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Abatacept

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121. Longterm Safety, Efficacy, and Inhibition of Structural Damage Progression Over 5 Years of Treatment with Abatacept in Patients with Rheumatoid Arthritis in the Abatacept in Inadequate Responders to Methotrexate Trial. Full Text available with Trip Pro

Longterm Safety, Efficacy, and Inhibition of Structural Damage Progression Over 5 Years of Treatment with Abatacept in Patients with Rheumatoid Arthritis in the Abatacept in Inadequate Responders to Methotrexate Trial. Evaluate the safety and efficacy of longterm abatacept (ABA) treatment over 5 years in methotrexate (MTX)-refractory patients with rheumatoid arthritis (RA).Patients from the 1-year, double-blind Abatacept in Inadequate Responders to Methotrexate (AIM) study (NCT00048568

2014 The Journal of rheumatology Controlled trial quality: uncertain

122. Orencia (abatacept (genetical recombination))

Orencia (abatacept (genetical recombination)) This English version of the Japanese review report is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA will not be responsible for any consequence resulting from the use of this English version. Report on the Deliberation Results May 6, 2010 Evaluation and Licensing Division, Pharmaceutical and Food Safety (...) Bureau Ministry of Health, Labour and Welfare [Brand Name] Orencia for I.V. Infusion 250 mg [Non-proprietary name] Abatacept (Genetical Recombination) (JAN*) [Applicant] Bristol-Myers K.K. [Date of application] September 18, 2008 [Results of deliberation] In the meeting held on April 23, 2010, the First Committee on New Drugs concluded that the product may be approved and that this result should be presented to the Pharmaceutical Affairs Department of the Pharmaceutical Affairs and Food Sanitation

2010 Pharmaceuticals and Medical Devices Agency, Japan

123. Efficacy and safety of abatacept in lupus nephritis: a twelve-month, randomized, double-blind study Full Text available with Trip Pro

Efficacy and safety of abatacept in lupus nephritis: a twelve-month, randomized, double-blind study To compare the efficacy and safety of intravenous (IV) abatacept, a selective T cell costimulation modulator, versus placebo for the treatment of active class III or IV lupus nephritis, when used on a background of mycophenolate mofetil and glucocorticoids.This was a 12-month, randomized, phase II/III, multicenter, international, double-blind study. A total of 298 patients were treated in 1 of 3 (...) IV treatment arms: placebo, abatacept at the standard weight-tiered dose (approximating 10 mg/kg), or abatacept at 30 mg/kg for 3 months, followed by the standard weight-tiered dose (abatacept 30/10). The primary end point, time to confirmed complete response, was a composite measure that required maintenance of glomerular filtration rate, minimal proteinuria, and inactive urinary sediment over the 52-week treatment period.There were no differences among treatment arms in the time to confirmed

2014 EvidenceUpdates Controlled trial quality: predicted high

124. Immunosuppressive Activity of Abatacept on Circulating T Helper Lymphocytes from Juvenile Idiopathic Arthritis Patients. Full Text available with Trip Pro

Immunosuppressive Activity of Abatacept on Circulating T Helper Lymphocytes from Juvenile Idiopathic Arthritis Patients. Abatacept is used in the treatment of juvenile idiopathic arthritis (JIA) patients, but the activity of the drug on T helper cell function is not yet fully known.The ability of abatacept to affect cytokine production in vitro and the proliferative response to both recall antigens and polyclonal stimulation was firstly assessed in healthy donors. Then, 10 JIA patients who were (...) due to start abatacept treatment were recruited and longitudinally evaluated during the first 90 days of therapy. Both their clinical response to the treatment and in vitro analysis aimed to assess the proliferative response to recall antigens and the proportions of circulating T helper subsets.Abatacept reduced the proliferative response to recall antigens and the production of proinflammatory cytokines such as IFN-γ and TNF-α in healthy donors in vitro. It was also efficient in improving

2016 International Archives of Allergy and Immunology

125. Body mass index and response to abatacept in rheumatoid arthritis. (Abstract)

Body mass index and response to abatacept in rheumatoid arthritis. Previous studies suggested that obesity could negatively affect the response to antitumour necrosis factor-α (TNFα) agents in rheumatoid arthritis (RA). However, data are lacking on whether obesity affects the response to abatacept (ABA). We aimed to determine whether body mass index (BMI) affects the response to ABA in RA.In this multicenter retrospective study, we included RA patients who received ABA. BMI was calculated

2016 European journal of clinical investigation

127. Early- and late-stage morphea subtypes with deep tissue involvement is treatable with Abatacept (Orencia). (Abstract)

Early- and late-stage morphea subtypes with deep tissue involvement is treatable with Abatacept (Orencia). This case series explores the potential efficacy of Abatacept in patients presenting with morphea subtypes and deep tissue involvement.Three patients with established morphea subtypes and deep tissue involvement and with no contraindication to Abatacept were included in this prospective open-label study. The index patient was exceptionally severely affected with a mean Modified Rodnan Skin (...) except for MRI. Patients were commenced on Abatacept as per body weight (10mg/kg) given intravenously with concomitant tapering dose of oral prednisolone. All three were re-assessed at 6 months and the index case was further re-assessed at 18 months.All patients tolerated the Abatacept well and showed dramatic improvement. The index patient's clinical signs and symptoms, whole-body MRI, and mean Modified Rodnan Skin Score improved dramatically from baseline by 37% at 6 months and by 74% at 18 months

2016 Seminars in arthritis and rheumatism

128. Treatment with abatacept prevents experimental dermal fibrosis and induces regression of established inflammation-driven fibrosis. (Abstract)

Treatment with abatacept prevents experimental dermal fibrosis and induces regression of established inflammation-driven fibrosis. Activated T cells are the main component of the inflammatory skin infiltrates that characterise systemic sclerosis (SSc). Our aim was to investigate the efficacy of abatacept, which tempers T-cell activation, in reducing skin fibrosis in complementary mouse models of SSc.The antifibrotic properties of abatacept were evaluated in the mouse models of bleomycin-induced (...) dermal fibrosis and sclerodermatous chronic graft-versus-host disease, reflecting early and inflammatory stages of SSc. Thereafter, we studied the efficacy of abatacept in tight skin (Tsk-1) mice, an inflammation-independent mouse model of skin fibrosis.Abatacept efficiently prevented bleomycin-induced skin fibrosis and was also effective in the treatment of established fibrosis. In this model, abatacept decreased total and activated T-cell, B-cell and monocyte infiltration in the lesional skin

2016 Annals of the Rheumatic Diseases

129. A Case of Pyoderma Gangrenosum in a Patient with Rheumatoid Arthritis Treated with Abatacept. Full Text available with Trip Pro

A Case of Pyoderma Gangrenosum in a Patient with Rheumatoid Arthritis Treated with Abatacept. 26912455 2017 01 16 2017 05 08 1651-2057 96 6 2016 08 23 Acta dermato-venereologica Acta Derm. Venereol. A Case of Pyoderma Gangrenosum in a Patient with Rheumatoid Arthritis Treated with Abatacept. 822-3 10.2340/00015555-2380 Akahoshi-Ikeda Maki M Department of Dermatology, Federation of National Public Service Personnel Mutual Aid Associations, Hamanomachi Hospital, Nagahama 3-3-1, Chuo-ku, Fukuoka (...) 810-8539, Japan. Yoshizawa Seiji S Motoshita Junichi J Furue Masutaka M Takeuchi Satoshi S eng Case Reports Journal Article Sweden Acta Derm Venereol 0370310 0001-5555 0 Antirheumatic Agents 7D0YB67S97 Abatacept IM Abatacept adverse effects Antirheumatic Agents adverse effects Arthritis, Rheumatoid complications drug therapy Female Humans Middle Aged Pyoderma Gangrenosum chemically induced 2016 2 26 6 0 2016 2 26 6 0 2017 1 17 6 0 ppublish 26912455 10.2340/00015555-2380

2016 Acta Dermato-Venereologica

130. The balance between Foxp3 and Ror-γt expression in peripheral blood is altered by tocilizumab and abatacept in patients with rheumatoid arthritis. Full Text available with Trip Pro

The balance between Foxp3 and Ror-γt expression in peripheral blood is altered by tocilizumab and abatacept in patients with rheumatoid arthritis. The balance between Th17 cells and regulatory T (Treg) cells has been shown to play an important role in the development of rheumatoid arthritis (RA). Recent studies have shown that treatment with abatacept (ABT) or tocilizumab (TCZ) affects Th17 and Treg cell populations. Although not unanimously accepted, several reports have shown that Treg cells

2016 BMC Musculoskeletal Disorders

131. Sustained improvements in MRI outcomes with abatacept following the withdrawal of all treatments in patients with early, progressive rheumatoid arthritis. Full Text available with Trip Pro

Sustained improvements in MRI outcomes with abatacept following the withdrawal of all treatments in patients with early, progressive rheumatoid arthritis. To assess structural damage progression with subcutaneous abatacept (ABA) in the Assessing Very Early Rheumatoid arthritis Treatment (AVERT) trial following abrupt withdrawal of all rheumatoid arthritis (RA) medication in patients achieving Disease Activity Score (DAS)-defined remission or low disease activity.Patients with early, active RA

2016 Annals of the Rheumatic Diseases Controlled trial quality: uncertain

132. Trial-based cost-effectiveness of abatacept for rheumatoid arthritis patients in Italy. (Abstract)

Trial-based cost-effectiveness of abatacept for rheumatoid arthritis patients in Italy. Rheumatoid arthritis (RA) is a chronic, inflammatory disorder leading to disability and reduced quality of life. Effective treatment is a significant economic burden on the Italian healthcare system. Economic models in RA are commonly based on indirect treatment comparisons.This study assessed the cost-effectiveness of abatacept relative to adalimumab for RA in Italy based on a head-to-head trial by means (...) of a cost-consequence analysis.Health benefits based on the most stringent efficacy criteria were in favor of abatacept compared to adalimumab. Rates for more costly adverse events were higher for adalimumab compared to abatacept, which was reflected in the lower costs for abatacept (-€237,246 or -€237per patient).The health economic value of abatacept compared with adalimumab from the perspective of the Italian NHS depends on the choice of health outcome. Health gains with abatacept were generally

2016 Expert review of pharmacoeconomics & outcomes research Controlled trial quality: uncertain

133. Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis Full Text available with Trip Pro

Postmarketing surveillance of the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis To perform a postmarketing surveillance study evaluating the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis (RA).Safety and effectiveness data were collected for all RA patients (at 772 sites) treated with intravenous abatacept between September 2010 and June 2011. Patients were treated by the approved dosing regimen according (...) to the package insert. Treatment effectiveness was evaluated at baseline and at weeks 4, 12, and 24 using Disease Activity Score 28 (DAS28) according to erythrocyte sedimentation rate or serum C-reactive protein concentrations.Overall, 3882 and 3016 abatacept-naïve RA patients were included in safety and effectiveness analyses, respectively. Adverse drug reactions (ADRs) were reported for 15.66% of patients and serious ADRs were detected for 2.52% of patients. The incidence of serious infections was 1.03

2016 Modern Rheumatology

134. Comparative effectiveness of abatacept versus tocilizumab in rheumatoid arthritis patients with prior TNFi exposure in the US Corrona registry Full Text available with Trip Pro

Comparative effectiveness of abatacept versus tocilizumab in rheumatoid arthritis patients with prior TNFi exposure in the US Corrona registry We compared the effectiveness of abatacept (ABA) vs tocilizumab (TCA) in tumor necrosis factor inhibitor (TNFi) experienced patients.We identified rheumatoid arthritis (RA) patients from a large observational US cohort (1 January 2010-31 May 2014) who had discontinued at least one TNFi and initiated ABA or TCZ in moderate or high disease activity based

2016 Arthritis research & therapy

135. Usability and Acceptability of the Abatacept Pre-Filled Autoinjector for the Subcutaneous Treatment of Rheumatoid Arthritis Full Text available with Trip Pro

Usability and Acceptability of the Abatacept Pre-Filled Autoinjector for the Subcutaneous Treatment of Rheumatoid Arthritis The purpose of the present study was to determine whether the abatacept autoinjector can be used by the intended population without patterns of preventable use errors, and is acceptable when assessed against key user needs.Two independently conducted simulated-use studies, with no active drug administered, quantified use errors and evaluated the abatacept autoinjector (...) attributes. Overall acceptability scores (7-point scale) were significantly higher for the abatacept versus competitor autoinjectors-formative study: patients 6.7 vs 5.2 (P = 0.0001), caregivers 7.0 vs 4.6 (P = 0.0093), HCPs 6.8 vs 5.1 (P = 0.0020); summative study: patients 6.5 vs 5.9 (P = 0.0404), caregivers 6.8 vs 5.8 (P = 0.0047), HCPs 6.8 vs 5.1 (P = 0.0002). The abatacept autoinjector was preferred to competitor devices: patients 85.7% vs 14.3% (P = 0.00002), caregivers 84.2% vs 15.8% (P = 0.00443

2016 Advances in therapy

136. Decreased use of glucocorticoids in biological-experienced patients with rheumatoid arthritis who initiated intravenous abatacept: results from the 2-year ACTION study Full Text available with Trip Pro

Decreased use of glucocorticoids in biological-experienced patients with rheumatoid arthritis who initiated intravenous abatacept: results from the 2-year ACTION study Prolonged glucocorticoid use may increase the risk of adverse safety outcomes, including cardiovascular events. The European League Against Rheumatism and the Canadian Rheumatology Association advise tapering glucocorticoid dose as rapidly as clinically feasible. There is a paucity of published data on RA that adequately describe (...) concomitant treatment patterns.ACTION (AbataCepT In rOutiNe clinical practice) is a non-interventional cohort study of patients from Europe and Canada that investigated the long-term retention of intravenous abatacept in clinical practice. We assessed concomitant glucocorticoids in patients with established RA who had participated in ACTION and received ≥1 biological agent prior to abatacept initiation.The analysis included 1009 patients. Glucocorticoids were prescribed at abatacept initiation in 734

2016 RMD open

137. Abatacept experience in steroid and rituximab-resistant focal segmental glomerulosclerosis Full Text available with Trip Pro

Abatacept experience in steroid and rituximab-resistant focal segmental glomerulosclerosis Primary focal segmental glomerular sclerosis (FSGS), one of the major causes of nephrotic syndrome, eventually results in end-stage renal disease. Currently, FSGS is treated with immunosuppressive therapies, which include calcinuerin inhibitors (cyclosporine), glucocorticoids, B-cell depleting agents (rituximab) and, recently, a T-cell co-stimulatory inhibitor (abatacept). Until recently, there had been (...) no cases reporting resistance to all current therapies. We report a case of a 62-year-old Caucasian man with biopsy-proven FSGS, who responded well to oral prednisolone therapy. However, 2 years later, he had a relapse and failed to respond to prednisolone. Subsequent treatments then included cyclosporine, rituximab and cyclophosphamide, which were not successful. The patient was then administered abatacept, a novel T-cell co-stimulatory inhibitor-though he did not experience any side effects

2016 BMJ case reports

138. EuroQol-5 dimensions utility gain according to British and Swedish preference sets in rheumatoid arthritis treated with abatacept, rituximab, tocilizumab, or tumour necrosis factor inhibitors: a prospective cohort study from southern Sweden Full Text available with Trip Pro

EuroQol-5 dimensions utility gain according to British and Swedish preference sets in rheumatoid arthritis treated with abatacept, rituximab, tocilizumab, or tumour necrosis factor inhibitors: a prospective cohort study from southern Sweden The development of EuroQol-5 dimensions (EQ-5D) utility over time in rheumatoid arthritis (RA) patients, treated with biologics other than tumour necrosis factor inhibitors (TNFi), based on the standard British (UK) and the new Swedish (SE) EQ-5D preference (...) sets, has not been previously described.Demographics, core set data, EQ-5D utility, and treatment characteristics for patients with established RA, receiving biologics in southern Sweden from January 2006 to March 2014, were retrieved from observational databases. Theoretical, UK, and experience-based, SE, EQ-5D mean utilities were plotted over time.Data regarding 2418 treatment courses with abatacept (ABA, n = 100), rituximab (RTX, n = 230), tocilizumab (TOC, n = 121), or TNFi (n = 1967) were

2016 Arthritis research & therapy

139. Successful Treatment of Focal Segmental Glomerulosclerosis after Kidney Transplantation with Plasma Exchange and Abatacept in a Patient with Juvenile Rheumatoid Arthritis Full Text available with Trip Pro

Successful Treatment of Focal Segmental Glomerulosclerosis after Kidney Transplantation with Plasma Exchange and Abatacept in a Patient with Juvenile Rheumatoid Arthritis Recurrent focal segmental glomerulosclerosis (FSGS) after renal transplantation is difficult to treat. Recently a series of four patients unresponsive to plasma exchange (PE) and rituximab, who were successfully treated with abatacept, has been reported. We present a 26-year-old Caucasian patient who suffered from juvenile (...) rheumatoid arthritis and developed severe proteinuria eleven days after transplantation. An allograft biopsy was suggestive of recurrent focal segmental glomerulosclerosis. He did not respond to PE therapy. A first dose of abatacept produced partial remission. Four weeks later proteinuria again increased and a second biopsy showed progression of disease. After another ineffective course of PE he was given a second dose of abatacept, which was followed by rapid, complete, and sustained resolution

2016 Case reports in transplantation

140. Abatacept Treatment Does Not Preserve Renal Function in the Streptozocin-Induced Model of Diabetic Nephropathy Full Text available with Trip Pro

Abatacept Treatment Does Not Preserve Renal Function in the Streptozocin-Induced Model of Diabetic Nephropathy Diabetic nephropathy (DN) is one of the most severe complications of diabetes and remains the largest cause of end-stage renal disease in the Western world. Treatment options are limited and novel therapies that effectively slow disease progression are warranted. Previous work suggested that treatment with CTLA4-Ig (abatacept), a molecule that binds and blocks B7-1 and is licensed (...) for the treatment of rheumatoid arthritis, could ameliorate DN. This study was designed to assess whether B7-1 signalling constitutes a promising therapeutic pathway for DN. Mice injected with streptozotocin (STZ) were treated with abatacept and glycemia and renal function were assessed. No differences were found in diabetes progression, albumin excretion rates or albumin/creatine ratios, while mesangial expansion was unaltered at endpoint. Except for increased renal CCL5, treatment did not affect a panel

2016 PloS one

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