutaneous Abatacept in Patients With Polyarticular‐Course Juvenile Idiopathic Arthritis: Results From a Phase III Open‐Label Study Full Text available with Trip Pro

Subcutaneous Abatacept in Patients With Polyarticular‐Course Juvenile Idiopathic Arthritis: Results From a Phase III Open‐Label Study To investigate the pharmacokinetics, effectiveness, and safety of subcutaneous (SC) abatacept treatment over 24 months in patients with polyarticular-course juvenile idiopathic arthritis (JIA).In this phase III, open-label, international, multicenter, single-arm study, patients with polyarticular JIA (cohort 1, ages 6-17 years and cohort 2, ages 2-5 years (...) ) in whom treatment with ≥1 disease-modifying antirheumatic drug was unsuccessful received weight-tiered SC abatacept weekly: 10 to <25 kg (50 mg), 25 to <50 kg (87.5 mg), ≥50 kg (125 mg). Patients who had met the JIA-American College of Rheumatology 30% improvement criteria (achieved a JIA-ACR 30 response) at month 4 were given the option to continue SC abatacept to month 24. The primary end point was the abatacept steady-state serum trough concentration (Cminss ) in cohort 1 at month 4. Other outcome

2018 Arthritis & rheumatology (Hoboken, N.J.)

48. Effects of denosumab on bone metabolism and bone mineral density with anti-TNF inhibitors, tocilizumab, or abatacept in osteoporosis with rheumatoid arthritis Full Text available with Trip Pro

Effects of denosumab on bone metabolism and bone mineral density with anti-TNF inhibitors, tocilizumab, or abatacept in osteoporosis with rheumatoid arthritis The aim of this 18-month retrospective study was to evaluate the differences in outcomes of denosumab with tumor necrosis factor (TNF) inhibitors (TNFis), tocilizumab (TCZ), or abatacept (ABT) treatment in osteoporosis (OP) patients with rheumatoid arthritis (RA).Patients were divided into TNFis-treated (TNF group; 44 cases), TCZ-treated

2018 Therapeutics and clinical risk management

49. Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting Full Text available with Trip Pro

Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting Methotrexate (MTX) remains the anchor drug in rheumatoid arthritis (RA) treatment, but is poorly tolerated or contraindicated in some patients. There is a wealth of data supporting the use of abatacept in combination with MTX, but data on alternative conventional synthetic disease-modifying antirheumatic drug (csDMARD (...) ) combinations with abatacept are scarce.In this post-hoc exploratory analysis, efficacy and safety data were extracted from abatacept RA studies in which combination with csDMARDs other than MTX was permitted: three interventional trials (ATTAIN, ASSURE, and ARRIVE) and one real-world study (ACTION). Patients with moderate-to-severe RA received abatacept in combination with MTX, hydroxychloroquine, sulfasalazine, azathioprine, or leflunomide for 6 months to 2 years according to the study design. Change from

2018 Arthritis research & therapy

50. Current treatment options for psoriatic arthritis: spotlight on abatacept Full Text available with Trip Pro

Current treatment options for psoriatic arthritis: spotlight on abatacept Psoriatic arthritis (PsA) is a chronic inflammatory disease of joints, tendon sheaths, and entheses affecting patients with established skin psoriasis, or, less frequently, patients without a personal history of psoriasis with a positive familial history. Many treatment options are now available to deal with the different aspects of the disease, including traditional and biological disease-modifying antirheumatic drugs (...) of abatacept. Abatacept is a biologic agent selectively targeting the T-cell costimulatory signal delivered through the CD80/86-CD28 pathway and was approved in December 2005 by the US Food and Drug Administration and in May 2007 by European Medicines Agency for the treatment of patients with rheumatoid arthritis in combination with methotrexate. Based on the relevant role of T-cells in PsA pathogenesis and following the positive results obtained in a phase III clinical trial, abatacept recently received

2018 Therapeutics and clinical risk management

51. Alternative tumour necrosis factor inhibitors (TNFi) or abatacept or rituximab following failure of initial TNFi in rheumatoid arthritis: the SWITCH RCT. Full Text available with Trip Pro

Alternative tumour necrosis factor inhibitors (TNFi) or abatacept or rituximab following failure of initial TNFi in rheumatoid arthritis: the SWITCH RCT. Rheumatoid arthritis (RA), the most common autoimmune disease in the UK, is a chronic systemic inflammatory arthritis that affects 0.8% of the UK population.To determine whether or not an alternative class of biologic disease-modifying antirheumatic drugs (bDMARDs) are comparable to rituximab in terms of efficacy and safety outcomes (...) in patients with RA in whom initial tumour necrosis factor inhibitor (TNFi) bDMARD and methotrexate (MTX) therapy failed because of inefficacy.Multicentre, Phase III, open-label, parallel-group, three-arm, non-inferiority randomised controlled trial comparing the clinical and cost-effectiveness of alternative TNFi and abatacept with that of rituximab (and background MTX therapy). Eligible consenting patients were randomised in a 1 : 1 : 1 ratio using minimisation incorporating a random element

2018 Health technology assessment (Winchester, England) Controlled trial quality: predicted high

52. Factors correlated with the improvement of endothelial dysfunction during Abatacept therapy in patients with rheumatoid arthritis Full Text available with Trip Pro

Factors correlated with the improvement of endothelial dysfunction during Abatacept therapy in patients with rheumatoid arthritis Rheumatoid arthritis patients are exposed to a high risk of cardiovascular morbidity and mortality even in the early phases of the disease.We evaluated carotid common carotid intimal media thickness (ccIMT) intimal thickness and brachial flow-mediated dilation (FMD) of 45 rheumatoid arthritis patients without known cardiovascular risk factors or heart disease (...) on a stable dose of prednisone 5.2±1.2 mg/day and Methotrexate 11.5±2.1 mg at baseline (T0) and after 12 months (T1) of treatment with Abatacept 125 mg/week. The comparison between T0 and T1 (t- and Mann-Whitney test), correlation (Spearman r), and predictivity (linear regression) of FMD, ccIMT vs clinical and laboratory parameters (disease activity 28 score, tumor necrosis factor alpha [TNFα], interleukin-6, erythrocyte sedimentation rate, C-reactive protein (CRP), CD3+, CD3+/CD4+, CD3+/CD8+, CD19+(B

2018 Journal of inflammation research

53. Conversion to seronegative status after abatacept treatment in patients with early and poor prognostic rheumatoid arthritis is associated with better radiographic outcomes and sustained remission: post hoc analysis of the AGREE study Full Text available with Trip Pro

Conversion to seronegative status after abatacept treatment in patients with early and poor prognostic rheumatoid arthritis is associated with better radiographic outcomes and sustained remission: post hoc analysis of the AGREE study To evaluate the effects of the T-cell costimulation blocker abatacept on anti-citrullinated protein antibodies (ACPA) and rheumatoid factor (RF) in early rheumatoid arthritis (RA), and associations between changes in serological status and clinical response.Post (...) hoc analysis of the phase III AGREE study in methotrexate (MTX)-naïve patients with early RA and poor prognostic factors. Patients were randomised to abatacept (~10 mg/kg intravenously according to weight range) or placebo, plus MTX over 12 months followed by open-label abatacept plus MTX for 12 months. Autoantibody titres were determined by ELISA at baseline and months 6 and 12 (double-blind phase). Conversion to seronegative status and its association with clinical response were assessed

2018 RMD open Controlled trial quality: uncertain

54. Cost-Effectiveness Analysis of Abatacept Compared with Adalimumab on Background Methotrexate in Biologic-Naive Adult Patients with Rheumatoid Arthritis and Poor Prognosis. Full Text available with Trip Pro

Cost-Effectiveness Analysis of Abatacept Compared with Adalimumab on Background Methotrexate in Biologic-Naive Adult Patients with Rheumatoid Arthritis and Poor Prognosis. To assess cost effectiveness of abatacept versus adalimumab, each administered with methotrexate, in treating patients with rheumatoid arthritis (RA) stratified according to baseline anticitrullinated protein antibody (ACPA) levels (marker of poor prognosis in RA).A payer-perspective cost-effectiveness model simulated disease (...) progression in patients with RA who had previously failed conventional disease-modifying antirheumatic drugs and were starting biologic therapy. Patients commenced treatment with abatacept or adalimumab plus methotrexate and were evaluated after 6 months. Therapy continuation was based on the European League Against Rheumatism treatment response; disease progression was based on the Health Assessment Questionnaire Disability Index score. These score changes were used to estimate health state utilities

2018 Value in Health

55. Phase I clinical trial evaluating abatacept in patients with steroid-refractory chronic graft-versus-host disease. Full Text available with Trip Pro

Phase I clinical trial evaluating abatacept in patients with steroid-refractory chronic graft-versus-host disease. Steroid-refractory chronic graft-versus-host disease (SR-cGVHD) remains a major cause of morbidity and mortality after allogeneic stem cell transplantation. Innovative immunotherapeutic strategies are urgently needed for the treatment of SR-cGVHD. We conducted a phase 1 clinical trial to evaluate the safety, efficacy, and immune effects of abatacept, a novel immunomodulatory drug (...) that acts as an inhibitor of T-cell activation via costimulatory blockade, in the treatment of SR-cGVHD. The study followed a 3+3 design with 2 escalating abatacept doses: 3 mg/kg and 10 mg/kg, with an expansion cohort treated at 10 mg/kg. Abatacept was well-tolerated with no dose-limiting toxicities. Of the 16 evaluable patients, 44% achieved a clinical partial response per 2005 National Institutes of Health Consensus Criteria. Importantly, abatacept resulted in a 51.3% reduction in prednisone usage

2018 Blood

56. No difference in cardiovascular risk of tocilizumab versus abatacept for rheumatoid arthritis: A multi-database cohort study. (Abstract)

No difference in cardiovascular risk of tocilizumab versus abatacept for rheumatoid arthritis: A multi-database cohort study. While tocilizumab may increase serum lipid levels, recent studies do not suggest a link between tocilizumab use and clinical cardiovascular risk in patients with rheumatoid arthritis (RA).To compare cardiovascular safety of tocilizumab with abatacept, we conducted a cohort study using data from Medicare (2010-2013), IMS PharMetrics (2011-2014) and MarketScan (2011-6/2015 (...) ). RA patients aged ≥18 years who newly started tocilizumab or abatacept entered the cohort on the day of their first use of tocilizumab or abatacept after a continuous enrollment period for ≥365 days. The primary outcome was a composite cardiovascular endpoint of hospitalization for myocardial infarction or stroke. To control for more than 60 confounders, tocilizumab starters were propensity score (PS)-matched to abatacept starters with a variable ratio of 1:3 within each database. A fixed-effects

2018 Seminars in arthritis and rheumatism

57. Abatacept in patients with rheumatoid arthritis and interstitial lung disease: A national multicenter study of 63 patients. Full Text available with Trip Pro

Abatacept in patients with rheumatoid arthritis and interstitial lung disease: A national multicenter study of 63 patients. Interstitial lung disease (ILD) is one of the most serious complications of rheumatoid arthritis (RA). In the present study, we aimed to assess the efficacy of abatacept (ABA) in patients with ILD associated to RA.National multicenter, non-controlled, open-label registry study of RA patients with ILD treated with ABA.63 patients (36 women) with RA-associated ILD undergoing

2018 Seminars in arthritis and rheumatism

58. Abatacept for Treatment of Rheumatoid Arthritis: Special Focus on the Elderly. (Abstract)

Abatacept for Treatment of Rheumatoid Arthritis: Special Focus on the Elderly. Targeted therapies have been developed for patients with rheumatoid arthritis (RA) for whom prior treatment with traditional disease-modifying anti-rheumatic drugs has failed. The numerous different signaling pathways now targeted by various classes of monoclonal antibodies and small molecule inhibitors may complicate treatment decisions. Abatacept selectively modulates a co-stimulatory signal necessary for T-cell (...) activation. Thus, abatacept is effective in biologic-naive patients and in those for whom biologic therapy has failed. Emerging evidence indicates different benefits depending on patient and disease characteristics. In RA, the clinical goal should be clinical and radiographic remission to prevent structural damage and functional impairment. Nevertheless, the management of elderly patients with RA is often less aggressive, and the treat-to-target strategy is less respected in this age category than

2018 Drugs & Aging

59. How does abatacept really work in rheumatoid arthritis? (Abstract)

How does abatacept really work in rheumatoid arthritis? The purpose of this review is to summarize the current knowledge concerning the mechanisms of action of Abatacept in patients with rheumatoid arthritis.Abatacept (CTLA-4Ig) represents a soluble, recombinant, fully humanized fusion protein, comprising the extracellular domain of CTLA-4 and the Fc portion of IgG1. Abatacept binds to the costimulatory molecules CD80 and CD86 on antigen-presenting cells (APC), thereby blocking interaction (...) with CD28 on T cells. In humans, Abatacept treatment was shown to be effective in patients with various autoinflammatory diseases including rheumatoid arthritis. Although the prevention of T-cell activation by interfering with signaling via CD28 still represents the main mechanism of action Abatacept acts on additional cell populations including regulatory T cells (Treg), monocytes/macrophages, osteoclasts, and B cells.Effects of Abatacept on other cell populations besides T cells have to be taken

2018 Current Opinion in Rheumatology

60. A Study to Determine the Risk of Cancer in Rheumatoid Arthritis (RA) Patients Who Use Abatacept and Other Biologic Agents

A Study to Determine the Risk of Cancer in Rheumatoid Arthritis (RA) Patients Who Use Abatacept and Other Biologic Agents A Study to Determine the Risk of Cancer in Rheumatoid Arthritis (RA) Patients Who Use Abatacept and Other Biologic Agents - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum (...) number of saved studies (100). Please remove one or more studies before adding more. A Study to Determine the Risk of Cancer in Rheumatoid Arthritis (RA) Patients Who Use Abatacept and Other Biologic Agents The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03670667 Recruitment Status : Active

2018 Clinical Trials

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