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Latest & greatest articles for Abatacept
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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
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
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
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
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
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
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
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
Maintenance of remission following 2 years of standard treatment then dose reduction with abatacept in patients with early rheumatoid arthritis and poor prognosis To evaluate maintenance of response while reducing intravenous abatacept dose from ~10 mg/kg to ~5 mg/kg in patients with early rheumatoid arthritis (RA) who achieved disease activity score (DAS)28 (erythrocyte sedimentation rate, ESR) <2.6.This 1-year, multinational, randomised, double-blind substudy evaluated the efficacy and safety (...) of ~10 mg/kg and ~5 mg/kg abatacept in patients with early RA with poor prognosis who had reached DAS28 (ESR) <2.6 at year 2 of the AGREE study. The primary outcome was time to disease relapse (defined as additional disease-modifying antirheumatic drugs, ≥2 courses high-dose steroids, return to open-label abatacept ~10 mg/kg, or DAS28 (C reactive protein) ≥3.2 at two consecutive visits).108 patients were randomised (~10 mg/kg, n=58; ~5 mg/kg, n=50). Three and five patients, respectively, discontinued
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
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
Abatacept (Orencia®) Abatacept (Orencia®) Abatacept (Orencia®) All Wales Medicines Strategy Group (AWMSG) 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 All Wales Medicines Strategy Group (AWMSG). Abatacept (Orencia®) Penarth: All Wales Therapeutics and Toxicology Centre (AWTTC), secretariat of the All Wales Medicines Strategy Group (AWMSG). AWMSG Secretariat (...) Assessment Report Advice No. 0114. 2014 Authors' conclusions Abatacept (Orencia®) is recommended as an option for use within NHS Wales in combination with methotrexate for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in paediatric patients 6 years of age and older who have had an insufficient response to other disease-modifying anti-rheumatic drugs including at least one tumour necrosis factor inhibitor. This recommendation applies only in circumstances where
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
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
Indirect treatment comparison of abatacept with methotrexate versus other biologic agents for active rheumatoid arthritis despite methotrexate therapy in the United kingdom Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.
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
Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase Iiib ALLOW study) To assess the effect of a temporary interruption in subcutaneous (SC) abatacept on immunogenicity, safety and efficacy in patients with active rheumatoid arthritis despite methotrexate in a phase III trial.Following a 12-week open-label introduction (period I; intravenous abatacept loading dose (...) and weekly fixed-dose SC abatacept 125 mg), patients were randomised 2:1 to double-blind SC placebo or SC abatacept for 12 weeks (period II). At the end of period II, patients receiving SC abatacept continued treatment and patients on placebo were reintroduced to SC abatacept (12-week open-label period III). The co-primary end points were ELISA-detected immunogenicity rate and safety at the end of period II. Efficacy was also monitored.Of 167 patients entering period I, 72% qualified for period II